Köhler, Tobias

Abstract Introduction Collagenase clostridium histolyticum (CCH, Xiaflex®; Endo Pharmaceuticals) is the only FDA-approved non-surgical therapy for Peyronie’s Disease (PD). CCH is an effective alternative to surgery for patients with PD who have a palpable plaque and a curvature deformity of ≥30°. Clinicians who administer CCH must complete risk mitigation training, and access to specialists varies by region across the US. Identifying areas with low provider availability may improve patient access to this and other treatments for PD. Objective To review the availability of clinicians offering CCH for the treatment of Peyronie’s Disease in the conterminous United States. Methods We utilized a publicly available search tool on a website provided by Endo Pharmaceuticals to identify certified providers offering CCH in the conterminous United States. We created a list of 23 zip codes that, when surrounded by a 500-mile radius, encompass the entire conterminous United States. We then utilized the search tool to identify providers within those radii. The data gathered included the provider’s name, specialty, and practice address. Duplicate addresses were removed, but a single provider offering CCH at 2 different locations was considered 2 different data points. We compared the data relative to the American Urological Association’s “The State of the Urology Workforce and Practice in the United States” and 2021 State Population Estimates from the US Census Bureau. Results In total, 1948 locations offering CCH were identified (Figure 1a). The mean number of locations offering CCH per 100,000 state residents was 0.61 [SD 0.27] (Figure 1b). Wyoming had the highest number of locations per 100k residents with 1.39. New Mexico had the lowest with 0.05. The 10 states with the highest ratio of clinicians/locations (from high-low) per capita were Wyoming, Georgia, Rhode Island, Nebraska, Maryland, New Jersey, Kansas, North Carolina, South Carolina, and Alabama. The 10 states with the lowest were New Mexico, Delaware, Maine, Mississippi, Minnesota, Vermont, Missouri, Indiana, New Hampshire, and Idaho. The mean proportion of urologists providing CCH to total urologists (Figure 1c) was 0.15 [SD 0.07]. Wyoming had the highest proportion of 0.40 and New Mexico had the lowest of 0.02. The 10 states with the highest proportion (from high-low) were Wyoming, Georgia, Utah, Nebraska, Kansas, Alabama, Nevada, Arizona, South Carolina, and Oklahoma. The 10 states with the lowest proportion (from low-high) were New Mexico, Delaware, Maine, Vermont, New Hampshire, Minnesota, Missouri, South Dakota, and Mississippi. Conclusions There are notable differences in the relative availability of CCH providers across the US. These discrepancies may impact access to care, supporting an opportunity to expand training efforts. States with low numbers of treatment locations offering CCH per 100k residents relative to other states also had a low total proportion of urologists offering CCH as a treatment. There is room for current practicing urologists in these states and others to expand their practice to offer CCH and improve patient access to this important non-surgical treatment option. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Endo Pharmaceuticals.

Abstract Introduction Climacturia has been reported in up to 64% of patients following radical prostatectomy (RP). In 2017, a prospective multicenter, multinational, investigational pilot study was conducted examining outcomes using a novel surgical technique, the Mini-Jupette sling, for the management of men with post-RP erectile dysfunction (ED) and climacturia and/or minimal stress urinary incontinence (SUI). We sought to report the 5-year outcomes from this original cohort. Objective To assess long-term safety and efficacy of the mini-jupette sling in the treatment of ED and concomitant mild SUI and/or climacturia Methods We identified patients who were enrolled in the previous multicenter study with post-RP ED and climacturia and/or mild SUI (2 ppd) and underwent IPP insertion with simultaneous placement of a Mini-Jupette sling. Data including current ppd, improvement in climacturia, complications, need for revision of IPP or additional urinary incontinence surgery, and date of most recent follow-up were collected. Results Of the original 38 patients, 5 have since died and 10 were lost to follow-up with 23/38 (61%) patients available for evaluation of long-term outcomes. The average follow-up time was 59 months (SD= 8.8) with a mean age of 69 years (SD= 6.8). Most patients (n=21, 91%) had subjective improvement of SUI and climacturia. One patient with persistent bothersome incontinence underwent artificial urinary sphincter (AUS) placement in 2018 with no complications, while the other is still considering a repeat procedure due to minor but persistent SUI. The mean ppd decreased from 1.4 preoperatively to 0.3 at a mean 5 years of follow-up. Most patients reported satisfaction in their urinary symptoms with 91% and 73% reporting improvement in SUI and climacturia respectively, compared to 86% and 93% respectively in the original series. One (4.3%) patient had an IPP revision for pump malfunction. There were no device infections reported. Conclusions The Mini-Jupette sling appears to be a safe and effective procedure with durable improvements in SUI and climacturia at 5 years of follow-up. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Clarus Therapeutics, Antares Pharma, Acerus, Intuitive Surgical, Fidalis, Hims & Hers Health Inc

Abstract Introduction Epididymectomy is indicated for patients with focal epididymal pain and bothersome epididymal cysts or masses. Similarly, spermatocelectomy is indicated for spermatoceles that have becomes symptomatic due to size or pain. The majority of scrotal surgeries are performed in the operating room (OR) using general or monitored anesthesia. Here, we sought to evaluate our experience with office-based epididymectomy and spermatocelectomy using only local anesthesia. Objective To evaluate post-procedural complications and pain resolution following epididymectomy or spermatocelectomy, comparing procedures performed in the clinic with only local anesthesia, compared to the OR. Methods We identified patients who underwent epididymectomy or spermatocelectomy at our institution from 2018-2021. A chart review was performed to identify pertinent information including whether the procedure was performed in the OR under monitored/general anesthesia versus in the clinic using only local anesthesia. Post-procedural outcomes including pain resolution (if applicable) and 30-day complications were compared between those who underwent epididymectomy or spermatocelectomy in the OR versus the office. Statistical analysis was performed using the chi-squared test. Results A total of 112 patients were identified, including 23 (20.5%) who underwent epididymectomy and 89 (79.5%) who underwent spermatocelectomy. Mean patient follow-up was 14.8 months (SD 11.6). Indications for epididymectomy or spermatocelectomy included pain (n= 50, 44.6%), epididymal cyst/mass (n=6, 5.4%), and mass effect secondary to spermatocele (n=56, 50.0%). Fifty-seven procedures (50.9%) were performed in the office under local anesthesia. Nitrous oxide was used in 21 (36.8%) of these cases. Thirty-four patients (30.3%) were on anticoagulation/antiplatelet therapy prior to surgery including 22 (64.7%) who continued anticoagulation/antiplatelet therapy due to high-risk comorbidities. The adverse event rate within 30 days was similar between patients who underwent surgery in clinic versus OR (p=0.67). Specifically, adverse events occurred in 9 patients (8.0%), of whom 4 had their procedure performed in the clinic (7.0% of clinic procedures) and 5 had their procedure performed in the OR (9.1% of OR procedures). Specific adverse events included postoperative hematoma in 6 patients (66%) and a single case of each of the following: infection, inability to void postoperatively, and intestinal obstruction. Hematoma rates did not differ significantly between those who were or were not on anticoagulation perioperatively (p=0.057). In patients with reported adverse events, 3 (33.3%) required reoperation. Of the 50 patients who underwent epididymectomy or spermatocelectomy for scrotal content pain, 39 had sufficient documentation available to evaluate pain resolution. 82% (n=32) reported 50% improvement in pain. There was no statistically significant difference in the likelihood of reporting significant pain reduction based on the location of the procedure (OR versus clinic). Conclusions Epididymectomy and spermatocelectomy can be successfully carried out in the office using only local anesthesia, including in those patients who are high risk for general anesthesia or require maintenance of anticoagulation perioperatively. Pain improvement may be anticipated in the majority of appropriately selected patients following treatment in either the clinic or OR. Disclosure No

Abstract Introduction There is no agreed-upon definition for acute/chronic phases of Peyronie’s Disease (PD). Collagenase Clostridium histolyticum (CCH) is the only FDA-approved treatment for PD, but original phase-3 trials included patients with symptom duration > 12 months (“chronic phase”). Objective Here, we sought to evaluate the influence of time between symptom onset and starting CCH on treatment outcomes. Methods Men receiving CCH from 2014-2021 were included in an IRB-approved database. Pertinent data were reviewed, including demographics and curvature assessments. The duration between symptom onset and starting treatment with CCH was assessed to determine if the time from symptom onset to treatment impacted objective outcomes. Results One hundred forty-five patients completed the entire series of 8 injections and had complete data for review. Mean baseline curvature 53.2o (SD 18). The mean time between symptom onset and CCH was 14.8 months (SD 18). Mean absolute and percentage improvements were 20.3o (SD 16) and 39.4% (SD 35). Symptom duration did not significantly impact curvature improvement (Figure 1). Similarly, symptom duration did not significantly impact the risk for CCH-related side effects. Conclusions The time between symptom onset and treatment did not significantly impact outcomes with CCH. Our findings support the utility of using CCH early in the course of PD and emphasize the opportunity to delay if necessary without compromising efficacy. Disclosure No

Abstract Introduction Intralesional Collagenase Clostridium histolyticum (CCH) is approved for men with Peyronie’s Disease (PD). Most studies use curve improvement ≥ 20% to define treatment success. Objective Here, we sought to further characterize objective and subjective treatment outcomes with CCH. Methods We reviewed our prospectively maintained database for all patients who underwent CCH at our institution from 2013 through the present. We specifically identified those who completed four series of CCH (or elected to discontinue prior to completing four series due to satisfactory penile straightening or lack of results) and had available curvature assessment data. Treatment outcomes were broken down by level of curve improvement (0%, 10%, 20%, 30%, and > 40% improvement). Treatment success was also evaluated by improvements in the ability to engage in penetrative sexual intercourse and perceived surgery avoidance. Statistical analyses were performed using JMP Pro 14.1.0 (SAS Institute, Cary, NC). Results 127 patients had complete data available. The mean age was 57 years (SD 8.4). The mean PD duration was 27 months (SD 59). The mean baseline curvature was 66.1O, and the mean post-treatment curvature was 45.1O (p<0001). The mean curvature improvement was 32% (SD 33). 68% of patients achieved a 20% or greater improvement in penile curvature, including 38% who achieved ≥ 40% improvement. 72% (n=48/67) felt that CCH prevented the need for surgery, and 68% reported CCH restored the ability to penetrate. Stretched flaccid penile length (SPL) increased by ≥ 1 cm in 50% of patients who used concurrent penile traction (PTT) and CCH, including 28% of patients who experienced ≥ 2 cm of length gain. In contrast, only 16% of patients who did not perform concurrent PTT had a ≥ 1 cm increase in SPL (p<0.0001). Conclusions CCH may restore the ability to penetrate with intercourse, and most patients feel that CCH prevents the need for surgery. Almost 40% of patients experienced a 40% or greater curvature improvement. However, 13% of patients may go through the entire series with minimal improvement. Concurrent PTT allows for simultaneous penile length gain in some patients. These data are helpful when counseling patients on expected outcomes. Disclosure No

Abstract Introduction Sexual therapy for male sexual dysfunction has been used to help patients address a variety of sexual dysfunction-related conditions. While this intervention is frequently recommended for patients by male sexual health experts, the rate of adherence to the recommended therapy and associated factors is unknown. Objective To understand factors leading to completion of sex therapy consultations and barriers that prevent it. Methods A survey was developed by experts in the management of male sexual dysfunction and sex therapy at our institution. The survey included questions focusing on the decision to pursue sex therapy (or not), barriers or facilitating factors, patient perceptions regarding the referral, and treatment success. A retrospective chart review was performed to identify those patients who were referred for sexual therapy after undergoing evaluation for male sexual dysfunction at an academic Men’s Health urology clinic from 2017 - present. The survey was mailed out to these patients, and respondent survey data was compiled to evaluate survey responses. Results To date, 23 patients completed the survey (20% response rate). Sixty-five percent of survey respondents were ≥ 50 years of age, 87% were straight, and 71% were married. Reasons for sex therapy referral were frequently multi-factorial and included erectile dysfunction (65%, n=15), low libido (43%, n=10), ejaculatory dysfunction (39%, n=9), performance anxiety (30%, n=7), relationship problems (30%, n-7), and genital pain (14%, n=3). Seventy-eight percent of patients (n=18) felt that sex therapy consultation was a reasonable part of their treatment plans. Six (26%) patients did not attend their recommended sex therapy consultations. Reported barriers included sense of shame (n=2), embarrassment (n=2), scheduling conflicts (n=1), lack of anticipated benefits (n=1), and feeling dismissed by the referring provider (n=2). Those who attended sex therapy frequently reported the perception that referral made sense based on their symptoms (n=10, 59%) and/or a feeling of desperation to “do anything do get better” (n=11, 65%). Seventy-eight percent of patients who attended sex therapy found it helpful and would recommend it to a friend with a similar concern. Conclusions The majority of male patients who are referred to sexual therapy feel it is beneficial. However, one in four men choose not to pursue this line of treatment despite recommendations from their treating physicians. Future work is needed to address barriers to pursuing sex therapy. Disclosure No

Abstract Introduction Penile dysmorphophobia is common, with up to 20% of men reporting dissatisfaction with their genital size. The global market for Sexual Enhancement Supplements is estimated at $300 Million in the year 2020 and is projected to reach $608 Million by 2027 in the US alone. Evidence for efficacy is minimal, and purported claims are hyperbolic. Objective We sought to assess penile elongation internet offerings, quantify cost, ingredients, and risk and investigate scientific literature of product ingredients when available. Methods Three online marketplaces (Amazon, Google market, and Walmart) were queried for dietary supplements available without a prescription to improve penile size. Product labels were reviewed to compile penile size-related claims and active ingredients. The one-course (60-day) cost of treatment and consumer star rating were assessed. MEDLINE, Web of Science, and Google Scholar were queried with labeled ingredients to assess the scientific evidence from published and lay sources. Results A total of 84 dietary supplements claimed either increased penile length, girth, enhanced sexual performance, or a combination thereof. Of these 84 products, 90 ingredients were listed. The Mean 60-day cost was $52 (range of $12–$222). The median score by consumers in the markets with a possibility of star rating was 3.5 (range 2.4-4.2) with obvious repetitive and self-promotional tactics. Unsurprisingly, no scientific evidence supporting change in penile size was found for any products in our search. Actual described physiologic activity from active ingredients included were described as antidepressant, lipid and glucose lowering/metabolizing, blood pressure effecting, anti-inflammatory, renally protective, cognitive function effecting, antioxidant, and several ingredients weakly enhancing erectile activity. Renal failure, warnings against long-term use, heart problems, neuropathy, blood pressure effects, fertility toxicity, bleeding, liver disease, and numerous interactions with diabetes, blood thinning, immunosuppressant, and PDE5 medications were found for the ingredients. Conclusions Dietary supplements claiming to enhance penile size contained ingredients with conflicting or no scientific evidence to support their claims. Several ingredients were dangerous. Clinician awareness of these sham “solutions” and their continued mass consumption highlight the magnitude of misinformation, unrealistic expectations, shame, and enhancement desperation regarding penile size in the male public psyche. Disclosure No

Abstract Introduction Sexual Health Curriculum (SHC) in medical schools has been insufficiently training medical students for many years. While most medical schools report teaching a SHC, many medical students and residents report being inadequately trained in sexual health. This has led to infrequent physician screening for sexual problems due to insufficient knowledge and a lack of training about sexual function and dysfunction. Objective To investigate the current body of literature for changes in SHC in medicals schools in the last 20 years, and to identify any discrepancies between SHC taught in medical school and resident and medical student comfort in treating Sexual Health Dysfunction. Methods A literature review was conducted in PubMed on “sexual health education in medical school”, and of 16,962 results 37 relevant papers published in the U.S. and Europe were identified and analyzed. Results In 2003 86% of medical schools reported teaching over 3 hours of SHC, but by 2021 only 65% of students and 50% of PGY 4/5 Urology residents recalled a dedicated SHC in medical school. Consistently 50% of medical students are unsatisfied with their SHC, 52% are rarely or never evaluated on their sexual history taking skills, and 7% report not learning about human sexuality at all. Most German medical students believe that sexual health courses should be mandatory. Medical students have overall positive attitudes towards sexual and gender minority populations but lack adequate knowledge, especially about transgender and intersex health. Only 55% of 3rd/4th year OBGYN residents reported feeling comfortable in performing a targeted sexual dysfunction exam, and 66% of residents in Family Med, IM, OBGYN, and Psych had no previous educational experience in sexual problem management. Conclusions Sexual health curriculum in medical schools has not significantly improved in the last 20 years, leading to students and residents inadequately prepared to treat sexual health dysfunctions. The adoption of previously proposed SHC competencies for medical schools should be strongly considered. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast

Abstract Introduction Collagenase Clostridium Histolyticum (CCH) is an FDA-approved treatment for Peyronie’s Disease (PD). Based on phase-3 trials, the recommended treatment course consists of 8-injections over the course of roughly 18-20 weeks. While its efficacy has been established, less is known about patient-specific reasons for electing to discontinue CCH injection therapy. Objective To evaluate patient-reported factors associated with premature CCH discontinuation. Methods We queried a database of all patients (n=406) who underwent CCH at a single institution from 2014-2021. Patients who did not complete the recommended 8 injections were identified, and a detailed review was undertaken to determine causes of discontinuation. Patients were excluded from our analysis for the following reasons: deceased at the time of chart review, declined to participate, or could not be reached in 3 phone calls. Results Out of 406 patients who underwent Xiaflex treatment at our single institution, 133 did not complete 8 injections (32.8%). The mean number of CCH injections was 4.42 (SD 1.65). The most common reasons for discontinuing Xiaflex were satisfactory curve reduction (27%), unsatisfactory curve reduction (21%), bothersome side effect (15%), and decision to pursue surgery (12%) [Figure 1]. Other less common reasons included other health concerns, pausing treatments due to the Covid-19 pandemic, high treatment cost, transferring care elsewhere, and lack of awareness that more injections were indicated. Conclusions In our single institution study, we find that nearly 1/3 of patients who begin Xiaflex injections will not complete the full recommended treatment course. Understanding the reasons for discontinuation can help providers better stratify patients for Xiaflex treatment versus other modalities. In addition, given previous studies that indicate that 2/3 of men who fail to achieve a 20% curve reduction after their first 4 injections will go on to achieve this curve reduction after their final 4 injections, our data points to the potential impact of improved patient education for the 21% of individuals who discontinue due to unsatisfactory curve reduction (Alom et al 2021). Disclosure No

Abstract Introduction Since the FDA approval of Collagenase Clostridium Histolyticum (CCH), few studies have been able to identify variables which predict curve improvements, with baseline extent of curvature most highly correlated. In addition to extent of baseline curvature, our team has previously identified curve direction and plaque calcification as additional predictive variables. We therefore sought to create an integrated predictive model which incorporated several factors to better estimate anticipated outcomes. Objective To report outcomes of a novel scoring system designed to better predict outcomes of men undergoing CCH injections for Peyronie’s disease (PD). Methods A prospective database has been maintained of men undergoing CCH injections for PD. Data were reviewed to identify variables predictive of curve improvements in men with isolated curvature as well as among those with key characteristics, including indentations, hourglass deformities, penile tapering, and calcification. A predictive model was subsequently developed to improve correlations between disease factors and subsequent CCH outcomes. The final model (CLINiC Score) assigned points as follows: +1 point for every 10 degrees of curvature (C for Curvature), +5 points for penile narrowing >25% (IN for INdent), +3 points for narrowing 0-25%, -4 points for pure lateral curvatures (L for Lateral), and -2 points for plaque calcification (C for Calcification). Patients were assigned scores based on the CLINiC model, and results were correlated with final curve outcomes. Results A total of 476 PD men were included in the current analysis. Baseline variables for the cohort included a mean age of 55.6 yrs (SD 10.9), PD duration 31.9 months (SD 61.4), composite curvature 64.6 degrees (SD 23.9), 47% with indentations, 42% with hourglass deformity, and 17% with calcification. The mean CLINiC score for the cohort was 6.9 (SD 3.4). For the overall cohort, the use of the CLINiC score increased the correlation coefficient from 0.35 to 0.46 (r-squared 0.13 vs 0.21), with a predictive linear formula of 2.1 - 3.2 * CLINiC score. The difference was more pronounced among a subset cohort of men who had pure lateral curvatures, plaque calcification, or narrowing deformity. In comparing the CLINiC predictive model to baseline curve alone, the correlation coefficient increased to 0.54 (r-squared 0.29, p<0.0001) compared to 0.38 (r-squared 0.15, p<0.001). The linear equation to predict curve improvement outcomes using the CLINiC score was 2.2 - 3.5 * total CLINiC score. Conclusions Use of a novel scoring system (CLINiC) improves upon baseline curvature alone to predict post-CCH curve improvements, with the difference more pronounced among men with pure lateral curvatures, plaque calcification, and/or narrowing deformities. External validation is warranted. Disclosure No