Article

Comparison of Satisfaction Rates and Erectile Function in Patients Treated with Sildenafil, Intracavernous Prostaglandin E1 and Penile Implant Surgery for Erectile Dysfunction in Urology Practice

Authors:
To read the full-text of this research, you can request a copy directly from the authors.

Abstract

We compared erectile function status and satisfaction rates in patients who received treatment for erectile dysfunction (ED) with sildenafil, intracavernous prostaglandin E1 (ICI) and penile implant surgery (IPP). A total of 138 consecutive patients who received treatment for ED between April 2000 and April 2001 were considered candidates for study. Mean followup was 19.54 months. Of the patients 27 were not available for followup and 26 were not on any form of treatment. Of the patients receiving treatment for ED 85 were administered the Erectile Dysfunction Inventory for Treatment Satisfaction (EDITS) questionnaire and the Erectile Function Domain (EFD) of the International Index of Erectile Function questionnaire. Three treatment groups were identified, including 31 patients on sildenafil citrate, 22 on ICI and 32 who underwent IPP. Mean total EDITS, EDITS Index and EFD scores in the 3 groups were considered for statistical evaluation. There was no statistical difference in the total EDITS (25.59 versus 27.06, p = 0.48), EDITS Index (58.16 versus 61.15, p = 0.49) or EFD (22.91 versus 20.26, p = 0.12) score between the groups on ICI and sildenafil citrate, respectively. Total EDITS, EDITS Index and EFD scores were significantly higher in patients who underwent IPP than those on sildenafil citrate (36.09 versus 27.06, p <0.001, 82.03 versus 61.51, p <0.001 and 27.88 versus 20.26, p <0.001, respectively). Total EDITS, EDITS Index and EFD scores were significantly higher in patients who underwent IPP than those on ICI (36.09 versus 25.59, 82.03 versus 58.16 and 27.88 versus 22.91, respectively, all p <0.001). At a mean followup of 19.54 months patients who underwent penile implant surgery had significantly better erectile function and treatment satisfaction than those receiving sildenafil citrate and intracavernous prostaglandin E1.

No full-text available

Request Full-text Paper PDF

To read the full-text of this research,
you can request a copy directly from the authors.

... Some have relied on surgeon self-assessment whereas others have used a variety of questionnaires, including the international index of erectile function (IIEF) questionnaire, 1,3,6,9,10 and the erectile dysfunction inventory of treatment satisfaction (EDITS) questionnaire. 4,7,8,10 Others used simplified postoperative satisfaction scales. 11 It is worth mentioning that none of these measurements tools have been validated to measure post-PI satisfaction specifically. ...
... Thus, a variety of questionnaires have been used for this purpose. Most studies have utilized the IIEF questionnaire, 1,3,6,9,10 or the EDITS questionnaire, 4,7,8,10 although neither has been validated for the PI population, thus interpreting data from such studies is fraught with problems. Some investigators have used a simple postoperative satisfaction 1 to 5 scale, 11 while others have used simple questions about the procedure by structured telephone interviews. ...
Article
Full-text available
Introduction: Despite the high satisfaction with penile implant (PI) surgery reported in the literature, a significant proportion of patients remain dissatisfied. Aim: To evaluate satisfaction after PI surgery, using a single question and a scoring system. Furthermore, we attempted to define factors that predicted high patient satisfaction. Methods: The study population consisted of all patients undergoing PI surgery between 2009 and 2015. Comorbidity, demographic, and implant information were recorded. Complications recorded included: minor (requiring no re-operation) such as penile or scrotal hematoma, superficial wound breakdown; major (requiring hospitalization or re-operation) such as device infection, erosion, and mechanical malfunction. Patient satisfaction was defined using a single question posed to the patient 6 months after surgery using a 5-point Likert scale (5 being the most satisfied). Descriptive statistics were used to define complication rates and multivariable analysis (MVA) was performed to define predictors of high satisfaction (score ≥ 4), including presence and degree of complications, Peyronie's disease (PD), diabetes mellitus (DM), number of vascular comorbidities, body mass index (BMI) > 30, and patient age. Main outcome measure: Patients with a major complication, with or without an additional minor complication, had a higher likelihood of being dissatisfied (25%) compared to patients with no complication or only minor complication 1.9% (no complications) and 3.7% (only minor complications), P < .001. Results: 902 patients were analysed. Mean age was 56.6 ± 10.6 years. Mean BMI was 30 ± 5. Comorbidity profile was diabetes 75%, dyslipidaemia 44%, hypertension 33%, cigarette smoking 32%, and PD 34%. 76% had a malleable implant (MPP) and 24% an inflatable implant (IPP). 31% had a minor complication and 9% a major complication. 93% had high satisfaction (score ≥4). Patients with any complication had a reduced rate of high satisfaction (97.5% vs 87.7%; P < .001) and even more pronounced with a major complication (96.7% vs 64.2%; P < .001). On MVA, only the absence of a major complication was a significant predictor of high satisfaction (OR 20, 95% CI 9-50, P < .001). Conclusion: A high percentage of men are satisfied after penile implant surgery. Only the presence of a major complication is linked to a lower likelihood of achieving high satisfaction. Habous M, Tal R, Tealab A, et al. Predictors of Satisfaction in Men After Penile Implant Surgery. J Sex Med 2018;XX:XXX-XXX.
... According to the literature, ICI treatment had an efficient response rates of erectile function in the patients with ED (Hatzimouratidis et al., 2010;Rajpurkar & Dhabuwala, 2003). Parallel to the guidelines, in our routine clinical practice, we use ICI treatment as second-line treatment method if patient is not willing to use or not gain benefit from oral PDE5I (Hatzimouratidis et al., 2010). ...
... Parallel to our study results, in the study that compared sildenafil, ICI prostaglandin E1, and penile implant, there was no statistical difference in the total EDITS scores between the groups on ICI and sildenafil citrate, but penile implantation EDITS scores were significantly higher than both other treatments. The most common problem with ICI, which observed in this study, is dropouts because of inconvenience (Rajpurkar & Dhabuwala, 2003). Mulhall and Simmons compared ICI and sildenafil, no difference was observed in the terms of IIEF-EF domain but EDITS scores were higher in ICI group (Mulhall & Simmons, 2007). ...
Article
There are various treatment modalities for erectile dysfunction with different success and satisfaction rates. We aim to compare patient satisfaction with tadalafil, intracavernosal injection, and penile prosthesis implantation in patients with erectile dysfunction. The records of 3448 men with erectile dysfunction were evaluated retrospectively. A total of 356 men with organic erectile dysfunction were enrolled into this study. Of these patients, 132 (37%) received tadalafil 20 mg twice a week for 12 weeks, 106 (30%) patients received tadalafil 5 mg once-daily for 12 weeks, 96 (27%) patients used intracavernosal injection therapy (Bi-mix; papaverine and phentolamine). Moreover, 22 patients underwent penile prosthesis implantation. Patient and partner satisfaction were assessed with International Index of Erectile Function (IIEF) and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire. Patients' mean age was 52.4 ± 25.76 (32-71). The etiology of erectile dysfunction was chronic systemic diseases in 133 (44%) and radical prostatectomy in 121 patients (40%). The mean IIEF-5 scores improvement after the treatment was higher in penile prosthesis implantation group (12.4 ± 1.3) compared with tadalafil 5 mg (6.7 ± 1.5) (p < 0.01), tadalafil 20 mg (6.2 ± 1.5) (p < 0.01), and intracavernosal injection group (8.4 ± 3.2) (p < 0.05). The EDITS score was significantly higher in penile prosthesis implantation group (78.2 ± 11.3) compared with intracavernosal injection (60.3 ± 6.3), tadalafil 5 mg (72.5 ± 4.5), and tadalafil 20 mg 70.7 ± 3.4 groups (p < 0.05). Partners' EDITS scores were 70.1 ± 10 in penile prosthesis implantation group, 50.2 ± 1.5 in intracavernosal injection group, 62.9 ± 7.8 in tadalafil 5 mg, and 61.3 ± 5.3 in tadalafil 20 mg group (p < 0.05). Erectile dysfunction patients who underwent penile prosthesis implantation seem to be more satisfied compared with tadalafil treatment and intracavernosal injection. Future clinical trials are warranted to confirm our results.
... Surgical options include plication, plaque incision and grafting, and penile prosthesis (PP) implantation, with PP implantation as the treatment of choice for medically refractory PD with ED. [1][2][3] In recent years, the "sliding technique" (ST) has been utilized for severe PD with ED as it allows for simultaneous PP implantation and penile length restoration. 4,5 Exposure of the penile shaft for the ST is ...
... [1][2][3] PP implantation is the most popular and widely utilized method due to its low mechanical failure rate, high success rates from 86% to 100%, and patient preference of the procedure over oral therapy and injection. 4 One nationwide US survey demonstrated that 75% of practicing urologists utilized PP for the treatment of PD. 5 Penile modeling, plication, or grafting procedures can be performed when it is necessary with PP implantation depending on the severity and the deformity of the PD. Despite satisfaction rates ranging from 72% to 100%, there are still a number of drawbacks from PP including pain, diminished sensitivity, mechanical failure, and infection. ...
... While IPP placement is typically reserved for refractory cases of ED, patients treated with IPP report higher rates of satisfaction than patients treated with other remedies. 1,2 Despite this, adverse outcomes of IPP continue to present a burdensome problem. Postoperative complications for IPP, namely infection and device malfunction, result in harm to the patient, patient dissatisfaction, and costly interventions. 3 Of these complications, postoperative infection has gained the most attention. ...
Article
Full-text available
Introduction Recent studies place the risk of infection following inflatable penile prosthesis (IPP) implantation at 1–2%. This risk may be underestimated due to the exclusion of high-risk patients, such as patients undergoing multiple revisions or revision following IPP infection, from data. Aim To calculate the rate of postoperative complications for all patients undergoing IPP implantation and revision, and to determine the risk factors predictive of complications following virgin implantation and revision independently. Methods The charts of 280 patients undergoing 331 IPP implantations performed over the last 20 years at a large academic medical center were reviewed for postoperative complications and suspected preoperative and operative risk factors. Main Outcome Measure This included the prevalence of adverse operative outcomes including postoperative infection and device malfunction. Results 63 (20.7%) surgeries resulted in postoperative complications: 38 (12.5%) resulting in device malfunction and 25 (8.20%) resulting in infection. Smoking (odds ratio [OR] = 4.14, P = .00) was associated with overall postoperative complications. Within subgroups, concomitant procedures (OR = 4.77, P = .03) were associated with infection for those undergoing virgin implantation, but not those undergoing revision procedures. Alternatively, diabetes mellitus (DM) (OR = 28.3, P = .02) was associated with postoperative infection for those undergoing revision procedures, but not those undergoing virgin implantation. Conclusion The rate of postoperative infection for all patients undergoing IPP was found to be 8.20%, a higher estimate than historically recorded. To varying degrees, smoking, concomitant procedures, and DM were associated with adverse operative outcomes. Subset analyses revealed significant associations between postoperative infections and either concomitant procedures or DM in those undergoing virgin implantations or revision surgeries, respectively. Miller JA, Bennett NE. Comparing Risk Factors for Adverse Outcomes in Virgin Inflatable Penile Prosthesis Implantations and Revisions: A Retrospective Cohort Study. J Sex Med 2020;XX:XXX–XXX.
... Reported complications following IPP implantation include infection, distal cylinder erosion, auto inflation, pump migration and reservoir displacement 165 . Overall, IPP placement is associated with excellent patient (92-100%) and partner (91-95%) satisfaction rates, significantly higher than satisfaction rates reported for oral, intraurethral and intracavernosal medical thera pies 166,167 . However, because of its associated high cost, potential complications and invasiveness of the proced ure, IPP implantation should only be offered to patients who fail more conservative measures (such as those described above). ...
Article
Erectile dysfunction is a multidimensional but common male sexual dysfunction that involves an alteration in any of the components of the erectile response, including organic, relational and psychological. Roles for nonendocrine (neurogenic, vasculogenic and iatrogenic) and endocrine pathways have been proposed. Owing to its strong association with metabolic syndrome and cardiovascular disease, cardiac assessment may be warranted in men with symptoms of erectile dysfunction. Minimally invasive interventions to relieve the symptoms of erectile dysfunction include lifestyle modifications, oral drugs, injected vasodilator agents and vacuum erection devices. Surgical therapies are reserved for the subset of patients who have contraindications to these nonsurgical interventions, those who experience adverse effects from (or are refractory to) medical therapy and those who also have penile fibrosis or penile vascular insufficiency. Erectile dysfunction can have deleterious effects on a man's quality of life; most patients have symptoms of depression and anxiety related to sexual performance. These symptoms, in turn, affect his partner's sexual experience and the couple's quality of life. This Primer highlights numerous aspects of erectile dysfunction, summarizes new treatment targets and ongoing preclinical studies that evaluate new pharmacotherapies, and covers the topic of regenerative medicine, which represents the future of sexual medicine.
... Continuous advancements in the field have resulted in PP technology having one of the lowest mechanical failure rates of any device implanted in humans (12), with success rates ranging between 86% and 100% (7,8,(13)(14)(15). Patients who have tried both oral therapy and injections also favor PP (16). ...
Article
The introduction of the inflatable penile prosthesis (IPP) has revolutionized the treatment of patients with both Peyronie's disease (PD) and erectile dysfunction (ED). A thorough literature review was performed in order to review the surgical strategies used to treat PD, using the PubMed online database with the keywords "penile prosthesis", "surgical management" and "Peyronie's disease". Patient satisfaction rates of 72-100% and partner satisfaction rates of 89% have been reported in the literature, although strong preoperative education may be needed to prepare patients for risks such as penile shortening, seen in up to 54% of patients. Three-piece IPPs are most commonly used, and when comparing the two most popular models (AMS 700 CX vs. Coloplast Titan), no significant differences were seen in functional outcomes or patient satisfaction. Simple insertion of an IPP has been shown to resolve curvature in 33-90% of patients, but surgeons may often need to also utilize ancillary straightening procedures for residual curvatures. Manual modeling can correct residual curvature with an 86-100% success rate, but with a 4% risk of urethral injury. When the post-modeling residual curvature exceeds 30 degrees, a plaque-releasing incision or plication is recommended to further reduce curvature. Grafting is recommended if the resulting incisional defect is larger than two centimeters. Alternative straightening techniques such as plication prior to IPP insertion, endoscopic plaque resection, the "scratch technique" and bone saw plaque incision have also been described.
... Penile prosthetic surgery is a strategic and highly qualifying surgical tool for both patients with severe erectile dysfunction and Urologists devoted to Sexual Medicine. The penile prosthesis option is the ED treatment presently reported to score the highest in terms of satisfaction among both patients and partners, compared to all the other available ED treatments (1,2). The paradox of the penile prosthesis is that, despite being an excellent solution for the patient with severe ED, majority of candidates to this treatment do not have access to it. ...
Article
Full-text available
Objectives: The Italian Society of Andrology, i.e. "Società Italiana di Andrologia" (S.I.A.), launched on December 2014 a prospective, multicenter, monitored and internal review board approved Registry for penile implants, the "INSIST-ED" (Italian Nationwide Systematic Inventarisation of Surgical Treatment for ED) Registry. Purpose of this first report is to present a baseline data analysis of the characteristics of penile implant surgery in Italy. Material and methods: The INSIST-ED Registry is open to all surgeons implanting penile prostheses (all brands, all models) in Italy, providing anonymous patient, device, surgical procedure, outcome, follow-up data, for both first and revision surgeries. A Registry project Board overviews all the steps of the project, and a Registry Monitor interacts with the Registry implanting surgeons. Results: As by April 8, 2016, 31 implanting surgeons actively joined the Registry, entering 367 surgical procedures in its database, that comprise: 310 first implants, 43 prosthesis substitutions, 14 device explants without substitution. Implanted devices account for: 288 three-component devices (81,3%), 20 two-component devices (5,4%), 45 non-hydraulic devices (12,3%). Leading primary ED etiologies in first implant surgeries resulted: former radical pelvic surgery in 111 cases (35,8%), Peyronie's disease in 66 cases (21,3%), diabetes in 39 cases (12,6%). Two intraoperative complications have been recorded. Main reasons for 57 revision surgeries were: device failure (52,6%), erosion (19,3%), infection (12,3%), patient dissatisfaction (10,5%). Surgical settings for patients undergoing a first penile implant were: public hospitals in 251 cases (81%), private environments in 59 cases (19%). Conclusions: The INSIST-ED Registry represents the first European experience of penile prosthesis Registry. This baseline data analysis shows that: three-pieces inflatable prosthesis is the most implanted device, leading etiology of erectile dysfunction (ED) in patient receiving a prosthesis is former radical pelvic surgery, primary reason for revision surgery is device failure, primary settings for first penile implant surgery are public hospitals. Evaluation of penile implant impact on recipients quality of life is presently ongoing.
... Patients with erectile dysfunction have reported that IPP is a satisfying and functional operative treatment 2 and in one study were more satisfied with IPP than with medication or injections. 3 Typically the IPP is placed using either an infrapubic or penoscrotal approach. The penoscrotal approach allows surgeons to easily place all components of the IPP through a well-hidden incision and then tuck the reservoir into the retropubic space while carefully avoiding the juxtaposed nerves and blood vessels. ...
Article
Background: The 3-piece inflatable penile prosthesis was introduced in 1973 as a treatment for men with erectile dysfunction. Consisting of 2 corporal cylinders, 1 pump, and a fluid-filled reservoir, the prosthesis is placed by blunt dissection into the retropubic space. The dissection for the reservoir is performed blindly into a space juxtaposed with nerves, vessels, and the bladder. Objective: To propose a novel approach for inflatable penile prosthesis reservoir placement involving gentle dilation of the retropubic space using a Foley catheter balloon. Methods: Patient medical records from 1 surgeon were reviewed. Patients did not have a history of pelvic surgery or prostatectomy. Each implant was approached using a penoscrotal incision, and the retropubic space was dilated with a 30-mL Foley catheter balloon filled to 100-mL capacity before reservoir placement. The postoperative visits were examined for complications, including reservoir infection and herniation. A literature search of penile prosthesis reservoir placement technique and complications (eg, herniation, infection) of reservoir placement was also performed. Results: Fifteen patient records were examined. The reservoir herniation rate was 0% and the infection rate was 7%. The average reservoir herniation rate is reported to be 1% to 3%, and the average infection rate is reported to be 1% to 5%. Conclusion: The use of a Foley catheter balloon is a safe, atraumatic, cost-effective, and easily performed method of dilating the retropubic space for subsequent inflatable penile prosthesis reservoir placement.
... Penil protezler hızlı sürdürülebilir ereksiyon sağlamaları ve kozmetik açıdan sorun oluşturmamaları nedeniyle hasta ve partnerleri tarafından tatmin edici olarak kabul edilirler. Çok parçalı penil protezler tek parçalılara kıyasla hastalar tarafından daha başarılı bulunmuştur [8,9]. Genel olarak çok parçalı penil protezlerde hasta memnuniyeti %80'lerin üzerindedir [10,11]. ...
Article
Objective: We aimed to evaluating the outcomes of in­flatable penile prosthesis implantations and partner sat­isfaction. Methods: Data of 52 patients who underwent penile prosthesis implantation in single center between May 2010 and December 2015 were retrospectively analyzed. Types of prosthesis, complication and satisfaction rates of patients were recorded by EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) questionnaire was used. Results: The mean age was 49.2±14.7 years for patients. The mean follow-up durations for 34.3±12.5 months. The mean hospital stay was 3.84±1.52 days. Evaluating of the couples satisfaction revealed that 44 (84%) of the patient were very satisfied. There was not any complication and no patient need to underwent revision surgery. Conclusion: Inflatable penile prosthesis implants, with high levels of treatment success, patient and partner sat­isfaction, are effective and safe options for treatment of organic erectile dysfunction with acceptable complication and revision rates.
... Фирма «Mentor» в сентябре 2002 г. начала использовать для своих протезов Alpha I гидрофильное покрытие из поливинилпироллидина. Применение такого Titan™-покрытия позволило перед выполнением имплантации погружать протез в раствор антибиотиков, благодаря чему частота развития бактериальной инфекции снизилась с 2,07 до 1,06% [18]. ...
Article
Full-text available
The earlier diagnosis of cancers, the improvement of a surgical technique, and advances in chemo- and hormonal therapy have increased survival rates. In this connection, some studies of quality of life have been recently under way after radical cyst- and prostatectomy. These mainly concern modifications of lifestyle, restoration of spontaneous urination and erectile function in males.
... A Korean study reported 5, 10 and 15 year implant survival rates of 89.1%, 71.4% and 60.5% with similar results previously published and patient satisfaction rates of >80% [14]. Another study directly compared satisfaction of IPPs compared to oral and injectable medications revealing significantly higher rates for IPPs [15]. Nevertheless, infected IPPs cause patient harm and healthcare dollars. ...
Article
Full-text available
Erectile dysfunction is prevalent among men and will continue to become more so with the aging population. Of the available treatment options, implantable prosthetic devices are typically thought of as a third line treatment even though they have the highest satisfaction rate and continually improving success rates. Infection and mechanical failure are the most common reasons for implant revision in the past. Since the development of more reliable devices, bacterial biofilms are coming to the forefront of discussion as causes of required revision. Biofilms are problematic as they are ubiquitous and exceedingly difficult to prevent or treat.
... Analysis from Rajpurkar et al. demonstrated that men who received an IPP had significantly higher scores on all measured indices of erectile function when compared to medically managed patients. Notably, the erectile function domain of the IIEF was over 37% higher in patients with an IPP when compared to those medically managed (16). Furthermore, the long-term mechanical efficacy of IPP has been well established. ...
Article
Erectile dysfunction (ED) is a common problem in older men and occurs with even greater frequency following the treatment of pelvic malignancies. Inflatable penile prosthesis (IPP) implantation is a safe and effective form of definitive ED treatment for those men who fail more conservative measures, and it can be used with similar outcomes in men following cancer therapy. Although many of these men remain dissatisfied with other therapeutic options for ED, IPPs are underutilized in this population. This review will discuss the current practice patterns, outcomes and nuances to surgical technique regarding the use of IPPs in patients with ED following cancer therapy.
... Implantation of PP is known to have excellent long-term patients and partners satisfaction rates when compared to PDE5I or intracavernosal injections [14]. Various studies have reported high satisfaction rates for patients and their partners after PP implantation (92-100% in patients and 91-95% in partners) [8,12,[15][16][17][18][19]. ...
Article
Full-text available
The implantation of a penile prosthesis (PP) may be recommended in patients with severe erectile dysfunction (ED) who do not respond to conservative treatments. The aim of this study was to evaluate complications, as well as functional and quality of life outcomes following primary and secondary implantation of PP at a tertiary referral center. In this retrospective study, a total of 51 patients (41 patients with primary (PPP) and 10 with secondary PP (SPP)) were included. Patients and operative characteristics were recorded and complications were analyzed using the Clavien-Dindo classification. To evaluate satisfaction of patients and their partners, as well as PP long-term function, follow-up data were collected by using questionnaires (Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) and QLQC30). Fifty-one patients with a median age of 61 years (IQR 52–68) received PP implantation (44 AMS 700, 7 Coloplast Titan). Main causes of ED were after radical prostatectomy (27.5%), diabetes (21,6%), and other unknown reasons (43.1%). Median time of intervention was 94.5 min (IQR 80.8–110.3) with no significant difference between PPP and SPP. Only one patient undergoing PPP surgery had grade 3 complication. Follow-up data from a total of 43 patients (84.3%) with a median follow-up of 26 months (IQR 17–41 mo) was recorded. At the time of follow-up, 88.4% of the PPs were still functional (PPP n = 34 (94.4%), SPP n = 4 (57.1%), p = 0.024). Overall estimated mean PP survival was 63.0 mo ((95% CI) 56.2–70.8 mo) with no significant difference between PPP and SPP. Overall satisfaction (EDITS und QLQC30) was high in both groups with no significant difference. PP implantation shows to be a safe treatment option in the management of severe ED.
... In fact, at this time of follow-up, patients are expected to have an adequate expertise in using the prosthesis and postoperative complaints including pain or swelling are generally resolved [26]. In our experience, the level of general satisfaction with the device was consistent with previously published data [25,[27][28][29], also in the subset analysis of frequency of the sexual activity [27]. Specifically, partner's satisfaction resulted to be strictly linked to patient's satisfaction in both groups, confirming Vakaloupulos findings [27]. ...
Article
Full-text available
Purpose: To compare perioperative results, safety and efficacy profile in patients receiving inflatable penile prosthesis (IPP) via penoscrotal (PS) or minimally invasive infrapubic (MII) approach for erectile dysfunction. Methods: A matched-pair analysis was performed including 42 patients undergoing IPP implantation via PS (n = 21) or MII (n = 21) between 2011 and 2016. Clinical and surgical data were prospectively collected. Patients' and partners' outcomes were assessed by the International Index of Erectile Function (IIEF), Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) and Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaires. Results: Mean (SD) operative time was 128 (40.6) min in group PS and 91 (43.0) min in group MII (p = 0.041). Complications occurred in 3/21 (14%) and 2/21 (10%) patients in groups PS and MII (p = 0.832). Overall, no differences were observed concerning the device utilisation (p = 0.275). However, in group MII 4/21 (19%) patients were able to resume sexual activity prior to 4 postoperative weeks, while in group PS no patient was (p = 0.012). Mean (SD) scores for questionnaires were similar between groups PS and MII: IIEF [20.9 (7.3) vs. 20.7 (4.8); p = 0.132], patient EDITS [76.0 (25.6) vs. 74.7 (20.8); p = 0.256] and partner EDITS [72.5 (29.1) vs. 73.1 (21.4); p = 0.114]. Similarly, QoLSPP showed comparable results among the groups PS and MII: functional domain [3.9 (1.4) vs. 4.0 (1.2); p = 0.390], personal [4.0 (1.2) vs. 4.1 (1.0); p = 0.512], relational [3.7 (1.5) vs. 3.9 (1.2); p = 0.462] and social [4.0 (1.2) vs. 3.9 (1.2); p = 0.766]. Conclusions: PS and MII demonstrated to be safe and efficient techniques, leading to high level of both patients and partners satisfaction. Additionally, the minimally invasive infrapubic approach showed a shorter operative time and a tendency for a faster return to sexual activity.
... Consistent with previous research that focused on heterosexual men, a substantial proportion of both the heterosexual men and GBM reported dissatisfaction with assistive sexual aids (Rajpurkar & Dhabuwala, 2003;Walker et al., 2015). There was a high degree of variability within and across groups in dissatisfaction with specific aids, suggesting individual differences need to be taken into account, regardless of sexual identity. ...
Article
Full-text available
The use of assistive aids in sexual rehabilitation after prostate cancer (PCa) was examined in 124 gay, bisexual, and other men who have sex with men (GBM) and 225 heterosexual men. GBM were significantly more likely to use assistive aids (79% versus 56%), to try multiple assistive aids (M = 1.65 versus M = 0.83) including medication, penile injection, penile implant, vacuum pump, and nonmedical sex aids, and to seek information about sexual rehabilitation on the Internet, through counseling, or in a support group. There were no differences between the groups in satisfaction with the use of assistive aids. However, use of aids was a significant negative predictor of sexual functioning for GBM and a significant positive predictor for heterosexual men. Interview accounts described satisfaction with assistive aids in terms of maintaining erectile functioning and relationships. The majority of men in the study also described hindrances, both physical and social, resulting in discontinuation of assistive aids, including perceived artificiality, loss of sexual spontaneity, side effects, failure to achieve erectile response, cost, and lack of access to information and support. It is concluded that the specific needs and concerns of GBM and heterosexual men regarding sexual rehabilitation after PCa need to be addressed by clinicians.
... Erektil işlev bozukluğu tedavi seçenekleri arasında, penil protez implantasyonunun en başarılı ve memnuniyet oranı en yüksek tedavi seçeneği olduğu literatürde bildirilmiştir. [13] Tüm protez tiplerinin hasta memnuniyetini etkileyecek farklı üstünlükleri ve olumsuz yanları mevcuttur. [14] Bükülebilir protezlerin giyinme ve işeme sırasında aşağıya, ilişki sırasında ise yukarıya bükülmeyi sağlayan yapısı vardır. ...
... They reported good sexual function (EPID score > 60) in 77% of men and treatment satisfaction in 94% (EDITS score > 50). Other studies have actually reported improved satisfaction for men undergoing early penile prosthesis insertion compared to those receiving sildenafil or intracavernosal injection therapy 6 months after radical prostatectomy [169,170]. ...
... Since its introduction in the United States in the early 1970s, the inflatable penile prosthesis (IPP) has become the most effective treatment modality for erectile dysfunction (ED). 1 However, IPP implantation is still not perfect, with the greatest complaint being penile shortening after the surgery. 2 Penile rehabilitation after IPP implantation includes leaving the device partially inflated so as to preserve penile length and to maintain hemostasis. 3 With a partially inflated device, the penis becomes more sensitive and more susceptible to unintended insults during the immediate postoperative management. ...
Article
Full-text available
Penile rehabilitation after inflatable penile prosthesis (IPP) implantation for the treatment of erectile dysfunction includes leaving the device partially inflated so as to preserve the penile length and to maintain hemostasis. With a partially inflated device, the penis becomes more sensitive and more susceptible to unintended insults during the immediate postoperative management. The "Wang Collar," a device intended to protect the penis in the early postoperative period, is hereby described. Three hundred and forty-eight patients had the "Wang Collar" included as part of their post-IPP management from August 2014 to February 2019. The protective collar, devised from a polystyrene cup with the bottom removed, is secured with a tape over the previously dressed and partially inflated penis. In order to evaluate the effectiveness of this device, we conducted surveys on the perioperative staff at three different institutions. The "Wang Collar" has been found to be beneficial in the early postoperative care of patients. Based on the answers to our questionnaire, the perioperative personnel found this device to be highly protective, especially when transporting the patient after IPP surgery, easy to work with, and almost never bothersome or irritative to the patient. We present a novel penile device after IPP placement, which we have found to improve patient satisfaction in the postoperative period. In addition, it eases the care of the patient by the perioperative staff. It is now our routine to use this device after IPP surgery. Further research is necessary to evaluate whether this device can decrease postoperative wound complications.
... Concerns over genital size have been shown to increase incidence of ED [14] . Satisfaction rates for PPI are quite high, 93.8% in one case series [15] . However, many patients complain of reduced penile size post operatively. ...
... Overall satisfaction rates for inflatable penile prostheses (IPPs) are estimated at over 80% [6,7]. Issues that may arise from IPPs include mechanical problems (pump failure, reservoir, or cylinder leakage) or non-mechanical issues (infection, erosion, and difficulty cycling pump) [7,8]. ...
Article
Full-text available
Our purpose was to determine if key pinch strength is predictive of patient preference for a single IPP model among three currently available models (Coloplast™ Titan, Coloplast™ Titan Touch, and the Boston Scientific AMS 700™). We prospectively recruited men without penile prostheses over 65 years old from our urology clinic. Demographic and medical history were recorded. To measure key pinch strength study participants squeezed a dynamometer between their thumb and index finger while seated with their arm resting at 90°; the strongest of three attempts was recorded. Participants were asked to operate three inflatable penile prosthesis devices installed within identical penis models. The number of pumps required to achieve erection with each device was recorded. Participants were asked to rate difficulty of inflation on a 1–5 scale. Participants ranked, from best to worst, which device they preferred based on ease of inflation. A total of 100 men completed the study. Median age and key pinch strength were 70.0 years and 19.0 pounds. Coloplast Titan was the most favored pump based on ease of inflation (58%). The median age, median key pinch strength, and median number of pumps required for erection were similar among men that favored Coloplast Titan as compared with AMS 700 and Coloplast Titan Touch. Multivariate linear regression of the 1–5 rating scale revealed lower grip strength to be associated with increased difficulty of inflation of Coloplast Titan Touch (p = 0.045). No other factors were associated with increased difficulty of inflation. Men with below-average key pinch strength may benefit from being offered a model other than Coloplast Titan Touch. Whether these findings translate to men who have already received implants remains to be determined. Nevertheless, evaluation of pinch strength should be considered in men prior to implantation of IPP.
Article
Introduction: Penile prosthesis implantation has emerged as a definitive treatment to restore sexual function to the motivated man with erectile dysfunction. Substantial improvements in the design of inflatable devices have been made since they first became available more than four decades ago. Aim: To review the history of the penile prosthesis, the indications, preoperative evaluation, and patient and partner satisfaction. The current approaches to addressing intra- and postoperative complications, provide an understanding of prosthesis infection, and placement of these devices will be reviewed. Methods: A committee of worldwide experts in this field was assembled during the 2015 International Consultation on Sexual Medicine (ICSM) and performed a systematic review of the peer-reviewed published medical literature pertaining to penile prosthesis. Particular attention was given to higher level trials when available. Recommendations are based upon the Oxford Criteria. Main outcome measures: Unfortunately there is limited level 1 and 2 evidence, and where expert opinion was utilized, the decision was unanimous within the committee with a goal of presenting a clinically relevant guideline pertaining to penile prostheses. Results: Penile prosthesis has undergone an evolution over the past 40 years resulting in a more effective and reliable treatment for advanced erectile dysfunction not responding to less invasive methods including oral treatment with PDE5 inhibitors, vacuum erection device, and intracorporal injection therapy. It should be considered an appropriate treatment option for the man who wishes to restore erectile function and who understands the potential risk of mechanical failure and infection, both of which are less common now as a result of improvements made in device design as well as surgical protocols adhered to in the operating room. Patients must be clearly informed of the risks associated with penile prosthesis including mechanical failure, infection, shortening of the penis, change in sensation and configuration of the penis, as well as injury to local structures. Intraoperative complications are unusual but do occur and can usually be addressed intraoperatively to allow placement of the device at the time of initial surgery. Postoperative complications may also be addressed when they occur but may require more advanced reconstructive surgical techniques. Men with Peyronie's disease, corporal fibrosis due to infection, trauma, prior prosthesis explantation, priapism, and men who have undergone construction of a neophallus may require additional advanced maneuvers to obtain optimum results with a penile prosthesis. Conclusion: Penile prosthesis remains as an important, viable, and effective treatment for male erectile dysfunction that does not respond to other less invasive approaches or when these approaches are contraindicated or not acceptable to the patient. These devices provide the patient with the ability to engage in penetrative sexual activity without interfering with urination, ejaculation, sensation, or orgasm. Although mechanical failure can occur, the current devices are more reliable as a result of design modifications. Infection remains the most dreaded complication but since the introduction of antibiotic and hydrophilic coatings, infection is less common. Overall, patient and partner satisfaction appear to be reasonably high when a penile prosthesis is used to restore erectile function.
Chapter
Die technische Entwicklung im Bereich der modernen penilen Implantate sowie die ständige Optimierung der Operationstechniken bieten Sicherheit für betroffene Patienten. Besonderheiten wie die antibakterielle Beschichtung (InhibiZone von AMS oder eine hydrophile Beschichtung von Coloplast Porgès) haben die Infektionsrate bei der Implantation dieser Systeme um bis zu 50 % reduziert. Die neuesten Konstruktionsentwicklungen, wie beispielsweise Touch Pumpe, Cloverleaf Reservoir und Zero Degree Winkel der Coloplast-Implantate, bieten dem Chirurgen bessere Voraussetzungen für die Implantation und letztlich bessere Ergebnisse für die Patienten. Auch operativ ergänzen und optimieren technische Innovationen wie z. B. der penoskrotale Zugang und die ektopische submuskuläre Reservoir-Implantationstechnik die Aspekte der modernen Implantologie. Mit diesem Buchkapitel beschreiben wir sowohl den Stand der heutigen Implantologie als auch die Operationstechnik mit penoskrotalem Zugang.
Chapter
Although the penile prosthesis has remained the preferred treatment for end-stage erectile dysfunction over the past 40 years, significant technical advances have recently been described. The transverse scrotal incision is most often used for implantation, but a rebirth in interest in the infrapubic incision has recently occurred. Prosthesis infection has been dramatically reduced by the use of infection-retardant-coated devices. New techniques of ectopic reservoir placement avoiding placement in the retroperitoneal space have been developed. Newly designed flat reservoirs have promoted insertion in the abdominal wall out of harm’s way. New surgical techniques are available to facilitate insertion of cylinders into scarred corporal bodies resulting from previously removed cylinders, priapism, vascular insufficiency, or Peyronie’s disease. New surgical instruments are available to facilitate the insertion without the necessity of extensive resection of the fibrotic tissue. Capsule formation around the device is a tough fibrous membrane which must be influenced in the postoperative period for optimal penile size to result. It is also useful as a natural tissue repair in repairs of impending cylinder erosion and reservoir hernia. This chapter will review the many technical advances in penile implant surgery.
Chapter
Hydraulische penile Implantate gehören zu den wenigen Implantaten in der Medizin, die zwei wichtige Erwartungen des Patienten erfüllen:
Article
Background The definitive treatment for erectile dysfunction is the surgical implantation of a penile prosthesis, of which the most common type is the 3-piece inflatable penile prosthesis (IPP) device. IPP surgery in outpatient freestanding ambulatory surgical centers (ASC) is becoming more prevalent as payers and health systems alike look to reduce healthcare costs. Aim To evaluate IPP surgical outcomes in an ASC as compared to contemporaneously-performed hospital surgeries. Methods A database of all patients undergoing IPP implantation by practitioners in the largest private community urology group practice in the United States, from January 1, 2013 to August 1, 2019, was prospectively compiled and retrospectively reviewed. Cohorts of patients having IPP implantation performed in the hospital vs ASC setting were compared. Main Outcome Measure The primary outcome measure was to compare surgical data (procedural and surgical times, need for hospital transfer from ASC) and outcomes (risk for device infection, erosion, and need for surgical revision) between ASC and hospital-based surgery groups. Results A total of 923 patients were included for this analysis, with 674 (73%) having ASC-based surgery and 249 (27%) hospital-based, by a total of 33 surgeons. Median procedural (99.5 vs 120 minutes, P < .001) and surgical (68 vs 75 minutes, P < .001) times were significantly shorter in the ASC. While the risk for device erosion and need for surgical revision were similar between groups, there was no higher risk for prosthetic infection when surgery was performed in the ASC (1.7% vs 4.4% [hospital], P = .02), corroborated by logistic regression analysis (odds ratio 0.39, P = .03). The risk for postoperative transfer of an ASC patient to the hospital was low (0.45%). The primary reason for mandated hospital-based surgery was medical (51.4%), though requirement as a result of insurance directive (39.7%) was substantial. Clinical Implications IPP implantation in the ASC is safe, has similar outcomes compared to hospital-based surgery with a low risk for need for subsequent hospital transfer. Strengths & Limitations The strengths of this study include the large patient population in this analysis as well as the real-world nature of our practice. Limitations include the retrospective nature of the review as well as the potential for residual confounding. Conclusion ASC-based IPP implantation is safe, with shorter surgical and procedural times compared to those cases performed in the hospital setting, with similar functional outcomes. These data suggest no added benefit to hospital-based surgery in terms of prosthetic infection risk. Weinberg AC, Siegelbaum MH, Lerner BD, et al. Inflatable Penile Prosthesis in the Ambulatory Surgical Setting: Outcomes From a Large Urological Group Practice. J Sex Med 2020;XX:XXX–XXX.
Article
Background In recent years, the assessment of erectile dysfunction (ED) has experienced a paradigm shift from objective, quantitative methods to subjective, qualitative patient-reported outcomes. Facilitated by this shift is the ongoing debate on questionnaire selection and need for standardization, particularly among sexual medicine specialists. Aim To review current literature on assessment of erectile function via patient-reported outcomes and discuss the context, advantages, and limitations of currently available questionnaires. Methods A thorough literature search of erectile function questionnaires developed from 1990 through 2019 was carried out using 3 methods: a search of the MedLine databases; hand-search of peer-reviewed urologic, sexual medicine, and health policy journals; and expert review. The following keywords were used: [assessment of], [inventory], [questionnaire], or [validated measure]; in combination with: [sexual function] or [erectile function]. Measures were stratified into one of the following 3 groups: screening, outcome, or disease-specific. 3 screening measures (International Index of Erectile Function, the Male Sexual Health Questionnaire, and Brief Male Sexual Inventory); 5 outcome measures (Sexual Health Inventory for Men, Erection Hardness Score, Erectile Dysfunction Inventory for Treatment and Satisfaction, and Treatment Satisfaction Scale); and 3 categories of disease-specific measures (cancer, Peyronie's disease, and spinal cord injury) were included. Outcomes Strengths, limitations, and valid uses of each erectile function questionnaire. Results There currently exists a wide variety of screening, outcome, and disease-specific measures for ED diagnosis, assessment, and treatment. Rigor of psychometric validation varies greatly across studies. However, depending on purpose of use, all abovementioned questionnaires have merit for use in clinical practice, are nonredundant, and can complement and supplement one another. Clinical Implications Before choosing a specific measure for ED diagnosis, assessment, or treatment, there must be careful consideration of the questionnaire's psychometric properties, context of validation, and its possible limitations. Strengths & Limitations The patient reported outcome measures highlighted in this article complement and supplement one another, as each emphasizes a related yet distinct central theme. During selection for use in clinical practice and research studies, special attention needs to be paid to the context, strengths, and weaknesses of each measure. Conclusion When used conscientiously, patient-reported questionnaires can significantly optimize patient management. Yafi FA, Huynh LM, Ahlering T, et al. What Is a “Validated Questionnaire”? A Critical Review of Erectile Function Assessment. J Sex Med 2020;XX:XXX–XXX.
Book
Full-text available
PREVALENCE OF MALE SEXUAL DYSFUNCTION AND ITS CORRELATION AT ANDROLOGY CLINICS IN EGYPT
Chapter
Erectile dysfunction (ED) treatment can be divided into three main categories. These are oral agents, intracavernosal and intraurethral therapies, and local devices, such as vacuum and penile prosthesis. The first-line treatment for ED is oral phosphodiesterase type 5 inhibitors (PDE5Is); second-line treatment options include any combination of intracavernosal agents, such as papaverine, phentolamine, PGE1, or transurethral alprostadil. For this reason, penile prosthesis continues to be an important form of treatment for ED. Penile prosthesis implantation is a highly effective treatment option which yields high success rates, increased patient satisfaction, and low complication rates for men who fail first- and second-line treatment. Penile prostheses are indicated in a variety of conditions which cause ED, such as diabetes mellitus (DM), Peyronie’s disease, corporal fibrosis following priapism, ED following radical prostatectomy for prostate cancer and spinal cord injury.
Article
The malleable prosthetic implant is widely accepted among patients and physicians owing to a lower degree of surgical complexity, its rare mechanic failures and lower cost. We have compared the degree of satisfaction with malleable prosthetic implant in 60 patients, 36 with Spectra (AMS) and 24 with Genesis (Coloplast). For assessment purposes, we implemented the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) satisfaction questionnaire adapted for penile prosthetic implants. The mean age and follow-up was 61.7 years (31–82) and 19.9 months (1–61), respectively. Mean EDITS scores did not indicate superiority of one implant over the other, overall satisfaction index being 77.1% and 75.6% for Genesis and Spectra prosthesis, respectively (P=0.4970). Our results revealed that these two models of malleable prostheses present a high level of satisfaction and confirm that the malleable prosthetic implant is an excellent option to treat patients with ED refractory to medical treatment.International Journal of Impotence Research advance online publication, 25 August 2016; doi:10.1038/ijir.2016.33.
Article
This article considers sexuality in older adults and the associated stereotypes and stigmas that lead to this area being underappreciated. Normal physiological changes in ageing are discussed and how they can cause sexual dysfunction. The elderly population has a higher burden of comorbid physical illness and this review considers evidence on the interplay between physical health and sexual health. Mental illness is also strongly linked with sexual functioning and is discussed, as is the evidence on psychotropics and sexual side-effects. Attitudes on sexuality in long-term care settings are highlighted and approaches to managing sexual disinhibition are included.
Article
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.
Article
Full-text available
The field of prosthetic urology demonstrates the striking impact that simple devices can have on quality of life. Penile prosthesis and artificial urinary sphincter implantation are the cornerstone procedures on which this specialty focuses. Modern research largely concentrates on decreasing the rates of complication and infection, as the current devices offer superior rates of satisfaction when revision is not necessary. These techniques are also able to salvage sexual function and continence in more difficult patient populations including female-to-male transgender individuals, those with ischemic priapism, and those with erectile dysfunction and incontinence secondary to prostatectomy. This review summarizes modern techniques, outcomes, and complications in the field of prosthetic urology.
Article
Post penile implant sexual satisfaction in elderly patients is a multifactorial issue. In the present study, we investigated the possible implication of age on satisfaction after malleable penile implant surgery in elderly patients. We compared post‐operative sexual satisfaction in the elderly with that of a younger age group (reference group). Patients were classified into three groups according to their ages (group I <45, group II between 45 and 65, and group III older than 65 years old). Modified Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire was used at 3, 6 and 12 months after implant surgery. EDITS scores showed statistically significant high satisfaction rates in all age groups. EDITS scores were higher in the early post‐operative period in younger groups compared to elderly patients. However, the difference between groups was insignificant at 12 months post‐operatively (p value = .06). Our results show that elderly patients have a high post‐operative satisfaction rate close to that of younger age groups, and they are suitable candidates for penile implant surgery with good and realistic post‐operative sexual satisfaction expectations.
Article
Introduction: Penile prosthesis implantation is believed to provide a high level of patient satisfaction. The International Index of Erectile Function and the Erectile Dysfunction Inventory of Treatment Satisfaction are two validated questionnaires that have been used to assess this outcome. The lack of a tool specifically validated for patients undergoing penile prosthesis surgery has led to the use of heterogeneous methods to assess patient satisfaction. Aim: To review the assessment of patient satisfaction with penile prosthesis surgery according to several factors. Methods: A literature review was performed through PubMed from January 2000 through February 2016 addressing patient satisfaction after penile prosthesis surgery. Main outcome measures: Patient satisfaction according to the characteristics of penile prosthesis devices and different clinical contexts. Results: Forty-eight articles were selected. Of these, 66.2% used non-validated questionnaires to assess patient satisfaction. Device characteristics, patient comorbidities, and partner profile are potential factors that can determine patient satisfaction. Conclusion: Patient satisfaction is a meaningful outcome of penile prosthesis surgery modulated by different conditions. The rigor of this assessment in the literature is limited. The validation of a scale designed for patients with penile prosthesis surgery is needed to optimize clinical practice. Akakpo W, Pineda MA, Burnett AL. Critical Analysis of Satisfaction Assessment After Penile Prosthesis Surgery. Sex Med Rev 2017;X:XXX-XXX.
Article
Purpose of Review Patient satisfaction with inflatable penile prosthesis (IPP) is an elective procedure that restores erectile function. Recent Findings While the return of usable erections is almost always achieved with IPP, patients may still be unhappy with the procedure if the outcome has not met their expectations. Optimizing patient satisfaction and outcomes should incorporate considerations for pre-, intra-, and postoperative factors. Length optimization regimens and improved pain control options have dominated the recent literature.
Article
Background: Unidentified distal crossovers, delayed distal crossovers, and impending lateral extrusion are complications of penile prosthesis implant insertion but are not as common as prosthesis infection or mechanical failure. Aim: To evaluate results of a surgical technique, the distal corporal anchoring stitch, that addresses fixation of the penile prosthesis in patients with these complications. Methods: A lateral sub-coronal incision is used on the side where the crossover or laterally extruding cylinder should be positioned. Dissection is carried through the Buck fascia, followed by a transverse incision of the tunica albuginea, where the distal aspect of the affected cylinder is delivered. A 4-0 PDS suture is threaded through the distal cylinder ring of the implant. A new, properly positioned intracorporal channel is created and the suture is passed through the distal end of the channel. Once the suture is through the glans and the cylinder is in the correct position, a small cruciate incision is made on the glans at the location of the anchor stitch. The suture is tied with the knot buried in the glans tissue. Outcomes: Fifty-three patients underwent treatment of their distal penile implant crossover with a distal corporoplasty using this method and their anatomic and functional outcomes and overall satisfaction were evaluated. Results: This technique ensured that the cylinder remained in the newly created, appropriately positioned channel. No patients developed infections, wound-healing defect, glandular hypoesthesia, anesthesia, or altered sensation or pain in the glans related to the suture and only two reported recurrence of a lateral herniation that did not require further treatment. Clinical implications: Distal fixation of the penile prosthesis is a useful surgical adjunct to treating patients with prosthetic lateral extrusions or crossovers that can be applied in almost all cases. Strengths and limitations: Considering these rare complications, our experience is based on a relatively large number of patients and showed a low incidence of complications and a high satisfaction rate. The main limitation of this study is the retrospective nature of the data and the series included patients from two high-volume surgeons that might not be generalizable to all practices. Conclusion: The distal corporal anchoring stitch is safe and effective in securing distal fixation of the extruding inflatable penile prosthesis. Antonini G, Busetto GM, Del Giudice F, et al. Distal Corporal Anchoring Stitch: A Technique to Address Distal Corporal Crossovers and Impending Lateral Extrusions of a Penile Prosthesis. J Sex Med 2017;14:767-773.
Chapter
Erectile dysfunction (ED) is defined as the inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse. ED may result from psychological, neurologic, hormonal, vascular, or impairment of cavernosal smooth muscle function. The last 3 decades have witnessed a phenomenal improvement in diagnosis and treatment of ED. In the current chapter we review contemporary medical and surgical treatments for ED and novel therapies in development.
Article
Introduction: Surgical frailty is a previously unrecognized clinical entity that objectifies a multiorgan decrease in physiologic reserve in those undergoing surgery. Although penile implantation has been demonstrated to be an effective means of restoring erectile function in patients whose previous conservative measures have failed, there are limited data regarding the assessment of frailty in patients undergoing penile implantation. Aim: To review the various objective methods used to describe surgical frailty in medical and surgical disciplines, report on methodologies of frailty assessment, and discuss the relevance of surgical frailty in the preoperative evaluation of patients undergoing implantation of an inflatable penile prosthesis. Methods: A literature review was performed through PubMed regarding surgical frailty in the disciplines of medicine, surgery, and urology. Key words and phrases included frailty, elderly, aging, erectile dysfunction, penile implantation, and penile prosthesis. Main outcome measure: Critical assessment of frailty in medicine and its application to male prosthetic health. Results: Frailty has been assessed by different metrics in multiple fields. Validated modalities to determine physiologic reserve include an accumulation of deficits and phenotypic objective assessments that are reviewed in detail. Frail patients experience longer length of stay, postoperative complications, unplanned returns to the operating room, and readmissions and are less likely to be discharged to home. Novel frailty assessments objectified through grip strength measurements from our institution demonstrate that a considerable number of patients, young and old, undergoing penile implantation exhibit surgical frailty. Conclusion: There is a growing need to incorporate frailty assessment in the preoperative risk stratification of patients undergoing penile implantation. Grip strength evaluation seems to be an obvious standard because it is likely the easiest to measure and is clinically relevant given the user's dependence on manual dexterity to use the device. Screening for frailty does not create a substantial time, financial, or resource burden for the urologist. Brennan MS, Barlotta RM, Simhan J. Frailty Assessments in Surgical Practice: What is Frailty and How Can It Be Used in Prosthetic Health? Sex Med Rev 2017;X:XXX-XXX.
Article
Introduction: Hydraulic penile prostheses have shown an overall good mechanical reliability up to 10 years after surgery; however, few data have been published on very long-term follow-up. Aim: We looked at long-term (≥15 years) complications, including functional and quality of life (QoL) outcomes, after 3-piece inflatable penile prosthesis (IPP) implantation in patients with erectile dysfunction (ED). Methods: Data regarding 149 patients submitting to IPP placement before 2001 were analyzed. All patients were implanted with AMS CX and Ultrex Plus 3-piece prostheses. Main outcome measure: Patients were reassessed to evaluate rates of complications and functional outcomes. The validated questionnaire Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) was used to assess patient QoL. Kaplan-Meier analysis estimated the probability of prosthesis survival (defined as working device/not-explanted). Results: Median follow-up of 51 patients was 206 months (interquartile range [IQR], 145-257). The etiology of ED was vasculogenic (n = 20; 39%), Peyronie's disease (n = 15; 29%), pelvic surgery (n = 4; 7.8%), organic other than vasculogenic (n = 3; 5.9%), or other (n = 9; 18%). Throughout the follow-up, 24 patients (49%) experienced complications: mechanical failure (n = 19; 79%), pain (n = 3; 12%), orgasmic dysfunctions (n = 1; 4.5%), or device infection (n = 1; 4.5%). The estimated IPP survival was 53% (95% CI, 36-67) at 20-year follow-up. Baseline characteristics (age, Charlson comorbidity index, body mass index, and erectile dysfunction etiology) were not significantly associated with the risk of IPP failure over time by Cox regression analysis. At 20-year follow-up, 41% (95% CI, 19-49) of the patients were still using the device. Among them, QoLSPP median domain scores were high: functional 22/25 (IQR, 20-23), relational 17/20 (IQR, 15-18), personal 14/15 (IQR, 12-15), and social 14/15 (IQR, 11-15). Clinical implications: The longevity of the device and long-term satisfaction rates should be comprehensively discussed during patient consultation for IPP surgery. Strengths & limitations: To our knowledge, this is the first study reporting long-term QoL outcomes using a dedicated questionnaire for penile prostheses. The low response rate for the telephone interviews, the retrospective design of the study, and the relatively small number of patients are the main limitations. Conclusion: Long-term follow-up data after IPP placement showed that almost half of the devices still worked properly 20 years after the original penile implant, as 60% of patients were still using the device with high satisfaction and adequate QoL outcomes. Both patients and physicians should be aware of the expected life and outcomes of IPP implants. Chierigo F, Capogrosso P, Dehò, et al. Long-Term Follow-Up After Penile Prosthesis Implantation-Survival and Quality of Life Outcomes. J Sex Med 2019;16:1827-1833.
Chapter
Erectile dysfunction (ED) is the inability to attain and/or maintain an erection sufficient for sexual intercourse. Fifty percent of men aged 40–70 years will be affected by ED. This may result in a significant deterioration in their quality of life and relationships. It is often associated with conditions affecting vascular circulation such as diabetes mellitus, hyperlipidaemia, smoking, obesity and hypertension. However, it may also be due to conditions affecting nerve innervation (pelvic surgery) or smooth muscle. Montorsi et al. provided the first significant evidence linking ED with cardiovascular disease [1]. In their landmark paper, 50% with acute chest pain and proven coronary artery disease also reported ED. Subsequent studies have strengthened their findings and ED should now be considered to precede a cardiovascular event by 3–5 years [2–5]. The reduction of risk factors associated with vascular disease may improve erectile function [6]. The second large group of men who will experience ED are those undergoing pelvic surgery; this group is increasing in numbers every year.
Article
Background: To evaluate the cost-effectiveness of alternate erectile dysfunction (ED) management options after failed first line phosphodiesterase-5-inhibitors (PDE5-I). Methods: An empiric, repetitive decision tree analysis model was constructed using literature review and expert clinical judgement. This assessed the expected costs and quality adjusted life years (QALYs) of decision alternatives over a 10-year period. The model incorporated interventions including alternate PDE5-Is, intracorporal injections (ICI) with alprostadil or trimix (alprostadil, phentolamine, and papaverine), and inflatable penile prosthesis placement (IPP) and included respective risks of failure, subsequent interventions, and other complications (including priapism risk). Average model QALY estimates obtained from the literature were as follows: ED =0.56, successful alternate PDE5-I =0.70, successful ICI =0.70, and successful IPP =0.78. Cost data were calculated from a high-volume academic center and published manufacturer data. Results: Over the 10-year period, IPP placement was the most cost-effective management option per preserved QALY (QALY =7.82, cost =$22,009/10 years) as compared to ICI alprostadil (QALY =8.51, cost =$62,890/10 years), ICI trimix (QALY =8.47, cost =$48,617/10 years) and alternate PDE5-I (QALY =7.73, $52,883/10 years). Conclusions: Using expert opinion and published utility, cost, and complication data in a decision analysis, we demonstrated that IPP placement is the most cost-effective ED intervention following failed initial PDE5-I over a 10-year period as compared to alternate treatment options. Such cost-effectiveness outcomes may be used in ED management counseling.
Article
The constant refrain for patients seeking penile implant is, “can you make it bigger?” It is a different request when the patient is young and fully potent compared with the mature individual suffering from erectile dysfunction (ED) for whom conservative therapies don’t work. The purpose of this workshop is to review strategies to make the ED patient undergoing inflatable penile prosthesis (IPP) have an enhanced penile appearance by having more of his phallus visible outside his body. Our common procedures are to use a combination of vacuum device preparation, oversizing the cylinders 1–2 cm, and daily aggressive cycling of the device for at least 6 months following implantation. More complex surgical solutions are also covered.
Article
Aim: To determine what constitutes a clinically important difference (CID) on the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), an 11-item validated questionnaire assessing treatment satisfaction used in clinical trials for patients with erectile dysfunction (ED). Methods: Erectile Dysfunction Inventory of Treatment Satisfaction data were evaluated from a double-blind, fixed-dose trial of 279 men aged 18-65 years with ED who were treated with sildenafil 50 or 100 mg or placebo. The primary anchor measure was the erectile function (EF) domain of the International Index of Erectile Function (IIEF), which has a 4-point minimal CID. The CID on the EDITS index score was determined using a regression analysis comparing EDITS and IIEF EF scores at the end of the 8-week treatment. A similar analysis was performed for EDITS and the Erection Hardness Score (EHS) instrument, a single-item questionnaire measuring hardness, which was used as a secondary anchor measure. Results: Erectile Dysfunction Inventory of Treatment Satisfaction and IIEF EF domain scores were highly correlated (Pearson correlation coefficient = 0.75). EDITS total scores across treatments at week 8 averaged (mean ± standard deviation [SD]) 67.5 ± 21.6 (range, 0-100; higher scores indicate greater treatment satisfaction); IIEF EF domain scores averaged 22.2 ± 6.9 (range, 1-30; higher scores indicate higher erectile functioning). The calculated CID for EDITS scores was 9.5 (95% CI, 8.5-10.4; 0.44 SD units), corresponding to a medium effect size. EDITS and EHS instrument scores also correlated highly (Pearson correlation coefficient = 0.64). Placebo-adjusted EDITS mean scores were more than twice the CID, at 23 (95% CI, 17-28) and 28 (95% CI, 23-33) for the 50- and 100-mg doses, respectively. Conclusion: Approximately 10 points on the EDITS index score is considered a CID. Serving as a benchmark, this finding aids interpretation of the clinical relevance of a difference in mean EDITS index scores between treatments for patients with ED.
Article
From 5/98 to 5/03, of the 1310 patients taking a medical therapy for erectile dysfunction (E.D.), only 137 took autointracavernosal injection (auto. ICI). 134 patients were contacted by phone and were asked to answer a definite questionnaire.
Article
Purpose of Review To provide an evidence based discussion of preoperative, intraoperative, and postoperative factors that lead to successful outcomes in penile prosthesis surgery. Recent Findings In the preoperative period, careful patient selection, appropriate counseling, thorough evaluation, and sufficient time for physical and emotional adaptation to an inflatable penile prosthesis are the key. During surgery, the entire device should be explanted whenever possible. A drain and retain strategy for the reservoir is a safe alternative in situation where the reservoir is not easily removable. The mechanical cleansing of lavage is more important than chemical sterilization. Postoperative instructions should be made clear and nursing phone calls may reduce the number of ER visits. Summary Careful preoperative counseling, attention to intraoperative details, and vigilance in the postoperative period are necessary for a successful outcome with penile prosthesis revision surgery.
Article
Full-text available
In the population of patients with prostate cancer, survivorship has come to the forefront of continuity-of-care. In addition to urinary control, erectile function is a significant issue after radical pelvic surgery. Penile prosthesis surgery remains an excellent option for restoring erectile function to those for whom more conservative measures have failed. This review article outlines the anatomical, surgical and post-operative consideration involved in the placement of a penile prosthesis in this special patient population.
Article
Full-text available
Erectile dysfunction (ED) is important to a man’s well-being and health, since it not only affects the individual but also causes strain on a couple’s lifestyle and relationship. There are multiple non-invasive treatments that exist for ED including lifestyle changes, oral medications (phosphodiesterase type 5 inhibitors), vacuum-assisted erectile devices, and intraurethral suppositories. While lifestyle changes and oral medications are typically first-line treatments for ED, more-invasive treatments including intracavernosal injections and surgically implanted prosthetic devices may be required for the management of complex cases. Additionally, novel therapies are currently being developed, and future treatment options may include shock-wave therapy, external prosthetic devices, and injection of stem cells or platelet-rich plasma. The current manuscript seeks to highlight advances in management and may eventually alter the treatment paradigm to allow more-inclusive care pathways.
Article
In patients with erectile dysfunction refractory to medical treatment, placement of a penile prosthesis is an effective treatment option. Despite advancements in prosthetic design, it is not without complications requiring reoperation.
Article
Full-text available
In the 3 y since its initial approval, sildenafil has become the most widely used treatment for erectile dysfunction (ED) and has been prescribed to more than 13 million patients worldwide. Significant improvements in erectile function have been demonstrated in double-blind, placebo-controlled studies in diverse patient populations. A significant treatment effect has been shown with sildenafil in men with ED and a history of diabetes, cardiovascular disease, minor depression, spinal cord injury and multiple sclerosis. In addition, promising results have been shown in patients with treated prostate cancer, end-stage renal disease, Parkinson's disease and spina bifida and in multiple-organ transplant recipients. Postmarketing data of the use of sildenafil in clinical practice confirm the efficacy and safety found in clinical trials and high satisfaction with treatment. Public awareness of the common occurrence of ED and the high likelihood of a potentially favorable response to an oral treatment increased dramatically with the introduction of sildenafil. Physicians, however, are still not comfortable with ED management, which negatively affects pharmacotherapy response rates and patients' compliance to treatment. Continuing medical education seems mandatory to overcome existing problems in ED management.
Article
Objective To determine if intracavernosal pharmacotherapy utilizing prostaglandin E1 (PGE1) injections is a well accepted and durable treatment modality for impotency.Method We reviewed the charts of 110 consecutive men who underwent a thorough impotency evaluation and were considered acceptable candidates for intracavernosal pharmacotherapy with PGE1.ResultsForty patients opted not to initiate treatment with PGE1 (16 due to loss of interestin sex), while 60 patients pursued home self-injection therapy; 10 patients were lost to follow-up. Thirty-six (60%) of those who initiated therapy discontinued the use of PGE1 with a mean follow-up of six months; 18 terminated PGE1 usage due to loss of interest in sexual activity and 3 due to return of spontaneous erections. However, many who lost interest in sexual activity in both groups directly attributed this to the required intracavernosal route of administration for PGE1. Thus, only 24 of the original 100 (24%) patients continued to use PGE1 as impotency therapy for an attrition rate of 76 percent.Conclusion Our study indicates that intracavernosal pharmacotherapy using PGE1 injectiontherapy is not a satisfactory long-term therapeutic modality for many patients with erectile dysfunction. The diverse reasons for this high attrition rate are discussed.
Article
Patient and partner satisfaction with the use of an AMS 700 inflatable penile prosthesis was evaluated by reviewing the records from 387 patients and questionnaires completed by 272 of these patients. The evaluation demonstrated that 83% of the patients and 70% of the partners were satisfied with use of this device. Couples who reported the lowest levels of satisfaction were characterized by men who required more than 1 procedure for prosthesis implantation. Pain and appearance of the penis were the most common causes for dissatisfaction with the device. Results from this evaluation recognize the importance of careful surgical technique to avoid any surgical complications but, more importantly, they emphasize the need for physician-manufacturer interaction to maximize mechanical reliability of the prosthesis.
Article
Patient satisfaction with the Mentor inflatable penile prosthesis was assessed by sending a thirty-six-item questionnaire to 251 patients who had undergone implantation of the device by the senior author (D.C.M.). A total of 152 (61%) of the patients responded. Recovery time, satisfaction, reasons for dissatisfaction, perceptions of erection quality, and psychosexual parameters were evaluated. Eight-eight percent of the patients were engaging in regular sexual activity. Depending on the definition of satisfaction, 81-89 percent of the respondents reported that they were satisfied with the prosthesis. Sixty-eight percent of the survey group were satisfied with the length, width, and firmness of their prosthetic-induced erection. The majority of patients reported improvement in psychosexual functioning after implantation. Reasons for dissatisfaction included inadequate penile length, insufficient firmness, and difficulty with inflation and deflation of the penile cylinders.
Article
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.
Article
Prostaglandin E1 (PGE1, alprostadil) is used worldwide for self-injection therapy in erectile failure and was recently officially approved for this purpose in the United States and most European countries. Therefore a comprehensive overview on biochemistry, pharmacology and therapeutic results of PGE1 is provided. The relevant literature on PGE1 was reviewed along with personal experience with 4,577 patients during a 7-year period. PGE1 was compared to other vasoactive drugs, such as papaverine, the mixture of papaverine and phentolamine or linsidomine alone. In Europe PGE1 was officially approved for the therapy of peripheral arterial occlusive disease of the lower limbs in 1984. The drug has direct relaxing effects on smooth muscle cells of vessels and cavernous bodies, shows inhibitory effects on platelet aggregation, on low-density lipoprotein entry into the vascular wall and on presynaptic noradrenaline release and, therefore, it prevents the progress of atherosclerosis. In erectile failure PGE1 shows a response rate of more than 70% and, compared to papaverine with phentolamine, a considerably lower risk of priapism (0.35% versus 6%, respectively) as well as of local fibrotic complications. Except for rare cases of blood pressure decrease, no systemic side effects were observed after intracavernous injection of PGE1. For self-injection therapy, PGE1 presently represents the most efficacious and safest drug. Ongoing trials with topical and especially intraurethral PGE1 are promising and may offer less invasive therapies in the near future.
Article
Erectile dysfunction is a common medical problem affecting many men. Although several intracavernosal therapies are available, their efficacy and safety have not been studied systematically. We investigated the efficacy and safety of alprostadil formulated for intracavernosal treatment in three separate multi-institutional, prospective studies in men with erectile dysfunction of vasculogenic, neurogenic, psychogenic, and mixed causes. Clinical and laboratory evaluations of erection and the feasibility of satisfactoriness of sexual activity as assessed both by the men and by their partners were the primary measures of efficacy. In a dose-response study of 296 men, all doses of alprostadil were superior to placebo and there was a significant dose-response relation (P < / = 0.001), resulting in higher response rates with increasing doses of alprostadil (from 2.5 to 20 microg). In a dose-finding study of 201 men, the minimal effective dose was < / = 2 microg in 23, 20, 38 and 23 percent of men with erectile dysfunction of neurogenic, vasculogenic, psychogenic, or mixed causes, respectively. In a six-month self-injection study in 683 men, the participants reported being able to have sexual activity after 94 percent of the injections. The men and their partners rated the sexual activity as satisfactory after 87 and 86 percent of the injections, respectively. Penile pain, usually mild, occurred in 50 percent of the men at some time but after only 11 percent of the injections. Prolonged erections occurred in 5 percent of the men, priapism in 1 percent, penile fibrotic complications in 2 percent, and hematoma or ecchymosis in 8 percent. In men with erectile dysfunction, intracavernosal injection of alprostadil is an effective therapy with tolerable side effects.
Article
We identified potential predictors, a high risk period and reasons for attrition, as well as the therapeutic alternatives chosen by men who discontinued intracavernous injection. After patients had followed the protocol of evaluation and a home trial, they were given prostaglandin E1; a triple mixture of papaverine, phentolamine and prostaglandin E1; papaverine and phentolamine, or papaverine and prostaglandin E1. Data on the 1,089 patients enrolled in the pharmacological erection program from 1988 to 1996 were retrospectively reviewed to compare characteristics of active patients and those who discontinued therapy. Our attrition rate was 37.6% overall and 27.5% among prostaglandin E1 users. Patients who continued active therapy remained in the program for a mean of 26 months. We could identify no risk factor for erectile dysfunction or associated condition as a risk factor for attrition. More than 50% of men who discontinued therapy did so within the first 2 months of the program but the attrition rate for the 2 years following this time was less than 10%. Among those who dropped out of therapy 52% received a penile prosthesis. Failure of prostaglandin E1 and triple drug therapy is the best predictor of failure of intracavernous injection. We suggest that clinicians carefully follow and counsel patients at high risk for failure about alternative treatment within the first 3 months. Remaining on intracavernous injection beyond the first 2 months is a likely predictor of long-term success, confirming intracavernous injections to be an effective long-term therapeutic option.
Article
We evaluated the quality of life effects of self-administered intracavernosal injection of alprostadil sterile powder for erectile dysfunction when used by patients for up to 18 months. Clinical and self-reported measurements were used to assess physiological and psychological status at baseline, and at 3, 6, 12 and 18 months for 579 patients who entered the self-injection phase of an open label, flexible dose clinical trial. Quality of life was measured using the Center for Marital and Sexual Health Sexual Functioning Questionnaire, which focuses on the psychosocial and physical dimensions of erectile dysfunction; the Brief Symptom Inventory, which measures mental health, and the Duke Health Profile, which measures general quality of life. The primary evaluations were quality of life changes from baseline to post-initiation periods and reasons for treatment discontinuation. The Center for Marital and Sexual Health Sexual Functioning Questionnaire displayed improvements at all post-initiation periods in 10 questions (p < 0.001, Student's paired t-tests) grouped into scales representing frequency of sexual activity, erection, orgasm and satisfaction domains. On the Brief Symptom Inventory interpersonal sensitivity, anxiety and depression as well as global scores improved (p < 0.001). Overall mental health as measured by the Duke Health Profile also improved (p < 0.01) between baseline and 6 months. The reasons most frequently cited for treatment discontinuation were nonfirm erections and injection site pain. Clinical improvements in erectile function due to alprostadil therapy were associated with improvements in sexual activity, sexual satisfaction and overall mental health.
Article
To develop a brief, reliable, self-administered measure of erectile function that is cross-culturally valid and psychometrically sound, with the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction. Relevant domains of sexual function across various cultures were identified via a literature search of existing questionnaires and interviews of male patients with erectile dysfunction and of their partners. An initial questionnaire was administered to patients with erectile dysfunction, with results reviewed by an international panel of experts. Following linguistic validation in 10 languages, the final 15-item questionnaire, the international index of Erectile Function (IIEF), was examined for sensitivity, specificity, reliability (internal consistency and test-retest repeatability), and construct (concurrent, convergent, and discriminant) validity. A principal components analysis identified five factors (that is, erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction) with eigenvalues greater than 1.0. A high degree of internal consistency was observed for each of the five domains and for the total scale (Cronbach's alpha values of 0.73 and higher and 0.91 and higher, respectively) in the populations studied. Test-retest repeatability correlation coefficients for the five domain scores were highly significant. The IIEF demonstrated adequate construct validity, and all five domains showed a high degree of sensitivity and specificity to the effects of treatment. Significant (P values = 0.0001) changes between baseline and post-treatment scores were observed across all five domains in the treatment responder cohort, but not in the treatment nonresponder cohort. The IIEF addresses the relevant domains of male sexual function (that is, erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction), is psychometrically sound, and has been linguistically validated in 10 languages. This questionnaire is readily self-administered in research or clinical settings. The IIEF demonstrates the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction.
Article
Intracavernosal injection therapy is one of the most popular therapies for erectile dysfunction today. Yet, most clinicians consider intracavernosal injection a palliative treatment for erectile dysfunction because of the high patient initiated dropout rate. In contrast, penile prostheses appear to offer a more permanent cure for erectile dysfunction. We compare the long-term outcomes of both therapies in contemporaneously treated patients and determine the reasons for failure of each. Telephone survey and chart review was conducted on the first 115 patients treated with intracavernosal injection and 65 patients undergoing insertion of a penile prosthesis during the same period at our institution. Mean patient age was 57 and 60 years, respectively, and mean followup of all patients was 5.4 years (range of 3.3 to 16). An equal percentage of patients were lost to followup in both groups, including 19% of the intracavernosal injection group and 18% of the penile prosthesis group. Of the intracavernosal injection patients 6 (6%) died during followup and 10 (19%) of the prosthetic patients died (p < 0.05). At the time of contact only 41% of the patients were still using intracavernosal injection. In contrast, 70% of the patients were still sexually active with the prosthesis (p < 0.01). Mean duration of use of the penile prosthetics was 63 months compared to 37 months for intracavernosal injection (p < 0.001). The most common reasons for discontinuing intracavernosal injection were inadequate erections (16 cases), lack of spontaneity (14), side effects (12), lack of partner (10), loss of sexual interest (6) and spontaneous return of normal erections (4). More than half of the patients (61%) who discontinued intracavernosal injection remain sexually active with other therapies, including penile prosthesis in 11, vacuum devices in 4, vascular surgery in 1 and oral medication in 1, and 14 without any therapy. We could not identify any significant clinical parameters that would accurately predict which patients most benefited by the long-term use of intracavernosal injection therapy. In contrast, only 6 patients discontinued use of the implant because of complications (infection, erosion and malfunction) and 7 for reasons independent of the implant (that is lack of partner, loss of sexual interest and co-morbidity). Intracavernosal injection serves as only a palliative therapy for the majority of patients with erectile dysfunction but there exists a core group who derives long-term satisfaction with its use. The majority of patients who discontinue intracavernosal injection remain sexually active yet do not progress to more invasive or effective therapies. The reason for discontinuing therapies for erectile dysfunction is often unrelated to the actual therapeutic modality. Our findings suggest that further improvements in intracavernosal injection therapy and the development of alternative methods of delivery of vasoactive agents will have only a limited impact on the overall outcome of therapy for erectile dysfunction and that increased attention to issues separate from the erection is warranted.
Article
Sildenafil is a potent inhibitor of cyclic guanosine monophosphate hydrolysis [corrected] in the corpus cavernosum and therefore increases the penile response to sexual stimulation. We evaluated the efficacy and safety of sildenafil, administered as needed in two sequential double-blind studies of men with erectile dysfunction of organic, psychogenic, and mixed causes. In a 24-week dose-response study, 532 men were treated with oral sildenafil (25, 50, or 100 mg) or placebo. In a 12-week, flexible dose-escalation study, 329 different men were treated with sildenafil or placebo, with dose escalation to 100 mg based on efficacy and tolerance. After this dose-escalation study, 225 of the 329 men entered a 32-week, open-label extension study. We assessed efficacy according to the International Index of Erectile Function, a patient log, and a global-efficacy question. In the dose-response study, increasing doses of sildenafil were associated with improved erectile function (P values for increases in scores for questions about achieving and maintaining erections were <0.001). For the men receiving 100 mg of sildenafil, the mean score for the question about achieving erections was 100 percent higher after treatment than at base line (4.0 vs. 2.0 of a possible score of 5). In the last four weeks of treatment in the dose-escalation study, 69 percent of all attempts at sexual intercourse were successful for the men receiving sildenafil, as compared with 22 percent for those receiving placebo (P<0.001). The mean numbers of successful attempts per month were 5.9 for the men receiving sildenafil and 1.5 for those receiving placebo (P<0.001). Headache, flushing, and dyspepsia were the most common adverse effects in the dose-escalation study, occurring in 6 percent to 18 percent of the men. Ninety-two percent of the men completed the 32-week extension study. Oral sildenafil is an effective, well-tolerated treatment for men with erectile dysfunction.
Article
During the last fifteen years the field of erectile dysfunction has grown tremendously, offering several treatment options to impotent patients, such as intracavernosal pharmacotherapy, vacuum therapy, penile vascular surgery and penile prosthetic surgery. Several multicenter clinical trials have been undertaken and numerous studies have been published, showing that the 'gold standard' treatment does not exist. As new oral, intraurethral and intracavernosal medications are added to the armamentarium of physicians and even more will be available for physicians and patients in the near future, the question becomes apparent: which treatment and when? The present paper critically reviews the existing information on currently available treatment options, and discusses future perspectives based on data from ongoing clinical trials. Considerations for the development of a new management strategy are also discussed.
Article
To develop Patient and Partner versions of a psychometrically sound questionnaire, the EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction), to assess satisfaction with medical treatments for erectile dysfunction. Treatment satisfaction differs from treatment efficacy as it focuses on a person's subjective evaluation of treatment received. Twenty-nine items representing the domain of treatment satisfaction for men and 20 representing partner satisfaction were generated. Two independent samples of 28 and 29 couples completed all items at two points in time. Spearman rank-order correlations were derived to assess test-retest reliability and couple coefficients of validity. Internal consistency coefficients were calculated for both Patient and Partner versions and a content validity panel was used to analyze content validity. Only items that met all the following criteria were selected to comprise the final questionnaires: (a) range of response four or more out of five; (b) test-retest reliability greater than 0.70; (c) ratings by at least 70% of the content validity panel as belonging in and being important for the domain; and (d) significant correlation between the subjects' and partners' responses. Eleven patient items met criteria and formed the Patient EDITS; five partner items met criteria and formed the Partner EDITS. Scores on the two inventories were normally distributed with internal consistencies of 0.90 and 0.76, respectively. Test-retest reliability for the Patient EDITS was 0.98; for the Partner EDITS, it was 0.83. Reliability and validity were well established, enabling the EDITSs to be used to assess satisfaction with treatment modalities for erectile dysfunction and to explore the impact of patient and partner satisfaction on treatment continuation.
Article
To determine the efficacy and safety of fixed-dose oral sildenafil in patients with erectile dysfunction (ED) of various etiologies. In a 12-week, double-blind, randomized, placebo-controlled, fixed-dose study, 514 men (mean age 56 years) with ED were randomized to receive 25, 50, or 100 mg of sildenafil or placebo. The primary etiology of ED was determined to be organic in 32% of men, psychogenic in 25%, or mixed in 43%. Sildenafil or placebo was taken in the home setting approximately 1 hour before sexual activity, not more than once daily. Efficacy was determined by responses to question 3 (ability to achieve an erection) and question 4 (ability to maintain an erection) of the 15-item International Index of Erectile Function (IIEF). Other measures of efficacy included the five sexual function domains of the IIEF, a global efficacy question, event log data, and a partner questionnaire. Sildenafil significantly increased patients' ability to achieve and maintain erections (P <0.0001), with efficacy increasing with increasing dose. Significant improvements were also observed in the IIEF domains for erectile function, orgasmic function, intercourse satisfaction, and overall sexual satisfaction (P <0.0001). The proportion of subjects who felt that treatment with sildenafil improved their erections was significantly greater (67% to 86%) than that with placebo treatment (24%, P <0.0001). The proportion of successful attempts at sexual intercourse also increased significantly with sildenafil treatment (P <0.001). Partner responses corroborated patient reports. Sildenafil was well tolerated at the three doses studied. Oral sildenafil is an effective, well-tolerated treatment for ED of various etiologies.
Article
We assess the clinical efficacy of sildenafil citrate and predictors of satisfactory outcome. All patients treated with sildenafil citrate within the first 6 weeks of its release were evaluated with a self-administered questionnaire before and at completion of therapy to assess etiology of erectile dysfunction, level of sexual function, libido, response to previous therapies, response to therapy with sildenafil citrate and quality of life. Sexual function was measured before and during therapy using an abbreviated version of the International Index of Erectile Function, with a successful outcome defined as a level of satisfaction of 4 or 5 on a 5-point scale. Followup was obtained in 267 of the 308 patients who entered the study. Mean age plus or minus standard deviation was 61+/-9.6 years and duration of erectile dysfunction was 4.1+/-3 years. Overall satisfaction with sildenafil citrate for the entire patient population was 65% and response to prior therapies did not affect satisfaction. There was a significant positive correlation between baseline sexual function and response to sildenafil citrate but even patients with severe erectile dysfunction had a 41% satisfaction rate. Etiology of erectile dysfunction had a significant impact on satisfaction rate, with neurogenic causes of erectile dysfunction (diabetes, prostate surgery and so forth) having significantly lower rates than psychogenic or vasculogenic erectile dysfunction. Sildenafil citrate is a highly effective oral agent for the treatment of erectile dysfunction in clinical practice. The best predictors for response to sildenafil citrate therapy are baseline sexual function and etiology of erectile dysfunction. However, we could not identify any patient characteristic that would predict absolute failure for sildenafil citrate therapy. Therefore, all patients with erectile dysfunction who do not have specific contraindications should be considered for sildenafil citrate therapy.
Article
We report the results of a prospective study of 1,381 Mentor Alpha I penile prostheses implanted to treat impotence, and compare original and enhanced penile prosthesis mechanical reliability. The study consisted of 410 original models manufactured before November 1992 and 971 enhanced models manufactured since December 1992. Implants were further stratified as first time (virgin) or replacements of a previous implant. Mechanical failure-free survival rates for the original prosthetic and enhanced models were compared. The 5-year survival rate increased from 75.3% for the original to 92.6% for the enhanced model overall (log rank p<0.0001), and from 75.3 to 93.6%, respectively, for the virgin implants only (log rank p<0.0001). The estimated failure rate of approximately 5.6% for the original model was fairly consistent during followup, while the significantly lower failure rate of 1.3% for the enhanced model was not. The failure rate of the enhanced model implants was about 0.8% per year during the first 3.5 years and increased to approximately 3.1% per year thereafter. Our results strongly support the premise that mechanical reliability is superior with the enhanced compared to the original model.
Article
We estimated the incidence of erectile dysfunction in men 40 to 69 years old at study entry during an average 8.8-year followup, and determined how risk varied with age, socioeconomic status and medical conditions. Data from a randomly sampled population based longitudinal study of Massachusetts men were analyzed. A total of 1,709 men completed the baseline interview during 1987 to 1989 and 1,156 survivors completed followup from 1995 to 1997. The analysis sample consisted of 847 men without erectile dysfunction at baseline and with complete followup information. Erectile dysfunction was assessed by discriminant analysis of 13 questions from a self-administered sexual function questionnaire and a single global self-rating question. The crude incidence rate for erectile dysfunction was 25.9 cases per 1,000 man-years (95% confidence interval [CI] 22.5 to 29.9). The annual incidence rate increased with each decade of age and was 12.4 cases per 1,000 man-years (95% CI 9.0 to 16.9), 29.8 (24.0 to 37.0) and 46.4 (36.9 to 58.4) for men 40 to 49, 50 to 59 and 60 to 69 years old, respectively. The age adjusted risk of erectile dysfunction was higher for men with lower education, diabetes, heart disease and hypertension. Population projections for men 40 to 69 years old suggest that 17,781 new cases of erectile dysfunction in Massachusetts and 617,715 in the United States (white males only) are expected annually. Although prevalence estimates and cross-sectional correlates of erectile dysfunction have recently been established, incidence estimates were lacking. Incidence is necessary to assess risk, and plan treatment and prevention strategies. The risk of erectile dysfunction was about 26 cases per 1,000 men annually, and increased with age, lower education, diabetes, heart disease and hypertension.
Article
We performed a long-term multicenter study of the AMS 700CX 3-piece inflatable penile prosthesis, focusing on longevity, morbidity and patient satisfaction in men implanted up to 134 months with a median followup of 47.7 months. We performed a large scale retrospective multicenter study in 2 phases. Phase 1 was a medical record review of 372 men who underwent implantation with the AMS 700CX penile prosthesis from 1987 to 1996 by 7 frequent penile prosthesis implanters. Phase 2 included a structured telephone interview of 207 patients by a neutral observer. For the 372 men in phase 1 mean device mechanical reliability plus or minus standard deviation was 92.1% + or - 3.3% after 3 and 86.2% + or - 4.6% after 5 years. Patient age was 21 to 79 years (mean 57.6 + or - 11.0) at implantation. The etiology of erectile dysfunction was vascular in 27.7% of the cases, Peyronie's disease in 16.9%, diabetes mellitus in 12.9% and radical surgery in 11.6%. Of the men 55.6% received previous treatment for erectile dysfunction. Postoperative infection and device malfunction developed in 3.2% and 17.5% of the cases, respectively. Of the 207 men interviewed in phase 2, 86% still had an AMS 700CX penile prosthesis implanted, including 87.1% with erection suitable for coitus. Currently 79% of those with a device use it at least twice monthly and 88.2% would recommend an implant to a relative or friend. The AMS 700CX penile implant produced suitable erection and excellent patient satisfaction at long-term followup in the majority of men. Implant reliability is excellent and postoperative morbidity is low.
Article
Intracavernous injection is a well established medical therapy for erectile dysfunction. We assessed the rate of success when patients with erectile dysfunction who were effectively treated with intracavernous injections of prostaglandin E1 were changed to oral therapy with sildenafil citrate. Only patients effectively managing erectile dysfunction by the intracavernous injection of 20 microg. or less prostaglandin E1 for more than 6 months were eligible for study enrollment. After a 4-week run-in phase while intracavernous prostaglandin E1 therapy continued and a 48-hour washout period 176 patients with erectile dysfunction received open label sildenafil orally for 12 weeks. Satisfaction with treatment was evaluated by the 11-item erectile dysfunction index of treatment satisfaction questionnaire. A successful change to sildenafil was prospectively defined as a questionnaire score of 0 to 100 after sildenafil that was greater than or equal to the score after intracavernous prostaglandin E1. Of the 176 patients 69% (95% confidence limit 62 to 76) successfully changed from intracavernous prostaglandin E1 injections to oral sildenafil and elected to continue oral treatment. Mean satisfaction score after sildenafil and prostaglandin E1 was 73.8 and 63.9, respectively (p <0.001). Only 3 patients (1.7%) discontinued therapy because of treatment related adverse events. More than two-thirds of the men with erectile dysfunction who were stable on intracavernous injections of 20 microg. or less prostaglandin E1 successfully changed to oral sildenafil, as determined by maintained or enhanced treatment satisfaction.
Article
To our knowledge comparative data on the effectiveness of and patient preference for intracavernous injection therapy and sildenafil are still not available. We evaluated the efficacy of sildenafil as well as patient preference in a group of impotent men on intracavernous injection for more than a year. Patients on intracavernous injection therapy for more than a year without neurological disease and/or a contraindication to sildenafil treatment were recruited for study. In phase 1 we determined the efficacy of 50 and 100 mg. sildenafil citrate at home. In phase 2 responders to sildenafil were asked to use the preferred dose orally for a month and choose intracavernous injection or sildenafil. In phase 3 patients were asked to continue either treatment for 3 more months. Patient preferences were reported at the end of phases 2 and 3. Of the 180 men recruited 155 with a mean age of 56.4 +/- 12.6 years on intracavernous injection for a mean of 26 +/- 9 months accepted and were included in our series. Overall 116 men (74.8%) responded to sildenafil during study phase 1. After 1 month of treatment 71 responders (61.2%) preferred to continue with the oral drug, 31 (26.7%) returned to intracavernous injection and 14 (12.1%) used each drug alternately. Three months later 74 of the 116 responders (63.8%) preferred oral treatment and 38 (32.8%) chose intracavernous injection, while 4 (3. 4%) continued to use each treatment alternately. Sildenafil is highly effective in intracavernous injection responders, although a certain group prefer to continue intracavernous injection. While sildenafil should be considered first line treatment, men with erectile dysfunction should be aware of all treatment options available because nonresponders to sildenafil may respond to intracavernous injection.
Article
We assessed the efficacy and safety of sildenafil citrate as treatment for erectile dysfunction. A total of 433 completely evaluated men with chronic erectile dysfunction were treated with sildenafil citrate. Response was assessed prospectively by baseline and followup physician interviews, and by a patient self-administered 15-item questionnaire on the domains of patient treatment response and satisfaction, partner treatment satisfaction, comparative previous treatment satisfaction, adverse effects, and patient and partner quality of life. Of the 304 men (70.2%) who completed the questionnaire 278 received sildenafil, including 186 who previously had undergone treatment for erectile dysfunction, principally involving intracavernous injection therapy. A response was elicited by a median dose of 100 mg. in 188 patients (67.6%) who achieved erection suitable for sexual intercourse. Those with psychogenic erectile dysfunction responded significantly better than those with organic dysfunction (p <0.001). Erection suitable for intercourse was attained by 30.8% of patients with erectile dysfunction after radical prostatectomy and 80% with cavernous veno-occlusive dysfunction. Of previous intracavernous injection responders 29.9% were refractory to sildenafil, while 33. 3% of previous intracavernous injection nonresponders responded to sildenafil. The sildenafil response was considered inferior to the intracavernous injection response by 43.6% of the men who previously responded to intracavernous injection, of whom 51.5% continued to receive intracavernous injection as the only treatment (19.5%) or as an alternative to sildenafil (32%). Adverse effects in 53.6% of cases were assessed as mild in 56.4%, moderate in 38.3% and severe in 5.3%. Multiple adverse effects were reported by 62.4% of patients, while 17 (6.1%) discontinued sildenafil as a direct result of intolerable adverse effects. The most common adverse effects were facial flushing in 33.5% of cases, headaches in 23.4%, nasal congestion in 12.6%, dyspepsia in 10.1% and dizziness in 10.8%. Baseline patient and partner quality of life scores significantly improved after sildenafil treatment (p <0.001), while significantly improved quality of life was noticed by 51.5% and 43.1%, respectively. Sildenafil citrate is effective oral first line treatment for erectile dysfunction. Although more than 50% of men reported adverse effects, most were considered mild and rarely resulted in treatment cessation. There was a trend in those on intracavernous injection who responded to sildenafil to continue intracavernous injection as the only therapy or as an alternative to sildenafil. Also, we noted that some cases refractory to sildenafil responded to intracavernous injection. These findings imply that intracavernous injection remains an effective erectile dysfunction treatment option.
Article
The socioeconomics of erectile dysfunction have been changed greatly by the introduction of the successful oral therapy, sildenafil. The population of patients presenting for treatment of erectile dysfunction has expanded significantly and rapidly. This article addresses the descriptive and analytic economic implications of erectile dysfunction treatment.
Article
Background Sildenafil is a potent inhibitor of cyclic guanosine monophosphate in the corpus cavernosum and therefore increases the penile response to sexual stimulation. We evaluated the efficacy and safety of sildenafil, administered as needed in two sequential double-blind studies of men with erectile dysfunction of organic, psychogenic, or mixed causes.
Socioeconomic considerations in erectile dysfunc-tion treatment In response to EDITS questionnaire question 4 on whether treatment met expectations 29 of 32 patients (90.63%) who under-went IPP said that treatment met expectations considerably or com-pletely compared with 14 of 31
  • R Shabsigh
  • Erectile Function After Erectile Dysfunction
  • Treatment
Shabsigh, R.: Socioeconomic considerations in erectile dysfunc-tion treatment. Urol Clin North Am, 28: 417, 2001 FIG. 4. In response to EDITS questionnaire question 4 on whether treatment met expectations 29 of 32 patients (90.63%) who under-went IPP said that treatment met expectations considerably or com-pletely compared with 14 of 31 (45.16%) on sildenafil and 8 of 22 (36.36%) on ICI. SATISFACTION AND ERECTILE FUNCTION AFTER ERECTILE DYSFUNCTION TREATMENT