The Diagnosis and Management of Recurrent Ischemic Priapism, Priapism in Sickle Cell Patients, and Non-Ischemic Priapism: An AUA/SMSNA Guideline.

PURPOSE: Priapism is a persistent penile erection that continues hours beyond, or is unrelated to, sexual stimulation and results in a prolonged and uncontrolled erection. Given its time-dependent and progressive nature, priapism is a situation that both urologists and emergency medicine practitioners must be familiar with and comfortable managing. METHODOLOGY: A comprehensive search of the literature on acute ischemic priapism and non-ischemic priapism (NIP) was performed by Emergency Care Research Institute for articles published between January 1, 1960 and May 1, 2020. A search of the literature on NIP, recurrent priapism, prolonged erection following intracavernosal vasoactive medication, and priapism in patients with sickle cell disease was conducted by Pacific Northwest Evidence-based Practice Center for articles published between 1946 and February 19, 2021. Searches identified 4117 potentially relevant articles, and 3437 of these were excluded at the title or abstract level for not meeting inclusion criteria. Full texts for the remaining 680 articles were ordered, and ultimately 203 unique articles were included in the report. RESULTS: This Guideline provides a clinical framework for the treatment (non-surgical and surgical) of NIP, recurrent ischemic priapism, and priapism in patients with sickle cell disease. The treatment of patients with a prolonged erection following intracavernosal vasoactive medication is also included. The AUA guideline on the diagnosis of priapism and the treatment of acute ischemic priapism was published in 2021. CONCLUSIONS: All patients with priapism should be evaluated emergently to identify the sub-type of priapism (acute ischemic versus non-ischemic) and those with an acute ischemic event should be provided early intervention when indicated. NIP is not an emergency and treatment must be based on patient objectives, available resources, and clinician experience. Management of recurrent ischemic priapism requires treatment of acute episodes and a focus on future prevention of an acute ischemic event. Sickle cell disease patients presenting with an acute ischemic priapism event should initially be managed with a focus on urologic relief of the erection; standard sickle cell assessment and interventions should be considered concurrent with urologic intervention. Treatment protocols for a prolonged, iatrogenic erection must be differentiated from protocols for true priapism.

Acute Ischemic Priapism: An AUA/SMSNA Guideline.

PURPOSE: Priapism is a persistent penile erection that continues hours beyond, or is unrelated to, sexual stimulation and results in a prolonged and uncontrolled erection. Given its time-dependent and progressive nature, priapism is a situation that both urologists and emergency medicine practitioners must be familiar with and comfortable managing. Acute ischemic priapism, characterized by little or no cavernous blood flow and abnormal cavernous blood gases (ie, hypoxic, hypercarbic, acidotic) represents a medical emergency and may lead to cavernosal fibrosis and subsequent erectile dysfunction. MATERIALS AND METHODS: A comprehensive search of the literature was performed by Emergency Care Research Institute for articles published between January 1, 1960 and May 1, 2020. Searches identified 2948 potentially relevant articles, and 2516 of these were excluded at the title or abstract level for not meeting inclusion criteria for any key question. Full texts for the remaining 432 articles were reviewed, and ultimately 137 unique articles were included in the report. RESULTS: This Guideline was developed to inform clinicians on the proper diagnosis and surgical and non-surgical treatment of patients with acute ischemic priapism. This Guideline addresses the role of imaging, adjunctive laboratory testing, early involvement of urologists when presenting to the emergency room, discussion of conservative therapies, enhanced data for patient counseling on risks of erectile dysfunction and surgical complications, specific recommendations on intracavernosal phenylephrine with or without irrigation, the inclusion of novel surgical techniques (eg, tunneling), and early penile prosthesis placement. CONCLUSIONS: All patients with priapism should be evaluated emergently to identify the sub-type of priapism (acute ischemic versus non-ischemic) and those with an acute ischemic event should be provided early intervention. Treatment of the acute ischemic patient must be based on patient objectives, available resources, and clinician experience. As such, a single pathway for managing the condition is oversimplified and no longer appropriate. Using a diversified approach, some men may be treated with intracavernosal injections of phenylephrine alone, others with aspiration/irrigation or distal shunting, and some may undergo non-emergent placement of a penile prosthesis.

Indications for Penile Prosthesis Revision: Lessons Learned to Limit Technical Causes of Reoperation.

INTRODUCTION: Reoperations are necessary in approximately 30% of penile prostheses over 15 years following original implantation. AIM: To determine the most common indications for initial penile prosthesis reoperation at our institution and to describe technical alterations that have improved postoperative outcomes. METHODS: A retrospective review of all patients who underwent penile prosthesis reoperation surgery at a single, high-volume Canadian center between 2006 and 2018 was performed. Patient demographic information, prosthetic device factors, and surgical complications were analyzed. MAIN OUTCOME MEASURE: The primary outcomes were the indications for and variables associated with initial penile prosthesis reoperation. RESULTS: During the study period, 99 first-time penile prosthesis reoperations were performed out of 1,161 penile prosthesis procedures (Figure 1). This included 14 (14.1%) explants, 32 (32.3%) revisions, and 53 (53.5%) explant and reimplants. Indications for reoperation included 49 (49.5%) mechanical failures, 28 (28.3%) technical causes (such as correction of malposition or device herniation), and 12 (12.1%) procedures to treat chronic postoperative pain. Median follow-up was 78.5 months, and median time to reoperation was 46 months. Mechanical failures commonly occurred in the tubing (n = 13, 26.5%) and cylinders (n = 13, 26.5%). The most frequently repositioned component was the valve pump (n = 11, 39.3%). Infection-related indications for reoperation were uncommon (n = 10, 10.1%). CLINICAL IMPLICATIONS: More than a quarter of penile prosthesis reoperations may have been preventable with alterations in surgical technique, device positioning, and postoperative care. STRENGTHS AND LIMITATIONS: This study evaluates a range of indications for initial penile prosthesis reoperation performed by a high-volume single surgeon over a 12-year period. Limitations include the retrospective nature of the study, loss of patients to follow-up, and lack of etiological determinants of prosthesis failure. CONCLUSIONS: Reoperation for device repositioning and herniation was required for more than a quarter of the initial penile prosthesis implants. Modifications in surgical technique and perioperative care can help reduce the incidence of these technical causes for reoperation. Chan EP, Punjani N, Campbell JD, et al. Indications for Penile Prosthesis Revision: Lessons Learned to Limit Technical Causes of Reoperation. J Sex Med 2019; 16:1444-1450.

A Worldwide Survey on Peyronie's Disease Surgical Practice Patterns Among Surgeons.

BACKGROUND: Despite published guidelines on Peyronie's disease (PD), there are limited data on actual surgical practice among surgeons. AIM: To evaluate the surgical practice patterns in PD among surgeons from different continents and members of various sexual medicine societies. METHODS: An anonymous survey on various pre-, intra-, and postoperative aspects of PD surgical care was distributed in printed format during International Society of Sexual Medicine meetings and as an online survey to International Society of Sexual Medicine members. OUTCOMES: 390 surgeons responded to the survey, with great variations in pre-, intra-, and postoperative strategies in PD surgical care. RESULTS: Most surgeons performed fewer than 10 penile plications and 10 graft surgeries per year. Modified Nesbit plication was the preferred option by most surgeons. Surgeons who received fellowship training were more likely to perform autologous than allograft surgery (odds ratio = 1.79, 95% CI = 1.13-2.82, P = .01). The use of penile color duplex ultrasound was inconsistently performed, with higher-volume surgeons (ie, >20 cases operated a year) more likely to use this diagnostic modality (odds ratio = 70.18, 95% CI = 20.99-234.6, P < .001). Most surgeons agreed that surgical intervention should be performed only after a 6-month history of stable penile curvature, although higher-volume surgeons were more inclined to perform surgery sooner (P = .08). CLINICAL IMPLICATIONS: Although it is unknown whether variations in PD surgery significantly affect clinical outcome and patient satisfaction rate, this worldwide survey study has the potential to assist in the formation of a new practice guideline and serve as the basis for future prospective multinational studies. STRENGTH AND LIMITATIONS: This is one of the largest surveys on PD practice and, to our knowledge, the only survey conducted across various sexual medicine societies, with the inclusion of many high-volume and experienced PD surgeons. This also is the 1st study to comprehensively evaluate many key aspects in surgical practice patterns for PD. However, the categorization on the questionnaire used in this survey was not designed to allow for direct comparison given the possibility of some surgeons with dual society memberships, reporting biases, large CIs in outcomes, different patient demographics, and cultural acceptance. CONCLUSION: There is great variation in surgical practice patterns in PD management, including key differences among surgeons across different continents and sexual medicine societies. Chung E, Wang R, Ralph D, et al. A Worldwide Survey on Peyronie's Disease Surgical Practice Patterns Among Surgeons. J Sex Med 2018;15:568-575.

EFFICACY AND SAFETY OF A NEW TOPICAL TESTOSTERONE REPLACEMENT GEL THERAPY FOR THE TREATMENT OF MALE HYPOGONADISM.

OBJECTIVE: Testosterone replacement therapy is indicated for male hypogonadism. This study aimed to evaluate the efficacy and safety of testosterone gel 2% (Tgel) over 90 days. METHODS: This phase 3, open-label, noncomparator study was conducted in adult hypogonadal men (2 consecutive fasting serum testosterone values <300 ng/dL and >86% subjects with symptoms consistent with testosterone deficiency). Subjects applied Tgel 23 mg/day (single pump-actuation using a hands-free cap applicator). The dose was uptitrated to 46 mg/day after 2 weeks if the 4-hour serum total testosterone level was <500 ng/dL. The dose could be further up- or downtitrated to 23, 46, and 69 mg on Days 21, 42, and 63. The primary endpoint included the percentage of subjects with average testosterone concentration (Cave (0-24)) between 300 and 1,050 ng/dL on Day 90. Safety endpoints were adverse events (AEs), laboratory parameters, and vital signs. RESULTS: Of the 159 who enrolled, 139 men completed the study. Approximately three-quarters (76.1%) of subjects met Cave criteria on Day 90. Most AEs were mild to moderate. There were 5 serious AEs, and 1 (myocardial infarction) was judged as possibly related to Tgel. Confirmed excessive increases in prostate-specific antigen or hematocrit levels were rare. Tgel had a favorable local skin tolerability profile. CONCLUSION: Overall, 76% of subjects achieved Cave between 300 and 1,050 ng/dL with Tgel. Symptoms of testosterone deficiency improved with few safety concerns. ABBREVIATIONS: AE = adverse event Cave(0-24) = average testosterone concentration CI = confidence interval Cmax = maximum concentration IIEF = International Index of Erectile Function MAF = Multidimensional Assessment of Fatigue PK = pharmacokinetic PSA = prostate-specific antigen SAE = serious adverse event SF-12 = Short Form 12 Health Survey Tgel = testosterone gel 2% Tmax = time to achieve maximum concentration TRT = testosterone replacement therapy.

9-Month Efficacy and Safety Study of Testosterone Solution 2% for Sex Drive and Energy in Hypogonadal Men.

PURPOSE: We evaluated the continued safety and efficacy of testosterone solution 2% (T-sol) in a 6-month open label extension study following a 3-month, double-blind, placebo controlled study in which T-sol was safe and efficacious for sex drive in men with androgen deficiency. MATERIALS AND METHODS: A total of 558 hypogonadal participants with a mean (SD) age of 55 (11) years entered the open label treatment study. Of these patients 275 had previously received placebo (formerly placebo group) and 283 had received active treatment with T-sol (continuing active group) during the double-blind phase. Outcome measures were the proportion of men with total testosterone levels within the normal range; assessment of treatment induced change in sex drive measured using the Sexual Arousal, Interest, and Drive scale; and assessment of treatment induced change in energy measured using the Hypogonadism Energy Diary. RESULTS: At the completion of the open label phase 60% and 66% of the participants had total testosterone levels within the normal range in the formerly placebo and continuing active groups, respectively. Participants assigned to both groups showed baseline to end point improvement in Sexual Arousal, Interest, and Drive score (both p <0.001) and Hypogonadism Energy Diary score (both p <0.001) during the open label phase. No new safety concerns were reported. CONCLUSIONS: Once daily T-sol administered for 6 months in an open label study did not indicate new safety concerns, and the outcomes of low sex drive and low energy showed further improvement after the double-blind phase.

Effect of Testosterone Solution 2% on Testosterone Concentration, Sex Drive and Energy in Hypogonadal Men: Results of a Placebo Controlled Study.

PURPOSE: We determined the effect of testosterone solution 2% on total testosterone level and the 2 symptoms of hypogonadism, sex drive and energy level. MATERIALS AND METHODS: This was a randomized, multicenter, double-blind, placebo controlled, 16-week study to compare the effect of testosterone and placebo on the proportion of men with a testosterone level within the normal range (300 to 1,050 ng/dl) upon treatment completion. We also assessed the impact of testosterone on sex drive and energy level measured using SAID (Sexual Arousal, Interest and Drive scale) and HED (Hypogonadism Energy Diary), respectively. A total of 715 males 18 years old or older with total testosterone less than 300 ng/dl and at least 1 symptom of testosterone deficiency (decreased energy and/or decreased sexual drive) were randomized to 60 mg topical testosterone solution 2% or placebo once daily. RESULTS: Of study completers 73% in the testosterone vs 15% in the placebo group had a testosterone level within the normal range at study end point (p <0.001). Participants assigned to testosterone showed greater baseline to end point improvement in SAID scores (low sex drive subset p <0.001 vs placebo) and HED scores (low energy subset p = 0.02 vs placebo, not significant at prespecified p <0.01). No major adverse cardiovascular or venous thrombotic events were reported in the testosterone group. The incidence of increased hematocrit was higher with testosterone vs placebo (p = 0.04). CONCLUSIONS: Once daily testosterone solution 2% for 12 weeks was efficacious in restoring normal testosterone levels and improving sexual drive in hypogonadal men. Improvement was also seen in energy levels on HED though not at the prespecified p <0.01. No new safety signals were identified.

Impact of Baseline Total Testosterone Level on Successful Treatment of Sexual Dysfunction in Men Taking Once-Daily Tadalafil 5 mg for Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia: An Integrated Analysis of Three Randomized Controlled Trials.

INTRODUCTION: Controversy exists as to whether erectile response to phosphodiesterase type 5 inhibitors is compromised in men with low total testosterone (TT) levels. This is amplified by reports of improved response to phosphodiesterase type 5 inhibitor therapy after coadministration of testosterone replacement therapy in hypogonadal men unresponsive to phosphodiesterase type 5 inhibitors. AIM: To determine whether TT and luteinizing hormone levels influence efficacy of tadalafil for erectile dysfunction in men with concomitant lower urinary tract symptoms and benign prostatic hyperplasia. METHODS: This integrated analysis included 1,075 men randomized to once-daily tadalafil 5 mg (n = 540) or placebo (n = 535) for 12 weeks in three prospective clinical trials who had not received concomitant testosterone replacement therapy. Subjects were categorized at baseline by low vs normal TT levels (n = 1,049; <300 vs ≥300 ng/dL) and normal vs high luteinizing hormone levels (n = 1,058; ≤9.4 vs >9.4 mIU/mL). Treatment-group differences in International Index of Erectile Function (IIEF) by hormone subgroups were assessed using analysis of covariance. MAIN OUTCOME MEASURES: Changes in IIEF erectile function domain and other domain scores. RESULTS: The overall study population was comprised primarily of white men (>86%) with a mean age range of 64 to 70 years. Median baseline TT level in the integrated population was 355 ng/dL; levels were lower than 300 ng/dL (cutoff for normal) in 32.4% of men. Men with low TT levels reported diabetes (21.8%), cardiovascular disease (54.1%), and hypertension (49.1%) numerically more often than men with normal TT levels (10.6%, 43.2%, and 36.7%, respectively). Low TT and high luteinizing hormone levels were associated with numerically, but not statistically significantly, lower 12-week IIEF domain scores compared with those with normal levels. Changes in most 12-week IIEF domain scores showed that tadalafil was significantly more effective than placebo (P < .02). CONCLUSION: Low TT levels at baseline did not negatively influence response to tadalafil in men of advancing age with concomitant lower urinary tract symptoms and benign prostatic hyperplasia and erectile dysfunction.

Efficacy of Continuous Dosing of Tadalafil Once Daily vs Tadalafil On Demand in Clinical Subgroups of Men With Erectile Dysfunction: A Descriptive Comparison Using the Integrated Tadalafil Databases.

INTRODUCTION: Various factors play a role in the development of erectile dysfunction (ED). AIM: To provide a descriptive comparison of erectile function response for tadalafil on-demand (PRN) and once-daily (OAD) dosing regimens in patients with common comorbid conditions, treatments, or risk factors that can be considered when treating ED. METHODS: In total, 17 PRN and 4 OAD placebo-controlled studies were included in the integrated database in these pooled analyses. Data were analyzed from patients treated with placebo, tadalafil 10 mg (low dose), and 20 mg (high dose) for the PRN studies and placebo, tadalafil 2.5 mg (low dose), and 5 mg (high dose) for the OAD studies. MAIN OUTCOME MEASURES: The effects of tadalafil were measured using the International Index of Erectile Function administered from baseline to week 12. A descriptive comparison of the efficacy of tadalafil PRN vs OAD was examined in the clinical populations. RESULTS: Baseline characteristics of 4,354 men were comparable between the PRN and OAD groups, with differences seen only in the variables of race, body mass index (BMI) of at least 30 kg/m(2), and alcohol use. Tadalafil was efficacious at improving erectile function for all clinical populations, except for the low-dose OAD group, which demonstrated a weaker effect vs placebo than the high-dose OAD group, and the low- and high-dose PRN groups vs placebo for patients with BMI of at least 30 kg/m(2) for patients without a cardiovascular disorder, smokers, patients with ED duration shorter than 1 year, and patients without previous phosphodiesterase type 5 inhibitor use. Tadalafil was efficacious for patients with or without diabetes mellitus, arterial hypertension, hyperlipidemia, and alcohol use at baseline. CONCLUSION: Tadalafil OAD and PRN regimens showed efficacy in patients with ED. No clinical populations of patients with ED seemed to benefit overwhelmingly from one dose regimen over the other.

Effects of Tadalafil Once-Daily or On-Demand vs Placebo on Return to Baseline Erectile Function After Bilateral Nerve-Sparing Radical Prostatectomy--Results from a Randomized Controlled Trial (REACTT).

INTRODUCTION AND AIM: The multicenter, randomized, double-blind, double-dummy, placebo-controlled REACTT trial suggested that treatment with tadalafil once daily (OaD) started early after bilateral nerve-sparing radical prostatectomy (nsRP) for prostate cancer may contribute to erectile function (EF)-recovery, which was predefined as achieving an International Index of Erectile Function (IIEF)-EF score ≥22. Here, we report descriptive post-hoc analyses, using the more strict definition for EF-recovery of returning back to the pre-surgery IIEF-EF-level ("back-to-baseline analysis"). METHODS: REACTT included 422 men <68 years with adenocarcinoma of the prostate and preoperative IIEF-EF ≥22 who underwent nsRP at 50 centers from 9 European countries and Canada. Patients were randomized post-nsRP 1:1:1 to 9-month double-blind treatment (DBT) with tadalafil 5 mg OaD (n = 139), tadalafil 20 mg on-demand (pro-re-nata, PRN; n = 142), or placebo (n = 141), followed by 6-week drug-free washout (DFW) and 3-month open-label tadalafil OaD treatment (OLT). MAIN OUTCOME MEASURES: Proportion of patients returning to their preoperative IIEF-EF category (22-25 or ≥26) at the end of DBT, DFW, and OLT. RESULTS: Overall, 92.4% of patients had pre-surgery (baseline) IIEF-EF scores ≥26 (tadalafil OaD 94.2%, PRN 91.6%, placebo 91.5%), 7.4% had IIEF-EF 22-25. At the end of DBT, 22.3% of patients on tadalafil OaD had achieved "back-to-baseline" IIEF-EF, compared with 11.3% on tadalafil PRN and 7.8% on placebo. Of all 58 patients "back-to-baseline" at the end of DBT, only 1 PRN-group patient had started from a baseline IIEF-EF <26. The treatment-group difference at the end of DBT was not maintained after DFW. After 3 months of OLT with tadalafil OaD, the proportion of patients with "back-to-baseline" IIEF-EF had almost doubled in all 3 groups. CONCLUSION: Changing the definition for EF-recovery from IIEF-EF ≥22 to the more strict definition of "returning back-to-baseline IIEF-EF" had no major impact. Tadalafil OaD started early after nsRP improved drug-assisted EF, but had no effect on unassisted EF following treatment cessation after 9 months.

Proportion of tadalafil-treated patients with clinically meaningful improvement in lower urinary tract symptoms associated with benign prostatic hyperplasia ­ integrated data from 1,499 study participants.

OBJECTIVES: To evaluate the proportion of patients achieving clinically meaningful improvement of lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH-LUTS) with tadalafil using two definitions of response. PATIENTS AND METHODS: Post hoc integrated analysis of four placebo-controlled studies in men (aged ≥45 years; International Prostate Symptom Score [IPSS] of ≥13; maximum urinary flow rate [Q(max)] of ≥4 to ≤15 mL/s) with BPH-LUTS randomised to tadalafil 5 mg (752 patients) or placebo (747) for 12 weeks after a 4-week placebo run-in. Responders were defined as having a total IPSS improvement of ≥3 points or ≥25% from randomisation to endpoint (Week 12). Response status was calculated per patient, and relative benefit and odds ratio (OR) with 95% confidence interval (CI) of tadalafil vs placebo was calculated using a logistic Generalised Mixed Model for Repeated Measures. RESULTS: Tadalafil 5 mg once daily resulted in a significantly greater proportion of patients achieving a ≥3-point IPSS improvement (71.1% and 56.0% for tadalafil and placebo patients, respectively [OR 1.9, 95% CI 1.5, 2.4; P < 0.001]) and achieving a ≥25% improvement in total IPSS randomisation to endpoint (61.7% and 45.5% for tadalafil and placebo patients, respectively [OR 2.0, 95% CI 1.6, 2.5; P < 0.001]). CONCLUSION: About two-thirds of tadalafil-treated patients achieve a clinically meaningful improvement in BPH-LUTS symptoms, based on two different definitions of responder status.

Direct effects of tadalafil on lower urinary tract symptoms versus indirect effects mediated through erectile dysfunction symptom improvement: integrated data analyses from 4 placebo controlled clinical studies.

PURPOSE: Tadalafil has regulatory approval for the treatment of men with signs/symptoms of benign prostatic hyperplasia with and without erectile dysfunction. We assessed whether the effects of treatment with tadalafil for lower urinary tract symptoms/benign prostatic hyperplasia are independent of improvements in erectile dysfunction. MATERIALS AND METHODS: Four separate analyses used integrated data from 4 randomized, double-blind, placebo controlled studies in men with lower urinary tract symptoms/benign prostatic hyperplasia with and without erectile dysfunction to test whether total I-PSS (International Prostate Symptom Score) improvement was due to improvement in IIEF-EF (International Index of Erectile Function-Erectile Function domain score). Unidirectional and bidirectional path analysis models determined direct and indirect treatment effects mediated by improvements in lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction symptoms. RESULTS: A total of 1,496 men, of whom 77% had erectile dysfunction, received at least 1 dose of tadalafil 5 mg once daily or placebo. The placebo adjusted treatment effect for men with erectile dysfunction was represented by a mean decrease of -2.3 (p <0.0001) in total I-PSS vs -2.2 (p = 0.0007) for men without erectile dysfunction. The correlation between change from baseline in total I-PSS and IIEF-EF was weak (r(2) = 0.08, p <0.0001). The unidirectional path analysis model suggested that the total treatment effect on total I-PSS score improvement (2.25) was derived from a direct treatment effect of 1.57 (70%, p <0.001) and an indirect treatment effect of 0.67 (30% via IIEF-EF improvement, p <0.001). Bidirectional path analysis showed that total I-PSS improvement was largely attributed to direct (92.5%, p <0.001) vs indirect (7.5%, p = 0.32) treatment effects via IIEF-EF improvement. CONCLUSIONS: Regardless of the analytical approach, self-reported erectile dysfunction status did not appreciably influence tadalafil treatment response in men with lower urinary tract symptoms/benign prostatic hyperplasia, supporting the dual action of tadalafil on lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction.

Three-year outcomes of recovery of erectile function after open radical prostatectomy with sural nerve grafting.

INTRODUCTION: Optimal oncologic control of higher stage prostate cancers often requires sacrificing the neurovascular bundles (NVB) with subsequent postoperative erectile dysfunction (ED), which can be treated with interposition graft using sural nerve. AIMS: To examine the long term outcome of sural nerve grafting (SNG) during radical retropubic prostatectomy (RRP) performed by a single surgeon. METHODS: Sixty-six patients with clinically localized prostate cancer and preoperative International Index of Erectile Function (IIEF) score >20 who underwent RRP were included. NVB excision was performed if the risk of side-specific extra-capsular extension (ECE) was >25% on Ohori' nomogram. SNG was harvested by a plastic surgeon, contemporaneously as the urologic surgeon was performing RRP. IIEF questionnaire was used pre- and postoperatively and at follow-up. MAIN OUTCOME MEASURES: Postoperative IIEF score at three years of men undergoing RRP with SNG. Recovery of potency was defined as postoperative IIEF-EF domain score >22. RESULTS: There were 43 (65%) unilateral SNG and 23 (35%) bilateral SNG. Mean surgical time was 164 minutes (71 to 221 minutes).The mean preoperative IIEF score was 23.4+1.6. With a mean follow-up of 35 months, 19 (28.8%) patients had IIEF score >22. The IIEF-EF scores for those who had unilateral SNG and bilateral SNG were 12.9+4.9 and 14.8+5.3 respectively. History of diabetes (P=0.001) and age (P=0.007) negatively correlated with recovery of EF. 60% patients used PDE5i and showed a significantly higher EF recovery (43% vs. 17%, P=0.009). CONCLUSIONS: SNG can potentially improve EF recovery for potent men with higher stage prostate cancer undergoing RP. The contemporaneous, multidisciplinary approach provides a good quality graft and expedited the procedure without interrupting the work-flow.

Clinical outcomes and patient satisfaction rates among elderly male aged ≥75 years with inflatable penile prosthesis implant for medically refractory erectile dysfunction.

PURPOSE: The purpose of the study is to assess the clinical outcomes and patient satisfaction rate between men aged under and over 75 years who underwent inflatable penile prosthesis (IPP) implantation. METHODS AND MATERIALS: A retrospective review of clinical database and follow-up independent telephone survey was undertaken in all men who underwent first-time IPP implantation between January 2006 and November 2010. Patient demographics, surgical outcomes, and patient satisfaction rate using Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores were recorded. RESULTS: A total of 216 first-time IPP were implanted. Of these, 30 patients were aged ≥75 years. In men aged ≥75 years, 3 patients had IPP revision surgery for mechanical malfunction (average 18.6 months; 12-24 months). While the 2-year Kaplan-Meier estimates of mechanical survival showed better outcome in men aged ≥75 years than men aged <75 years (95 vs. 92%; p = 0.38), there was no difference in the IPP mechanical survival between the 2 groups at 3 years follow-up. There were no statistically significant differences in the ease of IPP use, and EDITS scores among the two groups. The majority of men were satisfied and would recommend the IPP surgery to other men. CONCLUSIONS: Men aged ≥75 years reported satisfactory outcome with IPP surgery with no statistical significant difference identified across device survival and satisfaction rates compared to men aged <75 years.

A comparative study of the efficacy of intralesional verapamil versus normal saline injection in a novel Peyronie disease animal model: assessment of immunohistopathological changes and erectile function outcome.

PURPOSE: While intralesional injections improve penile curvature and decrease plaque volume, the exact mechanism of action on Peyronie disease is unknown. We evaluated penile curvature, immunohistology and erectile function outcomes after intralesional injections of verapamil and normal saline in a previously described Peyronie disease animal model. MATERIALS AND METHODS: Peyronie plaque was induced in 12 adult male rats using an established Peyronie disease animal model. At 4 weeks the rats were divided into group 1-5 with 0.1 mg/0.1 ml intralesional verapamil injected every second day for 2 weeks, group 2-5 with 0.1 ml intralesional normal saline injection and group 3-2 that served as controls. At weeks 6 and 8 penile pressure was measured and serial immunohistochemical staining of penile tissue sections was done. RESULTS: Intralesional injection of verapamil and normal saline resulted in macroscopic and microscopic changes to penile curvature and Peyronie plaque size. Decreased collagen and elastin fibers were measured with a significant reduction in smooth muscle α-actin (p <0.05). Changes were greater in group 1 than group 2 (p <0.05). Intralesional verapamil injection was associated with greater recovery of electrostimulated penile pressure, a surrogate of erectile function, than in the saline and control groups. CONCLUSIONS: To our knowledge this novel study offers for the first time histological evidence of cellular changes and improvement in penile pressure studies in rats with Peyronie plaque after intralesional verapamil injection therapy in a Peyronie disease animal model.

Tadalafil once daily in the treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in men without erectile dysfunction.

OBJECTIVES: To assess the safety and efficacy of tadalafil once daily on lower urinary tract symptoms suggestive of clinical benign prostatic hyperplasia (BPH-LUTS) in men without erectile dysfunction (ED). To compare these with effects in men with ED. PATIENTS AND METHODS: After a 4-week washout period and 4-week placebo run-in period, 1089 men without ED (n = 338) and with ED (n = 751) were randomly assigned to placebo or tadalafil 5 mg once daily for 12 weeks in three global clinical studies with similar designs. In the pooled dataset, post hoc analyses of covariance assessed the impact and severity of BPH-LUTS using the International Prostate Symptom Score (IPSS) and the BPH Impact Index (BII) and IPSS quality-of-life (IPSS-QoL) subscores. Safety was assessed using treatment-emergent adverse events. The treatment-by-ED-status interaction was used to assess efficacy differences between the with/without ED subgroups. RESULTS: Men without ED were similar in BPH-LUTS severity/previous therapy to men with ED. Tadalafil significantly reduced BPH-LUTS from baseline when compared with placebo in men without ED (IPSS -5.4 vs -3.3, P < 0.01; IPSS voiding subscore -3.5 vs -2.0, P < 0.01; IPSS storage subscore -1.9 vs -1.3, P < 0.05). Tadalafil also significantly improved quality of life from baseline when compared with placebo in men without ED (IPSS-QoL -1.0 vs -0.7, BII -1.4 vs -1.0; both P < 0.05). Between-ED-subgroup interactions were not significant (all P > 0.68). Tadalafil was safe and well tolerated. CONCLUSION: Tadalafil 5 mg once daily improved BPH-LUTS in men without ED by a magnitude similar to that observed in men with ED. The adverse event profile in men without ED was consistent with that observed in men with ED.

Sexual rehabilitation and cancer survivorship: a state of art review of current literature and management strategies in male sexual dysfunction among prostate cancer survivors.

INTRODUCTION: The challenges for prostate cancer survivors include the surveillance of prostate cancer recurrence and management of physical, cognitive, sexual, and socioeconomic quality of life issues. Sexual function remains an important issue in men, who often continue to be interested in sex after prostate cancer treatment. The various post-prostate cancer treatment-related sexual dysfunctions are penile deformities and erectile dysfunction (ED); sexual desire and mental health; ejaculatory and orgasmic dysfunctions; and changes in partner relationship and dynamics. AIMS: The aim of this study is to provide state of art review of the various male sexual dysfunctions in prostate cancer survivors and the management strategies in sexual rehabilitation. METHODS AND MATERIALS: A literature search for English language original and review articles either published or e-published was performed using PubMed database. Keywords included prostate cancer, prostate cancer treatment, prostate prostatectomy (RP), sexual dysfunction, erectile dysfunction (ED), sexual desire, mental health, ejaculation, orgasmic, climacturia, and relationship. RESULTS: There has been considerable volume of publication in recent years on prostate cancer-related male sexual dysfunction. Penile deformities and ED shared similar pathophysiology and that penile smooth muscle fibrosis ultimately results in structural alterations and end-organ failure. Penile rehabilitation using oral phosphodiesterase type 5 (PDE5) inhibitors is considered the standard of care especially in patients who received nerve-sparing RP and should be instituted as soon as possible to protect and prevent corporal endothelial and smooth muscle damage. However, there is no consensus on the exact timing, dose, and duration of PDE5 inhibitors and its impact in non-nerve-sparing RP and other forms of prostate cancer treatment modalities. Current literature on hypoactive sexual desire, ejaculatory, and orgasmic dysfunctions in patients who received prostate cancer treatment is limited. Psychological and sexual counseling play an important role in rehabilitation and treatment of various forms of male sexual dysfunctions. CONCLUSION: While several preventive and treatment strategies for the preservation and recovery of sexual function are available, no specific recommendation or consensus guidelines exist regarding the optimal rehabilitation or treatment protocol. While medical and surgical therapies are effective in erectile function recovery and/or preservation, psychological and sexual counseling are equally important in sexual rehabilitation.