Citations

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 The transgender population has largely been marginalized by society, causing inequities in health care delivery. The dearth of provider knowledge on transgender health issues further exacerbates these disparities. Objective A survey of the transgender population was conducted to help call attention to the often-overlooked aspect of care: fertility preservation prior to hormone therapy or gender affirmation surgery. Methods A survey of 65 transgender individuals was conducted, with participants recruited through Reddit transgender groups and local transgender associations, to assess their knowledge regarding fertility preservation and their experience with healthcare providers. Results were compiled and analysis was performed. Results Out of the 65 individuals who responded to the survey, approximately 88% were between the ages of 18 and 39. Seventy-four percent were assigned male gender at birth and 26% female. Sixty-two percent of individuals identified as female, 20% as male, and 18% as gender non-conforming. Only 35% of individuals had ever been cared for in a multidisciplinary transgender clinic. Interestingly, while 100% of surveyed individuals were aware that fertility would be irreversibly lost after hormonal or surgical affirmation surgery and 43% believed this to be an important issue, only 46% had any health care providers discuss fertility preservation options with them. Conclusions Hormonal therapy and gender affirming procedures affect the long-term reproductive potential of transgender individuals. While oncofertility is a prominent area of discussion, transgender care is still lagging. With an increase in medical and surgical therapy in younger individuals, health care providers must discuss fertility preservation options prior to affirmation therapy. 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 Age is often correlated with various medical conditions, including bother with the condition itself. Peyronie’s disease (PD) is a condition which is most often associated with men in their 50-60’s, however, it does affect younger men as well. Anecdotally, younger men with PD appear to be more bothered by their condition compared to older men. We therefore sought to evaluate whether there is a difference among older vs younger men as to the degree of bother linked to PD. Objective To evaluate age as a potential predictor of bother associated with PD. Methods A prospective database has been maintained of men seeking treatment for PD. Beginning in Feb 2020, we began implementing men routinely completed standardized intake questionnaires relating to PD, including the Peyronie’s Disease Questionnaire (PDQ). The PDQ consists of 15 questions broken down into three key subdomains: psychological and physical, penile pain, and symptom bother. Men who had completed the PDQ questionnaire were evaluated to determine the correlation between various clinicopathologic variables and the PDQ-bother domain. Results A total of 645 men were seen for symptoms of PD and had PDQ questionnaire data available for review. Baseline demographics included a mean age was 51.8 years (SD 17.6), mean PD symptom duration 31.3 months (SD 65.3), estimated curve of 40.9 degrees (SD 26.8), and mean PDQ-Bother score 8.9 (SD 3.1 – Note: lower is better). Several clinicopathology variables were found to be associated with increased PDQ-bother scores, including age (younger = less bothered, parameter estimate -.0.03, p=0.03), the presence of indentation or hourglass (yes 9.4, no 8.4, p<0.05), pain (yes 9.3, no 8.5, p=0.16), PD preventing penetrative intercourse (yes 9.5, no 8.7, p=0.07), penile shortening (yes 9.3, no 8.7, p=0.10), subjective erectile dysfunction (yes 9.6, no 8.5, p<0.01), and subjective premature ejaculation (yes 9.8, no 8.4, p<0.01). Interestingly, several variables did not correlate, including the duration of relationship, frequency of intercourse, duration of symptoms, direction of curve, degree of curvature, partner pain with intercourse, or libido. Conclusions Several notable factors are associated with PD bother (as assessed by the PDQ-bother domain), and equally importantly, several factors are surprisingly not associated (e.g. curvature degree and direction). These factors provide useful information to the practicing clinician to help better identify men who may be at greater risk for bother associated with the condition. 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 The presence and extent of penile calcifications is an important factor in disease management of Peyronie’s Disease (PD). Calcified plaques may necessitate plaque excision and grafting (E&G) in addition to other therapies or surgeries. PD pathology such as corporal septal involvement, multifocal calcifications, and circumferential corporal calcification can be difficult to assess on color doppler ultrasound (CDDU) due to device limitations. Computed tomography (CT) can be utilized for further characterization of PD. Objective The objective of our study was to review patients who underwent CT imaging for characterization of their Peyronie's Disease. Methods Twenty-three patients with a diagnosis of PD were retrospectively evaluated between 2017 and 2021. Patients underwent CDDU examination with artificial erection and were evaluated based on erectile function, plaque dimension, hourglass deformity, plaque septal involvement, and suspected calcification status. Patients with CDDU examination suggestive of calcification or significant complexity underwent non-contrast CT scan for 3-dimensional evaluation of the plaque prior to surgical discussion. CT complexity was defined as concern for multifocal calcified plaques (>2), partial/complete circumferential corpus cavernosum involvement, or septal involvement. Results All 23 patients had concerning findings on initial examination for calcified plaque which led to their CT evaluation; 9 of 23 (39.1%) patients had exam findings with hourglass deformity. On CT evaluation, calcification was confirmed in 22 of 23 patients (95.7%). Plaque dimensions on CT scan ranged from 0.4 x 0.2 x 0.5 cm to 4.0 x 2.0 x1.7 cm. Many of these measurements were approximations due to circumferential calcified plaque. A classic “gull-wing” appearance was noted in 6 of 23 (26%) patients; 12 of 23 (52.2%) of patients had septal involvement on CT; 8 of 23 patients (34.8%) had significant multifocal disease; 8 of 23 patients (34.8%) decided to proceed with surgical correction via E&G (n = 3), IPP with E&G (n =1), or via IPP with manual remodeling via Wilson technique (n = 4). Conclusions Non-contrast penile CT scan identifies calcification well in patients with Peyronie's Disease. CT allows for increased accuracy of surgical planning especially when evaluating for multifocal disease, circumferential plaque and/or septal involvement. These elements are critical for for providing accurate surgical recommendations and preoperative discussions. Disclosure No

Abstract Introduction Peyronie’s Disease (PD) is characterized by a fibrous scar of the tunica albuginea. PD is typically imaged with 2D ultrasound. We propose a classification system of these ultrasound findings in the evaluation of PD. Objective The purpose of this study is to establish a functional sonographic classification system for evaluating PD and to examine the relationship between PD grading and curvature, duration of PD, and vascular erectile status. Methods In our study, 395 patients with PD underwent intracavernosal injection with an erectile agent (ICI) followed by Color Doppler Duplex Ultrasound (CDDU). All CDDU studies were performed by a single examiner and all PD grading was done by two independent reviewers using saved images. Ultrasound findings including peak systolic velocities (PSV) and resistive indices (RIs) were recorded. PD grades of 2D images were classified into three grades: Grade 1 acoustic shadowing without calcification; Grade 2 focal microcalcifications of the tunica, pillars, or septal fibers; Grade 3 confluent calcification of the dorsal, septal, ventral tunica albuginea. Results There were 250 patients classified with Grade 1 (63%) sonographic changes, 75 with Grade 2 (19%), and 70 with Grade 3 (18%). All groups had similar median ages and body mass index (BMI): Grade 1 (59.3 yr), Grade 2 (59 yr) and Grade 3 (60.3 yr), p = 0.711; BMI 27.6, 28.2, 27.7, p = 0.813. Additionally, medical and surgical risk factors for erectile dysfunction were similar across the three groups; these included hypertension, heart disease, diabetes mellitus, hyperlipidemia, smoking history, and history of prostate surgery. Most patients had previously used PDE5-Inhibitors (293/395). History and/or physical findings of Dupuytren’s palmar contracture was noted in 30/395 (7.6%) of men. The median duration of PD was not significantly different across the three groups (12, 12, 14 months p = 0.639). Neither CDDU diagnoses (Table 1) nor curvature varied by sonographic grades (Table 2). Conclusions The scar resulting from PD seals together the outer longitudinal and inner circular layers of the tunica albuginea causing deformity of the erect shaft. PD plaques are usually palpable and associated with focal thickening of the tunica. On 2D ultrasound, the typical appearance is an acoustic shadow. Most of our patients presented with Grade I acoustic shadowing and no calcifications 250/395 (63%). On the other hand, 19% had acoustic plaque shadowing and additional findings of focal tunica or deep microcalcifications and 18% had confluent calcification of the dorsal, septal or ventral tunica. We propose a unique and reproducible classification system for Peyronie's Disease. This grading system is based on grayscale ultrasound of Peyronie’s plaques may serve the purpose of diagnostic evaluation, didactic teaching and integrated research. Disclosure No

Abstract Introduction Peyronie’s disease (PD) is characterized by penile pain, penile deformation and curvature, sexual dysfunction, and psychological implications. Fibrosis and plaque formation are often part of PD pathophysiology. Calcified plaques can alter treatment planning. Penile ultrasound with Doppler (PUS) is used to exclude erectile dysfunction and identify plaques. However, plaque extent and distribution can be obscured by acoustic shadowing, limiting complete plaque characterization. Non-contrast pelvis computed tomography (CT) provides a noninvasive method to identify plaques in 3 dimensions and quantify plaque Ca burden. Objective Our objective was to utilize Agatston Ca scoring measure Ca burden in patients with Peyronie's disease. Methods A retrospective database from 1/1/2017 and 6/30/2021 identified 25 men with calcified plaques on CT after PUS performed by a single urologist. Two abdominal radiologists reviewed CTs in consensus to measure calcified plaque size and distribution on Visage PACS. Semiautomated Agatston Ca scoring values were obtained with Syngo.via. Total Ca volume (mm3), total Ca score were correlated with hourglass deformity on clinical exam, plaque complexity on CT (>2 discrete calcified plaques, circumferential corpus cavernosum involvement, septal involvement), and surgical management using descriptive statistics and t-test. Results Mean Ca volume was 1417 mm3 (range 1.4-5425.7, standard deviation (SD) 1570); mean Ca score was 1691 (range 1.6-6048; SD 1862) with significantly higher Ca volume in patients with complex plaques (265 mm3 vs 472 mm3, p<0.05), and significantly longer plaque dimension for longest plaque dimension measured by CT vs US (31 vs 23, p<0.05). There was no significant difference in Ca volume for nonsurgical vs surgical (1791 vs 893, p=0.06) or for no hourglass vs hourglass deformity (1173 vs 1904, p=0.19). Conclusions CT scan and calcium scoring are useful tools in the assessment of PD. Semiautomated Ca scoring may help noninvasively identify complex calcified penile plaques to guide medical and surgical therapy for Peyronie’s disease. Disclosure No

Abstract Introduction The Optilume Urethral Drug Coated Balloon (DCB) is a novel endoscopic treatment for recurrent male anterior urethral strictures. An important topic of discussion with patients during counseling on treatment options includes the potential affect of treatment on sexual function and fertility. The ROBUST III study was a prospective, randomized study comparing standard of care endoscopic therapy against treatment with the Optilume DCB. Assessments included evaluation of sexual function and andrology parameters. Objective The objective was to study the potential affect of treatment with the Optilume DCB on sexual function and, for younger patients, fertility. Methods A total of 79 men were randomized to receive treatment with the Optilume DCB. Sexual function was assessed via the 15 item International Index of Erectile Function (IIEF) questionnaire. Erectile function, orgasmic function, and overall satisfaction sub-domains were assessed at 3, 6, and 12 months after treatment in patients that were sexually active at baseline. Fifteen additional subjects were enrolled in a non-randomized pharmacokinetic sub-study that included assessments of paclitaxel concentration in semen and sperm quality parameters through 6 months post-treatment. Results Average erectile function and overall satisfaction scores improved from baseline to 12 months post-treatment, while orgasmic function was not changed (Figure). The improvement in satisfaction was statistically significant at 12 months (p=0.003). No adverse events of de novo erectile or ejaculatory dysfunction were reported. Average ejaculate sperm concentration did not change from baseline to 6 months (49 million/mL vs 46.6 million/mL, p=0.88), nor did total spermatozoa per ejaculate (107.2 million vs 104.0 million, p=0.94). Paclitaxel concentration in semen after treatment was maximal at 30 days (2.99 ng/mL) and was reduced near the limit of quantitation of the analytical method by 6 months (0.12 ng/mL). Conclusions Treatment of male anterior urethral strictures with the Optilume DCB did not appear to have an impact on sexual function as measured by the IIEF and adverse event assessments. Average sperm quality parameters did not differ from baseline to 6 months post-treatment. Low levels of paclitaxel were detected in semen after treatment but were nearly undetectable by 6 months. Disclosure Yes, this is sponsored by industry/sponsor: Urotronic Inc. Clarification Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Sci, Coloplast, Medtronic USA Inc., PROCEPT BioRobotic Corporation, NeoTract Inc., Janssen Biotech Inc., Endo Pharmaceuticals Inc., Tolmar Pharmaceuticals, Inc., 180 Medical Inc., AbbVie Inc., Pfizer Inc., Bluewind Medical, Astellas Pharma US Inc., Antares Pharma Inc., Axonic Modulation Technologies Inc., Allergan Inc., Terumo Medical Corporation, Dendreon Pharmaceuticals llc, Blue Earth Diagnostics Limited, Ferring Pharmaceuticals Inc., Olympus America Inc., Karl Storz Endoscopy-America, Clovis Oncology Inc., Dornier MedTech America Inc., Travere Therapeutics Inc., Valeant Pharmaceuticals North America LLC