Ziegelmann, Matthew

Objective To report open‐label phase data from a recent randomized controlled trial (RCT), after previous data from that study showed improved penile length and erectile function among post‐prostatectomy men treated with Restorex penile traction therapy (RxPTT). Materials and Methods An RCT (NCT05244486) was performed to evaluate RxPTT vs no treatment (Tx) for 5 months, which was followed by a 3‐month open‐label phase. Men were stratified based on as‐treated data: Group 1 = No Tx; Group 2 = No Tx → Tx; Group 3 = Tx → No Tx; Group 4 = Tx. Assessments included stretched penile length and standardized (International Index of Erectile Function [IIEF]) and non‐standardized questionnaires. Results A total of 82 men were enrolled (mean age 58.6 years) with 9‐month data available in 45 of the men. Baseline characteristics were similar among the cohorts. Comparing Group 1 and Group 4 (respectively), notable differences included: IIEF Erectile Function domain (IIEF‐EF) score (−8 vs −0.5; P = 0.16), penile length (−0.1 vs +1.7 cm; P < 0.01), intracavernosal injection use (86% vs 14%; P < 0.01), Sexual Encounter Profile (SEP) Question 2 (50% vs 100%; P < 0.01), SEP Question 3 (33% vs 100%; P < 0.01). Men who crossed over to Tx (Group 2) failed to achieve equivalent improvements in length (+0.5 cm) or sexual function (IIEF‐EF score −6) compared to men treated early (Groups 3 and 4). Those who crossed over to no treatment after initial treatment (Group 3) experienced preserved length (+1.8 cm), and erectile function (IIEF‐EF score +0) despite therapy discontinuation. Conclusions Use of RxPTT beginning 1 month post‐prostatectomy results in improved penile length and erectile function, with benefits maintained after discontinuing therapy. If confirmed, these results represent the first postoperative therapy shown in a RCT to improve erectile function post‐prostatectomy. External validation is warranted.

AbstractBackgroundCollagenase Clostridium histolyticum (CCH) has been proven effective in multiple subpopulations of PD men; however, no studies have evaluated its role with congenital penile curvature (CPC).AimTo evaluate the safety and efficacy of CCH in men with CPC.MethodsA prospective registry was queried of men undergoing CCH injections at our institution. Beginning in 2016, CCH was administered to CPC men using a similar protocol to PD. A comparative analysis was performed between cohorts to evaluate the safety and efficacy of therapy.OutcomesObjective measures included penile length and curvature, while subjective outcomes included standardized (International Index of Erectile Function and Peyronie’s Disease Questionnaire) and non-standardized assessments. Curvature outcomes were categorized as follows: 1 – included all men, with the most recent assessment considered final, and 2 – only men who had completed eight CCH injections or stopped early due to satisfaction.ResultsFrom 2014 to Oct 2021, a total of 453 men (408 PD, 45 CPC) underwent one or more CCH injections. In comparing cohorts, CPC men were younger (33 vs 58 years, p&lt;0.0001), had lesser baseline curvatures (52.5 vs 65°, p&lt;0.01), more ventral curves (25.7 vs 9.2%, p&lt;0.01), and longer penile lengths (12.5 vs 12.0 cm, p=0.04). Following treatment, both cohorts experienced similar curvature improvements. Specifically, PD men experienced 20-25° or 33-35% improvements depending on definition compared to 25-30° or 40-50% in CPC men (all p-values &gt;0.05). CPC and PD men also demonstrated similar changes on standardized questionnaires, with the exception of the Psychological and Physical subdomain, which was more improved in CPC men (-11 vs -4, p&lt;0.01). Baseline curvature was positively correlated with greater absolute (degree) and relative (percent) improvements. Adverse events were similar between groups after controlling for confounders.Clinical ImplicationsCCH may be safely and effectively administered in men with CPC. These data provide the first evidence for the efficacy of a non-surgical therapeutic option in this cohort.Strengths and LimitationsStrengths – large, prospective series with standardized assessments; Limitations - non-randomized study, short-term follow-up, and lack of standardized method to differentiate CPC from PD.ConclusionsCCH may be safely and effectively administered to men with CPC, with similar success rates compared to PD. Increasing curvature was associated with greater absolute (degree) and relative (percent) improvements, supporting the role for CCH in men with mild, moderate, or severe curvatures. External validation is warranted prior to routine implementation.

AbstractBackgroundThe advent of antibiotic-coated devices has reduced the rate of inflatable penile prosthesis (IPP) infections; however, this may have altered microbial profiles when infections do occur.AimTo describe the timing and causative organisms behind infection of infection retardant–coated IPPs in the context of our institution’s perioperative antimicrobial protocols.MethodsWe retrospectively reviewed all patients undergoing IPP placement at our institution from January 2014 to January 2022. In all patients, perioperative antibiotic administration was congruent with American Urological Association guidelines. Boston Scientific devices are impregnated with InhibiZone (rifampin and minocycline), and all Coloplast devices were soaked in rifampin and gentamicin. Intraoperative irrigation was performed with betadine 5% irrigation prior to November 2016 and with vancomycin-gentamicin solution afterward. Cases involving prosthesis infection were identified, and variables were extracted from the medical record. Descriptive and comparative statistics were tabulated to identify clinical characteristics, including patient comorbidities, prophylaxis regimen, symptom onset, and intraoperative culture result. We previously reported an increased infection risk with Betadine irrigation and stratified results accordingly.OutcomesThe primary outcome was time to infectious symptoms, while the secondary outcome was description of device cultures at the time of explantation.ResultsA total of 1071 patients underwent IPP placement over 8 years with an overall infection rate of 2.6% (28/1071). After discontinuation of Betadine, the overall infection rate was significantly lower at 0.9% (8/919) with a relative risk of 16.9 with Betadine (P &lt; .0001). Primary procedures represented 46.4% (13/28). Of 28 patients with infection, only 1 had no identified risk factors; the remainder included Betadine at 71% (20/28), revision/salvage procedure at 53.6% (15/28), and diabetes at 50% (14/28). Median time to symptoms was 36 days (IQR, 26-52); almost 30% of patients had systemic symptoms. Organisms with high virulence, or ability to cause disease, were found in 90.5% (19/21) of positive cultures.Clinical ImplicationsOur study revealed a median time to symptoms of just over 1 month. Risk factors for infection were Betadine 5% irrigation, diabetes, and revision/salvage cases. Over 90% causative organisms were virulent, demonstrating a microbial profile trend since antibiotic coating development.Strengths and LimitationsThe large prospectively maintained database is a strength along with the ability to follow specific changes in perioperative protocols. The retrospective nature of the study is a limitation as well as the low infection rate, which limits certain subanalyses from being performed.ConclusionIPP infections present in a delayed manner despite the rising virulence of infecting organisms. These findings highlight areas for improvement in perioperative protocols in the contemporary prosthetics era.

Abstract Introduction Treatment recommendations for Peyronie's Disease (PD) differ based on whether a patient is in the acute/active versus chronic/stable phase of the disease, yet there are no agreed upon criteria for defining these clinical entities. Objectives To review the criteria used to define acute and chronic phase PD in modern PD intervention studies Methods We performed a search engine review to identify indexed publications for PD intervention studies and review articles / meta-analyses from the year 2011-2020. Outcomes results were catalogued and summarized across articles. As a result of the substantial heterogeneity of outcome measures and follow-up intervals, meta-analytic techniques were not applied to the data analysis. Results We identified a total of 104 studies that met inclusion criteria and had available information for review (n = 79 primary intervention studies; n = 25 review articles/meta-analyses/guidelines). Among the queried studies, we were unable to identify a consensus with respect to the criteria used to define acute and chronic phases of PD. 33% of primary intervention studies did not specifically define their criteria for acute and chronic phase PD, despite referencing these populations as part of the inclusion criteria in many instances. Studies used heterogenous criteria including total symptom duration, duration of “stable” symptoms, and presence/absence of pain. Conclusion Due to varying definitions across the literature, we were unable to create a standardized definition of acute and chronic phase Peyronie's in terms of time. Our findings emphasize the need for greater consensus in defining the treatment cohorts with future studies that assess treatment for men with PD.

Abstract To determine effects of sexual health curriculum (SHC) in medical school on future urology specialty and subspecialty selection, residents, fellows, and practicing urologists completed a 15-question survey regarding their exposure to SHC during medical school, topics covered, and the influence of mentors in career choice. 95 respondents, primarily post-graduate year 4 and 5 (46%), completed the survey. Approximately 50% recalled dedicated SHC during medical school with 46% planning to pursue fellowship training in sexual medicine/reconstruction. Topics commonly covered included reproductive anatomy/physiology and sexual history-taking, while respondents rarely recalled topics such as sexual aids/toys and pornography. Only 25% felt SHC provided an adequate fund of knowledge to address patient’s sexual health concerns, and only 14% believed SHC influenced their decision to pursue urology. Individuals pursuing fellowship were more likely to have an attending mentor, a mentor with expertise in sexual dysfunction, and considered their mentor as important or very important in their decision to subspecialize (p<0.05). Most urology trainees do not have strong exposure to SHC during medical school and cite mentorship as more important in the decision to pursue subspecialty training. These data support the need for a standardized formal SHC and continued exposure to sexual health experts during training.

ABSTRACT Introduction Literature concerning corporotomy location in multi-component inflatable penile prosthetic surgery via a penoscrotal approach is scarce if not non-existent. However, corporotomy location represents an important issue that may influence immediate and long-term outcomes regarding patient and partner satisfaction as well as device durability. Objective To report practices in low- and high-volume penile implant centers regarding corporotomy location. Methods Data from 18 (13 European and 5 American) implant centers were collected retrospectively between September 1st, 2018 and August 31st, 2019. Variables included: intraoperative proximal and distal corpus cavernosum length measurement, total corporal length measurement, total penile implant cylinder length, and length of rear tip extenders. Additionally, patient characteristics, indication for penile implant, operative time, type of implant utilized, reservoir characteristics and short term complications were reported. Results 809 virgin penile implant cases were included in the analysis. Mean age of participants was 61.5 +/- 9.6 years old. In total, 299 AMS 700TM (Boston Scientific) and 510 Coloplast Titan® devices were implanted. The mean proximal/distal corporal measurement ratio during corporotomy was 0.93 +/- 0.29. A statistically significant correlation between lower proximal /distal measurement ratio and higher age (p=0.0013), lower BMI (p&lt;0.0001), use of rear tip extenders (RTE) (p=0.04), lower RTE length (p&lt;0.0001) and absence of diabetes (p=0.0004) was reported. In a 3-month follow up period 49 complications and 37 revision procedures were reported. Conclusions This is the first study reporting and evaluating the current practices regarding corporotomy location during IPP placement in a multicenter cohort, particularly when including such a high number of patients. Nevertheless, the retrospective design limits the study outcomes. Even in experienced hands proximal length measurement in relation to distal length measurement in penoscrotal IPP surgery is in many cases sub-optimal, particularly when the tubing-cylinder connection of each device is taken into account. Disclosure No

ABSTRACTBackgroundDespite an increasing number of publications on Peyronie’s disease (PD), evidence-based clinical decision-making remains challenging due to the small number of well-designed clinical trials.AimTo perform a critical analysis of reporting quality in PD systematic reviews (SR) and meta-analyses (MA).MethodsStudy protocol registration was performed on the Open Science Framework platform. In January 2021, a systematic electronic search of the Medline/PubMed, Embase, Ovid, Scopus, Joanne Briggs Institute, and Cochrane databases was performed. Search terms included “Peyronie’s disease” and “systematic review OR meta-analysis OR meta-analysis.” Eligibility criteria were English-language, relevance to PD and specification of “systematic review” or “meta-analysis” in the title or abstract. Oxford Center for Evidence-Based Medicine levels of evidence were used to classify original studies reviewed within each publication. Risk of bias was assessed using the ROBIS tool. Data were tabulated and reported as means with standard deviation, median with interquartile range and t-testing as appropriate. Strength of association between variables was calculated using Pearson correlation coefficient. Statistical analyses were performed on RStudio (version 1.4.1106).OutcomesOutcomes included review type, level of evidence, authorship, journal, publication date, “A MeaSurement Tool to Assess systematic Reviews” (AMSTAR-2) score and “Preferred Reporting Items for Systematic Reviews and Meta-Analyses” (PRISMA) score.ResultsFrom 1974 to 2021, 340 articles were identified. After review, 17 full length articles were included. Thirteen were SR, 2 MA and 2 was combined. Significant heterogeneity was seen in evidence level of included studies. There was median 54% adherence to AMSTAR-2 criteria and 74% adherence to PRISMA criteria. Overall AMSTAR-2 confidence rating was Critically Low in 11 of 17 studies. Correlation analysis revealed very high positive association between AMSTAR 2 and PRISMA adherence (+0.95). ROBIS revealed “High” concern regarding methods used to collect data and appraise 12/17 studies (71%), and “High” concern regarding synthesis and findings in 8 of 17 studies (47%).Clinical ImplicationsMany SR include markedly heterogenous levels of evidence and fail to meet accepted methodological criteria for reporting.Strengths and LimitationsMain strengths include extensive literature review and analysis of standardized study reporting. One limitation is that aggregate scoring of AMSTAR-2 and PRISMA is not intended as primary method of quality assessment; however effect was minimized by reporting critical domains, overall quality assessments and specifics on globally poorly reported domains.ConclusionMore high quality randomized controlled PD trials are necessary; SR and MA should focus on these studies alone.