Ziegelmann, M.

Abstract Introduction Limited data currently exist on the role and efficacy of additional series of collagenase clostridium histolyticum (CCH) injections among Peyronie’s disease (PD) men who have previously failed a first series of injections. We sought to evaluate outcomes of a novel protocol for CCH injections among men who had previously failed 6-8 CCH injections using a traditional approach. Objective To evaluate whether additional rounds of CCH using a novel protocol in men previously unresponsive results in greater curve improvements. Methods A randomized, controlled trial (NCT05108558) is ongoing. All participants previously failed to achieve ≥20% curvature improvement with 6-8 prior CCH injections. Men were randomized 3:1 to receive either CCH + traction (RestoreX) + sildenafil (treatment) up front or initial observation followed by treatment (controls). Outcomes were compared between treatment and control groups. Key measures included objective curve improvements and standardized/non-standardized questionnaires, with assessments obtained at baseline, 6-weeks after completion of CCH (treatment arm), after the no treatment period (controls), and at 1 year. Results A total of 38/40 men have been randomized to date, with 22 having fully completed treatment. Mean age was 57 years, with a median PD duration of 22 months. Median composite baseline curvature was 65 degrees, with 40% having hourglass or indentation deformities, 8% calcification, median baseline IIEF-EFD 20, and 58% able to have penetrative intercourse. Median estimated improvement with the prior CCH series was 0% (IQR 0, 18.8), and the median number of prior injections was 8. The majority of men were dissatisfied with their prior series of CCH (58% vs 35% satisfied, 8% neutral). Of the 22 men who had completed the study protocol, 50% required 1 series, 14% 2 series, 29% 3 series, and 7% 4 series. Compared to the no treatment arm, treated men experienced significantly greater improvements (median 60 degrees vs 0, p = 0.01). IIEF-EFD was non-statistically higher in treated men (0 vs -5, p = 0.17). 92% of men reported a subjective major improvement in curvature, with the median subjectively estimated improvement 90%. 42% reported improved sensitivity (58% no change), while 63% reported improved or no change in erectile function, with 9% unsure, and 27% worse. Post-treatment, 92% of men were very satisfied with CCH as a treatment and 8% neutral. Conclusions Repeating CCH using a novel protocol after an initially unsuccessful course of CCH achieves significant improvements in curvature and patient satisfaction. Additional data, including external validation, are warranted. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: PathRight Medical.

Abstract Introduction Penile prosthesis (PP) implantation is associated with high patient satisfaction and improved sexual quality of life in medically refractory erectile dysfunction (ED). While reported patient satisfaction with this surgery is high, there are a variety of factors that can influence patient satisfaction after PP surgery. Objective We aimed to identify factors responsible for patient dissatisfaction after PP surgery. Methods We initiated a registry of patients undergoing surgery for placement of a PP. After consent, Perioperative study assessments and follow-ups were conducted. After surgery, patients were directed to fulfill a survey at 6 months and 12 months. Patients who completed both surveys were included in the analysis. Results A total of 304 patients had a PP placement, of these 101completed at least the first survey. Patients reported using their PP a median of 4 (2-8) times per month at 6 months, and 5 (2-9) at 12 months (p = 0.651). Main reasons of lack of use of the PP can be seen in Fig. 1A. The most frequent reported reason was lack of interest from partner (20.3% at 6-months, 18.8% at 12-months). Patient reported reasons for dissatisfaction are seen in Fig. 1B. Examples include penile pain (19% at 6-months, 11% at 12-months), difficulty with orgasm (39% at 6-months, 37% at 12-months), unsatisfactory penile cosmesis (28% at 6-months, and 25% at 12-months), problems inflating of the prosthesis (14.9% at 6-months, and 21.5% at 12-months), and problems deflating of the prosthesis (33.7% at 6-months, and 31.6% at 12-months). Despite these concerns, most patients found PP easy to use (83.2% at 6-months, and 82.1% at 12-months) and a reported a very or somewhat natural sensation with their erections (66.4% at 6-months, and 62.8% at 12-months) Fig. 1C. Conclusions There was a higher than anticipated rate of penile pain, difficulty achieving climax, and unsatisfactory cosmesis that warrant further investigation. Despite this, the majority of patients found their PP easy to use and a reported natural sensation when having erections. Disclosure Yes, this is sponsored by industry/sponsor: Coloplast. Clarification: Industry funding only - investigator initiated and executed study.

Abstract Introduction Since the FDA approval of Collagenase Clostridium Histolyticum (CCH) for the treatment of Peyronie’s Disease (PD), there has been significant debate as to its role and comparable efficacy in relation to surgical therapies. We have previously published results comparing the two therapies at 3-months post-treatment. Objective To compare various objective and subjective outcome measures at 12-months post-treatment between men undergoing CCH or surgery for PD. Methods A randomized, controlled trial (NCT04786106) is ongoing. Participants were randomized 1:1 to receive either CCH + traction (RestoreX) + sildenafil or penile surgery (plication and/or incision and grafting) + traction + sildenafil for PD. Objective, standardized (International Index of Erectile Function [IIEF] and Peyronie’s Disease Questionnaire [PDQ]), and non-standardized assessments were obtained at baseline, and post-treatment at 3, 6, 12, 24, 36, 48, and 60 months. Key outcomes included differences in standardized questionnaires, penile curvature, penile length, subsequent interventions, and non-standardized questionnaire responses. Curvature was measured in two planes and summed to provide a composite curvature. Penile length was measured from pubic symphysis to corona. All adjunctive therapies were stopped at 3-months post treatment completion (i.e., traction and sildenafil). Results A total of 40 men were randomized, with 38 completing treatment and 12-month data available on 28 men (CCH=12, surgery=16). Mean age at enrollment was 54.7 years, PD duration 37.4 months (mo), composite curvature 73.1 degrees (deg), and penile length 12.7 cm. All baseline variables were statistically similar between cohorts. Regarding primary outcomes, at 12-months post-treatment, CCH men reported being very satisfied 36%, satisfied 27%, and neutral 36% with none dissatisfied. Men in the Surgery cohort reported 14% very satisfied, 64% satisfied, 0% neutral, and 21% dissatisfied (p<0.01). For secondary outcomes, the median differences between CCH and Surgery were: IIEF-EFD (+2.0 vs +2.0, p=0.82), PDQ-physical (-5 vs -5, p=0.77, note, lower is better for PDQ scales), PDQ-pain (-1 vs 0, p=0.92), PDQ-bother (-7 vs -3, p=0.12), length change (+1.0 vs -0.13 cm, p<0.05), curvature absolute change (-37.5 vs -53.8 degrees, p=0.17), and curvature % improvement (55% vs 82%, p=0.15). Compared to 3-month data, Surgery men experienced greater curve recurrence (objective: Surgery +5 degrees vs -5 degrees CCH, p<0.05), decreased subjective penile length 62% vs 9% CCH (p<0.01) and decreased sensitivity (54% vs 27% CCH, p<0.05). Both groups reported similar rates of improved sexual function (CCH 82% vs 64%, p=0.30) and change in erectile function (CCH 55% improved, 9% worsened; Surgery 62% improved, 8% worsened, p=0.53). Both groups were also equally satisfied with their curvature (CCH 55% vs Surgery 54%, p=0.97), despite greater overall curve improvements in the Surgery arm. 75% of CCH men reported improved indentation/hourglass vs 56% Surgery, p<0.05. Both groups reported similar rates of being willing to do their treatment again (CCH 73% vs 77%, p=0.64), while 91% of CCH men would recommend it to a friend vs 77% Surgery (p=0.35). Conclusions Preliminary data suggests that when compared to surgery at 12-months, CCH men were more likely to be very satisfied, experience penile length increases, and less likely to experience dissatisfaction, curvature recurrence, and decreased penile sensation. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Matthew Ziegelmann - Endo Pharmaceuticals.

Abstract Introduction Climacturia, the inadvertent leak of urine during orgasm, is a well-known complication following radical prostatectomy and can cause significant patient/partner bother. The Mini-Jupette sling treats climacturia during placement of an inflatable penile prosthesis (IPP) but requires an extended corporotomy with a complex closure. Our modified Mini-Jupette technique utilizes a standard corporotomy and places the sling inferior as opposed to integrated into the corporotomy. Additionally, we perform an intraoperative drip test for urethral occlusion, which eliminates the need for guessing on sling tension. Corset sutures can then be utilized intraoperatively or in future revision surgeries in the event of sling loosening or recurrent climacturia. Objective To visually demonstrate the modified mini-jupette technique and intraoperative drip test. Methods An IPP surgical candidate with climacturia was identified. Intraoperative video of the Mini-Jupette technique was recorded using an overhead camera. The Mini-Jupette sling is placed with four vertical Ethibond (00) sutures placed inferior to the corporotomy stay sutures. The drip test is set up by retracting the catheter to the distal urethra and connecting it to a bedside irrigation system set 60cm above the patient. Stoppage of fluid flow during IPP inflation indicates that the sling is appropriately occluding the urethra. Results Successful demonstration of a modified Mini-Jupette technique and intraoperative drip test without complications. Conclusions Our modified Mini-Jupette and intraoperative drip test provide a reasonable alternative to the standard Mini-Jupette technique. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast.

Abstract Introduction Limited data currently exist on the role and efficacy of additional series of collagenase clostridium histolyticum (CCH) injections among Peyronie’s disease (PD) men who have previously failed a first series of injections. We have previously published outcomes of men undergoing a novel protocol for CCH injections and which demonstrated significant improvements compared to original IMPRESS I and II techniques. We therefore sought to evaluate results of men who had previously failed CCH injections to determine if they would respond to a repeat course using a more aggressive protocol. Objective To evaluate outcomes of a novel protocol for CCH injections among men who had previously failed 6-8 CCH injections using a traditional approach. Methods A randomized, controlled trial (NCT05108558) is ongoing. All participants had previously failed to achieve ≥20% curvature improvement with 6-8 prior CCH injections. Men were randomized 3:1 to receive either CCH + traction (RestoreX) + sildenafil (treatment) up front or initial observation followed by treatment (controls). Outcomes were compared between treatment and control groups. Key measures included objective curve improvements and standardized/non-standardized questionnaires, with assessments obtained at baseline, 6-weeks after completion of CCH (treatment arm), after the no treatment period (controls), and at 1 year. Results A total of 22/40 men have been randomized to date, with 11 having fully completed treatment. Mean age was 64 years, with a median PD duration of 24 months. Mean composite baseline curvature was 80 degrees, with 55% having hourglass or indentation deformities, 10% calcification, median baseline IIEF-EFD 15, and 60% able to have penetrative intercourse. Median estimated improvement with the prior CCH series was 0% (IQR 0, 19.4), and the median number of prior injections was 8. The majority of men were dissatisfied with their prior series of CCH (60% vs 30% satisfied, 10% neutral). Of the 11 men who had completed the study protocol, 64% required 1 series, 9% 2 series, 18% 3 series, and 9% 4 series. Compared to the no treatment arm, treated men experienced significantly greater improvements (mean 78 degree vs 15, p=0.01). IIEF-EFD was also improved more in treated men (+4.3 vs -5.7, p<0.05). 100% of men reported a subjective major improvement in curvature, with the average subjectively estimated improvement 91%. 67% reported improved sensitivity (33% no change), while 60% reported improved or no change in erectile function, with 20% unsure, and 20% somewhat worse. Post-treatment, 83% of men were very satisfied with CCH as a treatment and 17% somewhat satisfied. Conclusions Repeating CCH using a novel protocol after an initially unsuccessful course of CCH achieves significant improvements in curvature and patient satisfaction. Additional data, including external validation, are warranted. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Matthew Ziegelmann - Endo Pharmaceuticals.

Abstract Introduction Perception of penile curvature (PC) varies widely, and correction of PC is in the eye of the beholder. Objective We sought to investigate if patients with Peyronie’s Disease (PD) had differing opinions on correction of PC compared to general andrology (AD) patients without PD and general urology (URO) patients. Methods A cross-sectional survey was administered to adult patients in andrology and general urology clinics at 3 geographically separate institutions. Patients were grouped with having PD vs AD vs URO conditions. The survey consisted of unlabeled images of penis models with varying degrees of PC (range 10-90°). Respondents were asked to select the images they would want surgically corrected. Univariable and multivariable analyses were performed to identify demographic variables associated with willingness to consider correction. Results Ninety-four PD, 106 AD, and 302 URO patients were recruited. When comparing the 3 groups, besides obvious gender differences with PD patients, PD patients were less in 25-34 age range and more in 55-64 age range (p=0.01 and p=0.007). PD was less represented in Mid-Atlantic (p<0.001). 8% of PD, 12% of AD, and 20% of URO patients chose not to surgically correct any degree of PC (p=0.001). Among those who endorsed willingness to surgically correct PC, the average threshold for correction was 52.5° (SD 13) for PD, 37.2° (SD 29.5) for AD, and 51.0° (SD 19.9) for URO patients. When comparing PD patients with AD patients, no difference in the decision to surgically correct was found (p=0.42). This was also found to be the case when comparing PD with URO (p=0.46) and PD+AD patients vs URO (p=0.67). On univariable analysis, among AD patients, those ages 55-64 were more willing to undergo PC correction at lower degrees of PC (p=0.03) but did not hold up on multivariable analysis (p=0.40). No other demographic factors among PD and AD groups were found to have an impact on willingness to undergo PC correction (Table 1). Conclusions No significant differences were seen in the decision to surgically correct PC when comparing the perspectives of patients with PD, AD, and URO. Roughly 10% of all of these patients would defer on surgical management of any degree of PC. Despite having PC, no demographic differences were seen among PD patients’ willingness to correct PC. Disclosure No

Abstract Introduction Inflatable penile prosthesis reservoir herniation or migration may occur with space of Retzius or submuscular placement. The dangers of high submuscular placement include bowel or bladder perforation (from blind instrument passage) and or bowel herniation (from unintentional peritoneal placement and stretching of small opening with reservoir filling). Even under direct vision submuscular placement, reservoirs can ultimately reside into the scrotum, retroperitoneum, and lateral abdominal wall. The Tubing, Hitch And Lasso, Intussusception Anchor (THALIA) technique was recently developed to prevent reservoir migration with placement either submuscularly or in the space of Retzius, but video of this technique has not been previously published. Objective To visually demonstrate the proper surgical technique of THALIA during IPP reservoir placement. Methods An IPP surgical candidate at high risk of complications should reservoir migration occur was identified. Video of THALIA technique performed during IPP surgery was recorded using an in-light overhead camera and a GoPro aseptically positioned on the lead surgeon. Results Successful demonstration of THALIA technique during IPP placement. Conclusions THALIA technique is a feasible option to aid prevention of penile implant reservoir herniation. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast

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 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