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The Resurgence of the Vacuum Erection Device (VED) for Treatment of Erectile Dysfunction
Abstract
Introduction:
Vacuum erection devices (VEDs) have been approved in the United States since 1982 and offer a viable alternative to oral phosphodiesterase type 5 inhibitors (PDE5i), injections and transurethral suppositories. Studies have demonstrated efficacy in erectile dysfunction (ED) associated with a variety of conditions. More recently, this modality has been evaluated in initial phosphodiesterase inhibitor nonresponders as well as for post-prostatectomy penile rehabilitation.
Aim:
This article provides a detailed overview of the history of VEDs, a review of the literature, and a concise description of their new applications in modern urological practice.
Methods:
A retrospective review of publications relevant to the field of VEDs.
Main outcome measures:
Review of the historical milestones, evolution, and modern utilization of VEDs in modern urological protocols.
Results:
Studies have demonstrated efficacy in ED associated with a variety of conditions. Early penile rehabilitation after surgery for prostate cancer with the VED appears to improve erectile function and penile length. Adverse events are transient and not serious.
Conclusions:
The VED has continued to show efficacy for treatment of ED due to various etiologies and should be considered an attractive second-line therapy. In select cases such post-prostatectomy penile rehabilitation, as well as in men who cannot use a PDE5i, the vacuum device should be considered first-line treatment.
... Animal experiment by Ma et al. had demonstrated that the erectile response induced by the vacuum erection device may increase the smooth muscle/collagen ratio by decreasing hypoxia-inducible factor-1 and transforming growth factor-1, thereby improving penile blood flow (Yuan et al., Frontiers in Physiology frontiersin.org Brison et al., 2013). In addition, the device can only increase the oxygenation of the corpus cavernosum without the use of a shrink ring. ...
... This method can bypass the limitations of oral drugs and directly achieve an artificial erection, but it requires a normal and intact cavernous nerve to produce an erection (Lin and Wang, 2013;Beaudreau et al., 2021). Compared to other penile rehabilitation therapies, VED therapy has the advantages of being non-invasive and having fewer systemic side effects (Brison et al., 2013;Sultana et al., 2022) (Figure 2). The study by Sherry A Beaudreau et al. found that the correct use of the device resulted in an erection to complete normal intercourse in 90.7% of patients (49 of 54 patients), all of whom indicated that they would recommend the device to other ED patients. ...
... Although most patients and their partners are satisfied with the device, studies had shown that the use of the device causes a lot of discomfort for some patients. For example, insufficient lubrication may lead to bruising of the penis, numbness and/or pain of the penis, cold sensation of the penis and inability to ejaculate (Brison et al., 2013;Lin and Wang, 2013;Beaudreau et al., 2021). About 25% of the patients in a study reported some physical discomfort during and after use of the device (Beaudreau et al., 2021). ...
Erectile dysfunction (ED) is the most common male sexual dysfunction by far and the prevalence is increasing year after year. As technology advances, a wide range of physical diagnosis tools and therapeutic approaches have been developed for ED. At present, typical diagnostic devices include erection basic parameter measuring instrument, erection hardness quantitative analysis system, hemodynamic testing equipment, nocturnal erection measuring instrument, nerve conduction testing equipment, etc. At present, the most commonly used treatment for ED is pharmacological therapy represented by phosphodiesterase five inhibitors (PDE5i). As a first-line drug in clinical, PDE5i has outstanding clinical effects, but there are still some problems that deserve the attention of researchers, such as cost issues and some side effects, like visual disturbances, indigestion, myalgia, and back pain, as well as some non-response rates. Some patients have to consider alternative treatments. Moreover, the efficacy in some angiogenic EDs (diabetes and cardiovascular disease) has not met expectations, so there is still a need to continuously develop new methods that can improve hemodynamics. While drug have now been shown to be effective in treating ED, they only control symptoms and do not restore function in most cases. The increasing prevalence of ED also makes us more motivated to find safer, more effective, and simpler treatments. The exploration of relevant mechanisms can also serve as a springboard for the development of more clinically meaningful physiotherapy approaches. Therefore, people are currently devoted to studying the effects of physical therapy and physical therapy combined with drug therapy on ED. We reviewed the diagnosis of ED and related physical therapy methods, and explored the pathogenesis of ED. In our opinion, these treatment methods could help many ED patients recover fully or partially from ED within the next few decades.
... The key components in most intervention studies regarding penile rehabilitation is oral phosphodiesterase type 5 inhibitor (PDE5), injection therapy or different medical devices, often with positive results (6)(7)(8). However, most studies include patients after prostatectomy and do not target the often complex multi-factorial aetiology of sexual impairment (2). ...
... The intervention group was offered (details in Table 1): Table 1 Overview of the elements and professionals involved in the 5-hour ProCaRe pre-habilitation program including test program (in green boxes) The rst visit included assessment of sexual problems, information, and guidance about sexual adverse effects due to treatment with androgen deprivation therapy and radiotherapy, and instructions in the daily training of the pelvic oor and use of a vacuum erection device (VED) (7,8). ...
Objective
The randomised clinical trial ProCaRe (Prostate Cancer Rehabilitation) aimed to test the effect of sexual pre-habilitation in prostate cancer patients treated with radiotherapy concomitant with androgen deprivation therapy.
We planned recruitment of 92 participants. The complex intervention designed with previously treated patients and partners included sexual counselling, penile rehabilitation and supervised exercise in groups. The primary outcome was sexual functioning measured by the International Index of Erectile Function Score (IIEF-5). The secondary outcomes included a reduction in irritative urinary problems and improvement in quality of life.
Results
We identified eight eligible patients among nine screened between January 22th and June 1st, 2018. Among these patients, three accepted study enrollment but one withdrew because of a lack of energy. The study was closed because of slow recruitment, i.e. a low number of eligible patients and low participation rate (38%) according to the timeframe and intervention planned.
The study had a strong design but was not sufficiently pilot-tested because the study site had too few eligible patients. Furthermore, at this early time of the disease trajectory, sexual rehabilitation was not perceived relevant to the patients or prioritised. Future studies should be co-designed with patients more representative for the target group.
... Vacuum erection device is a common physical treatment modality for ED (Brison et al., 2013). The VED mechanism depends on its ability to boost arterial inflow by the vacuum effect while decreasing venous outflow from the penis by applying a rubber constriction band after penile blood engorgement (Pahlajani et al., 2012). ...
... Common causes of ED include diabetes mellitus, atherosclerotic disease, and radical lower abdominal surgeries (Mulhall et al., 2003). VED is a second line of ED treatment and is easy to undertake, widely available, with few contraindications and requires no testing or investigations prior to use (Yuan et al., 2010;Brison et al., 2013). Additionally, VED plays a key role in the maintenance of length and girth, return to sexual activity, and recovery of erectile function following radical prostatectomy (Kohler et al., 2007). ...
Patient concerns about penile length after penile prosthesis (PP) implantation for erectile dysfunction (ED) have significant impact on patients and their partners. In addition, corporal fibrosis is associated with difficult PP implantation. The preoperative use of vacuum erectile devices (VED) is an uncommon physical treatment for such concerns. Therefore, the current randomized controlled study assessed two outcomes: whether pre-operative VED use for a month before surgery would significantly increase flaccid stretched penile length (SPL) on the day of surgery, and facilitate easier corporal dilatation intraoperatively. Fifty-one patients scheduled for PP implantation for ED were randomized to either intervention group (pre-operative VED use; 10–15 min/day for ≥30 days; Group A; n = 25), or control group (no intervention; Group B; n = 26). A research assistant (blinded to the treatment assignments) recorded SPL at baseline (initial consultation) and on day of surgery. The surgeons performing the PP implantation (also blinded to the treatment assignments) provided subjective assessments of the ease of corporal dilatation. Baseline patient characteristics, demographics, and comorbidities were the same in both groups. Baseline measurements (SPL-1) were 10.71 ± 1.28 and 10.87 ± 1.26 cm in Group A and Group B, respectively; and the day of surgery measurements (SPL-2) were 11.50 ± 1.33 and 11.06 ± 1.34 cm in Group A and Group B, respectively. In terms of outcomes: mean SPL increase in Group A was significantly more by a mean of 0.80 ± 0.38 cm (p < 0.05) compared to Group B; and surgeons’ subjective report of surgical ease indicated smoother corporal dilatation for Group A compared to Group B. VED use (10–15 min/day during the month prior to PP implantation) was associated with significantly increased SPL on day of surgery, and facilitated easier corporal dilatation intraoperatively. Future studies should examine the long-term outcomes of penile prosthesis implantation after pre-operative use of vacuum erectile devices. Andrology. doi:10.1111/andr.12258
... After using VED treatment for these patients, their erectile function improved and their sexual desire increased. VED is the second-line treatment for ED, but it should be considered as the first-line treatment for some men who have tolerance to PDE5I or need penis rehabilitation (45). ...
Erectile dysfunction is a common disease of the male reproductive system, which seriously affects the life quality of patients and their partners. At present, erectile dysfunction is considered as a social-psychological-physiological disease with complex etiology and various treatment methods. Oral PDE5I is the first-line treatment for erectile dysfunction with the advantages of high safety, good effect and non-invasiveness. But intracavernosal injection, hormonal replacement therapy, vacuum erection device, penile prosthesis implantation can also be alternative treatments for patients have organic erectile dysfunction or tolerance to PDE5I. With the rapid development of technologies, some new methods, such as low-intensity extracorporeal shock wave and stem cell injection therapy can even repair the organic damage of the corpora cavernosa. These are important directions for the treatment of male erectile dysfunction in the future. In this mini-review, we will introduce these therapies in detail.
... The side effects reported with VED include penile ecchymoses, penile numbness, anejaculation or painful ejaculation, and skin injury 94 . The contradictions to VED use are priapism, coagulation diseases, and concurrent use of anticoagulation treatment 95 . ...
Introduction:
Erectile dysfunction (ED) is associated with diabetes mellitus with an estimated prevalence of 52.5% in the diabetic population. The first-line therapy for ED are phosphodiesterase type 5 inhibitors (PDE5i), but data suggests that diabetic men may be less responsive than non-diabetic men. Thus, other treatments, including intracavernosal injections, intraurethral prostaglandin, vacuum erection devices, and penile prosthetic surgery, should be considered in management of diabetic men with ED refractory to PDE5i. Furthermore, combination therapy of PDE5i and other oral treatments such as arginine or L-carnitine may have synergistic effects resulting in better outcomes. In addition, there are novel therapies such as low-intensity shockwave therapy and stem cell therapy which may also be effective targeted treatment modalities. Furthermore, studies suggest that ED can be improved by targeting concurrent comorbidities or metabolic diseases such as depression, hypertension, hypogonadism, and dyslipidaemia. We present an evidence-based narrative review focussing on the management of ED in diabetic men who have not responded to PDE5i.
Conclusions:
Both clinicians and patients should be aware of the different management options in Diabetic patients who have responded to PDE5i. This article is protected by copyright. All rights reserved.
... Although intracavernosal and transurethal alprostadil is also effective in diabetic patients with ED of mixed aetiology (16,17), however, the second-line therapeutic management is not usually accepted by patients and/or their sexual partners as a long-term therapeutic measure due to common adverse events such as burning, erythema, pain sensations from patients and vaginal burning or itching from sexual partners. VED could offer a viable alternative to intracavernosal injection, transurethral suppositories or topical administration of vasoactive agents (18). ...
IntroductionPhosphodiesterase type 5-inhibitors (PDE5is) are the first-line treatment for patients with diabetes mellitus-induced erectile dysfunction (DMED), however, some patients are non-responser to PDE5is. We performed a perspective, randomized, comparative study to explore the efficacy of low intensity extracorporeal shock wave treatment (Li-ESWT) combined with vacuum erectile device (VED) in the treatment of DMED patients who were unresponsive to PDE5is.Methods
One hundred and five eligible patients were randomly divided into three groups: group A (VED), group B (Li-ESWT) and group C (VED plus Li-ESWT). Follow-up was conducted at 4 weeks, 8 weeks and 12 weeks after the end of treatment. The erectile function was estimated by the international index of erectile function-erectile function domain (IIEF-EF), erection hardness score (EHS), sexual encounter profile questions 2 and 3 (SEP2 and SEP3) and global assessment question 1 and 2 (GAQ1 and GAQ2) before and after treatment. The changes of five points in IIEF-EF were calculated as the minimal clinical important difference (MCID), which was considered as the main index of efficacy.ResultsThe MCID was achieved in 14.7%, 14.7% and 17.6% patients in group A at the follow up on 4 weeks, 8 weeks and 12 weeks, respectively (36.4%, 39.4% and 36.4% in group B; 36.4%, 51.5%, and 66.7% in group C). There were significant differences in the percentage of MCID cases between group A and group C at the follow up on 12 weeks (P<0.001), as well as that between group B and group C (P=0.014). Additionally, comparison in MCID within group C showed that there were significant differences between 4 weeks and 12 weeks follow-up (P=0.014).Conclusion
Our findings indicated the combined therapy Li-ESWT and VED was more beneficial to shift turn PDE5is non-responders to responders for moderate patients with DMED than VED or Li-ESWT monotherapy. Moreover, this study provided evidence that patients with DMED who failed after taking oral PDE5is could attempt to opt for an alternative physicotherapy (Li-ESWT or VED) prior to more invasive alternatives.
... Geddings D. Osbon Sr. popularized VD and US FDA approved Ere-cAid for erectile dysfunction in 1982. 44 Both vacuum studies 21,21 in this systematic review have used the OsbonErecAid device for 3 months with negligible complications. ...
Introduction
Penile modeling to correct the penile curvature in Peyronie's disease (PD) may be achieved manually (intra-operatively or post-injection) or by using assisted devices (penile traction, vacuum device or penile prosthesis). To the best of our knowledge this is the first systematic review of the literature comprehensively evaluating penile modeling procedures.
Objective
To evaluate the efficacy, safety and satisfaction associated with penile modeling in patients with PD.
Methods
A PROSPERO registered (CRD42021241729) systematic search in MEDLINE and Cochrane Library was done in accordance with PRISMA. PICO: Studies were deemed eligible if they assessed patients with PD (P) undergoing modeling procedures (I) with or without comparative group(C) evaluating the efficacy, safety or patient satisfaction (O).
Results
A total of 23 studies, involving 1,238 patients were included in the systematic review. The majority (n=13) studied penile traction therapy and the least being manual modeling at home and manual modeling after collagenase injection (1 each). The studies were of low and intermediate quality (mean Newcastle-Ottawa Scale score of 5.7 and mean Jadad score of 3.3) with a mean level of evidence of 3.4. The mean penile curvature at baseline was between 31 and 80.8 degrees. Nine (39.1%) studies found a significant improvement (p<0.05) of penile curvature after penile modeling, ranging between 11.7 and 37.2 degrees. A increase in mean stretched penile length was reported in 7 (30.4%) articles, varying between 0.4 and 1.8 cm. Serious complications such as penile prosthesis malfunctions (3.3%-11.1%) and urethral injuries (2.9%) were only reported for intra-operative manual modeling.
Conclusion
Although individual studies have noted improvement in penile curvature and stretched penile length, specific recommendations regarding penile modeling in PD cannot be provided due to the inability to perform a pooled analysis of the included studies with significant heterogeneity and the absence of standardized methods to report complications and patient satisfaction. Further RCTs with adequate sample size, validated assessment tools and longer follow-up are needed.
Disclosure
Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Boston Scientific).
... Geddings D. Osbon Sr. popularized VD and US FDA approved Ere-cAid for erectile dysfunction in 1982. 44 Both vacuum studies 21,21 in this systematic review have used the OsbonErecAid device for 3 months with negligible complications. ...
Introduction
Penile modeling to correct the penile curvature in Peyronie's disease (PD) may be achieved manually (intra-operatively or post-injection) or by using assisted devices (penile traction, vacuum device, or penile prosthesis).
Objectives
To evaluate the efficacy, safety, and satisfaction associated with penile modeling in patients with PD.
Methods
A PROSPERO registered (CRD42021241729) systematic search in MEDLINE and Cochrane Library was done following PRISMA. PICO: Studies were deemed eligible if they assessed patients with PD (P) undergoing modeling procedures (I) with or without a comparative group(C) evaluating the efficacy, safety, or patient satisfaction (O). Retrospective and prospective primary studies were included. The primary outcome measure is the change in penile curvature after modeling. The secondary outcome measures are the change in stretched penile length, adverse events, and patient satisfaction after modeling.
Results
A total of 23 studies, involving 1,238 patients were included. Most studies (13, 56.5%) evaluated penile traction therapy. The studies were of low and intermediate quality (mean Newcastle-Ottawa Scale score of 5.7 and mean Jadad score of 3.3) with a mean level of evidence of 3.4. The mean penile curvature at baseline was between 31 and 80.8 degrees. Nine (39.1%) studies found a significant improvement (P < .05) of penile curvature after penile modeling, ranging between 11.7, and 37.2 degrees. An increase in mean stretched penile length was reported in 7 (30.4%) articles, varying between 0.4, and 1.8 cm. Serious complications such as penile prosthesis malfunctions (3.3–11.1%) and urethral injuries (2.9%) were only reported for intra-operative manual modeling.
Conclusion
Although individual studies have noted improvement in penile curvature and stretched penile length, specific recommendations regarding penile modeling in PD cannot be provided due to limited evidence available. Further RCTs with adequate sample size, validated assessment tools, and longer follow-up are needed.
Krishnappa P, Manfredi C, Sinha M et al. Penile Modeling in Peyronie's Disease: A Systematic Review of the Literature. Sex Med Rev 2021;XX:XXX–XXX.
... Die intrakavernöse Injektion von Papaverin, die im Laufe der 1980er-Jahre in die SKAT-Therapie mündete, war lange Zeit die einzige, wenn auch durchaus nicht Komplikationen freie Behandlungsstrategie [56]. Bereits 1982 wurde in den USAdie Vakuumpumpe nach Osborn zur nicht-medikamentösen Wiedererlangung der Potenz eingeführt [57]. Einen revolutionären Effekt auch für die Wiedererlangung der postoperativen Potenz hatte 1998 die Zulassung des Phosphodiesterasehemmers Sildenafil, der heute neben anderen PDE-5-Hemmern nicht nur für die Bedarfssondern auch als niedrigdosierte Dauertherapie zur verbesserten Schwellkörperdurchblutung eingesetzt wird [58]. ...
Zusammenfassung
Die Frage, was zuerst war – in diesem Falle die Diagnostik des Prostatakarzinoms oder seine Therapie – erscheint auf den ersten Blick widersinnig und erinnert an die klassische metapherartige Problemstellung, die schon den griechischen Schriftsteller Plutarch (45–125) beschäftigte. Ist es heute selbstverständlich, dass vor der Behandlung einer Erkrankung die sichere Diagnosestellung steht, so muss dies medizinhistorisch jedoch als nicht konsistent erachtet werden. Die Anfänge der radikalen Prostatektomie zur Behandlung des Prostatakarzinoms lassen sich, ähnlich wie die ersten operativen Therapien von Nieren- und Harnblasentumoren, in der Pionierzeit der Organchirurgie im Deutschen Kaiserreich (1871–1918) verorten. Die Etablierung dieses Eingriffs in seiner heutigen Form mit größeren Fallzahlen ist wiederum dem Nestor der US-amerikanischen Urologie, Hugh Hampton Young (1870–1945), zu verdanken, der 1904 die erste aus heutiger Sicht als vollumfänglich zu bezeichnende perineale Prostatovesikulektomie durchführte. Wenngleich die Indikation seither weitgehend unverändert geblieben ist, war dieser Eingriff in den letzten Jahrzehnten doch umfangreichen Veränderungen unterworfen. Wie aber hat sich die Diagnostik des Prostatakarzinoms in dieser Zeitspanne entwickelt? Naturgemäß sehr viel dynamischer! Denn als der Leiteingriff Prostatovesikulektomie bereits etabliert war, begann im Laufe des 20. Jahrhunderts erst langsam, dann dynamischer deren Entwicklung. Wir stellen anhand medizin(histor)ischer Originalquellen daher nicht nur die Grundlagen und Weiterentwicklungen des etablierten und zugleich immer wieder Innovationen unterworfenen Leiteingriffs der Urologie vor, sondern gehen vielmehr auch auf wesentliche Umfeldentwicklungen benachbarter medizinischer Disziplinen ein. Erst diese Entwicklungen schafften übrigens auch die Grundlage für die korrekte Indikationsstellung und das Aufzeigen von Alternativen zur radikalen Prostatovesikulektomie.
... VEDs have been used for penile rehabilitation after radical prostatectomy, where patients are more likely to develop immediate ED following treatment. 25,26 There are few studies examining VED use during or following radiation therapy. One report indicated that radiotherapy patients were less likely to use a VED compared to patients who had undergone prostatectomy. ...
Prostate cancer is the most common malignancy in men and the second leading cause of cancer-related death in men. Radiotherapy is a curative option that is administered via external beam radiation, brachytherapy, or in combination. Sexual dysfunction is a common toxicity following radiotherapy, similar to men undergoing radical prostatectomy, but the etiology is different. The pathophysiology of radiationinduced sexual dysfunction is multi-factorial, and the toxicity is a major cause of impaired quality of life among long-term prostate cancer survivors. Management of a patient's sexual function during and after radiotherapy requires multidisciplinary coordination of care between radiation oncology, urology, psychiatry, pharmacy, and dermatology. This review provides a framework for clinicians to better understand prostatic radiotherapy-induced sexual dysfunction diagnosis, evaluation, and a patient-centered approach to toxicity preventive strategies and management.
... Установлено, что ЛОД воздействует на нервно-рецепторный аппарат полового члена и центральную нервную систему, способствует улучшению функции плазматических мембран, транспорту кислорода в межтканевых пространствах и интенсификации метаболизма и, как следствие, возникновению эрекции. В эксперименте на крысах с моделью ЭД было показано, что проведение ЛОД у животных после радикальной простатэктомии вызывает антигипоксический, антиапоптотический и антифибротический эффекты [11][12][13][14][15][16][17][18]. ...
This article presents information on the application of apparatus physiotherapy for the treatment of the patients with erectile dysfunction. The authors report the results of the analysis of scholarly research designed to confirm the effectiveness of the physiotherapeutic methods applied for the treatment of the patients presenting with this pathology. Special attention is given to the mechanisms underlying the influence of the procedure with the use of local negative pressure-LOD therapy and shock wave therapy on the main pathogenetic components of erectile dysfunction. In addition, the article provides information about the effectiveness of the modern combined physiotherapeutic techniques including sinusoidal modulated current (SMT) electrophoresis of vasoactive substances and vibromagnetic-laser therapy in the combination with the general purpose methods as exemplified by intravenous laser irradiation. Based on the evidence presented in the article, the authors arrive at the conclusion about the prospects for further research on the development of new physiotherapeutic modalities and their introduction in the practical treatment of the patients with erectile dysfunction.
... [36] Interest in vacuum erection devices is resurging because they are cost-effective, less invasive treatment option that increases blood flow to the penile structures. [37][38][39] Our clinical experience also suggests that some gay men have incorporated vacuum devices into their sexual repertoire independent of use after PCa. Thus, the device may be especially appropriate for G/B men. ...
Little previous research has focused on gay and bisexual men who develop prostate cancer. However, a few small studies have recently been published that begin to tell the story of the specific problems gay and bisexual men with prostate cancer face. In this chapter, we summarize this recent literature and offer specific suggestions for changes to made by urologists and other cancer treatment providers to address the unique needs of gay and bisexual men for survivorship services. In addition, we discuss techniques that providers can use to make their practice more welcoming for gay and bisexual men facing prostate cancer.
... The VED is the only non-pharmacologic strategy among the choices for men who do not respond to PDE5Is or for those who have a contraindication (67). Numerous publications have suggested that VED therapy improves EF in 84-95% of patients (68,69). ...
The recent recognition that many men experience sexual dysfunction following their diagnosis and treatment of genitourinary cancers, has led to the development multiple varied strategies that attempt to restore or preserve that function. In this manuscript we review the understanding of why it happens, highlight novel management strategies and discuss the concept of penile rehabilitation (PR) following prostate cancer (PCa) treatment, glans preserving strategies among men diagnosed with penile cancer and address the controversial issue of testosterone therapy in men with PCa.
... Certainly, some patients opt to use a VED as an ED treatment option. 59,70 One small study (n = 20) showed evidence that the use of a VED improves penile oxygen saturation. 71 Two randomized controlled trials 72,73 suggest VEDs as a viable penile rehabilitation strategy. ...
Many therapies for erectile dysfunction (ED) after prostate cancer treatment improve erectile firmness, yet, most couples stop using aids within 1-2 years. Patients and partners who expect immediate and complete success with their first ED treatment can be demoralized when they experience treatment failure, which contributes to reticence to explore other ED aids. Comprehensive patient education should improve sustainability and satisfaction with ED treatments. Pre-emptive and realistic information should be provided to couples about the probability of recovering natural erections. Beginning intervention early and using a couple-based approach is ideal. Recommendations are provided about the timing of ED treatment, the order of aid introduction, and combination therapies. Renegotiation of sexual activity is an essential part of sexual adaptation. From the outset of therapy, couples should be encouraged to broaden their sexual repertoire, incorporate erection-independent sexual activities, and continue to be sexual despite ED and reduced libido.
... Despite the high prevalence of sexual problems in those living with disabilities, research has demonstrated that such concerns tend to go unaddressed in routine health care. This is especially problematic given that there are effective pharmacotherapy, physiotherapy, surgical, and psychotherapeutic interventions that can provide patients with relief from symptomatic barriers to sexual intimacy and improvement in sexual functioning [5][6][7][8][9][10][11]. However, research suggests that health professionals do not feel adequately prepared to address sexual concerns despite perceiving sexuality as important [12,13] and, therefore, tend not to initiate discussions about sexual health [3]. ...
Sexual dysfunction is a common concern among individuals with physical disabilities but often unaddressed by health care professionals, with many reporting lack of sufficient training and perceived lack of competence. The present study sought to examine educational factors and how they relate to health professions students' attitudes around the sexual health needs of individuals with physical disabilities. This was part of a larger study of 479 health professions students from training programs in the Southeast who completed a survey of attitudes and beliefs about sexual health topics. Significant differences were found across student field on the main outcome measure (attitudes related to sexual health of patients with disability). Differences were also found in quantity and quality of sexual health education across student field, with psychology students reporting the lowest quantity and quality of education. Item analysis of the main outcome measure revealed significant differences across student field on most items, with dentistry students generally reporting the most negative attitudes. Implications for health care providers working with patients with physical disabilities are discussed, and suggestions for implementing sexual health curriculum in training programs are provided.
... Efficacy rates of VED approach those of PDE5is and ICI, but VEDs have low overall acceptance and high long-term discontinuation rates due to the unnatural feeling of the erection and the mechanical procedure required to produce it [125]. Several reports describe improvement in erectile function with the use of VED in combination with PDE5is or ICI in comparison with monotherapy (reviewed in [126]). In addition, VED use is a standard part of postradical prostatectomy (RP) erectile preservation programs when used alone or in combination with PDE5i, ICI, or transurethral therapies and can be used to prevent penile shrinkage after RP and potentially prevent Peyronie's disease as well as after surgery to correct Peyronie's disease to prevent its recurrence [127]. ...
Erectile dysfunction (ED) affects a growing number of men in the USA and abroad, with significant impacts on sexual function and overall quality of life. The risk factors for ED are numerous and include a strong link to cardiovascular disease, such that men with ED should be screened for cardiovascular disease. The evaluation of men presenting with ED includes a comprehensive history and physical exam to aid in the identification of comorbidities as well as laboratory testing to evaluate hormone and lipid levels and sugar metabolism. Adjunct studies are also available, though their utility is often limited to specific subtypes of ED. Once the etiology of ED is established, treatment can be initiated using appropriate medical therapies, including phosphodiesterase type 5 (PDE5) inhibitors, and transurethral or intracavernosal therapies, with surgical intervention via revascularization or penile prosthesis placement in men demonstrating a lack of response to medical therapy. In all cases of ED, a psychogenic component is present and referral for psychological intervention with or without medical therapy should be considered.
... Geddings D Osbon, Sr, is regarded as the individual who popularized the vacuum erection device in the 1960s, and the US Food and Drug Administration approved the first marketed vacuum erection device in 1982. 30 The vacuum erection device creates an artificial erection by forming a vacuum via suction of air to draw blood into the penis. A constricting band can then be placed at the base of the penis in order to maintain the erection. ...
Success of cancer surgery often leads to life-changing side effects, and surgical treatment for malignant urologic disease often results in erectile dysfunction (ED). Patients that undergo surgical prostatectomy or cystoprostatectomy will often experience impairment of erections due to disruption of blood and nerve supply. Surgical technique, nerve sparing status, patient age, comorbid conditions, and pretreatment potency status all have an effect on post-surgical ED. Regardless of surgical technique, prostatectomy results in disruption of normal anatomy and nerve supply to the penis, which governs the functional aspects of erection. A variety of different treatment options are available for men who develop ED after prostatectomy, including vacuum erection device, oral phosphodiesterase 5 inhibitors (PDE5I), intracorporal injections, and penile prosthesis. The vacuum erection device creates an artificial erection by forming a vacuum via suction of air to draw blood into the penis. The majority of men using the vacuum erection device daily after prostatectomy, regardless of nerve-sparing status, have erections sufficient for intercourse. Phosphodiesterase 5 inhibitors remain a common treatment option for post-surgical ED and are the mainstay of therapy. They work through cyclic adenosine monophosphate and cyclic guanine monophosphate pathways and are recommended in all forms of ED. Intracorporal injections or intraurethral use of vasoactive substances may be a good second-line therapy in men who do not experience improvement with oral medications. Surgical placement of a penile prosthesis is typically the treatment strategy of choice after other options have failed. Semi-rigid and inflatable devices are available with high satisfaction rates. With careful patient counseling and proper treatment selection, patient satisfaction and improved erectile function can be achieved. We advise that patients use a vacuum erection device daily in the early postoperative period in combination with an oral PDE5I. For patients who do not respond to a vacuum erection device or PDE5I, consideration should be given to intraurethral alprostadil, intracorporal injections, or a penile prosthesis.
... This advantage of the VED, together with its ease of use, cost-effectiveness, and noninvasiveness make it an ideal treatment tool for post-RP penile rehabilitation. Whether it is used alone or in combination with other medical agents, vacuum therapy should be considered as a first-line treatment option to facilitate preservation of erectile tissue and promote recovery of erectile function postoperatively (Brison, Seftel, & Sadeghi-Nejad, 2013). ...
Erectile function recovery after radical prostatectomy (RP) is an increasingly prominent quality-of-life outcome following surgery. Following RP many men, despite the advent of cavernous nerve-sparing surgical technique, have moderately or significantly impaired erectile function (EF). The term penile rehabilitation (PR) is used to define interventions that maintain the health of erectile tissue in the context of nervous, vascular, and structural tissue injury. The goal of PR is to regain, as closely re-approximate, preoperative erectile function. PR is based on an increasing volume of preclinical and clinical data, but conclusive evidence of efficacy has not been established, and therefore the concept of PR remains controversial. The optimal PR regimen has not been established, but all strategies rely on one or more erectile dysfunction treatments to be administered on a regular basis regardless of actual use for sexual activity. This review highlights recent studies and evidence related to PR.
Background:
Radical prostatectomy (RP) and radiation treatment are standard options for localized prostate cancer. Even though nerve-sparing techniques have been increasingly utilized in RP, erectile dysfunction (ED) due to neuropraxia remains a frequent complication. Erectile function recovery rates after RP remain unsatisfactory, and many men still suffer despite the availability of various therapies.
Objective:
This systematic review aims to summarize the current treatments for post-RP-ED, assess the underlying pathological mechanisms, and emphasize promising therapeutic strategies based on the evidence from basic research.
Method:
Evaluation and review of articles on the relevant topic published between 2010 and 2021, which are indexed and listed in the PubMed database.
Results:
Phosphodiesterase type 5 inhibitors, intracavernosal and intraurethral injections, vacuum erection devices, pelvic muscle training, and surgical procedures are utilized for penile rehabilitation. Clinical trials evaluating the efficacy of erectogenic drugs in this setting are conflicting and far from being conclusive. The use of androgen deprivation therapy in certain scenarios after RP further exacerbates the already problematic situation and emphasizes the need for effective treatment strategies.
Conclusion:
This article is a detailed overview focusing on the pathophysiology and mechanism of the nerve injury developed during RP and a compilation of various strategies to induce cavernous nerve regeneration to improve erectile function (EF). These strategies include stem cell therapy, gene therapy, growth factors, low-intensity extracorporeal shockwave therapy, immunophilins, and various pharmacological approaches that have induced improvements in EF in experimental models of cavernous nerve injury. Many of the mentioned strategies can improve EF following RP if transformed into clinically applicable safe, and effective techniques with reproducible outcomes.
The use of stem cell therapy in the treatment of erectile dysfunction has been tested in both animal models and humans. The rationale for its use involves the regenerative properties of these cells to restore function to damaged cells and tissues via differentiation into healthy cells or to exert its paracrine effects to immunomodulate through secretion of cytokines and growth factors. We herein review the published data regarding effects of stem cells on erectile dysfunction and comment on the current state of clinical use/overuse of this treatment at the present time.
Objectives:
To identify factors associated with patient willingness to consider surgical treatment for erectile dysfunction (ED) prior to urologic consultation.
Methods:
A prospective database of patients presenting to the sexual health clinic at our institution was created from 2014-2018, consisting of pre-visit patient questionnaires and clinical information. Univariable and multivariable logistic regression analysis was performed to determine factors associated with consideration of surgery and decision to undergo surgery.
Results:
Of 1359 men presenting to the clinic, 991 men had a chief complaint of ED with 630 (63.6%) considering surgery. On multivariable analysis, factors significantly associated with pre-visit willingness for surgery included history of diabetes mellitus (p=0.0009), increasing symptom bother (p<0.0001) and decreasing relationship duration (p=0.0005). Approximately 16% (162/991) patients considering surgery prior to consultation ultimately underwent penile implant insertion. Multivariable analysis demonstrated that older age (p=0.003), history of diabetes mellitus (p=0.03), lower IIEF-EF domain (p=0.0009) and history of intracavernosal injection therapy (p<0.0001) were significantly associated with proceeding to ED surgery. Initial declaration of willingness to undergo ED surgery led to nearly 8 fold increased odds for surgery (p < 0.0001).
Conclusions:
Over 60% of patients presenting for ED consultation considered surgical intervention, of whom 25% underwent penile prosthesis. Both patient and relationship factors were predictors of surgical willingness. Pre-visit surgical willingness was associated with highest odds of eventual decision for surgery, suggesting that knowledge of ED treatment options in the general public may play a role. Our findings highlight opportunities for shared decision making in a patient-centered model of care.
Humans have been preoccupied with penile augmentation from time immemorial. In modern times, a wide variety of approaches have sought to increase penile length, girth, or, in some cases, both. While there is no consensus regarding appropriate indications, penile augmentation has been used in the setting of microphallus, fibrosis, trauma, and penile dysmorphia. Techniques for girth enhancement include injectable therapies, grafting, and implants. Penile lengthening procedures include traction therapy, suspensory ligament division, flap and liposuction procedures. This chapter aims to provide a brief review of historical and current approaches to penile augmentation, as well as a critical review of evidence regarding efficacy and complications.
Erectile dysfunction is a common condition. Many men do not self-report erectile dysfunction symptoms; thus, physicians must ask about sexual health and function to elicit concerns. Although the impact of untreated erectile dysfunction on quality of life should prompt physicians to ask about symptoms, so should the presence of cardiac and metabolic disease. Diagnosis of erectile dysfunction is made in the primary care office, and patients may be treated with oral, intraurethral, or intracavernosal medications; vacuum devices; or penile prosthesis. Treatment should be guided by patient preference with a goal of improving quality of life and mitigating chronic disease risk.
Vacuum erection device (VED), used to treat radical prostatectomy (RP)-associated erectile dysfunction, has attracted considerable attention. However, the optimal negative pressure remains to be determined. This investigation explored the optimal pressure for VED therapy in penile rehabilitation. Thirty-six 9-week-old male rats were randomly divided into six groups: control groups (sham group, bilateral cavernous nerve crush [BCNC] group) and VED therapy groups (-200 mmHg group, -300 mmHg group, -400 mmHg group, -500 mmHg group). BCNC group and VED therapy groups underwent BCNC surgery. Intracavernosal pressure (ICP)/mean arterial pressure (MAP) ratio was calculated to assess erectile function. Masson's trichrome (MT) staining, terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay, immunohistochemistry, and real-time polymerase chain reaction (RT-PCR) were performed to explore cellular and molecular changes of the penis. Compared to the BCNC group, ICP/MAP ratios in all VED treatment groups were improved significantly (all P < 0.05), but there were no statistically significant differences among VED therapy groups. With increased pressure, complications gradually emerged and increased in frequency. Expression of molecular indicators, such as endothelial nitric oxide synthase (eNOS) and alpha-smooth muscle actin (α-SMA), increased after VED therapy, and hypoxia-inducible factor 1α (HIF-1α) and transforming growth factor beta (TGF-β) decreased. In addition, VED therapy improved the outcomes of MT and TUNEL assay. This investigation demonstrated a pressure of -200 mmHg in a rat model is optimal for VED therapy for penile rehabilitation after RP. No further benefits were observed with increased pressure, despite an increase in complications.
Introduction : Cette étude monocentrique rétrospective avait pour objectif d’évaluer l’efficacité de VITAROS® chez les lésés médullaires. Ses effets indésirables et la satisfaction qu’en avaient les patients étaient également étudiés, et l’ensemble des résultats étaient comparés à ceux obtenus avec les traitements de référence. Méthode : Des lésés médullaires de 18 à 60 ans souffrant de dysfonction érectile secondaire à la lésion et pour qui VITAROS® avait été prescrit ont été inclus. Des auto-évaluations ont été réalisées pour évaluer chaque traitement (VITAROS®, IPDE5, IIC) ainsi que l’état basal, incluant l’EHS (Erection Hardness Score) et l’IIEF5, la durée d’action, les effets indésirables, la satisfaction globale et le traitement choisi pour l’usage ultérieur. Résultats : 40 patients ont été inclus, parmi lesquels 29 avaient complété tous les questionnaires. L’âge moyen était de 42,3 +/- 10,4 ans ; 8 étaient tétraplégiques et 21 paraplégiques. VITAROS® entraînait une amélioration significative de l’IIEF5 par rapport à l’état basal (12,1 vs 8,2 ; p=0,0005), et 24,14% des patients rapportaient des effets secondaires. Les scores EHS et IIEF5 étaient significativement plus importants avec IPDE5 et IIC que VITAROS®, et la durée d’action était plus longue avec les IIC (p=0,0020). Les effets indésirables étaient moins fréquents avec VITAROS®. 9 patients sur 29 ont finalement choisi VITAROS® pour leur usage ultérieur. Conclusion : VITAROS® semble être un traitement efficace de l’insuffisance érectile chez les lésés médullaires, mais moins que les IPDE5 et IIC : certains patients le choisissent pour leur futur usage car il présente moins d’effets indésirables et évite la voie intra-caverneuse.
Peyronie's disease (PD) is a fibrotic disorder of the tunica albuginea (TA). This study aimed to determine the therapeutic effects of a vacuum erection device (VED) in an animal model of PD and explore the possible mechanisms. Twenty‐seven male Sprague‐Dawley rats were used. The sham group (group A) (N = 9) received a 50‐μl‐saline vehicle injection into the TA, while the remaining 18 rats (groups B and C) received a TGF‐β1 injection into the TA. The treatment group (group C) underwent VED therapy for 10 days after the TGF‐β1 injection. Erectile function was then assessed at day 42. Rats injected with TGF‐β1 showed significantly lower intracavernous pressures than those in the sham group (p < 0.0001). After VED therapy, erectile function was significantly better in the treatment group than in the PD group (group B) (p < 0.0147). Masson's trichrome staining confirmed Peyronie's‐like plaques at the TGF‐β1 injection site in the PD group. Furthermore, the treatment group showed markedly smaller fibrotic plaque sizes than the PD group. A significant increase in TGF‐β1, SMAD2, SMAD3 and p‐SMAD2/3 protein expression was observed 6 weeks after the TGF‐β1 injection. However, the expression of the same proteins decreased after VED therapy. Protein expression trends were confirmed using immunohistochemistry analysis. The findings of this study demonstrate that VED therapy can reduce Peyronie's‐like plaque size in a rat model of PD while simultaneously improving erectile function.
Background:
Spinal Cord Injury (SCI) causes neurological impairment with resultant neurogenic sexual dysfunction which can compound preexisting psychological and medical sexual concerns. Understanding these concerns is important in managing the lifelong needs of persons with SCIs.
Objectives:
To provide an overview of the impact of SCI on sexuality along with a framework for treatment of sexual concerns. To briefly review male infertility and its treatments and pregnancy in females after SCI.
Methods:
Interdisciplinary literature review and synthesis of information.
Results:
The average age at SCI is increased, thus persons with SCIs may have preexisting sexual concerns. Sexual activity and satisfaction are decreased after SCI. Psychogenic sexual arousal is related to remaining sensation in the T11-L2 dermatomes. Orgasm occurs in approximately 50% of persons with SCIs with all injuries except subjects with complete lower motor neuron (LMN) injuries affecting the lowest sacral segments A structured approach to treatment including assessing preinjury function, determining the impact of injury, education, assessing and treating iatrogenic sexual dysfunction and treatment of concomitant problems is recommended. Basic and advanced methods to improve sexual arousal and orgasm are discussed and treatment of anejaculation and issues associated with pregnancy and SCI are reviewed.
Conclusions:
Sexual satisfaction is impaired after SCI; however, education and new therapies can improve responsiveness. Future research is warranted to improve sexual function and fertility potential in persons with SCIs.
Introduction:
Complications of prostate cancer treatments are responsible of a lower quality of life. We evaluated the prevalence and the perceptions of sexual consequences of prostate cancer treatments.
Materials and methods:
A retrospective self-administered questionnaire was sent to all the members of the Association Nationale des Malades du Cancer de la Prostate (ANAMACAP). All the answers were analyzed.
Results:
226 questionnaires were analyzed, the average age was 67.3 years old, the average follow-up was 58.1 months. 110 patients had surgery only, 29 had hormone therapy plus radiotherapy, 28 had radiation therapy only and 49 had combined treatments. After the treatment of the prostate cancer, an erectile dysfunction was reported by 75.2% of the patients; an orgasmic dysfunction by 69%; a climacturia by 21%; a reduced penile length by 70% of them and a less sensitive glans by 59%. They were responsible of a lower quality of life for 75% to 90% of the patients depending on the symptom. A PDE5-inhibitor treatment was effective for only 25.6% of them when taken daily and for 39% on demand.
Conclusion:
Functional consequences of prostate cancer treatments are common, diverse and directly involved in the sexual life. It is necessary to improve therapeutical education and onco-sexology with the help of patients' associations, to build a new balance in the couples.
Level of evidence:
3.
Even after the advent of nerve-sparing procedure a significant percent of patients still develop erectile dysfunction after radical prostatectomy [1]. Modifications in the surgical technique of robotic radical prostatectomy have aimed not only to spare the cavernous nerve but also to minimize any potential harm done from manipulation, traction, or thermal injury of the nerves in addition to sparing the microcirculation surrounding the prostate. The adjunctive measures to optimize early return of erectile function can be subdivided into intraoperative measures designed to optimize nerve preservation and minimize injury to the neurovascular structures surrounding the prostate, and postoperative penile rehabilitation to facilitate early return of erectile function.
Since receiving FDA approval in 1982, vacuum erection devices (VEDs) have benefitted millions of men suffering from erectile dysfunction (ED). Vacuum therapy has since been overshadowed by advances in pharmacologic and surgical therapies for ED; however, there has been a recent resurgence in the popularity of the VED. This is in large part due to its developing role in post-prostatectomy penile rehabilitation. As a treatment for erectile dysfunction, vacuum therapy remains notable as a noninvasive, nonpharmacologic, safe, cost-effective, and efficacious treatment option. This chapter will review the evolution of vacuum therapy as well as its mechanism of action, efficacy, safety profile, and expanding applications beyond the traditional realm of ED.
The treatment of erectile dysfunction (ED) employs a step-wise algorithm to achieve an optimal response. Treatment is progressive, with the initial use of oral pharmacotherapy, and becomes more invasive if initial therapies fail. Vacuum erection devices (VEDs) and intraurethral or intracavernosal vasoactive agents comprise second-line treatments. Comorbid conditions, such as hormonal deficiencies and cardiovascular disease, should be identified and managed concurrently using lifestyle modification or medical therapies. For refractory ED, penile prosthetic surgery is available for appropriate patients, resulting in high satisfaction rates. Addressing psychosocial factors contributing to ED can maximize treatment efficacy.
Besides causing frequently distress and limitation in lifestyle, erectile dysfunction is nowadays considered a harbinger of silent generalized cardiovascular disease since alterations of cardiovascular system compromise erectile function. Endothelial dysfunction, including a defective NO/cGMP pathway among others, seems to be the underlying condition linking erectile dysfunction to cardiovascular disease key factors, while lifestyle attitudes and interventions targeted to reduce cardiovascular disease risk would contribute to the preservation of erectile function. This chapter reviews in detail the hemodynamic process of penile erection, the vascular-related conditions increasing the risk of erectile dysfunction, the pathophysiological mechanisms underlying this disease, and the treatment options.
After the presentation of the first patient treated by embolization 1970, the authors present potential sources of gastrointestinal (GI) bleeding. The acutely bleeding patients need to have first endoscopic evaluation and eventual treatment. Diagnostic angiography is then described. Embolization with occlusion of the bleeding vessel is presently the preferred approach by most interventionalists. Depending on their preference and size of the bleeding vessel, interventionalists use particles of Gelfoam sponge or polyvinyl alcohol foam, coils, or liquid agents as N-butyl cyanoacrylate for embolization. Characteristics of agents are described, and examples are presented. In extra-alimentary sources of GI bleeding, hemobilia and bleeding from pancreas and fistulas with aorta and major arteries are discussed, and embolotherapy approaches are suggested.
Erectile dysfunction and premature ejaculation are the most common male sexual disorders and an increasing health problem in developed countries. Etiopathogenesis of the two disorders is multifactorial and includes several biological and psycological factors. Pharmacological, psychological and/or surgical treatment approaches depend on the type and severity of the disorder. Phosphodiesterase type 5 inhibitors are the drugs of choice in pharmacotherapy of erectile dysfunction. At present, dapoxetine, a short-acting selective serotonin reuptake inhibitor, is the only drug indicated to treat premature ejaculation. Several promising therapeutic approaches for treating male sexual dysfunction are being investigated, including stem cells and gene therapy.
Providers caring for cancer survivors often miss sexual dysfunction, which is a prevalent cause of distress and quality-of-life impairment. Routine open-ended questions exploring sexual function should help to more broadly identify these issues in cancer patients.
Sexual dysfunction following cancer treatment is highly prevalent, though often overlooked by healthcare providers. Cancer-related changes in sexual function are associated with worsened mental health for men and women including increased distress, depression, and anxiety. The research in male sexual medicine is more advanced than female sexual medicine. The treatments for men focus primarily on erectile function and include a number of approved pharmacological treatments, whereas treatments for women are primarily behavioral in nature and generally target dyspareunia or vaginismus. Interventions for both genders work best when they include both medical and psychological modalities to address the myriad of factors that may affect sexuality and intimacy in cancer survivors. Educational and psychosocial interventions and support resources may be used in conjunction with medical strategies to facilitate sexual recovery and promote satisfying sexual experiences for patients. It is strongly encouraged that interventions address sexual dysfunction from an individual and relational standpoint when a partner is involved or with consideration to patients’ perspectives on future partners.
Answer questions and earn CME/CNE Prostate cancer survivors approach 2.8 million in number and represent 1 in 5 of all cancer survivors in the United States. While guidelines exist for timely treatment and surveillance for recurrent disease, there is limited availability of guidelines that facilitate the provision of posttreatment clinical follow-up care to address the myriad of long-term and late effects that survivors may face. Based on recommendations set forth by a National Cancer Survivorship Resource Center expert panel, the American Cancer Society developed clinical follow-up care guidelines to facilitate the provision of posttreatment care by primary care clinicians. These guidelines were developed using a combined approach of evidence synthesis and expert consensus. Existing guidelines for health promotion, surveillance, and screening for second primary cancers were referenced when available. To promote comprehensive follow-up care and optimal health and quality of life for the posttreatment survivor, the guidelines address health promotion, surveillance for prostate cancer recurrence, screening for second primary cancers, long-term and late effects assessment and management, psychosocial issues, and care coordination among the oncology team, primary care clinicians, and nononcology specialists. A key challenge to the development of these guidelines was the limited availability of published evidence for management of prostate cancer survivors after treatment. Much of the evidence relies on studies with small sample sizes and retrospective analyses of facility-specific and population databases. CA Cancer J Clin 2014. © 2014 American Cancer Society.
Provoked and spontaneous nocturnal erections are thought to play a role in maintenance of male sexual health through oxygenation of the corpus cavernosa. Conversely, hypoxia is thought to be an etiological factor in the pathogenesis of cavernosal fibrosis and long-term erectile dysfunction. It has been hypothesized that the early penile hypoxia after radical prostatectomy (RP) may lead to fibrosis and consequently a decrease in stretched penile length and long-term erectile dysfunction.
The aim of this study was to assess the changes in penile tissue oxygenation with vacuum erection device (VED) use.
Twenty men between 2 and 24 months following RP were enrolled prospectively. Each man cycled a VED to achieve full erection 10 consecutive times over a period of approximately 2 minutes without constriction ring.
Tissue oximetry was measured at baseline and immediately after VED using a tissue oximeter at five sites: right thigh, right corpora, glans, left corpora, and left thigh. Additional measurements were captured over the course of an hour.
Mean age and time from surgery was 58.2 years and 12.6 months, respectively, and the average Sexual Health Inventory for Men score was 7. Use of the VED significantly increased both glanular and corporal oximetry relative to the baseline values for the entire 60 minutes. An initial increase of 55% was seen in corporal oxygenation with VED use.
This is the first study demonstrating that a single, brief application of the VED without a constriction ring results in significant improvement in penile oxygen saturation. The use of a VED has significant benefits for patients both with regard to cost and invasiveness when compared with other penile rehabilitation protocols. Welliver RC Jr, Mechlin C, Goodwin B, Alukal JP, and McCullough AR. A pilot study to determine penile oxygen saturation before and after vacuum therapy in patients with erectile dysfunction after radical prostatectomy. J Sex Med **;**:**-**.
Four weeks after bilateral nerve-sparing radical retropubic prostatectomy, men with normal erectile function before surgery were randomized to double-blind sildenafil (50 or 100 mg) or placebo nightly for 36 weeks, followed by an 8-week drug-free period before assessment of erectile function. Enrollment was prematurely ceased and only 76 men completed because, assuming a placebo response rate similar to the published literature (for example, 34% in meta-analysis), the 25% response at blinded interim review suggested a lack of treatment effect. On the contrary, spontaneous erectile function (a combined score of >or=8 for questions 3 and 4 of the International Index of Erectile Function and a positive response to 'Were erections good enough for satisfactory sexual activity?') occurred in only 4% of the placebo group (n=1 of 25) versus 27% (n=14 of 51, P=0.0156, Fisher's exact test) of the sildenafil group. Nightly sildenafil administration for 36 weeks after surgery markedly increased the return of normal spontaneous erections.
The American Cancer Society, the Centers for Disease Control and Prevention (CDC), the National Cancer Institute, and the North American Association of Central Cancer Registries (NAACCR) collaborate annually to provide updated information on cancer occurrence and trends in the United States. This year's report highlights brain and other nervous system (ONS) tumors, including nonmalignant brain tumors, which became reportable on a national level in 2004.
Cancer incidence data were obtained from the National Cancer Institute, CDC, and NAACCR, and information on deaths was obtained from the CDC's National Center for Health Statistics. The annual percentage changes in age-standardized incidence and death rates (2000 US population standard) for all cancers combined and for the top 15 cancers for men and for women were estimated by joinpoint analysis of long-term (1992-2007 for incidence; 1975-2007 for mortality) trends and short-term fixed interval (1998-2007) trends. Analyses of malignant neuroepithelial brain and ONS tumors were based on data from 1980-2007; data on nonmalignant tumors were available for 2004-2007. All statistical tests were two-sided.
Overall cancer incidence rates decreased by approximately 1% per year; the decrease was statistically significant (P < .05) in women, but not in men, because of a recent increase in prostate cancer incidence. The death rates continued to decrease for both sexes. Childhood cancer incidence rates continued to increase, whereas death rates continued to decrease. Lung cancer death rates decreased in women for the first time during 2003-2007, more than a decade after decreasing in men. During 2004-2007, more than 213 500 primary brain and ONS tumors were diagnosed, and 35.8% were malignant. From 1987-2007, the incidence of neuroepithelial malignant brain and ONS tumors decreased by 0.4% per year in men and women combined.
The decrease in cancer incidence and mortality reflects progress in cancer prevention, early detection, and treatment. However, major challenges remain, including increasing incidence rates and continued low survival for some cancers. Malignant and nonmalignant brain tumors demonstrate differing patterns of occurrence by sex, age, and race, and exhibit considerable biologic diversity. Inclusion of nonmalignant brain tumors in cancer registries provides a fuller assessment of disease burden and medical resource needs associated with these unique tumors.
Radical prostatectomy is commonly performed for the treatment of patients with prostate cancer. Several studies have demonstrated a reduction in penile size after open radical retropubic prostatectomy. The objective of this study is to describe changes in penile length after after robot-assisted laparoscopic radical prostatectomy (RALRP).
We performed a randomized, open label, multicenter study in men with normal erectile function who underwent bilateral nerve-sparing radical prostatectomy. We evaluated changes in measured stretched penile length (SPL), a secondary end point of the study, in a subset of men from a single site who underwent RALRP by one surgeon. They were randomized to either intraurethral alprostadil 125 to 250 μg daily or oral sildenafil citrate 50 mg daily for 9 months. SPL was measured from pubic bone to coronal sulcus using a semirigid ruler before surgery and at 1, 3, 6, 9, 10, and 11 months.
A total of 127 patients were enrolled and 94 completed the 11-month follow-up. The mean patient age was 56.5 years. Baseline mean SPL (cm) before surgery was 11.77 and decreased to 11.13 at 1 month (P<0.0001). A trend toward recovery of SPL was seen at 3 and 6 months. Mean SPL was not significantly different from baseline at 9, 10, and 11 months.
This report describes changes in SPL over time after RALRP for prostate cancer. The expected decrease in length was observed shortly after surgery, but, by 9 months, penile length had returned to the preoperative measurement.
Even nerve-sparing radical prostatectomy damages the cavernous nerves and leads to temporary erectile dysfunction (ED) in men recovering from prostate cancer surgery. Historically, patients recovering from prostate cancer surgery have been advised that the return of erectile function (EF) can take from 6 to 18 months, or even longer. Unfortunately, the return of sexual function in these patients remains variable, but is generally thought to be dependent on the individual patient's pre-surgery EF, as well as the degree of cavernous nerve disruption during prostate removal. Recently, there has been a growing movement to proactively treat patients postoperatively for presumed nerve damage to stimulate nerve recovery and possibly reduce the degree of irreversible damage. This would reduce the on-demand therapy these patients would require, and hopefully remove the requirement for an implantable prosthesis. The underlying hypothesis is that the artificial induction of erections shortly after surgery facilitates tissue oxygenation, reducing cavernosal fibrosis in the absence of nocturnal erections, potentially increasing the likelihood of preserving EF. Vacuum erection devices (VED), because of their ability to draw blood into the penis regardless of nerve disturbance, have become the centerpiece of penile rehabilitation protocols. This review will discuss the pathophysiology of radical prostatectomy induced ED and the rationale for rehabilitation. It will then discuss current protocols, including those involving the VED.
In Brief Erectile dysfunction is one of the most common complications of diabetes and also one of the most underdiagnosed. Providers need to understand the pathophysiology of this condition in their diabetic patients and make an effort to diagnose and treat it. By doing so, they will improve their patients' quality of life.
Twelve patients with erectile impotence related to diabetic neuropathy were treated with a vacuum device, Pos-T-Vac. Efficacy of the device and psychological evaluation (Dyadic Adjustment Scale for marital satisfaction and Hamilton Rating Scale for depression) were performed before and 3 months after treatment. Vacuum therapy was successful in 75% of the patients. Patients with successful impotence treatment and normal baseline marital satisfaction scores showed a modest increase in the scores of marital satisfaction (from 114 +/- 3 points, baseline, to 121 +/- 3 points, posttreatment; p <0.05). Vacuum therapy for the treatment of erectile dysfunction due to diabetic autonomic neuropathy appears to be safe and effective.
(C) Copyright 1992 Southern Society for Clinical Investigation
Introduction. The Journal of Sexual Medicine (JSM) held a debate at the annual fall meeting of the Sexual Medicine Society of North America (SMSNA). The motion was “Penile Rehabilitation Should Become the Norm for Radical Prostatectomy Patients.” At the suggestion of several SMSNA members, it was requested that this debate might be of interest to JSM readers in the form of a published controversy.
Methods. Two debate speakers with expertise and/or strong opinions in the area of penile rehabilitation submitted their literature-review, evidence-based opinions on the topic.
Main Outcome Measure. Literature review of laboratory basic science and clinical research studies on penile rehabilitation.
Results. Penile rehabilitation involves prophylactic procedures designed to improve oxygen delivery to penile erectile tissues, aimed at preserving erectile tissue health and minimizing erectile tissue damage that otherwise occurs during the period of neural recovery to the autonomic cavernosal nerve following radical prostatectomy. There are several studies in the sexual medicine literature on penile rehabilitation after radical prostatectomy, and the positive results appear to support this concept, the rationale, and mechanism. The use of prophylactic penile rehabilitation programs has not been fully elucidated, nor have the results been replicated in large multicenter placebo-controlled trials.
Conclusion. Penile rehabilitation may be performed along with counseling with the couple, vacuum erection therapy, and vacuum erection device therapy if it is the patient and partner's preference, provided that it is undertaken in a safe and effective manner and is monitored closely. Mulhall JP, and Morgentaler A. Penile rehabilitation should become the norm for radical prostatectomy patients. J Sex Med 2007;4:538–543.
To date, no data have been available from large, well-designed trials comparing on demand and nightly dosing of phosphodiesterase type 5 (PDE5) inhibitors on recovery of erectile function in postprostatectomy patients with erectile dysfunction (ED).
To investigate the effect of early postoperative dosing with vardenafil, administered either nightly or on demand, compared with placebo on recovery of erectile function in men with ED following bilateral nerve-sparing radical prostatectomy (NSRP) surgery.
A randomised, double-blind, double-dummy, multicentre, parallel group study conducted at 87 centres across Europe, Canada, South Africa, and the United States. For inclusion, patients had to be scheduled to undergo bilateral NSRP within 1 mo of screening and have a normal International Index of Erectile Function erectile function domain (IIEF-EF) score of > or =26 at screening. A total of 628 men, aged 18-64 yr, were randomised to treatment. Study design consisted of a 9-mo double-blind treatment period, a 2-mo single-blind washout period, and an optional 2-mo open-label period.
Patients received placebo, nightly vardenafil, or on demand vardenafil.
Primary outcome measure was the percentage of subjects with an IIEF-EF score of > or =22 after the 2-mo washout period. Secondary variables included mean per-patient success rates for Sexual Encounter Profile (SEP) questions 2 and 3.
No statistically significant differences were observed among treatment groups in the proportion of patients with an IIEF-EF score of > or =22 or in SEP3 success rates after the washout period. On-demand vardenafil treatment resulted in significantly greater IIEF-EF scores and better SEP3 response rates than placebo over the entire treatment period.
In this study of men with ED following bilateral NSRP, vardenafil was efficacious when used on demand, supporting a paradigm shift towards on demand dosing with PDE5 inhibitors in this patient group.
European clinical trials database (EudraCT; available at http://eudract.emea.europa.eu/). Trial registration number: 11336.
We report results in a series of 3,477 consecutive patients treated with anatomical nerve sparing radical retropubic prostatectomy (RRP) in terms of recovery of erectile function, urinary continence and postoperative complications.
From May 1983 through February 2003, 1 surgeon (WJC) performed anatomical RRP using a unilateral or bilateral nerve sparing modification when possible. Urinary continence and recovery of erections were evaluated in men with a minimum followup of 18 months. Excluded from potency analysis were men who were not reliably potent before surgery, those who did not undergo a nerve sparing procedure and those who received postoperative adjuvant radiotherapy or hormonal therapy within 18 months of surgery. Other postoperative complications in this patient population were also evaluated.
Erections sufficient for intercourse occurred in 76% of preoperatively potent men treated with bilateral (1,770) and 53% of men treated with unilateral or partial nerve sparing (64) surgery. Adequate erectile function was more common following bilateral than unilateral nerve sparing surgery in men younger than 70 years old (78% versus 53%, p = 0.001) compared with those 70 years old or older (52% versus 56%, p = 0.6). Recovery of urinary continence occurred in 93% of all men and was associated with younger age (p = 0.001) but not nerve sparing surgery, tumor stage, prostate specific antigen (PSA), Gleason grade or number of prior prostatectomies performed by the surgeon. Postoperative complications occurred in 320 (9%) of patients and were associated with older age (p <0.0001), nonnerve sparing surgery (p = 0.001), PSA era (p <0.0001) and surgeon experience. Complications were not significantly correlated with clinical stage, pathological stage, preoperative PSA or Gleason grade. There was no perioperative mortality.
Nerve sparing RRP can be performed with favorable potency and urinary continence. Better results are achieved in younger men. Other complications are reduced with increasing surgeon experience.
Treatment of erectile dysfunction (ED) subsequent to bilateral nerve sparing robotic prostatectomy (BNSRP) with tadalafil plus a vacuum erection device (VED) may improve return of sexual function.
Men with prostate cancer who had BNSRP were randomized to receive tadalafil, 20 mg three times weekly, or tadalafil plus a VED, 10 minutes unbanded per day for at least 5 days weekly. Treatments started 1 month after surgery; clinic visits were at 1, 3, 6, 9 and 12 months. Patients were requested to attempt intercourse at least twice before each visit. At every visit patients completed the International Index of Erectile Function (IIEF-5) questionnaire and a penile hardness scale (1-4) and were questioned as to their ability to have vaginal penetration and intercourse to orgasm.
Thirteen men started the combination regimen, and there were no dropouts; 10 patients started the tadalafil treatment, and three men dropped out. The mean IIEF-5 at months 6, 9 and 12 were significantly higher for the combination group, while the penile hardness scores were significantly greater for the combination group at 6 and 9 months. After 12 months 92% of combination patients responded yes to the vaginal penetration question versus 57% of the tadalafil group; corresponding figures were 92% and 29%, respectively, for intercourse to orgasm. Compliance to the VED was superior to that of tadalafil.
Men with ED subsequent to BNSRP had a more rapid and complete return of sexual function when treated with tadalafil plus VED versus tadalafil alone.
Despite a growing body of evidence supporting erectile function (EF) rehabilitation after radical prostatectomy (RP), there are no guidelines on this subject.
To explore EF rehabilitation practice patterns of American Urological Association (AUA) urologists.
A 35-question instrument was constructed assessing physician demographics, training, and EF rehabilitation practices after RP, and was e-mailed to AUA members by the AUA Office of Education. Data were acquired by the AUA and analyzed by the investigators.
Percentage of responders who recommend EF rehabilitation practices following RP, characterization of prevalent rehabilitation practices.
Of the 618 urologists who completed the survey, 71% were in private practice, 28% considered themselves as sexual medicine specialists, although only 4% were fellowship-trained, 43% were urologic oncology specialists (14% fellowship-trained), 86% performed RP, and 86% of responders recommended rehabilitation practices. Being a sexual medicine or a urologic oncology specialist was not predictive of rehabilitation employment. Forty-three percent rehabilitate all patients, 57% only selected patients. Selection for rehabilitation was dependent upon preop EF by 66%, nerve-sparing status by 22%, and age by 5%. Eleven percent started rehab immediately after RP, 97% within 4 months. 24%, 45% and 18% ceased rehab at <12, 12-18, and 18-24 months, respectively. Eighty-nine percent of RP surgeons performed rehabilitation vs. only 66% who do not perform RP (P < 0.0001). Eighty-seven percent prefer phosphodiesterase type 5 inhibitors (PDE5i) as their primary strategy followed (in order) by vacuum erection device (VED), intracavernosal injection (ICI), and urethral suppositories.
Among the respondents, penile rehabilitation is a common practice. Urologic oncologists and RP surgeons are more likely to use rehabilitation practices. The most commonly employed strategy is regular PDE5i use for 12-18 months after RP. .
Vacuum erection devices (VEDs) are becoming first-line therapies for the treatment of erectile dysfunction and preservation (rehabilitation) of erectile function following treatment for prostate cancer. Currently, there is limited efficacy of the use of phosphodiesterase type 5 inhibitors in elderly patients, or patients with moderate to severe diabetes, hypertension, and coronary artery disease.
The article aims to study the role of VED in patients following prostate cancer therapy.
Alternative therapies such as VED have emerged as one of the primary options for patients refractory to oral therapy. VED has also been successfully used in combination treatment with oral therapy and penile injections. More recently, there has been interest in the use of VED in early intervention protocols to encourage corporeal rehabilitation and prevention of postradical prostatectomy veno-occlusive dysfunction. This is evident by the preservation of penile length and girth that is seen with early use of the VED following radical prostatectomy. There are ongoing studies to help preserve penile length and girth with early use of VED following prostate brachytherapy and external beam radiation for prostate cancer. Recently, there has also been interest in the use of VED to help maintain penile length following surgical correction of Peyronie's disease and to increase penile size prior to implantation of the penile prosthesis.
VEDs can be one of the options for penile rehabilitation after prostate cancer therapy.
Sexual health is an integral part of overall health. Sexual dysfunction can have a major impact on quality of life and psychosocial and emotional well-being.
To provide evidence-based, expert-opinion consensus guidelines for clinical management of sexual dysfunction in men.
An international consultation collaborating with major urologic and sexual medicine societies convened in Paris, July 2009. More than 190 multidisciplinary experts from 33 countries were assembled into 25 consultation committees. Committee members established scope and objectives for each chapter. Following an exhaustive review of available data and publications, committees developed evidence-based guidelines in each area. Main Outcome Measures. New algorithms and guidelines for assessment and treatment of sexual dysfunctions were developed based on work of previous consultations and evidence from scientific literature published from 2003 to 2009. The Oxford system of evidence-based review was systematically applied. Expert opinion was based on systematic grading of medical literature, and cultural and ethical considerations.
Algorithms, recommendations, and guidelines for sexual dysfunction in men are presented. These guidelines were developed in an evidence-based, patient-centered, multidisciplinary manner. It was felt that all sexual dysfunctions should be evaluated and managed following a uniform strategy, thus the International Consultation of Sexual Medicine (ICSM-5) developed a stepwise diagnostic and treatment algorithm for sexual dysfunction. The main goal of ICSM-5 is to unmask the underlying etiology and/or indicate appropriate treatment options according to men's and women's individual needs (patient-centered medicine) using the best available data from population-based research (evidence-based medicine). Specific evaluation, treatment guidelines, and algorithms were developed for every sexual dysfunction in men, including erectile dysfunction; disorders of libido, orgasm, and ejaculation; Peyronie's disease; and priapism.
Sexual dysfunction in men represents a group of common medical conditions that need to be managed from a multidisciplinary perspective.
Given the paucity of literature on the time course of recovery of erectile function (EF) after radical prostatectomy (RP), many publications have led patients and clinicians to believe that erections are unlikely to recover beyond 2 years after RP.
We sought to determine the time course of recovery of EF beyond 2 years after bilateral nerve sparing (BNS) RP and to determine factors predictive of continued improved recovery beyond 2 years.
EF was assessed prospectively on a 5-point scale: (i) full erections; (ii) diminished erections routinely sufficient for intercourse; (iii) partial erections occasionally satisfactory for intercourse; (iv) partial erections unsatisfactory for intercourse; and (v) no erections. From 01/1999 to 01/2007, 136 preoperatively potent (levels 1-2) men who underwent BNS RP without prior treatment and who had not recovered consistently functional erections (levels 1-2) at 24 months had further follow-up regarding EF. Median follow-up after the 2-year visit was 36.0 months.
Recovery of improved erections at a later date: recovery of EF level 1-2 in those with level 3 EF at 2 years and recovery of EF level 1-3 in those with level 4-5 EF at 2 years.
The actuarial rates of further improved recovery of EF to level 1-2 in those with level 3 EF at 2 years and to level 1-3 in those with level 4-5 EF at 2 years were 8%, 20%, and 23% at 3, 4, and 5 years postoperatively, and 5%, 17%, and 21% at 3, 4, and 5 years postoperatively, respectively. Younger age was predictive of greater likelihood of recovery beyond 2 years.
There is continued improvement in EF beyond 2 years after BNS RP. Discussion of this prolonged time course of recovery may allow patients to have a more realistic expectation.
Penile rehabilitation (PR) is widely applied after radical prostatectomy. Vacuum erectile device (VED) therapy is the one of three PR methods used in the clinical setting that improve erectile function (EF) and is the only PR method which may preserve penile length. However, its unknown mechanism hampered doctors' recommendations and patients' compliance.
To assess the effects of VED therapy on erectile dysfunction (ED) in a rat model of bilateral cavernous nerve crush (BCNC) and to investigate the molecular mechanism of VED in postprostatectomy ED.
This was an experimental study using Sprague-Dawley rats in three groups: sham, BCNC, and BCNC plus VED.
Intervention included BCNC, electrical stimulation of the cavernous nerve (CNS), and VED therapy.
At the end of a 4-wk period, CNS was used to assess EF by maximum intracavernosal pressure (ICP)/mean arterial pressure (MAP) ratio and duration (area under the curve [AUC]). For the structural analyses, whole rat penis was harvested. Terminal deoxynucleotidyl transferase biotin-dUTP nick end labeling assay was used for the assessment of apoptotic indices (AI). Immunohistochemistry was performed for endothelial nitric oxide synthase (eNOS), α-smooth muscle actin (ASMA), transforming growth factor beta 1 (TGF-β1), and hypoxia inducible factor-1α (HIF-1α). Staining for Masson's trichrome was utilized to calculate the smooth muscle/collagen ratios.
EF was improved with VED therapy measured by ICP/MAP ratios and AUC. VED therapy reduced HIF-1α expression and AI significantly compared with control. Animals exposed to VED therapy had decreased TGF-β1 expression, increased smooth muscle/collagen ratios, and preserved ASMA and eNOS expression.
To our knowledge, this is the first scientific study to suggest that VED therapy in the BCNC rat model preserves EF through antihypoxic, antiapoptotic, and antifibrotic mechanisms.
Erectile dysfunction is the most common side effect after prostatectomy. There are currently five categories of available treatment options for erectile dysfunction for men following radical prostatectomy. The first and most common treatment is oral phosphodiesterase type 5 inhibitors (sildenafil, vardenafil, or tadalafil). Despite their popularity, these medications do not always produce an erection sufficient for intercourse after prostatectomy. The second treatment option is the noninvasive option of either a venous constriction band or the vacuum constriction device. Both treatments use a venous occlusive tension band or ring to maintain erection by retaining blood in the penis. The vacuum constriction device also utilizes external suction pressure to create an erection prior to application of the tension ring. The third treatment option is Muses, an intraurethral suppository containing alprostadil that dilates the penile blood vessels. The fourth treatment option involves penile injections. The fifth treatment is the penile prosthesis, in which artificial rods are surgically implanted into the corpora cavernosa to provide penile rigidity. Oral agents, the vacuum device, Muse, and injections have been used for penile rehabilitation to encourage spontaneous return of erectile function in men after radical prostatectomy with varied success. Untreated erectile dysfunction after radical prostatectomy has been associated with penile atrophy and further diminished erectile function. Therefore, it is critically important that clinicians provide comprehensive information about the positive and negative aspects of all treatment options and the penile rehabilitation potential of each. This will enable patients to make informed treatment choices about early intervention for erectile dysfunction.
The traditional theories believe that vacuum constriction devices (VCD) is the mechanism through a suction chamber promoting penile blood engorgement and maintaining tumescence with a constriction band. For that mechanical nature of the device, many authors and patients consider the devices are passive engorgement, lack of spontaneous erections, and only rely on the constriction bands to prevent venous outflow to maintain the erection. However, recent clinical studies show that many patients using the VCD devices without the constriction band, but still maintain the erections and return to natural erections. The current theories cannot explain this phenomenon. We think that the VCD devices not only through the mechanical nature to prevent venous outflow by the constriction bands to maintain the erection, but also through the suction chamber to stretch and stimulate the corpora cavernosa nerves, muscles, and blood vessels, and led to the neurotransmitter nitric oxide (NO) released. NO as the principal messenger molecule though the NO/cGMP signaling pathway to mediate corporal smooth muscle relaxation and penile erection. The relaxation of corporal smooth muscle creates pressure in the tunica albuginea can prevent venous outflow and maintain erection. This can explains the phenomenon of many patients using the VCD devices without the constriction bands also maintain the erections and return to natural erections. Thus, we put forward the hypothesis that the classical NO/cGMP signaling pathway is also involved in the penile erections when using the VCD devices. In the future, we could design and apply rat-specific VCD devices without the constriction bands in rat model to analyze the cell and molecular changes in rat corpora cavernosa to test this hypothesis.
To our knowledge we report the first large, randomized, prospective penile rehabilitation clinical trial to compare the effectiveness of nightly intraurethral alprostadil vs sildenafil citrate after nerve sparing prostatectomy.
We performed a prospective, randomized, open label, multicenter American study in men with normal erectile function who underwent bilateral nerve sparing radical prostatectomy. The International Index of Erectile Function erectile function domain was the primary end point. Subjects initiated nightly treatment within 1 month of surgery with intraurethral alprostadil or oral sildenafil citrate (50 mg) for 9 months. After 1-month washout and before sexual activity subjects self-administered sildenafil citrate (100 mg) for a total of 6 attempts in 1 month. Secondary end points were the global assessment question, sexual encounter profile, Erectile Dysfunction Inventory of Treatment Satisfaction and measured stretched penile length.
Of 139 men who started intraurethral alprostadil and 73 who started sildenafil citrate, 97 and 59, respectively, completed the trial. There were no statistically significant differences in International Index of Erectile Function erectile function domain and intercourse success rates to intraurethral alprostadil. The global assessment question was significantly better only at 6 months for intraurethral alprostadil (p <0.028). At completion there were no differences between treatments for any of the end points.
This is the first study to directly compare the ability of alprostadil and a phosphodiesterase-5 inhibitor to enhance penile recovery subsequent to bilateral nerve sparing radical prostatectomy. The use of nightly subtherapeutic intraurethral alprostadil is well tolerated after radical prostatectomy. The benefit to return of erectile function of nightly sildenafil citrate and subtherapeutic intraurethral alprostadil appears to be comparable within the first year of surgery.
Erectile dysfunction has usually been treated by a phosphodiesterase 5 inhibitor in men, especially in the past decade. Although sildenafil and vardenafil are widely used, there is a high percentage of people who do not respond to these drugs. This study was performed in order to evaluate the efficacy of the lastly presented phosphodiesterase 5 inhibitor, tadalafil, in nonresponder group of patients to sildenafil and vardenafil.
Forty married men with erectile dysfunction who had taken sildenafil or vardenafil at the maximum recommended doses and had not responded to the treatment were included. They were treated with tadalafil, 20 mg, at least 4 doses at different days. The effectiveness of the treatment was reviewed by different questionnaires, including the International Index of Erectile Function-5 (IIEF-5), Sexual Encounter Profile (SEP) questions 2 and 3, and the Global Assessment Question (GAQ), at the end of the 12th week.
The IIEF-5 scores were 11.90 +/- 4.78 and 12.67+/-6.70, before and after at least 4 doses of tadalafil, respectively (P = .30). The rate of positive responses to SEP2, SEP3, and GAQ questions were also insignificantly different after the treatment. During this period, flushing was seen in 10 and headache was seen in 5 patients.
The recommended maximum dose for tadalafil insignificantly improved the IIEF5, SEP2, SEP3, and GAQ scores in patients with erectile dysfunction who had not responded to sildenafil and vardenafil. The other treatment alternatives should be in mind after getting no response to the optimum doses and enough trials of sildenafil or vardenafil before trying a tadalafil regimen.
It has been suggested that the institution of a pharmacologically based penile rehabilitation program in the early stages after radical prostatectomy (RP) may benefit some patients.
This analysis was conducted to define if predictors of successful outcome with pharmacological penile rehabilitation following RP could be identified.
Retrospective statistical analysis was performed on a large database of patients who had participated in a post-RP rehabilitation program. Inclusion criteria included: presence of functional erections permitting sexual intercourse pre-RP and commencement of rehabilitation within 12 months of RP. Patients were instructed to obtain a penetration-rigidity erection on at least three occasions per week and to continue this regimen until at least 18 months after RP using either sildenafil or intracavernosal injection therapy (if oral therapy failed).
International Index of Erectile Function (IIEF) and visual analog scale erectile rigidity assessment. Stepwise logistic regression analysis was used to generate predictors of erectile function (EF) outcomes with penile rehabilitation.
Ninety-two patients constituted the study population. Mean patient age and duration post-RP at commencement of the rehabilitation program were 59 +/- 10 years and 7 +/- 3 months, respectively. Sixty-seven percent of operations were bilateral nerve sparing (BNS), 11% unilateral nerve sparing (NS), and 22% non-NS. Comorbidities included hypertension 22%, dyslipidemia 30%, coronary artery disease 7%, and diabetes 2%. Preoperative mean self-reported, partner-corroborated erectile rigidity during relations was 90 +/- 20%. At 18 months post-RP, 57% patients had partner-corroborated functional erections without phosphodiesterase type 5 inhibitors with a mean erectile rigidity during relations of 72 +/- 16% compared with 45 +/- 22% for those who denied functional erections postoperatively (P > 0.01). The IIEF-EF domain scores in these two cohorts were 21 +/- 7.5 and 13 +/- 9, respectively (P > 0.01). On multivariate analysis, factors that predicted failure of return of natural erections after RP having followed a rehabilitation program were age >60 years (relative risk [RR] = 1.3), non-BNS surgery (RR = 1.6), presence of >1 vascular comorbidity (RR = 2.1), commencement of rehabilitation >6 months post-RP (RR = 2.8), unsuccessful response to sildenafil at 12 months post-RP (RR = 4.5), and the use of trimix dose >50 units (RR = 8.1).
More than half of the patients committing to a pharmacological rehabilitation program had return of functional natural erections. Predictors of successful outcome included NS surgery, early post-RP presentation, young age, and absence of vascular comorbidities.
Radical prostatectomy (RP) remains the standard treatment for men with clinically localized prostate cancer, despite the range of alternative treatment modalities. Even with significant advances in surgical technique and superb results for cancer control and preservation of urinary function, erectile dysfunction (ED) following RP is a common complication. This is mainly attributed to temporary cavernous nerve damage (neuropraxia) resulting in penile hypoxia, smooth muscle apoptosis, fibrosis and veno-occlusive dysfunction. One of the most promising new approaches is the concept of early penile rehabilitation, which is thought to prevent ED after RP by countering post-RP pathophysiological changes during the period of neural recovery. Various treatments, such as vacuum constriction devices, intraurethral and intracorporal alprostadil, and phosphodiesterase type 5 (PDE5) inhibitors, might serve to facilitate recovery of erectile function. PDE5 inhibitors are considered as the first-line treatment for early penile rehabilitation, with superior erectile function outcomes compared to placebo. Definitive conclusions regarding the success of penile rehabilitation cannot be drawn at this time because of differences in study design, data acquisition, and definitions of potency. Continued prospective, rigorous study is needed to develop and bring forward this important field and to establish the best evidence basis for counseling and treating patients suffering from ED after RP.
Oral phosphodiesterase type 5 inhibitors (PDE5i) have improved treatment options for erectile dysfunction (ED). In case of unresponsiveness to PDE5i, alternative therapies are considered.
To evaluate whether combination of vacuum erection device (VED) and PDE5i is effective as salvage therapy in subjects with ED in whom PDE5i alone failed.
From September 2007 to May 2008, we evaluated 69 men (aged 36-82 years) in whom PDE5i treatment at the highest recommended dose, with at least 4-6 attempts at intercourse during a 3 months period, had failed. The clinical efficacy of combination therapy was evaluated using the International Index of Erectile Function-5 (IIEF-5) questionnaire, Sexual Encounter Profile (SEP)-2, SEP-3, and Global Patient Assessment Scale (GPAS).
Scores on IIEF-5, SEP-2, SEP-3, and GPAS before and after combination therapy were measured.
After 4 weeks of combination therapy, the mean IIEF-5 score increased significantly over baseline from 9.0 to 17.6 (P < 0.001). Of the 34 subjects with a SEP-2 response of "no" at baseline, 27 (79%) responded "yes" after combination therapy (P < 0.001). Of the 50 subjects with a SEP-3 response of "no" at baseline, 35 (70%) responded "yes" after combination therapy (P < 0.001). Furthermore, of the 42 subjects with a GPAS response of "not at all" or "slightly" improved at baseline, 31 (74%) responded "moderately" or "greatly" improved after combination therapy (P < 0.001). One subject (1.5%) experienced device-related intermittent penile pain, which resolved after 4 days without any action.
Statistically significant improvements over baseline were seen in IIEF-5, SEP-2, SEP-3, and GPAS measures following 4 weeks of combination therapy of PDE5i and VED. This study supports the use of PDE5i with VED in men in whom PDE5i alone failed. This combination therapy may be offered to patients not satisfied with PDE5i alone before being switched to more invasive alternatives.
Vacuum erection devices (VED) are becoming first-line therapies for erectile dysfunction and preservation (rehabilitation) of erectile function following treatment for prostate cancer. Currently, phosphodiesterase-5 inhibitors have limited efficacy in elderly patients or patients with moderate to severe diabetes, hypertension, and coronary artery disease. Alternative therapies, such as VED, have emerged as a primary option for patients refractory to oral therapy. VED has also been successfully used in combination treatment with oral therapy and penile injections. More recently, there has been interest in the use of VED in early intervention protocols to encourage corporeal rehabilitation and prevention of post-radical prostatectomy venoocclusive dysfunction. This is evident by the preservation of penile length and girth seen with the early use of the VED following radical prostatectomy. There are ongoing studies to help preserve penile length and girth with early use of VED following prostate brachytherapy and external beam radiation for prostate cancer. Recently, there has also been interest in VED to help maintain penile length following surgical correction of Peyronie's disease and to increase penile size before implantation of the penile prosthesis.
Erectile dysfunction is common after radical prostatectomy. Erectile dysfunction has a negative impact on health-related quality of life. Penile rehabilitation is defined as the use of any drug or device at or after radical prostatectomy to maximize erectile function recovery. This is an up-to-date review of the current state of science supporting penile rehabilitation after radical prostatectomy.
The purpose of penile rehabilitation is to prevent corpus cavernosal smooth muscle structural alterations to not only maximize the chances of a man to recover functional erections but also return him to his preoperative erectile function level. Current animal and human data support the use of PDE5 inhibitor and the generation of early erections after radical prostatectomy as a strategy to improve erectile function recovery. The magnitude of this improvement is currently unclear.
The results from animal and human studies imply that the use of PDE5 inhibitor and the generation of erections early after radical prostatectomy are of some benefit to erectile function recovery. Although the definitive protocol for rehabilitation is not defined, future work is aimed at determining this.
Sexual dysfunction is a frequent result of traumatic and non traumatic neurological disorders, including spinal cord injury, stroke, traumatic brain injury and autonomic neuropathy (for example, as may be seen in patients with diabetes mellitus). Although many methods have been suggested for the treatment of some of these problems in male patients, most are invasive and have a substantial morbidity. This is the report of a pilot trial of vacuum tumescence constriction therapy for 30 patients with chronic neurological impotence. Seventeen of these patients, following sexual counselling and training, decided to purchase such a device. At follow up, a mean of 21 months, over 50% of those who had purchased the device were still actively using it. The frequency of coitus increased from 0.3/wk to 1.5/wk (t = -5.7; p less than 0.0001). No significant morbidity was reported by patients. Vacuum tumescence constriction therapy shows promise as a noninvasive method for the treatment of neurological impotence.
Duplex ultrasound with pulsed Doppler and color flow sonography were used to image the penis and conduct blood flow velocity studies in 5 patients. Cavernous body cross sectional area, cavernous artery diameters and peak systolic velocities were measured in the flaccid shaft, after transient exposure to negative pressure in a vacuum constriction device, and with a vacuum constriction device band applied to the tumescent shaft. We found that exposure to vacuum transiently increased central cavernous arterial blood flow velocities compared to baseline values in all patients. After a trial of a vacuum constriction device and application of the constricting band cavernous body cross sectional areas doubled. Despite increased cavernous arterial diameters in 4 of 5 patients and increased blood flow in all patients after vacuum-induced tumescence alone, we could not visualize arterial inflow in the penile shaft once the constricting band was in place. Color Doppler ultrasound can detect cavernous artery systolic flow as low as 2 to 9 cm. per second. Our data suggest that the erectile state maintained distal to the vacuum constriction device band is low flow and relatively ischemic.
The treatment of impotence in diabetic men with vacuum tumescence therapy was studied in a specialist clinic. Of 54 diabetic men referred with impotence, seven declined treatment, three chose self-injection with papaverine, and 44 chose vacuum therapy. Patients underwent autonomic function testing (heart rate response to respiration), measurement of penile blood flow (duplex Doppler scanning), and estimation of serum prolactin and testosterone levels. After 2 months, 33 men (75%) were able to have satisfactory intercourse using vacuum therapy. Three others could produce a satisfactory erection with vacuum therapy but their partners found it unacceptable. Eight men (18%) were unable to have satisfactory intercourse; six of these were later treated by self-injection. The median frequency of use of vacuum therapy was 5.5 (1-26) times a month. Outcome was independent of penile blood flow, autonomic function or endocrine status. Impotent diabetic men should be given counselling and offered a choice of the available treatments. Vacuum tumescence therapy is an effective and simple treatment which requires little investigation.
Vacuum constriction devices for the treatment of impotence achieve entrapment of blood in the penis following mechanically produced tumescence. Following application, blood flow is sustained, and the majority of users can achieve either an erection or an erection-like state that is satisfactory for intercourse. Properly motivated men can use these devices long-term without serious side effects. The devices are particularly effective in the management of partial impotence; they represent an attractive alternative to surgical procedures upon the penis, intracavernosal injection of vasoactive drugs, and sexual abstinence.
The majority of spinal cord injured (SCI) men with upper motor neuron lesions have reflex erections. However, these erections are often not adequately sustained making it difficult if not impossible to have intercourse. The majority of SCI men with lower motor neuron lesions do not have erections. Penile implants are effective in producing erections following SCI. However, they have the disadvantages of being a surgical procedure and of having the risk of infections and erosion of the implant through the skin. Intracavernous injections of papaverine and phentolamine and vacuum erection devices have recently been added to our armamentarium of ways to treat erectile dysfunction. A major concern particularly in SCI men is that papaverine and phentolamine may cause prolonged erections in SCI men. We presently have little data on the use of vacuum devices in SCI men, but preliminary reports on those who are using FDA-approved devices appear promising.
Patient acceptance of and satisfaction with an external negative pressure device as a treatment for impotence were retrospectively analyzed among 100 men. The over-all satisfaction rate was 68%. Reasons for dissatisfaction with and discontinuing the use of the device included premature loss of penile tumescence and rigidity, pain or discomfort either during application of suction or during intercourse and inconvenience. Negative pressure therapy is an effective treatment for impotence of various etiologies and should be among treatment options offered to the impotent patient.
The Synergist erection system is a silicone sheath vacuum device for management of erectile dysfunction. The efficacy of this device was assessed in the spinal cord injured population. All patients were referred through a spinal cord injury center at a major medical facility. Twenty patients with neurogenic impotence, who were injured at least one year previously and who had a regular sexual partner, were evaluated. Erectile function was assessed by neurologic examination, patient and partner questionnaires, and snap-gauge evaluations. Overall, patient and partner assessments of device efficacy and sex life satisfaction with the device were very good to excellent. The device was simple to use and without significant side effects. In our initial experience, the Synergist system was an effective, safe, noninvasive alternative for the management of impotence secondary to cord injury.
A mechanical device for treatment of impotence based on the concept of entrapment of blood in the penis following vacuum-assisted tumescence is described and more than 15,000 units have been marketed. A total of 1,517 users who acquired the device between 1974 and 1987 completed a questionnaire concerning the system. Of these patients 92 per cent either achieved an erection or an erection-like state that was satisfactory for intercourse and 77 per cent had intercourse at least every 2 weeks. No serious ill effect from use of the device has been reported a and it is particularly effective in the management of partial impotence. In selected patients the device is an alternative to either surgical placement of a penile prosthesis, intracavernous injection of vasoactive drugs or sexual abstinence.
Intracavernous injections and vacuum constrictor devices have been used for the nonoperative management of impotence and sexual dysfunction. Although most men are able to use these methods successfully, it currently is well known that up to 30 to 35 per cent of the patients may have only a partial response to the injections. We observed 22 men with partial tumescence after an intracavernous injection of papaverine (15 to 30 mg.) and phentolamine (0.5 to 1.0 mg.). The penis was not rigid and the buckling pressures never exceeded 50 mm. Hg after 20 minutes of observation. In each case we immediately applied a vacuum constrictor device because these devices had been used successfully by other men with similar diagnoses. A total of 21 men responded within 30 to 60 seconds and achieved a rigid erection with buckling pressures of greater than 100 mm. Hg (16) and 60 mm. Hg (5). These findings indicate that a vacuum constrictor device may be used to augment a partial response to an intracavernous injection and that the availability of injections and vacuum constrictor devices provides these men with a more complete nonoperative program.
In 35 men with organic impotence we have tested a noninvasive device which uses a vacuum to produce an erection-like state and rubber bands to maintain this state. The subjects were first evaluated to determine the cause of their impotence and to establish that it had an organic basis. Using this device 32 of the 35 subjects achieved penile rigidity sufficient for vaginal penetration. Subjects were studied with the rubber bands constricting the base of the penis for thirty minutes. During that period, blood flow continued, but at a less than normal rate. Of 30 men followed up from eight to twenty-two months, 24 use the device regularly and report that they are satisfied. Four subjects have not yet tried to use it, and 1 no longer needs it. One man was dissatisfied because the rigidity begins to decrease after five to ten minutes of sexual activity, even though it did not change over a thirty-minute period when originally tested in the laboratory. Ecchymoses of the penis, probably due to excess vacuum, developed in 3 subjects. In 8 other men petechiae of the skin of the penis developed on one or more occasions. These ecchymoses and petechiae were painless and disappeared without treatment. No other complications occurred. The vacuum device appears to be a safe and inexpensive way for an impotent man to make the penis rigid enough to engage in sexual intercourse.
In patients who recover erectile function after radical prostatectomy (with preservation of at least 1 neurovascular bundle), a recovery time of 6 to 18 months is not uncommon. As this is also the usual time required for regeneration of spinal nerves, we believe that regeneration of cavernous nerves, partially damaged inadvertently, may be responsible. In a rat model, we examined the long-term effect of unilateral and bilateral cavernous nerve transection on the nonadrenergic/noncholinergic (NANC) nervous system and erectile function.
To determine the efficacy and possible beneficial effects of the Catalyst vacuum device (VD) in the treatment of impotence, the ischaemic state of the penis after application of a constriction ring and the origin of the blood in the corpus cavernosum after application of the VD.
Thirty men (mean age 62 years; range 46-76) suffering from erectile dysfunction were selected for the trial after using the VD for 2 weeks at home. Changes in penile tumescence and rigidity before, during and after the VD were assessed using the Rigiscan monitor. Blood gas analysis (BGA) was performed in selected patients whilst using the VD, allowing calculation of the proportional contribution of venous and arterial blood to the increase in penile volume. The efficacy of the VD was also assessed by questionnaires completed before treatment and at the 6 month follow-up.
Four patients were lost to follow-up but the 26 impotent men who used the VD for 6 months were able to have sexual intercourse after using the VD. The average rigidity measured at the base and tip of the penis after application of the VD was > 80%. The duration and extent of nocturnal penile tumescence and rigidity at the start and the end of the study improved, although only one variable increased significantly. Patients reporting spontaneous morning erections showed significant improvements in total erection-time, erection-phase and plateau-phase duration, effective rigidity and tumescence increase. BGA determined 30 min after applying a constriction ring showed ischaemia of the penile blood and the mean contribution of arterial and venous blood to penile blood volume was by 58 and 42%, respectively.
The efficacy of the Catalyst vacuum device was objectively determined and the quality of the nocturnal erections improved in some patients. After application of a constriction ring an ischaemia of the penis developed. In contrast to previous reports, the increased penis volume during the application of the VD is caused not only by arterial inflow but also by venous backflow.
We studied the effect of combining intracavernous injection and an external vacuum in 10 men with erectile dysfunction who previously failed attempts at treatment with either method as single therapy. We measured the length, circumference and buckling pressure of the penis at baseline, after applying negative pressure (250 mm. Hg for 2 minutes), 15 minutes after intracavernous injection of 60 mg. papaverine or 30 micrograms prostaglandin E1 and after combining both modalities. No patient achieved adequate rigidity (defined as a penile buckle pressure greater than 450 gm.) with single therapy. The mean buckle pressure using vacuum alone was 125.0 +/- 53.6 gm. After intracavernous injection the mean buckle pressure was 117.0 +/- 38.3 gm. In contrast, all 10 subjects responded to combination therapy with a mean buckle pressure of 565.0 +/- 56.8 gm. (p < 0.0001). After 10 months of followup 3 subjects were still using the combination and were satisfied with the erectile response, 1 found that he no longer needed the addition of external vacuum after using combination therapy for 3 months, 1 used the combination for 9 months and then stopped because of an intervening acute illness, 1 lost the partner due to death, 2 found combination therapy to be too cumbersome and 2 were lost to followup. We conclude that external vacuum devices can augment a partial response to intracavernous injection and the combination may be an alternative treatment before intrapenile prosthesis implantation.
To establish the efficacy of a vacuum device (ErecAid) in the management of organic impotence.
Cohort study; questionnaire before and after a 6-month study period.
Groote Schuur Hospital, Cape Town.
A total of 19 men with organic impotence, 8 diabetic and 11 with previous pelvic surgery or radiotherapy.
Vacuum device (ErecAid, Osbon Medical Systems).
Efficacy of ErecAid.
Six of 8 diabetics and 6 of 11 non-diabetics reported successful intercourse, while 16 of the participants would recommend the device to others. Some difficulty with the device was experienced by 11 and only 9 described an increase in self-esteem.
Although some difficulties may be experienced in the use of the ErecAid, it clearly has a role to play in the management of patients with organic impotence, who ideally should be able to select their preferred form of therapy.
Erectile dysfunction is a common feature in men with diabetes. The efficacy and acceptability of a new battery-powered vacuum assist device, the 'Active' was assessed over 6 months in 19 diabetic men, median age 59 (38-66) years, of whom 9 had ECG evidence of autonomic neuropathy. Their pre-treatment duration of impotence was 24 (12-168) months and their expectation of restored sexual activity was 8 (1-28) times per month. The effect of the device was assessed using visual analogue scales (range 1-10) at 3 and 6 months. Eleven patients continued to use their device over 6 months. Self-assessment values for sexual satisfaction, partners's sexual satisfaction, and self-esteem significantly increased over 6 months. In those continuing to use the device, it was considered highly effective, painless in use and not embarrassing. Despite wearing a constriction ring to maintain their erection, ejaculation was satisfactory. The device was used four times per month on average.
We provide current, normative data on the prevalence of impotence, and its physiological and psychosocial correlates in a general population using results from the Massachusetts Male Aging Study. The Massachusetts Male Aging Study was a community based, random sample observational survey of noninstitutionalized men 40 to 70 years old conducted from 1987 to 1989 in cities and towns near Boston, Massachusetts. Blood samples, physiological measures, socio-demographic variables, psychological indexes, and information on health status, medications, smoking and lifestyle were collected by trained interviewers in the subject's home. A self-administered sexual activity questionnaire was used to characterize erectile potency. The combined prevalence of minimal, moderate and complete impotence was 52%. The prevalence of complete impotence tripled from 5 to 15% between subject ages 40 and 70 years. Subject age was the variable most strongly associated with impotence. After adjustment for age, a higher probability of impotence was directly correlated with heart disease, hypertension, diabetes, associated medications, and indexes of anger and depression, and inversely correlated with serum dehydroepiandrosterone, high density lipoprotein cholesterol and an index of dominant personality. Cigarette smoking was associated with a greater probability of complete impotence in men with heart disease and hypertension. We conclude that impotence is a major health concern in light of the high prevalence, is strongly associated with age, has multiple determinants, including some risk factors for vascular disease, and may be due partly to modifiable para-aging phenomena.
Treatment of sexual dysfunction is an integral part of the rehabilitation of the patient with spinal cord injury. The degree of sexual dysfunction varies with the level and completeness of injury. A multidisciplinary approach is necessary to evaluate and treat these patients. Intracorporeal injections of vasoactive medications or vacuum devices are effective means of restoring erections in selected patients with spinal cord injury. Penile prostheses are rarely indicated for this purpose.
From November 1985 to April 1990, 216 consecutive patients were treated with the vacuum constriction device. Patients were mailed an initial questionnaire (group 1) and a long-term questionnaire (group 2) at a median followup of 3 and 29 months, respectively. Of 202 available patients 161 in group 1 (75%) and 115 in group 2 (57%) responded. Regular use of the vacuum constriction device was reported by 69% group 1 and 70% group 2 patients. patient and partner satisfaction was 82% and 87% in group 1, and 84% and 89% in group 2, respectively. There were no significant differences between the groups with respect to regular use and patient or partner satisfaction (p < 0.05). Quality of erection was evaluated for hardness, length and circumference, and with satisfaction greater than 90% in both groups. Median times per month of successful intercourse were 1, 4 and 4 for the year before, during and after obtaining the vacuum constriction device in group 2. Also, 79% of the patients in group 2 reported a statistically significant increase in the frequency of intercourse per month in the first year, which was sustained beyond the first year in 77% (p < 0.01). Our results support the efficacy of the vacuum constriction device for the treatment of impotence. Overall regular use rates as well as patient and partner satisfaction appear to be high. Furthermore, excellent initial results appear durable in most patients.
To assess the efficacy of and patient and partner satisfaction with a vacuum erection device (VED) to treat erectile dysfunction of spinal cord injury.
Case series.
University hospital outpatient clinic.
Twenty spinal cord injured men with erectile dysfunction and their heterosexual partners, recruited from outpatient population and by advertisement.
Use of a VED to obtain erections for sexual activity.
Efficacy in obtaining adequate penile erection, and patient and partner satisfaction with the device (survey).
At 3 months, 93% of the men and 83% of the women reported rigidity sufficient for vaginal penetration, with an average duration of 18 minutes. These numbers decreased somewhat at the 6-month control. At 6 months, 41% of the men and 45% of the women were satisfied with the device, with premature loss of rigidity during intercourse the most commonly reported complaint. Sixty percent of men and 42% of women indicated an improvement of the sexual relationship. Minor side effects, such as petechiae and penile skin edema, occurred frequently, but there were no complications that required treatment.
The VED is effective in many couples in the treatment of erectile dysfunction associated with spinal cord injury. The devices were not universally accepted, but had a significant impact on sexual activity and sexual satisfaction for nearly half the couples. Vacuum erection devices should be presented to SCI men along with other options for treatment of erectile dysfunction.
This study is a prospective multicenter cooperative survey of the evaluation and treatment of erectile dysfunction in men with spinal cord injury (SCI). Uniform database questionnaires were completed prospectively by patients seeking therapy for erectile dysfunction. Eighty-five SCI men aged 17-68 years (mean age = 26 +/- 17) were enrolled. Mean duration of traumatic SCI was 3 +/- 3.2 years (Range = 0.3-18 years). The level of injury was cervical in 20 patients, thoracic in 31, lumbar in 29 and sacral in five. Patients were fully evaluated and then counseled as to their therapeutic options. Twenty-eight chose to use a vacuum erection device (VED), 26 preferred pharmacological penile injection and five used both intracorporeal therapy and VED. The remainder were managed with marriage and sexual counseling in 10 patients, three underwent penile prosthesis placement and two used topical pharmacotherapy. Four patients used other forms of treatment and in nine no therapy was recommended. Of the patients that used pharmacologic injection only, 74 percent used papaverine as a single agent, 20 percent used papaverine with phentolamine, five percent used prostaglandin E (PGE1) alone and one percent used a mixture. Patients using injection therapy report sexual intercourse a mean of 3 +/- 3.4 times per month as compared with 5 +/- 3.2 times per month in those using VED. Five intracorporeal injection patients developed priapism while two patients using the VED developed subcutaneous bleeding and one developed penile ischemia. We conclude that although a spectrum of erectile dysfunction treatment is present among SCI centers, VED and pharmacological penile injection are by far the two most popular methods of treatment and papaverine is the most common drug. The incidence of complications is small in the model centers.
Neurogenic factors contributing to erectile dysfunction may be found in up to 20 per cent of organically impotent men. Although many options have been suggested for the treatment of some of these problems in male patients, most are invasive and have substantial morbidity.
Our study group comprised 32 patients with spinal cord injury. These 32 patients with neurogenic impotence, who had been injued at least one year previously and had a regular sexual partner were evaluated. We selected external vacuum therapy as the treatment modality.
During the initial phase of the study, six patients refused treatment due to negative cultural perception and they were excluded from the study group. Four patients discontinued treatment because of minor complications such as ecchymoses, petechiae and lack of motivation.
Our data suggest that external vacuum therapy is a feasible, safe, noninvasive alternative and possibly a better initial treatment for the management of impotence secondary to spinal cord injury.
This review assesses the continuing role of noninvasive vacuum therapy as treatment for erectile dysfunction and discusses the action of negative pressure in producing assisted erection. Through recent research in this area has centered on the development of pharmaceutical therapies, vacuum-therapy programs appear to be a consistent long-term option for patients experiencing either chronic or occasional impotence of any etiology. Very little testing is required before the initiation of vacuum treatment, and the overall; clinical success rate is approximately 90%. Significant success has been reported in more difficult patient populations, including those with veno-occlusive disorders and explanted penile prostheses. Vacuum therapy may also be used in conjunction with other therapies to enhance results. Contraindications to the use of vacuum therapy are few and primarily include patients with unexplained intermittent priapism and bleeding disorders. Side effects such as occasional numbness, pain, penile bruising, or petechiae have a low incidence. A recently reported survey of 5,847 vacuum users showed that 83.5% of patients continue to use the device for intercourse as desired. Patients should receive individual instruction in the use of these devices and should expect a learning or practice period to achieve optimal results. As newer treatments for erectile dysfunction gain increasing attention, it should be kept in mind that nearly every patient showing impotence of any degree or duration as well as patients who have failed other therapeutic choices are candidates for vacuum therapy.
This study was aimed at assessing prospectively the effect of postoperative intracavernous injections of alprostadil on the recovery of spontaneous erectile function after nerve-sparing radical retropubic prostatectomy.
A total of 30 potent patients with clinically localized prostate cancer (clinical stage B1 or B2, Gleason sum 7 or greater, prostatic specific antigen less than 20 ng./ml.) underwent nerve-sparing radical retropubic prostatectomy and was subsequently randomized to alprostadil injections 3 times per week for 12 weeks (group 1, 15 patients) or observation without any erectogenic treatment (group 2, 15 patients). Patients were assessed at the 6-month followup by sexual history, physical examination, color Doppler sonography of the cavernous arteries and polisomnographic recording of nocturnal erections.
In group 1, 12 patients (80%) completed the entire treatment schedule and were evaluated at the long-term followup. Eight patients in this group (67%) reported the recovery of spontaneous erection sufficient for satisfactory sexual intercourse, compared with 3 patients (20%) in group 2. The difference between the 2 groups was statistically significant (p <0.01). In group 1, all but 1 patient reporting normal postoperative erections also showed normal erections at nocturnal testing, whereas color Doppler sonography demonstrated normal penile hemodynamics in all of them. In these patients, failures were the result of cavernous veno-occlusive dysfunction (2 cases, 17%) and cavernous nerve injury (2 cases, 17%). In group 2, patients with normal erections showed both normal nocturnal testing and penile hemodynamics, whereas failures were the result of cavernous veno-occlusive dysfunction (8 cases, 53%), cavernous arterial insufficiency (2 cases, 13%) or cavernous nerve injury (3 cases, 20%). Complications in patients treated with alprostadil injections accounted for 2 cases (13%) of a penile nodule and 1 further case (6%) of prolonged penile erection. Complications were not seen in group 2 patients.
Early postoperative administration of alprostadil injections significantly increases the recovery rate of spontaneous erections after nerve-sparing radical retropubic prostatectomy. It is our belief that programmed vasoactive injections improve cavernous oxygenation, thereby limiting the development of hypoxia-induced tissue damage. The potential complications related to the use of intracavernous injections must be clearly explained to patients.
Sexual dysfunction remains a common and often distressing problem in the male dialysis population. Traditionally its management has consisted of correction of anemia, optimization of dialysis, removal of implicated medication, and finally depot injections of a testosterone ester. At a dedicated renal impotence clinic, we studied the effectiveness of testosterone replacement in men with biochemically proven hypogonadism and then vacuum tumescence therapy in those with continued erectile dysfunction. Depot testosterone was given to 27 patients (aged 52.4+/-2.5 years; duration of dialysis, 2.00+/-0.40 years; and duration of sexual dysfunction, 2.92+/-0.49 years): sexual function was fully restored in only three (11.1%), and two gradually lost the response over 18 months. Nineteen patients (70.3%) had partial responses, varying from an increased sense of well-being alone to restored sexual function apart from an impairment of the duration of penile erection. Five patients (18.5%) had no response, and testosterone was contraindicated in another four. Four of the treated patients (14.8%) reported fluid retention. Vacuum tumescence devices were then offered to 32 patients who remained impotent but declined by six. Twenty-six patients (aged 49.6+/-2.2 years; duration of dialysis, 2.50+/-0.58 years; and duration of sexual dysfunction, 3.26+/-0.56 years) used the devices, with 19 (73.1%) having full correction of their erectile dysfunction; six also continued with depot testosterone to maintain their libido. Penile discomfort was described by five patients (19.2%) whose potency was not restored. A further five predialysis patients have used the devices, and all had correction of their erectile dysfunction. The correction of biochemical hypogonadism in the male dialysis population with testosterone rarely restores sexual function to normal, whereas vacuum tumescence therapy corrects penile erection dysfunction in most patients.
In a retrospective study, the medical and psychological outcome of the use of external vacuum devices in the treatment of erectile dysfunction in 190 patients was evaluated, using a questionnaire and a clinical examination. 110/190 patients (57.8%) answered the questionnaire. 22/110 patients (20%) rejected the device primarily and 34/110 (30.9%) after a period of up to 16 weeks (primary rejection rate 50.9%). A secondary drop-out rate of 8/110 (7.3%) was observed after an intermediate time of 10.5 months. 46/110 (41.8%) patients were long-term users (median 27.6 months, range 7-70 months). Long-term users were mainly patients who did not respond to intracavernosal pharmacotherapy. In the group of long-term users, 98% of patients and 85% of their partners were satisfied with the vacuum therapy. Complications were minor (hematoma 9.8%; skin injury 2.2%), 69.8% of long-term users never had problems with the device. 74% of users reported regular orgasm. Vacuum therapy is a safe and effective non-invasive treatment of erectile dysfunction with a limited primary acceptance and low drop-out rates in long-term follow-ups.
We determine the impact of nerve sparing techniques on quality of life after radical retropubic prostatectomy for prostate cancer.
The RAND/UCLA Prostate Cancer Index and several questions about surgical outcomes, including sexual function, were sent to 170 consecutive patients at least 1 year after radical retropubic prostatectomy. Statistical analysis was performed on data for the entire group as well as subgroups of patients after nerve sparing and nonnerve sparing surgery.
Nonnerve sparing surgery was performed in 83 of 129 responders (nonnerve sparing group) and the remaining 46 were treated with unilateral nerve sparing surgery (nerve sparing group). Scores for sexual function, sexual bother, physical function and physical limitation domains were significantly better in the nerve sparing group. Spontaneous erectile activity was reported by 50% of nerve sparing group patients. Nerve sparing status did not affect urinary function, bowel function or disease outcome.
Nerve sparing techniques have positive effects on quality of life and sexual function for patients undergoing radical retropubic prostatectomy.