Laurence A. Levine

Summary of the recommendations on sexual dysfunctions in men

INTRODUCTION Sexual health is an integral part of overall health. Sexual dysfunction can have a major impact on quality of life and psychosocial and emotional well-being. AIM To provide evidence-based, expert-opinion consensus guidelines for clinical management of sexual dysfunction in men. METHODS An international consultation collaborating with major urologic and sexual medicine societies convened in Paris, July 2009. More than 190 multidisciplinary experts from 33 countries were assembled into 25 consultation committees. Committee members established scope and objectives for each chapter. Following an exhaustive review of available data and publications, committees developed evidence-based guidelines in each area. Main Outcome Measures.  New algorithms and guidelines for assessment and treatment of sexual dysfunctions were developed based on work of previous consultations and evidence from scientific literature published from 2003 to 2009. The Oxford system of evidence-based review was systematically applied. Expert opinion was based on systematic grading of medical literature, and cultural and ethical considerations. RESULTS Algorithms, recommendations, and guidelines for sexual dysfunction in men are presented. These guidelines were developed in an evidence-based, patient-centered, multidisciplinary manner. It was felt that all sexual dysfunctions should be evaluated and managed following a uniform strategy, thus the International Consultation of Sexual Medicine (ICSM-5) developed a stepwise diagnostic and treatment algorithm for sexual dysfunction. The main goal of ICSM-5 is to unmask the underlying etiology and/or indicate appropriate treatment options according to mens and womens individual needs (patient-centered medicine) using the best available data from population-based research (evidence-based medicine). Specific evaluation, treatment guidelines, and algorithms were developed for every sexual dysfunction in men, including erectile dysfunction; disorders of libido, orgasm, and ejaculation; Peyronies disease; and priapism. CONCLUSIONS Sexual dysfunction in men represents a group of common medical conditions that need to be managed from a multidisciplinary perspective.

Randomized, double-blind, placebo-controlled study of postoperative nightly sildenafil citrate for the prevention of erectile dysfunction after bilateral nerve-sparing radical prostatectomy

Four weeks after bilateral nerve-sparing radical retropubic prostatectomy, men with normal erectile function before surgery were randomized to double-blind sildenafil (50 or 100 mg) or placebo nightly for 36 weeks, followed by an 8-week drug-free period before assessment of erectile function. Enrollment was prematurely ceased and only 76 men completed because, assuming a placebo response rate similar to the published literature (for example, 34% in meta-analysis), the 25% response at blinded interim review suggested a lack of treatment effect. On the contrary, spontaneous erectile function (a combined score of ⩾8 for questions 3 and 4 of the International Index of Erectile Function and a positive response to ‘Were erections good enough for satisfactory sexual activity?’) occurred in only 4% of the placebo group (n=1 of 25) versus 27% (n=14 of 51, P=0.0156, Fishers exact test) of the sildenafil group. Nightly sildenafil administration for 36 weeks after surgery markedly increased the return of normal spontaneous erections.

The Management of Peyronie's Disease: Evidence‐based 2010 Guidelines

INTRODUCTION The field of Peyronies disease is evolving and there is need for a state-of-the-art information in this area. AIM To develop an evidence-based state-of-the-art consensus report on the management of Peyronies disease. METHODS To provide state-of-the-art knowledge regarding the prevalence, etiology, medical and surgical management of Peyronies Disease, representing the opinion of leading experts developed in a consensus process over a 2-year period. MAIN OUTCOME MEASURES Expert opinion was based on grading of evidence-based medical literature, widespread internal committee discussion, public presentation, and debate. CONCLUSIONS The real etiology of Peyronies disease and the mechanisms of formation of the plaque still remain obscure. Although conservative management is obtaining a progressively larger consensus among the experts, surgical correction still remains the mainstay treatment for this condition.

Clinical guidelines panel on erectile dysfunction: Summary report on the treatment of organic erectile dysfunction

PURPOSE The American Urological Association convened the Clinical Guidelines Panel on Erectile Dysfunction to analyze the literature regarding available methods for treating organic erectile dysfunction and to make practice recommendations based on the treatment outcomes data. MATERIALS AND METHODS The panel searched the MEDLINE data base for all articles from 1979 through 1994 on treatment of organic erectile dysfunction and meta-analyzed outcomes data for oral drug therapy (yohimbine), vacuum constriction devices, vasoactive drug injection therapy, penile prosthesis implantation and venous and arterial surgery. RESULTS Estimated probabilities of desirable outcomes are relatively high for vacuum constriction devices, vasoactive drug injection therapy and penile prosthesis therapy. However, patients must be aware of potential complications. The outcomes data for yohimbine clearly indicate a therapy with marginal efficacy. For venous and arterial surgery, based on reported outcomes, chances of success do not appear high enough to justify routine use of such surgery. CONCLUSIONS For the standard patient, defined as a man with acquired organic erectile dysfunction and no evidence of hypogonadism or hyperprolactinemia, the panel recommends 3 treatment alternatives: vacuum constriction devices, vasoactive drug injection therapy and penile prosthesis implantation. Based on the data to date, yohimbine does not appear to be effective for organic erectile dysfunction and, thus, it should not be recommended as treatment for the standard patient. Venous surgery and arterial surgery in men with arteriolosclerotic disease are considered investigational and should be performed only in a research setting with long-term followup available.

UROLOGICAL COMPLICATIONS OF CYCLOPHOSPHAMIDE

Complication frequente de la cyclophosphamide: la cystite hemorragique. Article de synthese sur la toxicite de la cyclophosphamide et sur les preventions et traitements possibles de ces complications

A SURGICAL ALGORITHM FOR THE TREATMENT OF PEYRONIE'S DISEASE

PURPOSE When conservative treatment of Peyronies disease fails, the optimal surgical approach is not well defined. Multiple factors, including penile rigidity, degree of curvature, shaft narrowing with hinge effect and erectile response to vasoactive penile injections, indicate that no single approach is likely to solve the problem in all patients. MATERIALS AND METHODS A surgical algorithm was developed for the treatment of Peyronies Disease based on our previous surgical experience, which was used prospectively in 103 consecutive men. Penile straightening without prosthesis was offered to patients with adequate rigidity for coitus. Specifically, for mild to moderate curvature less than 60 degrees without hourglass or hinge effect deformity the less complicated tunica albuginea plication procedure was performed. For those men with more severe, complex curvature greater than 60 degrees and/or significant hourglass or hinge effect deformity plaque incision or partial excision with dermal grafting was offered to limit shaft shortening and to reconstruct a shaft with normal caliber to provide optimal axial support during intromission. For men with poor sexually induced erections and/or inadequate response to intracavernosal pharmacotherapy penile prosthesis placement was recommended to provide adequate straightening and rigidity. RESULTS Of 22 patients who underwent plication procedures 91% remained potent and the penis remained straight postoperatively. Of 52 patients who underwent an incision or partial excision and grafting procedure, 48 had dermal grafts with the penis remaining straight in 94% and 75% remaining potent postoperatively. A total of 29 patients received a prosthesis with the penis remaining straight in 93% who were sexually active postoperatively. During the follow up period (mean 22.3 months) there have been no mechanical device failures. CONCLUSIONS Surgical outcome was optimized with this algorithm, which correlates surgical complexity to the underlying severity of the penile deformity and erectile capacity.

Intralesional Verapamil Injection for the Treatment of Peyronie’s Disease

Peyronies disease remains a therapeutic dilemma for the practicing urologist. Multiple nonoperative therapies have been offered with variable suboptimal response rates. Calcium channel blockers have been shown to alter the metabolism of fibroblasts, resulting in decreased extracellular matrix secretion of collagen as well as increased collagenase activity. In this nonrandomized dose-escalating format study 14 men received biweekly injections of verapamil into the Peyronies plaques for 6 months. Subjectively, there was significant improvement in plaque-associated penile narrowing (100%) and curvature (42%). Objectively, a decreased plaque volume of greater than 50% was noted in 30% of the subjects. Plaque softening was noted in all patients, while 83% noticed that plaque-related changes in erectile function had arrested or improved. There was no toxicity nor did symptoms recur when improvement was noted. This preliminary study suggests that intralesional calcium antagonist (verapamil) therapy offers an economical and sensible nonoperative approach to the treatment of Peyronies disease.

EXPERIENCE WITH INTRAPLAQUE INJECTION OF VERAPAMIL FOR PEYRONIE'S DISEASE

PURPOSE We examined the use of intraplaque injection of verapamil for the treatment of Peyronies disease through its effects on pain, curvature, indentation, sexual function and erectile capacity. MATERIALS AND METHODS A total of 156 men underwent treatment with intraplaque verapamil injection. Patients were assessed objectively, during dynamic penile duplex ultrasound, as well as subjectively using a questionnaire before and after initiation of the treatment protocol. Patients were also stratified by duration of disease before therapy and into 1 of 3 Kelami classification groups based on pretreatment plaque size and severity of curvature. Differences before and after treatment and among the Kelami classification groups were assessed. RESULTS Of the 140 patients who completed treatment 73 (60%) had an objectively measured decrease in curvature while 79 (62%) reported a subjective decrease in curvature during the followup interview. After treatment 111 (83%) men reported an increase in girth, 107 (80%) an increase in rigidity distal to the plaque and 92 (71%) an improvement in sexual function. Among each Kelami class curvature was objectively measured to decrease in 41%, 68% and 62% of patients in classes I, II and III, respectively. There was no significant difference in response based on duration of disease (60% improvement versus 61% improvement for disease duration of less or greater than 1 year in duration, respectively). Mean followup was 30.4 months (range 10 to 81) and there was no reported recurrence of penile deformity in those men with an initial posttreatment positive response. CONCLUSIONS Verapamil injection of Peyronies plaques appears to be a clinically effective treatment option for pain and curvature and can contribute to subjective improvement in sexual function and erectile capacity. The low incidence of complications indicates that this therapy is also clinically safe.

Impact of Peyronie's Disease on Sexual and Psychosocial Functioning: Qualitative Findings in Patients and Controls

INTRODUCTION There are no validated scales for assessing the psychosocial impact of Peyronies disease (PD), which affects approximately 5-10% of men over age 50. AIM To develop a psychometrically valid outcome measure for assessing psychosocial and sexual consequences of PD. To conduct a qualitative study of men with PD and age-matched controls, and design a new patient-reported outcome measure of PD. METHODS An expert advisory panel identified relevant topics and conceptual areas to be addressed based on clinical experience and literature reviews. A conceptual model was developed to serve as a discussion guide for qualitative interviews with geographically and ethnically diverse PD subjects and controls. Interviews were conducted in a focus-group format by a trained interviewer and were recorded and transcribed for qualitative analysis according to grounded theory concepts. MAIN OUTCOME MEASURE Focus-group interviews. RESULTS Focus-group interviews were conducted with 64 men (28 PD patients, 36 controls) in 13 separate focus groups over a 3-month period. Blinded analysis of the interview transcripts identified four core domains: (i) physical appearance and self-image; (ii) sexual function and performance; (iii) PD-related pain and discomfort; and (iv) social stigmatization and isolation. Based on feedback from participants and experts, a new outcome questionnaire was developed to assess core domain responses in a structured, self-report format. CONCLUSIONS This qualitative study helped to refine and broaden the focus of the conceptual model for further assessment. It also confirmed that PD has a major impact on sexual and psychological function in these patients.

MECHANICAL RELIABILITY AND SAFETY OF, AND PATIENT SATISFACTION WITH THE AMBICOR INFLATABLE PENILE PROSTHESIS: RESULTS OF A 2 CENTER STUDY

PURPOSE We reviewed the experience with the 2-piece Ambicor penile prosthesis (American Medical Systems, Minnetonka, Minnesota) at 2 medical centers to investigate its mechanical reliability and complication rates as well as patient and partner satisfaction with the device. MATERIALS AND METHODS From 1995 through 1999, 131 men underwent implantation of an Ambicor penile prosthesis at 2 medical centers. We performed a 3-part study consisting of a retrospective clinical record review, mailed patient and partner questionnaire, and mailed modified patient and partner Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire. Mean followup was 43.4 months (range 12 to 73). RESULTS All 131 men had a history consistent with an organic etiology of erectile dysfunction, including vascular disease in 62%, radical retropubic prostatectomy in 17%, Peyronies disease in 15%, neophallus construction in 4% and radical pelvic surgery in 2%. Mean patient age was 56.8 years (range 22 to 76) at implantation. Overall there were complications in 10 cases (7.6%), including infection, hematoma and mechanical failure in 6 (4.6%), 1 (0.7%) and 3 (2.3%), respectively. A total of 112 men (85%) and 91 partners completed the questionnaire. All patient respondents still had an Ambicor prosthesis implanted and 96.4% had erection suitable for coitus. Overall patient and partner satisfaction was 96.4% and 91.2%, respectively. Of the respondents 92.9% of patients and 90.1% of partners would recommend the device to others. Of the 85 men (65%) and 46 partners who completed the modified Erectile Dysfunction Inventory of Treatment Satisfaction survey 90.6% and 82.6%, respectively, were satisfied or very satisfied overall with the penile prosthesis. CONCLUSIONS The Ambicor penile prosthesis is associated with a low complication rate and reliable mechanical function. High satisfaction was reported by patients and partners.