Transdermal application of H100 gel to the penile shaft in patients with Peyronie's disease infiltrates the tunica albuginea.

Treatment options for Peyronie's disease (PD) remain limited. Topical H100 gel, (Hybrid Medical, Edina, USA), which contains nicardipine, super oxide dismutase and emu oil showed safety and efficacy in a previous small double-blind placebo-controlled pilot study. The present study evaluates if topically applied H100 gel applied to the penile shaft infiltrates the tunica albuginea. Nicardipine is a key active ingredient in H100 and serves as a surrogate marker. Three men already scheduled to undergo a planned surgical procedure for PD applied commercially available H100 gel twice daily to the penile shaft for up to 30 days prior to the procedure. Tunica albuginea samples were obtained at surgery. Nicardipine evaluation was performed using isotope dilution technique via liquid-chromatograph-mass spectrometry (LCMS). All three patients tolerated H100 gel application without side effects. All three tunica albuginea specimens showed detectable nicardipine in the tunical tissue. Transdermal application of commercially available H100 gel is able to penetrate the tunica albuginea tissue and is detectable in men with acute and chronic PD. This finding may support the encouraging results found in the prior H100 pilot study.

National Trends in the Management of Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.

PURPOSE OF REVIEW: To gain an understanding of current practices in the management of lower urinary tract symptoms (LUTSs) in the setting of benign prostatic hyperplasia (BPH). Including both medication therapy and emerging minimally invasive options including peri-procedure considerations, expected outcomes, and value-based considerations. RECENT FINDINGS: Medical therapy, primarily alpha blockers (ABs), and 5 alpha reductase inhibitors (5-ARI) remain the most commonly utilized intervention for LUTS associated with BPH. Several minimally invasive surgical treatments (MISTs) have emerged to provide efficacious and durable results, while largely sparing men from the sexual adverse effects of more invasive surgical options. The introduction of value-based health care has led to more cost-conscious medical care and is poised to influence the landscape of LUTS associated with BPH treatment. As the population-based and societal needs continue to influence medical care for men with LUTS associated with BPH, a paradigm shift in management is expected.

Infectious Adverse Events Following the Placement of a Penile Prosthesis: A Systematic Review.

INTRODUCTION: Infection remains a prominent concern following penile implantation. Recognition of the risk factors for infection may help to guide surgeons toward reducing the risk of prosthetic contamination. AIM: To gain a further understanding of infectious adverse events following penile prosthesis, we performed a systematic literature review. METHODS: As part of the 2018 American Urological Association Erectile Dysfunction Clinical Guidelines and with the support of the American Urological Association, we performed a comprehensive review of the PubMed, Embase, and Cochrane databases to search for eligible articles published between January 1, 1965, and July 20, 2016, to identify articles reporting infectious adverse events following prosthesis placement. MAIN OUTCOME MEASURE: The main outcome measure was infectious adverse events following penile prosthesis placement. RESULTS: Ninety-one articles reporting infectious adverse events representing 97 study arms were identified. Prosthetic infection rates ranged from 0% to 24.6% across all series. Inflatable penile prostheses displayed a wider range (0-24.6%) than malleable devices (0-9.1%); the most frequently reported infection rate for inflatable devices was 5% or less. With the advent of device coatings and improved surgical techniques, infectious adverse events have decreased. Infections among diabetic patients also decreased throughout the reviewed body of literature, with the most recent series reporting rates consistent with those of non-diabetic patients. Furthermore, no glycosylated hemoglobin cutoff was found to infer increased or decreased risk of prosthesis infection. CONCLUSION: Overall penile prosthetic infectious adverse events have decreased as surgical techniques have improved and the use of antimicrobial coating has gained in popularity. These advances have demonstrated significant benefits for all patients, particularly diabetic patients who experience infection rates similar to those of non-diabetic patients in recent reports. Further technological advancements for the prevention of biofilm formation is warranted. Mahon J, Dornbier R, Wegrzyn G, et al. Infectious Adverse Events Following the Placement of a Penile Prosthesis: A Systematic Review. Sex Med Rev 2020;8:348-354.

Etiology of Erectile Dysfunction and Duration of Symptoms in Patients Undergoing Penile Prosthesis: A Systematic Review.

INTRODUCTION: Inadequate treatment of men with erectile dysfunction (ED) subjects them and their partners to lost quality of life, yet little is known about the cause and duration of symptoms that lead to penile prosthesis (PP) placement. AIM: We performed a systematic review addressing cause and duration of symptoms before implantation. METHODS: We searched PubMed, Embase, and Cochrane for articles published between January 1, 1965-July 20, 2016, reporting on PP for ED. Studies were assessed for quality. Body of evidence strength was categorized in accordance to American Urological Association (AUA) categorization: grade A (well-conducted, highly-generalizable randomized controlled trials (RCTs) or exceptionally strong observational studies with consistent findings), grade B (RCTs with some weaknesses of procedure/generalizability or moderately strong observational studies with consistent findings), or grade C (RCTs with serious deficiencies of procedure/generalizability, have small sample sizes, or other problems that potentially confound interpretation). This review was performed as part of the 2018 AUA ED Clinical Guidelines, with the support of the AUA. MAIN OUTCOME MEASURES: Cause and duration of symptoms before PP were assessed. RESULTS: We reviewed 113 articles constituting 150 study arms. All studies were observational (body of evidence strength grade C). Of these arms, only 19 reported on ED duration. Mean duration was 56 months for men undergoing inflatable penile prosthesis (IPP) placement (38.7 months for those after prostatectomy) and 72 months for those undergoing malleable penile prosthesis placement. Diabetic patients undergoing IPP had mean ED duration of 75 months. Among arms reporting on IPPs, causes of ED were vascular disease (47 arms; range 2.9-62.0%; mean 31.9%), diabetes (61 arms; range 12.8-77.8%; mean 28.3%), and pelvic surgery or trauma (49 arms; range 0.5-49.7%; mean 20.3%). CONCLUSION: Nearly all men undergoing PP have ED of organic causes, whereas diabetic patients and patients receiving malleable penile prosthesis have the longest ED duration. Factors driving this relative delay require additional investigation. Post-prostatectomy IPP placement is offered relatively late, on average. Bajic P, Mahon J, Faraday M, et al. Etiology of Erectile Dysfunction and Duration of Symptoms in Patients Undergoing Penile Prosthesis: A Systematic Review. Sex Med Rev 2020;8:333-337.

Is Sexual Function Better Preserved After Water Vapor Thermal Therapy or Medical Therapy for Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia?

BACKGROUND: Men often experience deterioration of sexual function after the use of α-blockers and 5-α reductase inhibitors for the treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia. Thus, an alternative treatment with water vapor thermal therapy (Rezum System, Boston Scientific, Marlborough, MA, USA) which is an efficacious minimally invasive surgical treatment that preserves sexual function was examined. AIM: To compare sexual function over 3 years after continuous daily treatment with pharmaceutical agents in the Medical Therapy of Prostatic Symptoms (MTOPS) study vs a single thermal therapy procedure (Rezum study) in subjects with matched criteria for LUTS severity and prostate size. METHODS: We used sexual function data from sexually active cohorts in the MTOPS study (1,209) randomized to doxazosin, finasteride, combination drugs and placebo, and sexually active men who received thermal therapy (86). MTOPS study participants completed the Brief Male Sexual Function Inventory; men in the Rezum trial completed the International Index of Erectile Function and Male Sexual Health Questionnaire. MAIN OUTCOME MEASURE: Estimated mean changes from baseline for sexual function variables were compared using a linear mixed repeated measures model with fixed effects for treatment and follow-up visits. RESULTS: With continued daily drug use, men experienced significant worsening of sexual desire, erectile and ejaculatory function with finasteride and combination drug therapy, and reduced desire and erectile function with doxazosin. Thermal therapy was not associated with significant negative changes in sexual function throughout 3 years after treatment. CLINICAL IMPLICATIONS: Water vapor thermal therapy can result in greater LUTS improvements than either doxazosin or finasteride alone, whereas combination drug therapy may equal that of this Rezum procedure, but all drug therapies did have a significant negative impact on sexual function in contrast to the preservation of libido, erectile, and ejaculatory function after thermal therapy. STRENGTH & LIMITATIONS: The report includes high-quality data from 2 large randomized controlled trials in subjects with similar baseline inclusion criteria for LUTS severity and prostate size. It is the first longitudinal assessment of sexual function domains restricted to sexually active men treated with drugs or a single minimally invasive surgical treatment with the Rezum procedure. A limitation of the study is the use of 2 different, although validated sexual function inventories (Brief Male Sexual Function Inventory and International Index of Erectile Function). CONCLUSION: A single water vapor thermal therapy procedure for targeted prostate tissue ablation for LUTS/ benign prostatic hyperplasia had no deleterious effect on 4 sexual function domains compared with appreciable worsening of sexual function after long-term single or combination drug use. McVary KT, Rogers T, Mahon J, et al. Is Sexual Function Better Preserved After Water Vapor Thermal Therapy or Medical Therapy for Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia? J Sex Med 2018;15:1728-1738.

Phenazopyridine: A Preoperative Way to Identify Ureteral Orifices.

OBJECTIVE: To identify difficult to see ureteral orifices (UOs), urologists need a method to stain the urine. Phenazopyridine, a urinary analgesic which discolors the urine orange, can be administered orally preoperatively. We evaluated the usefulness of phenazopyridine in identifying the UOs and optimal timing of administration. METHODS: Adult patients undergoing endoscopic procedures at the Stratton VA were prospectively enrolled. Preoperative metabolic panels were reviewed. Exclusion criteria were renal insufficiency (creatinine clearance <50 mL/min), severe hepatitis or severe liver disease, glucose-6-phosphate dehydrogenase deficiency, previous hypersensitivity to phenazopyridine, or pregnancy. In phase 1, patients undergoing office flexible cystoscopy were administered 200 mg phenazopyridine the morning of the procedure. Because of the robust orange color of the urine, phase 2 was implemented. In phase 2, patients undergoing rigid cystoscopy in the operating room took 200 mg phenazopyridine at 7 PM the night before surgery. Upon entry into the bladder, UOs were identified and urine color was graded (0 = no dye, 1 = weak, 2 = moderate, and 3 = strong). Patients were assessed postoperatively for side effects. RESULTS: Five patients were included in phase 1. The mean time from medication to cystoscopy was 153 minutes (range 17-304 minutes). One-third of patients had excretion of grade 3 orange urine that obscured inspection of the bladder mucosa. The study design was adjusted and we transitioned to phase 2. Twenty-three patients were enrolled in phase 2. The mean time from phenazopyridine dose to cystoscopy was 14 hours (range 13-17 hours). Seventy-three percent of patients had grade 2 efflux from the UOs. CONCLUSION: Phenazopyridine can successfully identify UOs and can be administered as early as the evening before the procedure.

Hypoandrogenism is Prevalent in Males With Urethral Stricture Disease and is Associated with Longer Strictures.

OBJECTIVE: To assess the association of hypoandrogenism (HA) with urethral stricture disease in a series of patients undergoing urethroplasty at 2 institutions. HA has recently been associated with increased urethral atrophy in artificial sphincter failures and decreased androgen receptors and periurethral vascularity. HA might be an etiologic factor in urethral stricture disease. METHODS: We reviewed the charts in 202 men with anterior urethral strictures between 2011 and 2017. We excluded patients with radiation-induced stricture, previous prostatectomy, previous urethroplasty, pelvic fracture-related strictures, or those on testosterone replacement. We defined HA by a total testosterone of less than 300 ng/dL. We used as age-matched cohort from a national database (National Health and Nutrition Examination Survey), as a reference. Stricture characteristics, such as length, location, and etiology were compared in HA and eugonadal groups. RESULTS: Of 202 men with anterior urethral strictures, we excluded 45. Of the remaining 157 patients, 115 (73%) had preoperative testosterone measurements. Overall, hypoandrogenism (HA) was found in 65 of 115 (57%) men in the urethral stricture group compared with 28% of age-matched men in the national database. Mean stricture length in HA and eugonadal men was 7.2 cm and 4.8 cm, respectively (P = .02). CONCLUSION: HA may be more prevalent and associated with increased disease severity in men with anterior urethral strictures. The relationship between HA and stricture formation and its potential impact on therapeutic outcomes merit further prospective investigation.

Serum levels of enclomiphene and zuclomiphene in men with hypogonadism on long-term clomiphene citrate treatment.

OBJECTIVES: To determine the relative concentrations of enclomiphene (ENC) and zuclomiphene (ZUC) isomers in men with hypogonadism on long-term clomiphene citrate (CC) therapy, and to determine whether patient age, body mass index (BMI) or duration of therapy were predictive of relative concentrations of ENC and ZUC. PATIENTS AND METHODS: Men already receiving CC 25 mg daily therapy for secondary hypogonadism for a minimum of 6 weeks were recruited to have their ENC and ZUC levels assessed. Total testosterone, free testosterone, oestradiol, follicle stimulating hormone (FSH), and luteinizing hormone (LH) before initiation of and while on CC therapy were recorded for all patients. Patient demographics including age, BMI and medical comorbidites were recorded. Serum samples were obtained at the time of enrolment to determine ENC and ZUC concentrations. RESULTS: A total of 15 men were enrolled in the period from June 2015 to August 2015. The median (range) patient age was 36 (22-70) years, BMI 32.0 (21.1-40.3) kg/m2 and duration of treatment 25.9 (1.7-86.6) months. Baseline median total testosterone, oestradiol and LH levels were 205.0 ng/dL, 17.0 pg/mL and 4.0 mlU/mL, respectively. The post-treatment median total testosterone, oestradiol and LH level increased to 488.0 ng/dL, 34.0 pg/mL and 6.1 mIU/mL, respectively (all P<0.001). The median ENC and ZUC concentrations were 2.2 and 44.0 ng/mL, respectively. After at least 6 weeks of CC therapy, the median ZUC: ENC serum concentration ratio was 20:1. On linear regression analysis. patient age, BMI, duration of treatment and serum testosterone levels were not predictive of ENC or ZUC concentrations. CONCLUSIONS: Long-term CC therapy resulted in a significant alteration of ENC and ZUC concentrations, with ZUC as the predominant isomer. Given the vastly different biochemical and toxicological properties of ENC and ZUC, this study supports the need for the development of a pure selective oestrogen receptor antagonist for the treatment of men with hypogonadism.