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

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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.

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... Understandably, ED was the most popular Google search term related to men's health for the past five years [15]. Penile prosthesis implant (PPI) surgery is an effective treatment option for ED with satisfactory rates above 90% [14,16]. Although surgery was classically considered third-line therapy for ED [17], the 2018 American Urological Association guidelines for ED now suggest a shared decision-making model where surgical options are considered first-line along with medical therapy [18]. ...
... The two individual scorer's results were averaged and then analyzed to mitigate subjectivity. Websites were then defined as very poor (15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26), poor (27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38), fair (39-50), good (51-62), or excellent (63-75) quality from the averaged sum scores. This replicates an approach used by multiple studies to evaluate quality with the DISCERN instrument [3,12,22,26]. ...
... Therefore, it is paramount that patients have access to high-quality OHI that is comprehensible and accurate. Erectile dysfunction, a common urologic issue for men [13], is the highest-trending online search topic concerning men's health [15], and PPI surgery is an excellent treatment option [18] that can provide patients with higher satisfaction rates than medical therapy [16,28]. As a result, it is important to evaluate whether the online information patients are reading on PPIs is acceptable or not. ...
Article
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Background: Online health information (OHI) has become widely accessible and affects patient decisions regarding their healthcare. The purpose of this study was to assess the readability, quality, and accuracy of information available to patients online about penile prosthesis implants (PPIs). Methods: We performed a Google search using the keywords “penile implant” and “penile prosthesis.” The first 30 search results for both terms were analyzed, and advertisements, news articles, duplicates, and videos were excluded. Websites were categorized as institutional, commercial, and personal/patient support. Readability of each website was determined using the Flesch-Kincaid grade level (FKGL) readability formula within the readable tool. Quality was measured by Health On the Net (HON) certification status and the DISCERN scoring method. For website accuracy, a score of 1-4 (1=0-25%, 2=25-50%, 3=50-75%, and 4=75-100%) was assigned. Results: Forty-four websites met the criteria (23 institutional, 12 commercial, and 9 personal/patient support). The mean total FKGL score was 9.55. No statistical difference was detected between mean FKGL for each website category (p=0.69). Only eight websites (18%) scored ≤8th-grade reading level (average US adult level), while 36 (82%) were >8th-grade level. Mean total DISCERN sum score was 39.74/75, with no statistical difference in mean DISCERN score between website types (p=0.08). Over half (55%) of the websites were defined as “very poor” or “poor” quality by DISCERN scoring. Mean total overall quality rating was 2.67/5. HON certification was verified for only nine websites (20%). Twenty-five percent of websites were classified as 0-25% accurate, 23% were 25-50% accurate, 30% were 50-75% accurate, and 23% were 75-100% accurate. Conclusion: Most information on the Internet about PPIs is reasonably accurate; however, the majority of websites are deficient in quality and unreadable to the average patient, irrespective of website type.
... Implant infection (1-3% at first time implant), mechanical failure (7%), glans ischemia, glans hypoesthesia and paresthesia (2%), and device erosion must also be discussed in detail. [3,4] The use of color duplex Doppler ultrasound can augment the preoperative evaluation. While information on penile vasculature can be helpful in establishing diagnostic etiology in ED, it can also better characterize the deformity in patients with PD. ...
... The dorsal neurovascular bundle is dissected from the tunica albuginea, and isolated. [3] A releasing incision is made in the tunica albuginea at the point of maximal curvature. [4] Residual curvature is minimal other hemostatic patch material such as Nu-Knit (cellulose mesh) and Evarrest (cellulose mesh with addition of thrombin and fibrinogen on one side), which are strictly hemostatic [25]. ...
Article
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Purpose of Review Up to 20–30% of patients with Peyronie’s disease (PD) suffer from some degree of erectile dysfunction (ED). When medical management fails, the surgical approach towards those with PD and ED relies on the penile prosthesis. Recent Findings Graft material has advanced in recent years, and hemostatic patch material has emerged as a promising, easy to use, and cost-effective approach. Intracorporal techniques that obviate the need for neurovascular bundle mobilization have recently been described, and can be considered a frontier for further investigation. Summary A thorough literature review was performed using the PubMed online database with query: “Penile Prosthesis” and “Peyronie’s disease” with “Plaque excision,” “Plaque incision,” “Tunica albuginea plication,” “Modeling,” and “Excision and grafting.” While the three-piece inflatable penile prosthesis (IPP) is commonly used, malleable implants may also achieve success where three-pieces are unavailable or not appropriate for use. When implant alone does not correct the deformity, manual modeling is a mainstay in treating residual curvature. Tunica plication, incision, and excision/graft techniques are required in patients with more severe/complicated plaques.
... 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
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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.
... In patients with ED that does not respond to, or unwilling to continue with medications, penile prosthesis (PP) is typically regarded as a "last resort" therapeutic option. High satisfaction rates of 80 to 90% were achieved in the last 40 years as a result of numerous advancements in surgical and material methods [3,4] . Nevertheless, complications do arise and can range from 7 to 20% [5] , with the majority being related to erosion, infection, and mechanical failure. ...
... 31 One publication showed that patients with ED who underwent penile implant surgery had significantly better erectile function and treatment satisfaction rates than patients who received PDE5Is. 32 Unfortunately, PPI accessibility could be a barrier to treatment; only 4 out of 100 practicing urologists are trained to perform PPI in the United States. 17 Ensuring sufficient penile prosthesis implanters could mitigate the potential physical, emotional, and social burden of untreated ED. ...
Article
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Introduction: Penile prosthesis implantation (PPI) is a treatment option recommended in clinical guidelines for erectile dysfunction (ED). However, a limited number of urologists perform PPI procedures in the United States. Aim: To quantify the number of insured men with ED in the United States and project the number of potential candidates for PPI in 2022. Methods: An Excel-based disease impact model was constructed using a top-down estimation approach. The starting US male population consisted of adult men from 2022 US Census data after exclusion of age-specific mortality rates from the National Vital Statistics Reports. Men with health insurance were included in the model based on insurance status data from the US Census database. ED prevalence and ED treatment rates were obtained from administrative claims data analyses-the Merative MarketScan Commercial Database (18-64 years) and the 5% Medicare Standard Analytical Files (≥65 years)-and literature-based estimates of patient-reported ED prevalence. Outcomes: The number of men with ED in the United States and the number of potential candidates for PPI were estimated. Results: By utilizing ED prevalence based on administrative claims, an estimated 8.3% of insured men (10,302,540 estimated men [8,882,548 aged 18-64 years and 1,419,992 aged ≥65 years]) had a diagnosis of ED and sought ED care, out of 124,318,519 eligible US men aged ≥18 years in 2022. An estimated 17.1% of men with an ED diagnosis claim could benefit from PPI in 2022 (1,759,248 men aged ≥18 years). Patient self-reported ED prevalence across all ages ranged from 5.1% to 70.2%. Scenario analyses applying the patient self-reported ED prevalence range revealed the number of men in the United States who could benefit from PPI could have been higher than 1.7 million if their ED symptoms were diagnosed by health care providers. Clinical implications: Most men with ED in the United States are undertreated, and many could benefit from PPI. Strengths and limitations: This analysis is a US population-level estimation. However, given this study utilized a variety of assumptions, the results may vary if different model assumptions are applied. Conclusions: This disease impact model estimated that approximately 10.3 million men were diagnosed with ED by their health care providers and sought ED care in the United States in 2022. Of those, 1.7 million men could be PPI candidates and benefit from the treatment option.
... Following radical prostatectomy (RP) for prostate cancer, erectile dysfunction (ED) has been reported to occur in up to 68% of men (1). In refractory cases, inflatable penile prosthesis (IPP) has been associated with high patient and partner satisfaction (2)(3)(4). Stress urinary incontinence (SUI) is also common after RP and can often coexist with ED (5). The surgical treatment of SUI centers around artificial urinary sphincter (AUS) and male slings depending on the severity of incontinence and radiation history (6). ...
Article
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Background: In 2017, a prospective multicenter, multinational, investigational pilot study was conducted examining outcomes using a novel surgical technique, the Mini-Jupette sling, for the management of erectile dysfunction (ED) patients with climacturia and/or minimal stress urinary incontinence (SUI) after prostate procedures. Climacturia has been reported in up to 64% of patients following radical prostatectomy (RP). We sought to report the 5-year outcomes from this original cohort to assess long-term safety and effectivity of the mini-jupette sling in the treatment of ED and concomitant mild SUI and/or climacturia. Methods: This is a single-arm, multicenter, retrospective, observational study. We identified patients who were enrolled in the previous multicenter study with post-RP ED and climacturia and/or mild SUI- 2 PADS PER DAY (PPD) and underwent inflatable penile prosthesis (IPP) insertion with simultaneous placement of a mini-jupette sling. Data were collected including current PPD, subjective improvement in climacturia/SUI, complications, need for revision of IPP or additional urinary incontinence surgery, and date of most recent follow-up. SPSS was used for statistical analysis. Results: Of the original 38 patients, 5 have since died and 10 were lost to follow-up with 23/38 (61%) patients available for evaluation of long-term outcomes. The average follow-up time was 59 months (SD =8.8) with a mean age of 69 years (SD =6.8). Most patients (n=21, 91%) had subjective improvement of SUI and climacturia. One patient with persistent bothersome incontinence underwent artificial urinary sphincter (AUS) placement in 2018 with no complications, while the other is still considering a repeat procedure due to minor but persistent SUI. The mean PPD decreased from 1.4 preoperatively to 0.4 at a mean of 5 years of follow-up. Most patients reported satisfaction in their urinary symptoms with 91% and 73% reporting improvement in SUI and climacturia respectively, compared to 86% and 93% respectively in the original series. One (4.3%) patient had an IPP revision for pump malfunction. There were no device infections reported. Conclusions: The mini-jupette sling appears to be a safe and effective procedure with durable improvements in SUI and climacturia at 5 years of follow-up.
... This is a lower value than when compared to previously stated satisfaction rates of 75-98% seen in the literature. 2,8,[10][11][12][13][14][15][16] Until recently, however, no validated questionnaire existed for satisfaction following penile implant and therefore comparison between studies is difficult due to significant methodological heterogeneity and geographic and cultural differences. 17 Our cohort also includes patients undergoing revision surgeries, as well as malleable implants, which has been shown to have lower satisfaction. ...
Article
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Introduction: Surgical management via penile prosthesis is an option for patients who have failed medical management. There is a paucity of literature surrounding factors contributing to patient satisfaction after implant surgery. The objective of this study was to characterize patients' and surgeons' attitudes toward factors affecting satisfaction with this procedure. Methods: Two patient cohorts were identified and contacted via email: a medical management of erectile dysfunction (ED) cohort and a penile implant patient cohort. A third cohort, Canadian urologists who perform penile implant surgeries, was also contacted. The surveys consisted of 5- 7 questions, including a rating question regarding the importance of various penile implant factors. Results: Forty-six ED patients, 45 post-implant patients, and 12 urologists completed the survey. The mean overall satisfaction on a 10-point scale was 6.49 (standard deviation [SD] 2.92). Most (67%) urologists selected patient satisfaction as one of their least favorite aspects of penile implant surgery. Compared to post-implant patients, ED patients reported greater importance in the areas of appearance (p=0.035), soft glans (p=0.040), and concealment of implant (p=0.007). Urologists ranked natural feel (p=0.019) and generating a discrete erection (p=0.022) as less important than patients. Conclusions: This is the first study that examines which specific variables of penile implant surgery are associated with satisfaction while comparing surgeons' understanding of what patients desire from this surgery. This study identifies several factors deemed important by patients but under-recognized by urologists. This knowledge can aid urologists in optimizing preoperative counselling and improving patient satisfaction.
... Satisfaction rates of patients who undergo penile prosthesis implantation (PPI) are generally high overall, ranging from 83 to 98 percent [1,2]. Compared to oral and injection pharmacotherapy, PPI has been shown to result in better erectile function and satisfaction [3]. However, patients commonly complain of penile shortening after implantation [1]. ...
Article
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Patients who undergo penile prosthesis implantation as treatment for erectile dysfunction commonly complain of penile shortening after implantation. We conducted a study to determine whether knowledge of pre-operative stretched penile length measurement influences patient satisfaction. This prospective study consisted of 149 patients undergoing inflatable penile prosthesis (IPP) implantation from August 2017 to December 2019. Study group participants underwent pre-operative stretched penile length measurement in clinic while the control group did not. Six months post-operatively, patients completed a modified 14-item Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire to assess overall satisfaction and penile length satisfaction. A total of 102 patients were eligible for final analysis (49 in study group, 53 in control). Mean scores for overall treatment satisfaction were 3.57 and 3.53 (scale from 0 to 4) in the study versus control group, respectively (p = 0.483). Mean scores for satisfaction with penile length were 4.08 and 4.11 (scale from 1 to 5) in the study vs. control group (p = 0.645). The study suggests that knowledge of pre-operative stretched penile length does not influence post-operative satisfaction after penile prosthesis implantation. Therefore, performing pre-operative measurements in clinic solely for informing the patient may be unnecessary. Current interventions aimed at conserving penile length may be effective at maintaining satisfaction with penile length. Trial Registration- This trial is registered and approved by the IRB committee at our institution, ID: HSC-MS-19-0320.
... The penile prosthesis was introduced in the 1970s and remained the most effective treatment to erectile dysfunction refractory to oral and injectable drugs [1,2]. In the last 40 years, several improvements in materials and surgical techniques led to high satisfaction rates of 80 to 90% [3,4]. However, complications do exist and range from 7 to 20% [5], mostly related to mechanical malfunction, infection, and erosion. ...
Article
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Background Infection is the most feared complication of a penile prosthesis. Diabetes mellitus (DM) is widely known to increase the risk of several infections, but its role in the penile prosthesis is still controversial. This systematic review aims to show the contemporary scenario of penile prosthesis infection and present a meta-analysis about DM contribution to penile prosthesis infection. Methods The review was performed with no language or time limitation, including ten databases. The included articles were about the male population who received a penile prosthesis with no model restriction, with a minimum follow up of 1 year, and outcomes adequately reported. Results The mean infection incidence of penile prosthesis ranged from 0.33 to 11.4%. In early 2000, the general incidence of infection was 3 to 5%, then, the introduction of coated materials decreased it to 0.3 to 2.7%. The meta-analysis showed that diabetes mellitus is related to an increased risk of penile prosthesis infection with an odds ratio of 1.53 (95% CI 1.15–2.04). Conclusions Penile prosthesis infection decreased in the last decades but remains a significant cause of reoperation, and it is related to lower prosthesis survival. Meta-analysis concludes that diabetes mellitus is related to a higher risk of penile prosthesis infection.
... In der Studie von Rajpurkar et al. [14] wurden drei Therapieoptionen (orale PDE-5-Hemmer, intrakavernöse Injektion und die PP) verglichen. Hierbei zeigte sich eine höhrere ZR bei den Patienten mit PP im Vergleich zu den anderen Therapieoptionen. ...
Article
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Background Erectile dysfunction is a condition that shows a continuously growing prevalence in the male population. The penis prosthesis implant (PPI) qualifies as an effective form of therapy.Objectives The aim of this study was to analyze the sexual satisfaction rate and quality of life in patients who had suffered from erectile dysfunction and who were treated with a penile prosthesis. The patient’s partners were also surveyed.Methods We collected data from patients who underwent surgery in the Center of Excellence for Penile Implants, University Hospital Schleswig–Holstein, Campus Kiel, Kiel, Germany. Questionnaires with validated scores (EDITS, EDITS Partner) were sent to all patients and their partners via mail.ResultsThe satisfaction rate in this study was high which shows that the patients and partners are pleased, and the high sexual satisfaction rate led to a higher quality of life.Conclusion The penile prosthesis implantation as a last option of therapy for erectile dysfunction is useful and brings more than adequate results.
... Urologists performing penile prosthesis operations must be familiar with their complications, revision procedures, reconstruction techniques and salvage methods. While recent data have shown satisfactory operative rates for primary implantation of 96% at 5 years and 60% at 15 years [3], refining the surgical technique used for managing penile prosthetic cylindrical complications may further improve patient safety and satisfaction. ...
Article
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Introduction Patients with proximal penile prosthetic cylindrical complications (PPPCC) can be treated with a direct crural technique without using the original traditional approach. In this article we present our novel direct crural approach for management of patients with PPPCC. Materials and methods Between 2014 and 2019, data were retrospectively collected from 13 patients who underwent surgical revision using our novel direct crural approach for PPPCC. The procedure commences with identification of the affected zone. The patient is in a low lithotomy position. A 2-centimeter longitudinal incision is made directly over the affected site. Dissection is carried down through Colles’ fascia, followed by a longitudinal incision through the tunica albuginea at the proximal part of the affected cylinder. Via the incision we can deliver out the cylinder and manage its problem. Results Mean operative time was 40 min. No intra or post-operative complications were reported. All patients (Mean age = 57) were discharged on the same day. Postoperative follow-up found correction of all existing deformities at month 1, 3 and 6. All patients were satisfied and reported less pain and faster recovery than the first procedure. Conclusion Our technique, which can be used for all types of penile prosthesis, is both feasible and safe. It may simplify PPPCC revision by avoiding adhesions below the original incision, without jeopardizing the already implanted materials or the urethra. It may also improve patients’ safety and satisfaction, by reducing iatrogenic injury and post-operative recovery time.
... 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
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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.
... Since the advent of antibiotic coated penile implants, post-operative infection rates have declined significantly to <1% 52,53 with infection and complication rates not influenced by a history of RT. 54 Patients are typically cleared for sexual activity four-six weeks after surgery. Among all treatments for ED, the inflatable penile prosthesis (IPP) has the highest patient satisfaction, 55 with series reporting 92-100% in patients, and 91-95% satisfaction in female partners 56,57,58 Thus, the IPP is often considered the gold standard Q9 in penile prosthesis surgery. ...
Article
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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.
... In the literature, among the treatment options for ED, PPI has been reported to be the most successful surgical method with the highest level of satisfaction (10). Different prostheses have different advantages and disadvantages that may affect the satisfaction of the patient (11). ...
Article
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Objective: To compare the surgical results, complications, and satisfaction levels of patients who underwent malleable penile prosthesis implantation (M-PPI) and Ambicor penile prosthesis implantation (A-PPI). Material and methods: One hundred forty two patients who underwent penile prosthesis implantation [M-PPI (Promedon- Tube®, Cordoba, Argentina): 81, and A-PPI (American Medical Systems, Minnesota, USA): 61] between 2013-2018 were evaluated retrospectively. Patients' age, body mass index, smoking history, etiological factors, modified "Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire" scores, shortening of the penis, and complications were recorded. Results: The patients who performed A-PPI implantation were younger (56.27 ± 10.81 vs. 51.47 ± 11.79, p = 0.009). The EDITS scores of 31(38.2%) patients who underwent M-PPI and 44 (72.4%) patients who underwent A-PPI were available. It was observed that the scores on the following questions were statistical significantly higher in the A-PPI group: "Overall, are you satisfied with your penile prosthesis?, How much of your expectations did penile prosthesis meet?, How often do you use your penile prosthesis?" (p = 0.05, p = 0.048, p = 0.038). No difference was observed between the groups in terms of the scores on the other three questions (p = 0.447, p = 0.326, p = 0.365). A 61.3% of patients in MPPI (19/31) group, and 56.8% of patients in A-PPI (25/44) group stated penile shortening (p = 0.417). Mean shortening was reported as 2.1 ± 0.45 cm, and 2.12 ± 0.52 cm, in M-PPI and A-PPI groups, respectively (p = 0.90). Conclusion: It is remarkable that the patients who underwent A-PPI experienced higher satisfaction with their prosthesis. Even though it has not been evidenced in the current literature data, patients who have had either M-PPI or A-PPI should be informed about the risk of penile shortening.
... In the last 40 years several improvements in materials and surgical technique led it to satisfaction rates of 80 to 90% (3). Moreover, better erectile function and sexual satisfaction was reported among patients who opted by penile prosthesis than those who used sildenafil citrate and intracavernous injections (4). However, complications range from 7 to 20% (5), mostly related to mechanical malfunction, infection and erosion. ...
Preprint
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Background: Infection is the most feared complication of penile prosthesis. Diabetes mellitus is a well known to increase risk of several kinds of infection, but its role upon penile prosthesis is not defined. The aim of this systematic review is to show the contemporary scenario of penile prosthesis infection and perform a meta-analysis about diabetes mellitus contribution to penile prosthesis infection. Methods: the review was performed with no language or time limitation, in 10 data bases. There were included articles about male population who received a penile prosthesis with no model restriction, with a minimum follow up of one year and proper outcomes report. Results: The mean incidence of infection after penile prosthesis implant ranged from 0.33 to 11.4%. In early 2000, after several improvements, the general incidence of infection was 3 to 5%. Then, the introduction of coated materials decreased infection to 0.3 to 2.7% . Also, no touch technique and centers of reference with high volume surgeons contributed to reduce infection rates. Meta-analysis showed that diabetes mellitus increases penile prosthesis infection with odds ratio of 1.56 (95% CI: 1.12 - 2.044). Conclusions: Penile prosthesis infection decreased in the last decades, but remains an important cause of reoperation and it is related to lower prosthesis survival. Meta-analysis concludes that diabetes mellitus increases penile prosthesis infection and it should be considered as a risk factor.
... stopping smoking, losing weight) and oral vasodilating phosphodiesterase type-5 inhibitors, which act to increase blood flow to the penis (Krzastek 2019). Newer techniques include intracavernous injections of prostaglandin E1 and penile implant surgery (Rajpurkar 2003). An even more novel treatment being explored is low-intensity extracorporeal shockwave therapy, which acts by promoting neovascularisation (Vardi 2010). ...
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.
... 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
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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. ...
... In analyzing the satisfaction rates following revision surgery for IPPs, Caire [9] demonstrated a 58.3% rate of satisfaction with a revised IPP (compared with > 90% for primary IPP [11]), with 75% of patients indicating that they would be willing to undergo the surgery again. These findings serve to demonstrate that there is often an unfulfilled psychological aspect of many patients desiring revision surgery for an otherwise functional device. ...
Article
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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.
... 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]. ...
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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.
... 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]. ...
... Despite the invasive nature of penile implantation, the procedure maintains the highest satisfaction rate among ED treatment. Overall satisfaction rates for penile injections, phosphodiesterase type 5 inhibitors (PDE5i), and penile implants in one study were 40%, 51%, and 93%, respectively [1]. Insertion of penile implants has also been associated with improvements in psychosexual well-being [2]. ...
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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.
... 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. ...
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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.
... 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]. ...
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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.
Article
Objective: To describe the infectious and non-infectious complications in men undergoing Inflatable penile prosthesis (IPP) revision with partial and complete component exchange for mechanical malfunction. Methods: We performed a multicenter retrospective cohort study of patients who underwent IPP revision. Men undergoing procedures for implant infection were excluded. Patients were divided into those who had complete exchange of the entire device or partial exchange of only one or 2 components. Infectious and non-infectious complications were compared between groups. Results: Three hundred sixty-eight men had complete exchange of the entire device and 85 had partial component exchange. Men undergoing partial exchange had a significantly higher infection rate (7.1% vs 2.2%, P = .031). The partial exchange group also was more likely to receive antifungals (51.8 vs 16.6%, P < .001), have a modified salvage washout (77.4 vs 60.2%, P = .004), and less likely to receive vancomycin and gentamicin (63.5 vs 83.7%, P < .001). Time to revision was significantly shorter in the partial exchange group (44.9 vs 168.2 months, P < .001). Mean follow-up was slightly longer in the complete exchange group (18.3 vs 13.0 months). In multivariable analysis, partial exchange surgery, vancomycin and gentamicin prophylaxis, modified salvage washout, and antifungal prophylaxis were no longer associated with postoperative infections. The partial exchange group had greater rates of non-infectious complications (21.2% vs 9.5%, P = .005) such as pump malfunction and tubing breakage. Conclusion: Patients undergoing partial component revision had more infectious and non-infectious complications. These findings suggest that partial component exchange increases complications in men undergoing IPP revision.
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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.
Article
Purpose: To determine if the AUA recommended prophylaxis (vancomycin + gentamicin alone) for primary inflatable penile prosthesis (IPP) surgery is associated with a higher infection risk than non-standard regimens. Materials and methods: We performed a multicenter, retrospective study of patients undergoing primary IPP surgery. Patients were divided into those receiving vancomycin + gentamicin alone and those receiving any other regimen. A Cox proportional-hazards model was constructed adjusted for major predictors. A subgroup analysis to identify the appropriate dosage of gentamicin was also performed. Results: 4,161 patients underwent primary IPP placement (2,411 received vancomycin + gentamicin alone and 1,750 received other regimens). The infection rate was similar between groups, 1 vs 1.2% for standard vs non-standard prophylaxis. In the multivariable analysis, vancomycin + gentamicin (HR: 2.7, 95%CI: 1.4-5.4, P = .004) and diabetes (HR: 1.9, 95%CI: 1.03-3.4, P = .04) were significantly associated with a higher risk of infection. Antifungals (HR: 0.08, 95%CI: 0.03-0.19, P<.001) were associated with lower risk of infection. There was no statistically significant difference in infection rate between weight-based gentamicin compared to 80 mg gentamicin (HR: 2.9, 95% CI: 0.83 to 10, P=.1). Conclusions: Vancomycin + gentamicin alone for antibiotic prophylaxis for primary IPP surgery is associated with a higher infection risk than non-standard antibiotic regimens while antifungal use is associated with lower infection risk. A critical review of the recommended antimicrobial prophylactic regimens is needed. Prospective research is needed to further elucidate best practices in IPP antimicrobial prophylaxis.
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Medical treatment for erectile dysfunction (ED) has dramatically evolved in the last decades. However, to set realistic expectations with the patient, a correct counselling is fundamental. Every kind of medical treatment must be discussed with the patient regarding risk factors, prognostic factors, treatment alternatives, correct drug use, and adverse reactions [1].
Article
Objective To evaluate sexual functions of patients with erectile dysfunction (ED) and their female partners. Methods A total of 90 consecutive ED patients who received different ED therapies and their partners and 90 consecutive controls and their partners were divided into four groups. All participants were evaluated by the 15-item international index of erectile function and the Arabic version of female sexual function index (Ar-FSFI). Results All ED patients who received sildenafil demonstrated significant improvements of their erectile function compared to baseline. Their partners did not demonstrate improvements in frequency of pain during vaginal penetration (3.86 ± 0.58, 3.93 ± 0.45, p = 0.477), confidence of becoming aroused (3.86 ± 0.58, 3.93 ± 0.45, p 0.477), frequency of satisfaction with arousal (3.07 ± 0.37, 3.03 ± 0.49, p 0.712), and maintenance of lubrication (4.37 ± 0.49, 4.23 ± 0.73, p 0.354). All ED patients who received quadmix demonstrated significant improvements of their erectile function compared to baseline. Their partners did not demonstrate improvements in desire level (2.6 ± 0.67, 2.63 ± 0.85, p = 0.869) and lubrication maintenance (3.53 ± 0.82, 3.47 ± 0.82, p = 0.423). Finally, All ED patients who underwent semi rigid penile implant demonstrated significant improvements of their erectile function compared to baseline. Their female partners demonstrated significant improvements in all items of FSFI-19 compared to baseline except the frequency of pain during vaginal penetration (3.86 ± 0.58, 3.93 ± 0.45, p = 0.477), confidence of becoming aroused (3.86 ± 0.58, 3.93 ± 0.45, p = 0.477), frequency of satisfaction with arousal (3.07 ± 0.37, 3.03 ± 0.49, p = 0.712), and maintenance of lubrication (4.37 ± 0.49, 4.23 ± 0.73, p = 0.354). Conclusions Sexual functions of ED males significantly improved after ED therapies. Nevertheless, some sexual functions of their partners were not positively impacted.
Article
Objectives: We analyzed the long-term results of malleable and inflatable penile prosthesis: the rates of complications, revision surgery and patient satisfaction. Materials and methods: Between January 1996 and December 2020, a total of 138 patients underwent implantation of a malleable or inflatable types penile prosthesis. The data of the patients were derived from the patient files and digital recording system. The patients were contacted face-to-face interaction if possible. If it is not possible, phone connection was made. Results: The median age of patients was 56 (21-83) years. Fourteen (10.2%) 1-piece, 46 (33.3%) 2-piece and 78 (56.5%) 3-piece penile prosthesis were implanted. The mostly used perioperative antibiotic was teicoplanin+amikacin in 107 patients. Total complication rate was 30% (n=42). Prosthesis infection constituted 9% (n=13) of these complications. The total satisfaction rate was 89.1%. There was no correlation between the complications and antibiotic regimen or prosthesis type (P=0.488, P=0.454, respectively). The rate of infection showed a slight increase in 3-piece penile prosthesis without any statistically significance (P=0.633). The patients with complications expressed more dissatisfaction compared to those without complications (P=0.001). Conclusions: In our series, penile prosthesis implantation seems to be a recommended treatment method with high patient satisfaction in the treatment of refractory erectile dysfunction. Level of evidence: 4.
Article
Objective: Our objectives were to explore the association between phosphodiesterase 5 inhibitor (PDE5i) use and lumbar decompression surgery (LDS) by evaluating the prevalence of LDS in a treatment group of patients with lumbar spinal stenosis (LSS) compared to a control group. Design: We performed database review and extracted data including LDS prevalence, PDE5i dosage and fill dates. Treatment group was defined as those with PDE5i fill dates less than 30 days prior to surgery, and control group was defined as those with PDE5i fill dates at any other time. LDS prevalence rates for both groups were calculated. Results: Our study found 599 LSS patients who were prescribed PDE5i. 338 underwent LDS. Of these, 71 (21%) filled their prescription less than 30 days prior to surgery, while 267 (79%) filled their prescription during a different time period. The majority (94.6%) of surgical patients received decompression at 2-or-more spinal levels. Conclusion: Prevalence of LDS for LSS was significantly lower in patients in the treatment group on PDE5i therapy compared to the control group. Among many potential explanations, the vasodilatory effect of PDE5i may have contributed to a lower surgical rate. This is the first study to explore this novel association. Future prospective studies are necessary to better define the utility of PDE5i in LSS.
Article
Introduction: Penile prosthesis for erectile dysfunction in patients with spinal cord injury or multiple sclerosis is sometimes discussed after failure of drug or instrumental treatments (vacuum). The objective of this study was to evaluate the complications, evolution and patient satisfaction after the implantation of a penile prosthesis in the neurological patient. Materials and methods: Multi-center retrospective study of 27 consecutive patients including 18 spinal cord injured patients and 9 patients with multiple sclerosis benefiting from the implantation of a penile prosthesis for erectile dysfunction purposes in two French centers between 2009 and 2019. Post-implantation complications, evolution of the use of the prosthesis and global patient satisfaction were evaluated using the standardized questionnaire Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) during a telephone call between March and May 2020. Results: The average age of implantation was 46.4 years (±12.74). The length of follow-up to date of call was 6.05 years (±2.86). 8/27 patients (29.6 %) had at least one complication of any Clavien-Dindo grade included 2 infection. 2/27 (7,4 %) patients had a mechanical prosthesis injury during follow-up. The patient's dexterity with inflation of the prosthesis was perfect in 85 % of cases, and 75 % for deflation. The satisfaction rate for prosthesis use at the time of the call was 75.36/100pts for the patient and 66.88/100pts for the partner. Conclusion: This study found an increased rate of prothesis infection compared to the general population in the neurologic patient, but patient and partner satisfaction remain sustainable after more than 5 years of implantation. Dexterity was maintained over the long term, demonstrating a good selection of indications. These data invite to favorably consider the installation of a penile prosthesis in neurological patients who have failed first-line treatments. Level of evidence: 4.
Article
OBJECTIVE To investigate how surgeons approach ethically challenging scenarios that arise in penile prosthesis surgery and identify patient-related factors that impact their approach. METHODS A survey was distributed to the Society for Urologic Prosthetic Surgeons membership consisting of 6 ethically challenging scenarios: an HIV+ patient, a patient with cognitive disability, a registered sex offender, a nonverbal patient, a litigious patient, and an uncontrolled diabetic patient whose insurance will lapse soon. Additional clinical information was provided to assess how the likelihood to offer surgery might change. The primary outcome was the likelihood of offering surgery in each scenario. RESULTS The response rate was 15.6% (n = 29). When compared to the baseline patient, respondents had a lower likelihood of offering surgery in all scenarios except the HIV+ patient, with the lowest likelihood of offering surgery to a sex offender (P < .01). Within each scenario, factors associated with an increased odds of offering surgery included knowledge that a patient with Down Syndrome is high functioning (odds ratio [OR] 5.0, confidence interval [CI]: 1.4-17.8), that a prior sex offender is currently married (OR 16.5, CI:3.5-99.8), that a litigious patient sued a surgeon for a retained sponge (OR 6.3, CI:1.7-24.3), and that a nonverbal patient had expressed prior interest in penile prosthesis surgery (OR 4.5, CI: 1.3-16.2). CONCLUSION Ethical principles, including respect for autonomy, nonmaleficence, beneficence, and justice, are appropriately applied by urological prosthetic surgeons when ethical challenges arise. While the likelihood of offering penile prosthesis surgery is decreased with most ethical dilemmas, specific clinical factors often augment decision-making.
Article
Objectives: To identify factors associated with patient willingness to consider surgical treatment for erectile dysfunction (ED) prior to urologic consultation. Methods: A prospective database of patients presenting to the sexual health clinic at our institution was created from 2014-2018, consisting of pre-visit patient questionnaires and clinical information. Univariable and multivariable logistic regression analysis was performed to determine factors associated with consideration of surgery and decision to undergo surgery. Results: Of 1359 men presenting to the clinic, 991 men had a chief complaint of ED with 630 (63.6%) considering surgery. On multivariable analysis, factors significantly associated with pre-visit willingness for surgery included history of diabetes mellitus (p=0.0009), increasing symptom bother (p<0.0001) and decreasing relationship duration (p=0.0005). Approximately 16% (162/991) patients considering surgery prior to consultation ultimately underwent penile implant insertion. Multivariable analysis demonstrated that older age (p=0.003), history of diabetes mellitus (p=0.03), lower IIEF-EF domain (p=0.0009) and history of intracavernosal injection therapy (p<0.0001) were significantly associated with proceeding to ED surgery. Initial declaration of willingness to undergo ED surgery led to nearly 8 fold increased odds for surgery (p < 0.0001). Conclusions: Over 60% of patients presenting for ED consultation considered surgical intervention, of whom 25% underwent penile prosthesis. Both patient and relationship factors were predictors of surgical willingness. Pre-visit surgical willingness was associated with highest odds of eventual decision for surgery, suggesting that knowledge of ED treatment options in the general public may play a role. Our findings highlight opportunities for shared decision making in a patient-centered model of care.
Article
Introduction Erectile dysfunction incidence is about 19–26 cases for every 1000 men/year, requiring about 20,000 penile implants/year. There is high demand for information on the part of patients, however, there is a lack of evidence about the sources of information prior to penile implant and the figure of the Expert Patient (EP) has never been described in this area. Aims To evaluate the sources of information used by candidates for penile implant as well as to describe the role of the EP as an information source. Methods Pilot study of candidates for penile prosthesis. Patients already implanted attending for exchange or reallocation surgery were excluded. Each patient had an interview with an EP, and commercial documentation was given. Each source of information was evaluated in a face-to-face interview. SPSS™ version 20.0 was used. Main outcome measures The EP was evaluated by the International Index of Erectile Function, the Generalized Anxiety Disorder 7 questionnaire, and the Erectile Dysfunction Inventory of Treatment Satisfaction. Each source of information was evaluated by a non-validated 6-section questionnaire. Results Ten patients were included. Mean age was 60 ± 10.3 years. Medical interview with the urologist resulted in a global value and truthfulness score of 9.2 ± .9 and 9.8 ± .4, respectively. Commercial information had a global score of 8.5 ± .9 and a truthfulness score of 8.6 ± .6, while the internet had 6.8 ± .8 points for global value and 7.2 ± 1 for truthfulness. The global score of the EP was 8.7 ± 1.2 points and their veracity scored 9.6 ± .5 points. Conclusions The urologist remains the main source of information for patients with erectile dysfunction candidates for penile prosthesis implant. However, the EP is an alternative and could be a key pillar in presurgical counselling.
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
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.
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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.
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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: 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.
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
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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
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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
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. Results 49 patients (36.5%) still perform auto-ICI therapy while 85 (63.5%) had given up. 53% of the patients still using auto-ICI make the injection 4, or more times a month, with an erection lasting a considerable time (30–60 minutes). Nobody referred the presence of corpora cavernosa fibrosis. The reasons put forward by patients who stopped the therapy were: a perception of ineffectiveness, therapy rejection, fear of injections and the appearance of intolerable side effects. Conclusions Auto-ICI therapy remains a valid option for patients with E.D. not responding to oral therapy but it needs greater involvement by the physician in order to evaluate the patient's psychological discomfort and reduce or eliminate intolerable side effects.
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
Introduction: Penile prostheses (PPs) are a discrete, well-tolerated treatment option for men with medical refractory erectile dysfunction. Despite the increasing prevalence of erectile dysfunction, multiple series evaluating inpatient data have found a decrease in the frequency of PP surgery during the past decade. Aims: To investigate trends in PP surgery and factors affecting the choice of different PPs in New York State. Methods: This study used the New York State Department of Health Statewide Planning and Research Cooperative (SPARCS) data cohort that includes longitudinal information on hospital discharges, ambulatory surgery, emergency department visits, and outpatient services. Patients older than 18 years who underwent inflatable or non-inflatable PP insertion from 2000 to 2014 were included in the study. Outcomes: Influence of patient demographics, surgeon volume, and hospital volume on type of PP inserted. Results: Since 2000, 14,114 patients received PP surgery in New York State; 12,352 PPs (88%) were inflatable and 1,762 (12%) were non-inflatable, with facility-level variation from 0% to 100%. There was an increasing trend in the number of annual procedures performed, with rates of non-inflatable PP insertion decreasing annually (P < .01). More procedures were performed in the ambulatory setting over time (P < .01). Important predictors of device choice were insurance type, year of insertion, hospital and surgeon volume, and the presence of comorbidities. Clinical implications: Major influences in choice of PP inserted include racial and socioeconomic factors and surgeon and hospital surgical volume. Strengths and limitations: Use of the SPARCS database, which captures inpatient and outpatient services, allows for more accurate insight into trends in contrast to inpatient sampling alone. However, SPARCS is limited to patients within New York State and the results might not be generalizable to men in other states. Also, patient preference was not accounted for in these analyses, which can play a role in PP selection. Conclusions: During the past 14 years, there has been an increasing trend in inflatable PP surgery for the management of erectile dysfunction. Most procedures are performed in the ambulatory setting and not previously captured by prior studies using inpatient data. Kashanian JA, Golan R, Sun T, et al. Trends in Penile Prosthetics: Influence of Patient Demographics, Surgeon Volume, and Hospital Volume on Type of Penile Prosthesis Inserted in New York State. J Sex Med 2017;XX:XXX-XXX.
Article
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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
Switching from intracavernous prostaglandin E1 injections to oral sildenafil citrate in patients with erectile dysfunction: results of a multicenter European study
  • Giuliano
Comparison of long-term outcomes of penile prostheses and intracavernosal injection therapy
  • Sexton