The Discontinuation Rate With Collagenase Clostridium histolyticum for Peyronie's Disease in a High-volume Practice Is Unexpectedly High: Identifying Opportunities for Patient Care Improvement.

OBJECTIVE: To elucidate reasons for premature discontinuation of Collagenase Clostridium histolyticum (CCH) injections for the treatment of penile curvature associated with Peyronie's disease. METHODS: A database of men who underwent CCH injections at a single institution was queried to identify men who completed fewer than 8 injections. Chart review was conducted to identify reasons for treatment discontinuation. When this could not be identified, patients were contacted first via the online patient portal and next by phone. RESULTS: Of 406 patients who underwent CCH treatment, 133 did not complete 8 injections (32.8%). The most common reasons for discontinuation were satisfactory curve reduction (27%), unsatisfactory curve reduction (21%), bothersome side effect (15%), and pursuit of surgery (12%). Other less common reasons included other health concerns, pausing treatment due to the COVID-19 pandemic, high cost, transferring care elsewhere, and lack of awareness that more injections were indicated. CONCLUSION: We present the largest series of patients to date dedicated to evaluation of CCH discontinuation. We find that up to 1/3 of patients who begin CCH injections will not complete the full treatment course. Understanding the reasons for discontinuation can help providers better stratify patients for CCH treatment vs other modalities. In addition, as previous studies indicate curvature improvements are equally likely to be seen in the final four injections as the first four, our data points to the potential impact of improved patient education for individuals who discontinue due to unsatisfactory curve reduction.

Healthcare system contact following ureteroscopy: does discharge instruction readability matter?

INTRODUCTION: We aimed to assess the impact of discharge instruction (DCI) readability on 30-day postoperative contact with the healthcare system. MATERIALS AND METHODS: Utilizing a multidisciplinary team, DCI were modified for patients undergoing cystoscopy, retrograde pyelogram, ureteroscopy, laser lithotripsy, and stent placement (CRULLS) from a 13th grade to a 7th grade reading level. We retrospectively reviewed 100 patients including 50 consecutive patients with original DCI (oDCI) and 50 consecutive patients with improved readability DCI (irDCI). Clinical and demographic data collected including healthcare system contact (communications [phone or electronic message], emergency department [ED], and unplanned clinic visits) within 30 days of surgery. Uni/multivariate logistic regression analyses used to identify factors, including DCI-type, associated with increased healthcare system contact. Findings reported as odds ratios with 95% confidence intervals and p values (< 0.05 significant). RESULTS: There were 105 contacts to the healthcare system within 30 days of surgery: 78 communications, 14 ED visits and 13 clinic visits. There were no significant differences between cohorts in the proportion of patients with communications (p = 0.16), ED visits (p =1.0) or clinic visits (p = 0.37). On multivariable analysis, older age and psychiatric diagnosis were associated with significantly increased odds of overall healthcare contact (p = 0.03 and p = 0.04) and communications (p = 0.02 and p = 0.03). Prior psychiatric diagnosis was also associated with significantly increased odds of unplanned clinic visits (p = 0.003). Overall, irDCI were not significantly associated with the endpoints of interest. CONCLUSIONS: Increasing age and prior psychiatric diagnosis, but not irDCI, were significantly associated with an increased rate of healthcare system contact following CRULLS.

The clinical significance of imperfection: is idiopathic corporal asymmetry related to curvature during penile prosthesis placement?

Patient satisfaction after inflatable penile prosthesis (IPP) has been linked to preexisting curvature; however the association with intraoperative asymmetric corporal measurements (ACM) has not been well described. We sought to identify incidence of ACM during IPP surgery, and relationship to penile curvature. A retrospective review of all patients undergoing primary IPP placement between 6/2019 and 6/2021 was performed. Logistic regression analysis was performed to identify factors associated with ACM and need for adjunct straightening techniques. A total of 273 patients underwent primary IPP. 27.8% had Peyronie's disease (PD) diagnosed preoperatively or detected intraoperatively. ACM was identified in 20.1% (55/273) patients. There was no significant difference in ACM in PD versus non-PD patients (p = 0.55). Most patients with ACM (78.2%, 43/55) underwent placement of asymmetric device. ACM did not predict need for invasive straightening maneuvers (p = 0.12). However ACM patients were significantly more likely to have mild residual curvature than those with symmetry (p < 0.0001). Our study is first to address management of idiopathic ACM and association with curvature, providing new insight into a common situation. While ACM was detected in 20%, it did not predict need for adjunct straightening techniques. Our findings may provide reassurance to urologists troubleshooting idiopathic ACM during corporal dilation during IPP surgery.

A novel upper tract ureteroscopic biopsy technique: the "form tackle"

ABSTRACT Introduction and Objective: Upper tract urothelial carcinoma (UTUC) represents 5% of all urothelial malignancies (1-3). Accurate pathologic diagnosis is key and may direct treatment decisions. Current ureteroscopic biopsy techniques include cold-cup, backloaded cold-cup and stone basket (4-6). The study objective was to compare a standard cold-cup biopsy technique to a novel cold-cup biopsy technique and evaluate histopathologic results. Materials and Methods: We developed a novel UTUC biopsy technique termed the "form tackle" biopsy. Ureteroscope is passed into ureter/renal collecting system. Cold-cup forceps are opened and pressed into the lesion base (to engage the urothelial wall/submucosal tissue) then closed. Ureteroscope/forceps are advanced forward 3-10mm and then extracted from the patient. We compared standard versus novel upper tract biopsy techniques in a series of patients with lesions ≥1cm. In each procedure, two standard and two novel biopsies were obtained from the same lesion. The primary study aim was diagnosis of malignancy. IRB approved: 21-006907. Results: Fourteen procedures performed on 12 patients between June 2020 and March 2021. Twenty-eight specimens sent (14 standard, 14 novel) (Two biopsies per specimen). Ten procedures with concordant pathology. In 4 procedures the novel biopsy technique resulted in a diagnosis of UTUC (2 high-grade, 2 low-grade) in the setting of a benign standard biopsy. Significant difference in pathologic diagnoses was detected between standard and novel upper tract biopsy techniques (p=0.008). Conclusions: The "form tackle" upper tract ureteroscopic biopsy technique provides higher tissue yield which may increase diagnostic accuracy. Further study on additional patients required. Early results are encouraging.

Conservative management of suspected fractures in men undergoing collagenase clostridium histolyticum for Peyronie's Disease is not associated with worsening of erectile function.

The optimal management of suspected penile fractures post collagenase clostridium histolyticum (CCH) remains indeterminate, with some advocating for observation and others surgical repair. To address this issue, the current study sent surveys to 158 men with Peyronie's Disease (PD) who completed four CCH injection series. The survey included the Erectile Function Domain from the International Index of Erectile Function (IIEF-EFD) and questions regarding potential symptoms of corporal rupture (hematoma, popping, and detumescence). Men were categorized as having a suspected fracture (SF+) if they reported a popping sensation or rapid detumescence. All SF(+) men were managed conservatively without surgical intervention. Results were compared statistically against baseline IIEF-EFD values and between SF(+) and SF(-) groups. The key study objective was to determine whether erectile function was negatively impacted by conservative management of suspected fractures. Of the 53 returned surveys, 45 had complete data for review. The sample was statistically representative of the broader cohort of 158 men, except being older (60.0 vs 57.1 [SD 6.0 vs 9.0], p = 0.01) with shorter durations of PD (median 9 [IQR 5, 19] mo vs 13 [IQR 8, 24], p = 0.01). Overall, 7/45 (16%) of men were defined as SF(+), with all fractures occurring within 6 weeks of CCH administration. No demographic or pathophysiologic characteristics predicted SF(+). Importantly, SF(+) men did not experience worsened erectile function compared to SF(-), with a median IIEF-EFD change of +2 vs +1, p = 0.16, respectively. Curvatures were improved to a greater degree among SF(+) men (primary: median -30 [IQR -20, -32.5] vs -15 [-5, -26], p = 0.04; composite: -35 [-25, -40] vs -25 [-7, -30], p = 0.15). We concluded that suspected penile fractures in PD men undergoing CCH may be reasonably managed without surgical intervention and portend greater improvements in curvature correction.

A novel upper tract ureteroscopic biopsy technique: the "form tackle".

INTRODUCTION AND OBJECTIVE: Upper tract urothelial carcinoma (UTUC) represents 5% of all urothelial malignancies (1-3). Accurate pathologic diagnosis is key and may direct treatment decisions. Current ureteroscopic biopsy techniques include cold-cup, backloaded cold-cup and stone basket (4-6). The study objective was to compare a standard cold-cup biopsy technique to a novel cold-cup biopsy technique and evaluate histopathologic results. MATERIALS AND METHODS: We developed a novel UTUC biopsy technique termed the "form tackle" biopsy. Ureteroscope is passed into ureter/renal collecting system. Cold-cup forceps are opened and pressed into the lesion base (to engage the urothelial wall/submucosal tissue) then closed. Ureteroscope/forceps are advanced forward 3-10mm and then extracted from the patient. We compared standard versus novel upper tract biopsy techniques in a series of patients with lesions ≥1cm. In each procedure, two standard and two novel biopsies were obtained from the same lesion. The primary study aim was diagnosis of malignancy. IRB approved: 21-006907. RESULTS: Fourteen procedures performed on 12 patients between June 2020 and March 2021. Twenty-eight specimens sent (14 standard, 14 novel) (Two biopsies per specimen). Ten procedures with concordant pathology. In 4 procedures the novel biopsy technique resulted in a diagnosis of UTUC (2 high-grade, 2 low-grade) in the setting of a benign standard biopsy. Significant difference in pathologic diagnoses was detected between standard and novel upper tract biopsy techniques (p=0.008). CONCLUSIONS: The "form tackle" upper tract ureteroscopic biopsy technique provides higher tissue yield which may increase diagnostic accuracy. Further study on additional patients required. Early results are encouraging.

Continuing Collagenase Clostridium Histolyticum Injections Among Initial Nonresponders Results in Significant Curvature Improvements in the Majority of Peyronie's Disease Men.

BACKGROUND: It is currently unclear if men with Peyronie's Disease (PD) who achieve minimal benefits with the first 2 series of Collagenase Clostridium Histolyticum (CCH) injections should continue with additional injections. AIM: To analyze curvature improvements from the final two series of CCH injections based on amount of improvement during the first 2 series. METHODS: A prospective registry was analyzed of all men undergoing CCH injections for PD at a single institution. Men were included if they had completed a full 4 series (8 injections) of CCH and had baseline, interval (after 2 series), and/or final (after 4 series) curvature assessments available. Men were stratified into cohorts using baseline-to-interval assessments of ≤10° (or ≤20%) and >10° (or >20%), and improvements were compared using interval-to-final assessments. OUTCOMES: The primary outcome was interval-to-final curvature improvements stratified by ≤10°/>10° or ≤20%/>20% improvements achieved during the baseline-to-interval period. Secondary outcomes included analyses of demographic and pathophysiologic variables to determine associations with significant improvements during the final 2 CCH series. RESULTS: A total of 296 PD men were identified as receiving at least one CCH injection, of whom 175 had baseline-to-interval, 84 interval-to-final, and 115 with baseline-to-final measurements. Mean age was 56.6, PD duration 28.6 months, baseline curvature 63.4°, hourglass deformity 36.2%, and calcification 20%. Mean overall curve improvement was -21.5° (33.1%). Among men who experienced ≤20% improvements after 2 series, the mean subsequent curvature change was -24.6% during the final two series (vs +4.3% of those with >20% initial improvement, P< .001), and they were 2.7x more likely to experience >20% subsequent curve improvements. Thirty-one percent of those who achieved >10° during the first 2 series experienced benefits during the final 2 series compared to 70% of men who had ≤10° improvement initially. No demographic or pathophysiological variables predicted likelihood for improvements during the final 2 series of injections. CLINICAL IMPLICATIONS: Men who fail to achieve significant benefits with 2 series of CCH injections may benefit from completing the final 2 series. STRENGTHS AND LIMITATIONS: Strengths including a relatively large, prospective series. Limitations include a single center, nonrandomization, nonblinded assessments, and restriction to men who completed eight injections. CONCLUSIONS: In the current series, approximately 2/3 of men who fail to achieve >10° or 20% curve improvements with an initial 2 series of CCH injections achieved >10° or 20% improvements with the subsequent 2 series. Alom M, Burgon H, Ziegelmann M, et al. Continuing Collagenase Clostridium Histolyticum Injections Among Initial Nonresponders Results in Significant Curvature Improvements in the Majority of Peyronie's Disease Men. J Sex Med 2021;18:1092-1098.

Predictors of Patient Willingness to Consider Surgery Prior to Consultation at Sexual Health Clinic.

OBJECTIVE: To identify factors associated with patient willingness to consider surgical treatment for erectile dysfunction (ED) prior to urologic consultation. METHODS: A prospective database of patients presenting to the sexual health clinic at our institution was created from 2014 to 2018, consisting of previsit patient questionnaires and clinical information. Univariable and multivariable logistic regression analysis was performed to determine factors associated with consideration of surgery and decision to undergo surgery. RESULTS: Of 1359 men presenting to the clinic, 991 men had a chief complaint of ED with 630 (63.6%) considering surgery. On multivariable analysis, factors significantly associated with previsit willingness for surgery included history of diabetes mellitus (P = .0009), increasing symptom bother (P <.0001), and decreasing relationship duration (P = .0005). Approximately 16% (162/991) patients considering surgery prior to consultation ultimately underwent penile implant insertion. Multivariable analysis demonstrated that older age (P = .003), history of diabetes mellitus (P = .03), lower international index of erectile function-EF domain (P = .0009) and history of intracavernosal injection therapy (P <.0001) were significantly associated with proceeding to ED surgery. Initial declaration of willingness to undergo ED surgery led to nearly 8-fold increased odds for surgery (P <.0001). CONCLUSION: Over 60% of patients presenting for ED consultation considered surgical intervention, of whom 25% underwent penile prosthesis. Both patient and relationship factors were predictors of surgical willingness. Previsit surgical willingness was associated with highest odds of eventual decision for surgery, suggesting that knowledge of ED treatment options in the general public may play a role. Our findings highlight opportunities for shared decision-making in a patient-centered model of care.

Outcomes of RestoreX Penile Traction Therapy in Men With Peyronie's Disease: Results From Open Label and Follow-up Phases.

BACKGROUND: A randomized, controlled clinical trial evaluating the efficacy of RestoreX traction therapy in men with Peyronie's disease (PD) has been completed, with the 3-month results previously reported. The present study presents outcomes from the open-label and follow-up phases of the original trial. AIM: To report 6-month (open-label phase) and 9-month (follow-up phase) outcomes from a randomized, controlled trial (NCT03389854). METHODS: A randomized controlled trial was performed from 2017 to 2019 in 110 all-comer men with PD. Men were randomized 3:1 to RestoreX (PTT) or no therapy (control) for 3 months, followed by 3-month open-label and follow-up phases. Key outcomes included adverse events (AEs), changes in penile curvature and length, erectile function, and standardized and nonstandardized assessments of PD. OUTCOMES: The primary outcomes are safety, penile length, penile curvature, Peyronie's Disease Questionnaire, International Index of Erectile Function, and satisfaction. RESULTS: 6-month (n = 64) and 9-month (n = 63) outcomes were reported, with a mean duration of PTT use of 31.1 minutes. No significant AEs were reported, with temporary erythema and discomfort being most common and resolving within minutes. On intent-to-treat analysis, control-to-PTT men experienced significant length (1.7-2.0 cm) and curvature improvements (18-20%). PTT-to-PTT men also achieved additional length (0.6-0.8 cm) without further curvature improvements. An as-treated analysis of PTT use ≥15 minute/day demonstrated 2.0- to 2.3-cm length gains (largest of any PTT to date) and 18-21% curve improvement. All sexual function domains of the International Index of Erectile Function and Peyronie's Disease Questionnaire were significantly improved (except orgasmic domain). 95% of men treated for 6 months experienced length gains (mean 2.0-2.2 cm), and 61% had curve improvements (16.8-21.4° [32.8-35.8%]). RestoreX was preferred 3-4:1 over all other PD treatments, and 100% preferred it over other PTT devices. CLINICAL IMPLICATIONS: Use of RestoreX 30 minutes daily results in significant length and curve improvements in PD men without significant AEs. STRENGTHS & LIMITATIONS: Strengths include largest randomized study of PTT, blinded assessments, and inclusion of all-comers with few restrictions; limitations include sample size that precludes comparisons between treatment cohorts and lack of long-duration (>3-9 hours) treatment arm. CONCLUSION: PTT with RestoreX results in significant improvements in length, curve, and subjective and objective measures of sexual function without significant AEs. RestoreX PTT represents a safe, conservative, low-cost option for managing men with PD. Joseph J, Ziegelmann M, Alom M, et al. Outcomes of RestoreX Penile Traction Therapy in Men With Peyronie's Disease: Results From Open Label and Follow-up Phases. J Sex Med 2020;17:2462-2471.

Adding carboplatin to chemotherapy regimens for metastatic castrate-resistant prostate cancer in postsecond generation hormone therapy setting: Impact on treatment response and survival outcomes.

BACKGROUND: The clinical course in metastatic castrate-resistant prostate cancer (mCRPC) can be complicated when patients have disease progression after prior treatment with second generation hormone therapy (second HT), such as enzalutamide or abiraterone. Currently, limited data exist regarding the optimal choice of chemotherapy for mCRPC after failing second generation hormone therapy. We sought to evaluate three common chemotherapy regimens in this setting. METHODS: We retrospectively identified 150 mCRPC patients with disease progression on enzalutamide or abiraterone. Of these 150 patients, 92 patients were chemo-naïve while 58 patients had previously received docetaxel chemotherapy before being started on second HT. After failing second HT, 90 patients were assigned for docetaxel-alone (group A), 33 patients received carboplatin plus docetaxel (group B), while 27 patients received cabazitaxel-alone (Group C). A favorable response was defined by more than or equal to 50% reduction in prostate-specific antigen from the baseline level after a complete course of chemotherapy. Survival outcomes were assessed for 30-month overall survival. RESULTS: Patients in group (B) were 2.6 times as likely to have a favorable response compared to patients in group (A) (OR = 2.625, 95%CI: 1.15-5.99) and almost three times compared to patients in group (C) (OR = 2.975, 95%CI: 1.04-8.54) (P = .0442). 30-month overall survival was 70.7%, 38.9% and 30.3% for group (B), (A), and (C), respectively (P = .008). We report a Hazard Ratio of 3.1 (95% CI, 1.31-7.35; P = .0037) between patients in group (A) versus those in group (B) and a Hazard Ratio of 4.18 (95% CI, 1.58-11.06; P = .0037) between patients in group (C) compared to those in group (B) CONCLUSION: This data demonstrates improved response and overall survival in treatment-refractory mCRPC with a chemotherapy regimen of docetaxel plus carboplatin when compared to docetaxel alone or cabazitaxel alone. Further investigations are required.

Prevalence and Predictors of Climacturia and Associated Patient/Partner Bother in Patients With History of Definitive Therapy for Prostate Cancer.

BACKGROUND: Climacturia is an under-reported complication of definitive therapy for prostate cancer (PCa) - that is, radical prostatectomy (RP) and/or radiation therapy (RT). AIM: We sought to identify the prevalence and predictors of climacturia and associated patient/partner bother in patients with and without prior PCa treatment. METHODS: We analyzed a database of patients who presented to our Men's Health clinic and filled out a questionnaire related to sexual function and pertinent medical histories. The prevalence of climacturia and associated patient/partner bother in patients with/without prior RP/RT was calculated. Univariable and multivariable logistic regressions were performed to identify predictors associated with climacturia and patient/partner bother. OUTCOMES: The primary outcomes were the prevalence and predictors of climacturia and associated patient/partner bother in patients with/without history of definitive PCa treatment. RESULTS: Among 1,117 patients able to achieve orgasm, 192 patients (17%) had prior history of definitive therapy for PCa (RP alone = 139 [72%]; RT alone = 22 [11%]; RP + RT = 31 [16%]). Climacturia was reported by 39%, 14%, 52%, and 2.4% of patients with history of RP alone, RT alone, RP + RT, and neither RP nor RT, respectively (P < .05 between all groups). 33 to 45 percent of patients with climacturia noted significant patient/partner bother. Factors significantly associated with climacturia were prior RP, prior RT, history of other prostate surgery, and erectile dysfunction, although erectile dysfunction was not significant on multivariable analysis. Significant reduction in climacturia prevalence was noted for patients who were ≥1 year out from RP, compared with patients who were <1 year out. Among patients with prior RP/RT, stress urinary incontinence was associated with increased risk of climacturia, whereas diabetes was associated with decreased risk. No factors were associated with patient/partner bother. Among patients with prior RP, nerve-sparing technique did not predict presence of climacturia but was associated with reduced patient/partner bother. CLINICAL TRANSLATION: Given significant prevalence of climacturia and associated patient/partner bother, patients should be counseled on the risk of climacturia before undergoing RP/RT. STRENGTHS AND LIMITATIONS: Strengths include the large study population and the focus on both RP and RT. Limitations include the facts that this is a single-institution study that primarily relies on patients' subjective reporting and that the study population may not represent the general population. CONCLUSIONS: Climacturia affects a significant proportion of patients with history of RP/RT for PCa, and many patients and their partners find this bothersome. Jimbo M, Alom M, Pfeifer ZD, et al. Prevalence and Predictors of Climacturia and Associated Patient/Partner Bother in Patients With History of Definitive Therapy for Prostate Cancer. J Sex Med 2020;17:1126-1132.

The Etiology of Peyronie's Disease: Pathogenesis and Genetic Contributions.

INTRODUCTION: Peyronie's disease (PD) is a chronic fibrosing condition that contributes to penile deformity, curvature, and pain. Initial familial studies demonstrated potential genetic links to PD. Since that time, very few investigations have significantly advanced the science in this area. Hence, there is a large opportunity and significant need to better study the underlying genomics and pathogenesis of PD. AIM: To summarize the current genomic literature relevant to PD. METHODS: A review was performed of all PubMed-indexed literature from 1970-2018 relating to the pathophysiology and genetics of PD. Key findings were categorically summarized to include epidemiology, risk factors, inheritance patterns, chromosomal instability, genetic associations, epigenetics, differential gene expression, and preclinical models of PD. MAIN OUTCOME MEASURES: Summary of the current literature on the genetics of PD. RESULTS: PD is a common condition and has several known risk factors and comorbid disease associations. Although men with PD are believed to be genetically predisposed, there are likely several subtypes of the condition, each with varied pathophysiological disorders and contributing factors. Available data suggest that PD is associated with underlying genetic instability, including dysregulation of genes relating to fibrosis and cellular degradation, thus, resulting in abnormal plaque development and penile deformity. Preclinical models, including cell cultures and rat models, demonstrate several consistencies with PD clinical and histopathologic characteristics; however, an ideal model with spontaneous development of PD is lacking. CONCLUSION: Based on limited data, PD likely represents a heterogeneous condition, with both heritable and environmentally-driven epigenetic factors contributing to its development and progression. However, there remains a significant gap in the literature on the underlying cause and pathophysiology of the condition, suggesting a substantial need for further investigation and study. Sharma KL, Alom M, Trost L. The Etiology of Peyronie's Disease: Pathogenesis and Genetic Contributions. Sex Med Rev 2020;8:314-323.

Office-based, Minimal-Incision Modified Fenestration Technique for Symptomatic Hydroceles Under Local Anesthesia.

OBJECTIVE: To describe a minimal-incision modified fenestration technique (MIMFeT) for symptomatic hydroceles utilizing local anesthesia. METHODS: A database was maintained for men undergoing in-office MIMFeT for symptomatic hydroceles between June 2015 and August 2018. Following local anesthesia, the hydrocele was sequentially everted through a small upper hemiscrotal incision, excised, and oversewn without delivering the testicle through the wound. Patient demographics and clinical outcomes were subsequently reviewed. RESULTS: A total of 54 men (median age 67) underwent MIMFeT under local anesthesia for symptomatic hydrocele. Median estimated hydrocele size was 250 mL (IQR 150;500). Medical comorbidities included coronary artery disease (12%), hypertension (43%), diabetes (13%), and current antiplatelet or anticoagulant (44%) use. Six patients (11%) were deemed unsafe for monitored or general anesthesia. About 48 patients had follow-up data available (median 9 months; IQR 2-18). Mild recurrent scrotal swelling occurred in 4 patients (8%) and 9/48 (18%) experienced postoperative complications including hematoma (n = 2), prolonged pain (n = 3), wound infection (n = 2), and partial incisional separation (n = 2). No patient required repeat hydrocelectomy. CONCLUSION: Our early results suggest that the MIMFeT for management of symptomatic hydroceles can be safely performed in the office setting under local anesthesia, including in those patients who are determined to be unsafe for monitored and general anesthesia.

Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie's Disease.

BACKGROUND: Previous studies of penile traction therapy (PTT) devices have demonstrated limited/no efficacy when combined with intralesional therapies for Peyronie's disease (PD). Recently, randomized data have demonstrated the efficacy of a novel PTT device, RestoreX, developed in cooperation with the Mayo Clinic, in men with PD. AIM: To assess the safety and efficacy of treatment with the RestoreX device plus collagenase Clostridium histolyticum (CCH) compared with CCH alone and CCH with other PTT devices. METHODS: A prospective registry has been maintained of all men undergoing CCH injections for PD between March 2014 and January 2019. Assessments were performed at baseline, during each series, and after completion of treatment. Those completing therapy (8 injections or sooner if satisfied) were categorized into group 1 (CCH alone), group 2 (CCH plus any PTT device other than RestoreX), or group 3 (CCH plus RestoreX). OUTCOMES: Changes in penile length, curvature, and subjective perception and the occurrence of adverse events. RESULTS: Of 287 men with data on PTT use, 113 had completed therapy with all objective data available and compose the current cohort. Baseline demographic and pathophysiological variables were similar among the 3 groups except penile length and previous PD medications. Following treatment, group 3 demonstrated significantly greater improvements in curvature (mean, 20.3°/31% for group 1, 19.2°/30% for group 2, and 33.8°/49% for group 3), length (-0.7 cm/-4%, -0.4 cm/-2%, and +1.9 cm/+17%, respectively), and subjectively estimated curvature improvement (44%, 32%, and 63% respectively), despite shorter daily PTT use (0.9 vs 1.9 hours/day). Group 3 was more likely than the other groups to experience ≥20°, ≥20%, and ≥50% curvature improvements, ≥1 cm length gain, and ≥20% length improvement. All results were statistically significant for group 3 versus groups 1 and 2, but not between groups 1 and 2, even after controlling for baseline features and isolating a subset of ≥3 hours/day PTT use (group 2). Group 3 was 6.9 times more likely to achieve ≥20° curvature improvement, and 3.5 times more likely to achieve ≥50% curvature improvement, and 10.7 times more likely to experience ≥20% length improvement. Adverse events were similar among the 3 groups. CLINICAL IMPLICATIONS: Use of the RestoreX device enhances mean curvature outcomes by 71% and increases penile length in men with PD receiving CCH therapy. STRENGTHS & LIMITATIONS: Study strengths include a prospective registry, consistent assessments, the largest single-site series with complete posttreatment outcomes reported to date, the largest PTT series reported to date, and a true-to-life clinical design. Limitations include the nonrandomized methodology and single-site setting. CONCLUSION: The combination of RestoreX and CCH is associated with significantly greater curvature and length improvements compared with CCH alone or CCH with other PTT devices. Alom M, Sharma KL, Toussi A, et al. Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie's Disease. J Sex Med 2019;16:891-900.

Safety and Efficacy of Collagenase Clostridium Histolyticum in Peyronie's Disease Men With Ventral Curvatures.

OBJECTIVE: To evaluate the safety and efficacy of collagenase clostridium histolyticum (CCH) in men with ventral penile curvatures secondary to Peyronie's Disease (PD). METHODS: A prospective registry has been maintained of PD men undergoing CCH at our institution. Curvature assessments and subjective questioning were obtained at baseline and following 2 and 4 injection series. Clinicopathologic data were abstracted including history, exam, ultrasound, and end-point curvature assessments. Primary outcomes were adverse events (AE), and secondary outcomes included improvements in curvature by direction and subjective responses to questionnaires. RESULTS: A total of 228 patients undergoing CCH for PD (mean age 57.2 years, mean PD duration 24.3 months) were identified from March 2014 through March 2018. Baseline curvature directions were individually analyzed (total of 329 measures), including 83%, 50%, and 11% with some degree of dorsal, lateral, and ventral angulation. Mean primary and secondary (where applicable) curvatures were 52.9 and 11.4 degrees, respectively. Following treatment, ventral and lateral curvatures experienced greater relative improvements in curvature compared to dorsal (ventral 29.5 degrees [49%], lateral 11.4 [38%], dorsal 15.0 [25%], P < .05). Ventral and lateral curvatures were also more likely to experience ≥50%, ≥75%, and ≥90% improvements compared to dorsal. AEs were similar among curvature directions, and no urethral complications occurred. CONCLUSION: Men with ventral PD may be effectively treated with CCH with similar AEs compared to other directions. Ventral and lateral curvatures are more likely to experience significant improvements (50% or more) compared to dorsal.

Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial.

PURPOSE: Current penile traction therapy devices have significant limitations, including the need to use them for 3 to 8 hours per day. Given these issues, the novel RestoreX® penile traction therapy device was developed in cooperation with Mayo Clinic. MATERIALS AND METHODS: We performed a randomized, controlled, single-blind, intent to treat trial (ClinicalTrials.gov NCT03389854) in men with Peyronie's disease who were assigned to the penile traction therapy device for 30 to 90 minutes per day or to no therapy for 3 months. Study inclusion criteria were curvature 30 degrees or greater with no study exclusions due to complex curvature, hourglass deformity, prior Peyronie's disease therapy or surgery, or calcification. The primary outcome was safety and secondary outcomes were penile length and curvature, and questionnaire responses. RESULTS: A total of 110 men were randomized 3:1 to the penile traction therapy group or the control group. The cohorts were well matched with a mean age of 58.4 years, a 49.7-month Peyronie's disease history and 59.3 degree curvature. Overall penile traction therapy was well tolerated with only transient and mild adverse events reported. At 3 months men undergoing penile traction therapy demonstrated significant improvements over controls in penile length (1.5 vs 0 cm, p <0.001), curvature (-11.7 vs 1.3 degrees, p <0.01) and erectile function (4.3 vs -0.7, p = 0.01) according to the International Index of Erectile Function-Erectile Function among men with erectile dysfunction. Overall 77% of the men on penile traction therapy experienced improved curvature (mean -17.2 degrees in 28.2% of responders) while 94% achieved increased length (1.6 cm in 10.9%). Counter bending and the white line indicator improved efficacy, validating key device innovations. Of men who had previously used other penile traction therapy devices 100% preferred the RestoreX device. CONCLUSIONS: Penile traction therapy with the RestoreX device for 30 to 90 minutes per day was safe, and resulted in significant and clinically meaningful improvements in penile curvature and length in men with Peyronie's disease, and in erectile function in men with erectile dysfunction and Peyronie's disease with no significant adverse events. To our knowledge these data represent the only reported improvements for any device used less than 3 to 8 hours per day.

Emerging Complications Following Alternative Reservoir Placement during Inflatable Penile Prosthesis Placement: A 5-Year Multi-Institutional Experience.

PURPOSE: Alternative or ectopic reservoir placement has recently gained popularity among prosthetic surgeons to avoid injury to pelvic structures during inflatable penile prosthesis implantation. However, the true incidence of complications associated with these new techniques remains under studied. We performed a 5-year multicenter, retrospective study with the aim of evaluating complications related to alternative reservoir placement. MATERIALS AND METHODS: We retrospectively reviewed the database of inflatable penile prosthesis surgery at 3 institutions from February 2011 to December 2016. The mechanism of failure and complications related to reservoir placement were analyzed. RESULTS: A total of 974 inflatable penile prostheses were placed in the 5-year period by 3 surgeons, including 612 surgeries with alternative reservoir placement. Mean followup to the emergence of reservoir related complications was 20.4 months. There was no significant difference in complication rates between primary and revision cases (p = 0.72). A total of 12 cases (2.0%) required revision for reservoir related complications in the alternative reservoir placement group vs 1.3% in the space of Retzius group (p = 0.44). The most common complication in the alternative reservoir placement group was reservoir leakage, which developed in 5 patients. Three cases required revision due to abdominal muscular pain. Torsion in the tubing of 3 Conceal™ reservoirs was found which caused blockage of fluid transportation. One reservoir was incidentally found to be intraperitoneal on unrelated imaging. CONCLUSIONS: Alternative reservoir placement is a safe and mechanically reliable approach, including in men with prior pelvic surgery. However, there are associated risks, including reservoir leakage, tubing torsion, muscle discomfort and unintended reservoir malposition which may require surgical revision.

Implementation of multiparametric magnetic resonance imaging technology for evaluation of patients with suspicion for prostate cancer in the clinical practice setting.

OBJECTIVES: To investigate the impact of implementing magnetic resonance imaging (MRI) and ultrasonography fusion technology on biopsy and prostate cancer (PCa) detection rates in men presenting with clinical suspicion for PCa in the clinical practice setting. PATIENTS AND METHODS: We performed a review of 1 808 consecutive men referred for elevated prostate-specific antigen (PSA) level between 2011 and 2014. The study population was divided into two groups based on whether MRI was used as a risk stratification tool. Univariable and multivariable analyses of biopsy rates and overall and clinically significant PCa detection rates between groups were performed. RESULTS: The MRI and PSA-only groups consisted of 1 020 and 788 patients, respectively. A total of 465 patients (45.6%) in the MRI group and 442 (56.1%) in the PSA-only group underwent biopsy, corresponding to an 18.7% decrease in the proportion of patients receiving biopsy in the MRI group (P < 0.001). Overall PCa (56.8% vs 40.7%; P < 0.001) and clinically significant PCa detection (47.3% vs 31.0%; P < 0.001) was significantly higher in the MRI vs the PSA-only group. In logistic regression analyses, the odds of overall PCa detection (odds ratio [OR] 1.74, 95% confidence interval [CI] 1.29-2.35; P < 0.001) and clinically significant PCa detection (OR 2.04, 95% CI 1.48-2.80; P < 0.001) were higher in the MRI than in the PSA-only group after adjusting for clinically relevant PCa variables. CONCLUSION: Among men presenting with clinical suspicion for PCa, addition of MRI increases detection of clinically significant cancers while reducing prostate biopsy rates when implemented in a clinical practice setting.

Penile Traction Therapy and Vacuum Erection Devices in Peyronie's Disease.

INTRODUCTION: Peyronie's disease (PD) has historically been managed by at least 1 treatment, including oral supplements or medications, intralesional injections, or surgery. Adjunctive mechanical therapies also have been described, including penile traction therapy (PTT) and vacuum erection devices (VEDs), although relatively limited data are available on their use with PD. AIM: To review and summarize the published literature on the role and efficacy of PTT and VED in men with PD. METHODS: A PubMed search was performed of all publications on PTT and VED in men with PD from inception through September 2017. MAIN OUTCOME MEASURES: Changes in penile curvature, length, girth, erectile function, and adverse events with PTT or VED. RESULTS: PTT and VED exhibit mechanisms to improve aspects of PD, although clinical outcomes data are limited. Based on current data, PTT likely has a potential role as a primary lengthening therapy (modest improvements), in curvature correction (acute phase; unclear role in chronic phase), before penile prosthesis insertion, and after surgical correction of PD. The role of PTT as a combination therapy during collagenase Clostridium histolyticum injections is unclear. Fewer and lower level-of-evidence studies are available on VEDs and suggest potential roles in curvature correction, before penile prosthesis placement, or after PD surgery. Guideline statements from the American Urological Association and International Consultation on Sexual Medicine also support the potential role of PTT and VED in managing PD. CONCLUSIONS: PTT and VED represent viable therapeutic options for managing PD, with more data currently available on PTT. Because all PTT studies used a similar style of traction device, it is unclear whether results reflect outcomes of these particular devices or traction more broadly. Further studies are required to better delineate the benefits of PTT and VED, particularly in relation to other established treatments. Avant RA, Ziegelman M, Nehra A, et al. Penile Traction Therapy and Vacuum Erection Devices in Peyronie's Disease. Sex Med Rev 2019;7:338-348.

The Temporal Association of Robotic Surgical Diffusion with Overtreatment of the Small Renal Mass.

PURPOSE: We evaluated contemporary practice patterns in the management of small renal masses. MATERIALS AND METHODS: We identified 52,804 patients in the NCDB (National Cancer Database) who were diagnosed with a small renal mass (4 cm or less) between 2010 and 2014. Utilization trends of active surveillance, ablation and robotic, laparoscopic and open surgical techniques were compared among all comers, elderly patients 75 years old or older and individuals with competing health risks, defined as a Charlson index of 2 or greater. Multivariable logistic regression models were used to assess factors associated with robotic renal surgery and active surveillance. RESULTS: Surgery remained the primary treatment modality across all years studied, performed in 75.0% and 74.2% of cases in 2010 and 2014, respectively. Although increases in active surveillance from 4.8% in 2010 to 6.0% in 2014 (p <0.001) and robotic renal surgery (22.1% in 2010 to 39.7% in 2014, p <0.001) were observed, the increase in the proportion of small renal masses treated with robotic partial and radical nephrectomy was greater than that of active surveillance (82.0% and 63.0%, respectively, vs 25.0%). Subgroup analyses in individuals 75 years old or older, or with a Charlson index of 2 or greater likewise revealed preferential increases in robotic surgery vs active surveillance. On multivariable analysis later year of diagnosis was associated with increased performance of robotic renal surgery compared to active surveillance (2014 vs 2010 OR 1.44, 95% CI 1.20-1.72, p <0.001) and nonrobotic procedural interventions (2014 vs 2010 OR 2.59, 95% CI 2.30-2.93, p <0.001). CONCLUSIONS: Robotic surgical extirpation has outpaced the adoption of active surveillance of small renal masses. This raises concern that the diffusion of robotic technology propagates overtreatment, particularly among elderly and comorbid individuals.