Analysis of the clinical safety of intralesional injection of collagenase Clostridium histolyticum (CCH) for adults with Peyronie's disease (PD).

OBJECTIVE: To examine the safety of intralesional injection of collagenase Clostridium histolyticum (CCH) for the treatment of Peyronie's disease (PD), using a pooled safety analysis of patients who received at least one dose of CCH in any of six clinical studies. PATIENTS AND METHODS: Patients from six clinical studies, including three randomised, double-blind, placebo-controlled studies and three open-label safety and efficacy studies, were included if they had received at least one dose of 0.58 mg CCH. Adverse events (AEs), including treatment-emergent AEs, treatment-related AEs, and serious AEs (SAEs), were characterised. Potential immunogenicity-related AEs were evaluated through examination of increased anti-AUX-I and anti-AUX-II antibody levels, AEs, and reported terms possibly associated with immunological or hypersensitivity events. RESULTS: Overall, 85.8% of 1 044 pooled patients reported at least one treatment-related AE. The most frequently reported (≥25.0% of patients) treatment-related AEs included penile haematoma (82.7% had the verbatim 'penile bruising'), penile pain, and penile swelling. Most patients (75.2%) had mild- or moderate-severity treatment-related AEs, and 14.2% had no treatment-related AEs. Nine patients (0.9%) had treatment-related SAEs: five with penile haematoma and four with corporal rupture. There was no association between AEs and anti-AUX-I or anti-AUX-II antibody levels across treatment cycles, and no systemic hypersensitivity reactions occurred. CONCLUSIONS: This pooled safety analysis shows that although non-serious and serious treatment-related AEs can occur after CCH treatment for PD, most were non-serious and the SAEs were manageable. Providers should be prepared to manage possible SAEs.

Low testosterone has a similar prevalence among men with sexual dysfunction due to either Peyronie's disease or erectile dysfunction and does not correlate with Peyronie's disease severity.

INTRODUCTION: Low testosterone (T) has been suggested as a risk factor for Peyronie's disease (PD) that may correlate with disease severity. Low T is common in men with sexual dysfunction but its role in the pathogenesis of PD remains unclear. AIM: The aim of this study was to compare the prevalence of low T (<300 ng/dL) in patients presenting with PD or erectile dysfunction (ED), as well as disease severity between men with PD and either low T or normal T (≥300 ng/dL). METHODS: Retrospective review of 300 men with either PD or ED was conducted. Men were excluded for combined PD and ED, psychogenic ED, or prior T use. For men with PD, plaque size, degree of curvature, and surgical correction rate were compared. MAIN OUTCOME MEASURES: The main outcome measures were (i) mean T levels in men with PD or ED and (ii) plaque size, degree of curvature, and surgical correction rates among men with PD and either low T or normal T. RESULTS: Eighty-seven men with PD and 98 men with ED were identified. Men with PD had mean total T and free T of 328 ng/dL and 11.5 ng/dL, while men with ED had mean levels of 332 ng/dL and 12.1 ng/dL, respectively (P > 0.05). Of PD men, 52.9% had low T, compared with 45.9% of men with ED (P = 0.35). T levels did not correlate with plaque size or degree of curvature in the PD group (P > 0.05). CONCLUSIONS: Men with sexual dysfunction characterized by either PD or ED had similarly low T levels, and low T did not correlate with PD severity or surgical correction rate. The comparable prevalence of low T in men with PD or ED suggests the high rate of low T in PD men may be related to a common process among men with abnormal erectile physiology and not specifically causative in plaque formation.

Outcomes of surgical treatment of Peyronie's disease.

The aims of the present review were to assess the literature on published outcomes and complications associated with surgical treatments for Peyronie's disease (PD) and to assist clinicians in the effective management of PD by increasing understanding and awareness of the outcomes associated with current surgical treatment options. A PubMed literature search was conducted to identify relevant, peer-reviewed clinical and review articles published between January 1980 and October 2013 related to outcomes of surgical correction of PD. Search terms for this non-systematic review included 'Peyronie's disease', 'outcomes', 'complications', 'erectile dysfunction or ED', 'patient expectation', and 'patient satisfaction'; search terms were searched separately and in combination. Case studies and editorials were excluded, primary manuscripts and reviews were included, and bibliographies of articles of interest were reviewed and key references were obtained. Assessment of the study design, methodology, clinical relevance and impact on the surgical outcomes of PD was performed on the sixty-one articles that were selected and analysed. Currently, there are several investigational minimally invasive and non-surgical treatment options for PD; however, surgical treatment remains the standard of care for patients with stable disease and disabling deformity or drug-resistant erectile dysfunction. Each of the different surgical procedures that are used for treatment of PD, including tunical shortening, tunical lengthening (plaque incisions or partial excision and grafting), and use of inflatable penile prostheses, carries its own advantages and disadvantages in terms of potential complications and postoperative satisfaction. Because of the variety of ways that PD may present in affected patients, no single, standard, surgical treatment for this disorder has prevailed and multiple variations of each type of procedure may exist. Surgical outcomes of the most commonly used procedures are not substantially different; therefore, the appropriateness of each treatment option may often depend on disease and patient characteristics (e.g. deformity and erectile function). Surgical algorithms have been published to guide surgeons and patients through the selection of surgical procedures in the absence of conclusive, long-term outcome data. Accumulating data on outcomes associated with established procedures, modifications to these procedures, and new surgical techniques and materials may serve to further guide practice and refine evidence-based selection of the surgical approach.

Minimally invasive treatment of Peyronie's disease: evidence-based progress.

Peyronie's disease (PD) is often physically and psychologically devastating for patients, and the goal of treatment is to improve symptoms and sexual function without adding treatment-related morbidity. The potential for treatment-related morbidity after more invasive interventions, e.g. surgery, creates a need for effective minimally invasive treatments. We critically examined the available literature using levels of evidence to determine the reported support for each treatment. Most available minimally invasive treatments lack critical support for effectiveness due to the absence of randomised, placebo-controlled trials (RCTs) or non-significant results after RCTs. Iontophoresis, oral therapies (vitamin E, potassium para-aminobenzoate, tamoxifen, carnitine, and colchicine), extracorporeal shockwave therapy, and intralesional injection with verapamil or nicardipine have shown mixed or negative results. Treatments that have decreased penile curvature deformity in Level 1 or Level 2 evidence-based, placebo-controlled studies include intralesional injection with interferon α-2b or collagenase clostridium histolyticum.

Society of Urologic Prosthetic Surgeons' Coding and Billing Position Statement on Ancillary/Adjunct Penile Prosthesis Surgical Procedures: Part I.

OBJECTIVE: To create a society position statement on common adjunct penile prosthesis (PP) procedures. While the Medicare Current Procedural Terminology code book lists descriptions of procedures, it is very brief and lacks detail in the small subspecialty of prosthetic urology. At educational/research meetings, wide variation was found in how experts in prosthetic urology code the same procedures, and need for a standardized format in billing common ancillary surgery was voiced. METHODS: A subcommittee within the Society of Urologic Prosthetic Surgeons developed a survey assessing coding options for several procedures commonly adjunct to PP placement, which was distributed in the fall of 2022. The results of the survey were used to develop consensus statements on coding adjunct PP procedures; statements were distributed among society membership and meetings for approval. RESULTS: Thirty members replied to the survey; demographics were obtained as follows: 73% were trained in a fellowship, 50% identified as university/academic practitioners, and 50% in community/private practice; and 63% respondents place more than 50 implants annually. Only 1 of the 30 respondents stated confidence in coding for these ancillary procedures. Specifically, differences in how to code curvature correction procedures were observed throughout the survey results. CONCLUSION: Only 1 in 30 prosthetic urologists expressed confidence in coding and billing of adjunct PP procedures, further confirming the need for a society position statement. Therefore, we generated a consensus society position statement on common surgeries that are adjunct to PP placement.

Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of peyronie disease in 2 large double-blind, randomized, placebo controlled phase 3 studies.

PURPOSE: IMPRESS (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) I and II examined the clinical efficacy and safety of collagenase Clostridium histolyticum intralesional injections in subjects with Peyronie disease. Co-primary outcomes in these identical phase 3 randomized, double-blind, placebo controlled studies included the percent change in the penile curvature abnormality and the change in the Peyronie disease questionnaire symptom bother score from baseline to 52 weeks. MATERIALS AND METHODS: IMPRESS I and II examined collagenase C. histolyticum intralesional injections in 417 and 415 subjects, respectively, through a maximum of 4 treatment cycles, each separated by 6 weeks. Men received up to 8 injections of 0.58 mg collagenase C. histolyticum, that is 2 injections per cycle separated by approximately 24 to 72 hours with the second injection of each followed 24 to 72 hours later by penile plaque modeling. Men were stratified by baseline penile curvature (30 to 60 vs 61 to 90 degrees) and randomized to collagenase C. histolyticum or placebo 2:1 in favor of the former. RESULTS: Post hoc meta-analysis of IMPRESS I and II data revealed that men treated with collagenase C. histolyticum showed a mean 34% improvement in penile curvature, representing a mean ± SD -17.0 ± 14.8 degree change per subject, compared with a mean 18.2% improvement in placebo treated men, representing a mean -9.3 ± 13.6 degree change per subject (p <0.0001). The mean change in Peyronie disease symptom bother score was significantly improved in treated men vs men on placebo (-2.8 ± 3.8 vs -1.8 ± 3.5, p = 0.0037). Three serious adverse events (corporeal rupture) were surgically repaired. CONCLUSIONS: IMPRESS I and II support the clinical efficacy and safety of collagenase C. histolyticum for the physical and psychological aspects of Peyronie disease.

Diagnosis and treatment of erectile dysfunction for reduction of cardiovascular risk.

PURPOSE: We established erectile dysfunction as an often neglected but valuable marker of cardiovascular risk, particularly in younger men and men with diabetes. We also reviewed evidence that lifestyle change, combined with informed prescribing of pharmacotherapies used to mitigate cardiovascular risk, can improve overall vascular health and sexual functioning in men with erectile dysfunction. MATERIALS AND METHODS: We performed a PubMed® search for articles and guidelines pertinent to relationships between erectile dysfunction and cardiovascular disease, cardiovascular and all cause mortality, and pharmacotherapies for dyslipidemia and hypertension. The clinical guidance presented incorporates the current literature and the expertise of the multispecialty investigator group. RESULTS: Numerous cardiovascular risk assessment tools exist but risk stratification remains challenging, particularly in patients at low or intermediate short-term risk. Erectile dysfunction has a predictive value for cardiovascular events that is comparable to or better than that of traditional risk factors. Interventional studies support lifestyle changes as a means of improving overall vascular health as well as sexual functioning. Statins, diuretics, ß-blockers and renin-angiotensin system modifiers may positively or negatively affect erectile function. Furthermore, the phosphodiesterase type 5 inhibitors used to treat erectile dysfunction may have systemic vascular benefits. CONCLUSIONS: Erectile dysfunction treatment should be considered secondary to decreasing cardiovascular risk. However, informed prescribing may prevent worsening sexual function in men receiving pharmacotherapy for dyslipidemia and hypertension. As the first point of medical contact for men with erectile dysfunction symptoms, the primary care physician or urologist has a unique opportunity to identify those who require early intervention to prevent cardiovascular disease.

Long-term infection outcomes of 3-piece antibiotic impregnated penile prostheses used in replacement implant surgery.

PURPOSE: Patients who undergo device revision surgery are at higher risk for infection than virgin implant recipients. The revision rate due to virgin implant infection is statistically significantly lower for minocycline/rifampin impregnated than for nonimpregnated inflatable penile prostheses. We determined whether the frequency of infection revision events after device replacement surgery would also be lower for minocycline/rifampin impregnated inflatable penile prostheses. MATERIALS AND METHODS: Patient information forms voluntarily submitted to AMS® after replacement inflatable penile prosthesis implantation between 2001 and 2007 were retrospectively reviewed to compare secondary infection related revision events for antibiotic impregnated vs nonimpregnated implants. Only men who received an inflatable penile prosthesis at a first recorded operation to replace a previously implanted penile prosthesis were included in the study. Life table survival analysis was done between the groups to compare infection related events resulting in a second surgical revision after replacement implantation. Survival function extrapolation was based on parametric analysis using the Weibull distribution model. RESULTS: On life table survival analysis secondary revision due to infection was significantly less common in the minocycline/rifampin impregnated group than in the nonimpregnated group (log rank p = 0.0252). At up to 6.6 years of followup 2.5% of 9,300 men with vs 3.7% of 1,764 without an impregnated device underwent secondary revision due to infection. CONCLUSIONS: This long-term device survival analysis provides clinical evidence of a significant decrease in infection related secondary revisions using minocycline/rifampin impregnated prostheses vs nonimpregnated inflatable penile prostheses at replacement implant surgery.

Exogenous testosterone, cardiovascular events, and cardiovascular risk factors in elderly men: a review of trial data.

INTRODUCTION: Increasing interest in the use of supplemental testosterone has led to a heightened focus on the safety of testosterone in elderly males, with a particular emphasis on cardiovascular risk. AIMS: To evaluate, based on available clinical trial data, whether exogenous testosterone administration in middle-aged to elderly men increases cardiovascular risk, and to assess whether these effects differ in hypogonadal vs. eugonadal subjects. METHODS: MEDLINE search from 2004 to present of all meta-analyses and randomized, controlled clinical trials of testosterone administration in male subjects ≥ 45 years old that included measurements of cardiovascular outcomes or known cardiovascular risk factors before and after treatment with testosterone. MAIN OUTCOME MEASURES: The effects of testosterone treatment on cardiovascular events and cardiovascular risk factors were assessed. RESULTS: In clinical trials where testosterone has been used in patients with preexisting cardiovascular conditions, the effect on disease symptoms has typically been either neutral or beneficial. Based on clinical trial data, testosterone treatment has minimal effect on cardiovascular risk factors with the exception of an increase in hematocrit, which is consistently seen with testosterone treatment, and a decrease in high-density lipoprotein cholesterol, which is an inconsistent response. Responses of hypogonadal and eugonadal men to testosterone treatment in terms of cardiovascular risk are generally similar. Testosterone treatment has not been reported to increase the incidence of cardiovascular events with the possible exception of one trial in frail elderly men. CONCLUSIONS: Available clinical trial data indicate that the use of testosterone in middle-aged to elderly men does not increase cardiovascular risk nor does it unfavorably modify cardiovascular risk profile. Prospective data from large, well-designed, long-term trials of testosterone treatment are lacking and will be required to verify the cardiovascular efficacy/safety of chronic treatment.

Dorsal penile nerve block prior to inflatable penile prosthesis placement: a randomized, placebo-controlled trial.

INTRODUCTION: Dorsal penile nerve block (DPNB) has been previously shown to provide effective analgesia for penile surgeries. To date, few studies have examined the role of DPNB prior to inflatable penile prosthesis (IPP) implantation. AIM: The purpose of this study was to assess the efficacy of local penile nerve block prior to IPP implantation for postoperative pain control. MAIN OUTCOME MEASURES: The primary outcome was postoperative pain rated using the visual analog scale (VAS). Secondary outcome measures included total narcotic usage during hospitalization. METHODS: Institutional Review Board approval was obtained. Patients with erectile dysfunction scheduled for IPP implantation were approached for study participation. Patients were excluded if they had a previous IPP scheduled for revision or replacement or were undergoing additional procedures during the same operative session. Patients were then randomized to either DPNB with 1% lidocaine and 0.5% bupivacaine without epinephrine or injectable saline placebo. Only the resident surgeon assisting in the case was aware of randomization. All procedures were performed by a single surgeon (C.C.C.). Postoperatively, patients were asked to rate their pain using a VAS hourly while in recovery, at 4 hours, and at 23 hours postoperatively. Total narcotic usage was also measured. RESULTS: A total of 30 patients underwent randomization with 15 patients in each group. Baseline demographic data were similar in each group. There was a significant reduction in pain in the immediate postoperative period and at 4 hours after surgery in the treatment group when compared with placebo (VAS 2.5 vs. 5.3, P = 0.009 at 0 hours; VAS 2.8 vs. 5.1, P = 0.011 at 4 hours). Narcotic usage was similar among both groups. There were no perioperative or early postoperative complications in either group. CONCLUSIONS: DPNB is safe and effective for reducing pain in the early postoperative period following penile prosthesis implantation.

An outcomes analysis of over 200 revision surgeries for penile prosthesis implantation: a multicenter study.

INTRODUCTION: Inflatable penile prosthesis (IPP) implantation is a well-established treatment for medically refractory erectile dysfunction, with long-term reliability. Overall survival is 96% at 5 years and 60% at 15 years for primary (virgin) implantation. AIM: The aim of this study was to explore factors associated with success and complications of IPP revision surgery in a multicenter study. MAIN OUTCOME MEASURES: Reasons for revision including mechanical issues, patient dissatisfaction, corporal deformity, and supersonic transport (SST) deformity were recorded. METHODS: At four institutions, 214 clinically uninfected IPP revisions were performed between November 2000 and November 2007. Data were incomplete for 28 cases (14%). Failure-free survival was estimated using Kaplan-Meier's Meier product limit method. RESULTS: The majority of revisions were secondary to mechanical failure (N = 109; 65%) and combined erosion or infection (N = 17 + 15 = 32; 19%). Sixteen percent (N = 26) were carried out on functional uninfected prostheses secondary to patient dissatisfaction (N = 9), SST deformity (N = 10), scrotal hematoma (N = 2), or upsize revision because of corporal fibrosis (N = 5). Average age at revision was 66 years. Mean follow-up time was 55.7 months. In this study, 12 individuals required a secondary revision procedure or suffered a complication. Despite prior reports of high infection rates with revision surgery, only 5.7% of clinically uninfected and noneroded prostheses were complicated by infection or impending extrusion/erosion, following a revision washout protocol. Overall, 93% of cases were successfully revised, providing functioning IPPs. CONCLUSIONS: For this study population, component exchange followed by revision washout showed a low incidence of infection and subsequent mechanical failure.

Long-term infection outcomes after original antibiotic impregnated inflatable penile prosthesis implants: up to 7.7 years of followup.

PURPOSE: Although some studies suggest that most infections associated with inflatable penile prosthesis implantation develop within year 1 after surgery, device related infections have been reported 5 years after implantation or later and the infection risk with time is not well characterized. We previously reported a statistically significantly lower infection rate for original inflatable penile prostheses impregnated with antibiotic treatment with minocycline and rifampin vs nonimpregnated inflatable penile prostheses at 1-year followup. Long-term data are now available on infection revision after initial implantation of antibiotic impregnated vs nonimpregnated prostheses. MATERIALS AND METHODS: We retrospectively reviewed patient information forms voluntarily filed with the manufacturer after the initial implantation of more than 39,000 inflatable penile prostheses to compare the revision rate due to infection for antibiotic impregnated vs nonimpregnated implants between May 1, 2001 and December 31, 2008. Life table analysis was used to evaluate device survival from revision surgery. RESULTS: On life table survival analysis initial revision events due to infection were significantly less common in the impregnated vs the nonimpregnated group (log rank p <0.0001). At up to 7.7 years of followup 1.1% of 35,737 vs 2.5% of 3,268 men with impregnated vs nonimpregnated implants underwent initial revision due to infection. CONCLUSIONS: To our knowledge this long-term outcome analysis provides the first substantial clinical evidence of a decrease in costly infection related revision using an antibiotic impregnated inflatable penile prosthesis.

Racial differences in hypogonadal improvement and prostate-specific antigen levels in hypogonadal men treated with testosterone replacement therapy.

PURPOSE: To observe hypogonadal men undergoing testosterone replacement therapy (TRT) and assess racial differences in hypogonadal improvement and prostate-specific antigen (PSA) levels. MATERIALS AND METHODS: In a retrospective analysis, 75 hypogonadal men were followed for an average 34 months after initiating TRT. Total testosterone and PSA levels were assessed every 6 months, and patients diagnosed with prostatitis or prostate cancer during treatment were excluded. RESULTS: For 16 African American men, the average age at diagnosis of hypogonadism was 53.5 years, compared with 57.8 years in 59 Caucasian men (p=NS). Pre- and post-treatment testosterone was 219 ng/dL and 310 ng/dL in African American men, and 247 ng/dL and 497 ng/dL in Caucasian men (p=NS). Symptomatic response was 81% in African American men and 93% in Caucasian men (p=NS). Baseline PSA level was 1.32 ng/mL in African American men and 1.27 ng/mL in Caucasian men, and there was no significant difference in PSA between racial groups at 6-month intervals, although there was a small decreasing trend in the PSA of African Americans compared with Caucasians. CONCLUSIONS: Hypogonadal African American men have a similar normalization of testosterone and symptomatic response as hypogonadal Caucasian men, and PSA levels remain stable over time in both groups. In this hypogonadal cohort, in contrast to studies of eugonadal men, higher PSA levels in African Americans were not observed.

Artificial urinary sphincter: current status and future directions.

Urge urinary incontinence (UUI) is one of the most troublesome complications of surgery of the prostate whether for malignancy or benign conditions. For many decades, there have been attempts to reduce the morbidity of this outcome with variable results. Since its development in the 1970s, the artificial urinary sphincter (AUS) has been the "gold standard" for treatment of the most severe cases of UUI. Other attempts including injectable bulking agents, previous sphincter designs, and slings have been developed, but largely abandoned because of poor long-term efficacy and significant complications. The AUS has had several sentinel redesigns since its first introduction to reduce erosion and infection and increase efficacy. None of these changes in the basic AUS design have occurred in the past three decades, and the AUS remains the same despite newer technology and materials that could improve its function and safety. Recently, newer compressive devices and slings to reposition the bladder neck for men with mild-to-moderate UUI have been developed with success in select patients. Similarly, the AUS has had applied antibiotic coating to all portions except the pressure-regulating balloon (PRB) to reduce infection risk. The basic AUS design, however, has not changed. With newer electronic technology, the concept of the electronic AUS or eAUS has been proposed and several possible iterations of this eAUS have been reported. While the eAUS is as yet not available, its development continues and a prototype device may be available soon. Possible design options are discussed in this review.

The impact of obesity on the diagnosis of prostate cancer using a modern extended biopsy scheme.

PURPOSE: The effect of obesity on prostate cancer detection and behavior remains uncertain. We evaluated the impact of obesity, as measured by body mass index, in a case series of 500 consecutive men who underwent a modern 10 to 12 core biopsy approach. MATERIALS AND METHODS: We retrospectively reviewed the records of a consecutive series of 500 men who underwent transrectal ultrasound guided prostate biopsy using a 10 to 12 core biopsy scheme. Variables, including patient age, prostate specific antigen, prostate specific antigen density, digital rectal examination findings, transrectal ultrasound prostate volume and biopsy outcome, including grade, were compared to anthropometric measures, including body mass index. RESULTS: Of the men 26% were obese according to body mass index (greater than 30 kg/m(2)). A total of 223 men (45%) had a positive biopsy. Obese men were younger (62.0 vs 63.8 years), had a larger prostate (57.7 vs 47.8 cc) and were less likely to have any abnormality on digital rectal examination (19.6% vs 30.8%). Obese men were also less likely to have a positive biopsy based on chi-square analysis (38.8% vs 46.2%). On statistical modeling for the OR in nonobese vs obese men there was a trend toward lower detection based on crude and age adjusted ORs but not on multivariate OR controlling for age, prostate specific antigen and prostate volume. In addition, when examining for high grade disease (Gleason 4 + 3 or greater), no differences were observed on OR modeling. In men with negative biopsies those who were obese vs nonobese had a larger prostate volume and trended toward a higher median prostate specific antigen and age. These differences and trends were not observed in obese men with positive biopsies. CONCLUSIONS: Of men undergoing prostate biopsy using a modern extended biopsy scheme obese men were younger, had a larger prostate and were less likely to have abnormal digital rectal examinations. Although some trends toward a lower detection rate in obese men were observed, such differences were not observed on multivariate analysis, nor were any differences observed in the incidence of higher grade tumors, thus questioning the effect of obesity on prostate cancer detection and behavior in our cases series.

Prostate-specific antigen changes and prostate cancer in hypogonadal men treated with testosterone replacement therapy.

OBJECTIVES: To retrospectively review hypogonadal men receiving testosterone replacement therapy (TRT), and evaluate the changes in prostate-specific antigen (PSA) levels over an extended period, and thus evaluate the occurrence of prostate cancer, as a primary concern in treating late-onset hypogonadism (LOH) is the potential increased risk of prostate cancer; we also recorded the cardiovascular effects of TRT. PATIENTS AND METHODS: In all, 81 hypogonadal men (mean age 56.8 years) were followed for a mean (range) of 33.8 (6-144) months after starting TRT. All men had a normal baseline PSA level before TRT and had routine laboratory investigations, including measurements of body mass index (BMI), haematocrit, lipid profile, and liver function tests (LFTs). Testosterone and PSA levels were assessed every 6-12 months. Patients with a biopsy-confirmed or recent history of prostatitis before treatment were excluded. TRT was discontinued in men who developed prostate cancer. RESULTS: Before and 36 months after treatment the total testosterone levels were 241.1 and 379.8 ng/dL (P < 0.05), respectively. Four men (4.9%) developed prostate cancer at a mean (range) of 32.5 (22-41) months after starting TRT. In men without prostate cancer (95.1%), PSA levels did not increase significantly at 1-year intervals for 5 years. There was no statistical difference in PSA level change from baseline to 36 months when patients without prostate cancer were stratified into groups according to age (< or =50, 55-65 and > or =70 years). In men with prostate cancer there was an increase in mean PSA level from baseline to 18 months of 1.8 ng/mL, and to 36 months of 3.2 ng/mL (P < 0.05). Total cholesterol improved from 203.8 to 166.6 mg/dL (P < 0.05) after 36 months of TRT; the BMI, haematocrit and LFTs did not change significantly. CONCLUSIONS: LOH is an increasingly prevalent disease characterized by a symptomatically low testosterone level, and TRT is effective in normalizing serum testosterone levels, providing a beneficial cardiovascular effect, and improving sexual function and overall quality of life. PSA levels remain stable after normalization of testosterone for > or =5 years, prostate cancer can be effectively diagnosed and treated in men taking TRT, and the incidence of prostate cancer among men with LOH on TRT is no greater than that in the general population.

Peyronie's surgery: graft choices and outcomes.

Peyronie's disease (PD), a localized fibrosis of the tunica albuginea surrounding the penile corpora, results in penile curvature and sexual dysfunction. Men with significant penile curvature and satisfactory erectile function are often treated with plaque incision or excision and grafting. The advantages and disadvantages of various grafting materials have long been debated. Graft materials can be divided into three categories: autologous tissue harvested from the patient's body, allograft or xenograft from another person or species, and synthetic grafts. Despite groundbreaking advances in physiology, synthetic materials, and tissue engineering, the ideal graft material has yet to be established. This review presents and discusses the variety of graft materials available for the surgical correction of PD. For this purpose, a MEDLINE search was conducted on PD until May 2009.

Lower urinary tract symptoms are associated with depressive symptoms in white, black and Hispanic men in the United States.

PURPOSE: The relationship between lower urinary tract symptoms and depressive symptoms was assessed using data from the Male Attitudes Regarding Sexual Health study. MATERIALS AND METHODS: Lower urinary tract symptoms, depressive symptoms and erectile dysfunction were assessed using International Prostate Symptom Score, Center for Epidemiologic Studies Depression Scale and a validated question from the Massachusetts Male Aging Study. Sociodemographic, clinical and other data were also collected. Odds ratios and 95% CIs were determined using weighted multivariate logistic regression stratified by race/ethnicity and age. RESULTS: Of 3,291 randomly selected men 2,173 completed the interview. Overall odds of lower urinary tract symptoms were increased in men who reported depressive symptoms (OR 2.68, 95% CI 1.60-4.47, p <0.01), erectile dysfunction (OR 1.73, 95% CI 1.11-2.71, p <0.05) and unhappiness/dissatisfaction on the International Prostate Symptom Score quality of life item (OR 10.72, 95% CI 5.56-20.69, p <0.01), and those 60 to 69 years old (OR 1.99, 95% CI 1.14-3.46, p <0.05) and 70 years or older (OR 1.91, 95% CI 1.06-3.43, p <0.05). Increased odds of lower urinary tract symptoms were associated with depressive symptoms for white (OR 2.60, 95% CI 1.39-4.85, p <0.01) and Hispanic men (OR 4.14, 95% CI 1.15-14.95, p <0.05). Odds of depressive symptoms were increased in men reporting lower urinary tract symptoms (OR 2.64, 95% CI 1.57-4.43, p <0.001), especially Hispanic men 50 to 59 years old (OR 133.17, 95% CI 18.40-963.87, p <0.01) and black men older than 60 years (OR 21.61, 95% CI 3.04-153.55, p <0.01), as well as men 40 to 49 years old expressing unhappiness/dissatisfaction on the International Prostate Symptom Score quality of life item (OR 6.80, 95% CI 1.77-26.16, p <0.01), and Hispanic (OR 10.76, 95% CI 3.88-29.80, p <0.01) and black men reporting erectile dysfunction (OR 4.77, 95% CI 1.15-19.78, p <0.05), but not white men reporting erectile dysfunction (OR 1.05, 95% CI 0.48-2.28, p <0.91). CONCLUSIONS: Lower urinary tract symptoms and depressive symptoms are strongly associated, and exhibit reciprocal relationships. Erectile dysfunction increases the odds of both disorders.