Abstract Introduction Peyronie’s disease is characterized by penile plaque or scar within the tunica albuginea. This results in penile deformity, most commonly penile curvature but also volume loss deformity such as hourglass or indentation. This volume loss occurs in up to 65% of men with Peyroine’s disease. Surgical management for patients with significant deformity includes plaque incision/partial excision and penile grafting with an absorbable grafting material. In the original description of extra-tunical grafting, the grafting material was placed over Buck’s fascia via a ventral longitudinal incision. In our modified technique, the grafting material is placed under Buck’s fascia and superficial to the tunica albuginea, which allows the grafting material to be less palpable in the flaccid condition. Objective To demonstrate a modified approach to Extra-Tunical Grafting for peyronie’s disease indentation deformity. Methods Intra-operative video of modified extra-tunical grafting was recorded with an overhead surgical camera. Results Successful modified extra-tunical grafting with excellent penile straightening and restoration of penile girth and minimal palpability of the graft. Conclusions Our modified extra-tunical grafting technique is a reasonable option compared to the standard grafting technique Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast.
(134) Efficacy of a Novel Collagenase Clostridium Histolyticum Protocol for Peyronie’s Disease Among Prior Non-responders: A Randomized, Controlled, Single-Blinded Study
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.
(074) Safety and Efficacy Varying Doses of Prednisone Post Vasectomy Reversal: Results from a Randomized, Controlled Trials
Abstract Introduction There has been significant ongoing debate on the role and utility of prednisone post-vasectomy reversal to improve sperm counts and long-term patency. However, there are relatively limited data available on the efficacy, with essentially no data available on pregnancy outcomes. Objective To report outcomes of randomized, clinical trial evaluating varying protocols for prednisone administration post vasectomy reversal. Methods A randomized, controlled trial was performed (NCT04788823) with an anticipated 100 men randomized to one of four prednisone protocols post vasectomy reversal: no treatment (Control), prednisone 20 mg taper over 1 month beginning the first month post-op and then every other month x 6 months (High Dose), prednisone 20 mg taper over 1 month if declining sperm counts or a 0 count were identified (PRN), and prednisone 5 mg daily x 1 week, followed by no treatment x 1 week, continued for 6 months (Low Dose). Randomization tables were created a priori to ensure an equal representation of differing durations of time since the original vasectomy as well as an equal distribution of VV/VV vs VV/EV vs EV/EV procedures. All men had semen analyses obtained monthly for a first 12 months. Surveys were sent periodically to follow-up on subsequent pregnancies. Inclusion criteria included having a female partner <36 years of age with no known fertility factors. Results A total of 75 men were ultimately enrolled due to interim findings suggesting inferiority of the High Dose and PRN treatment arms and decision to close those arms before completing full enrollment. Final enrollment included: Control (n=25), High Dose (n=14), PRN (n=11), and Low Dose (n=25). The mean patient age was 38.5 years, mean partner age 29.6, and mean time since vasectomy 6.3 years (SD 5.0). 82% of men underwent VV/VV, while 15% VV/EV, and 3% EV/EV. All men underwent successful anastomosis bilaterally with no cases of one-sided or no anastomosis performed. At a mean follow-up of 16.5 months (range 7.6 to 25.1), an overall patency (sperm observed on sample) rate of 93% was noted (Control 96%, High Dose 93%, PRN 100%, Low Dose 88%, p=0.41). The mean sperm concentration post-op was 34.4 million/ml (Control 24.0, High Dose 38.4, PRN 21.0, Low Dose 49.8, p=0.33). Patency rates at 6- and 12-months were: 6-months (Control 88%, High Dose 80%, PRN 83%, Low Dose 94%, p=0.75); 12-months (Control 75%, High Dose 71%, PRN 75%, Low Dose 91%). Mean sperm concentrations at 6- and 12-months were: 6-months (Control 15.7, High Dose 21.5, PRN 6.9, Low Dose 25.7, p=0.50); 12-months (Control 12.6 million/ml, High Dose 17.1, PRN 36.1, Low Dose 50.4, p=0.64) At the 6-month post-op time point, the overall rate of pregnancy was 47%, with notable differences between cohorts: Control 57%, High Dose 10%, PRN 38%, and Low Dose 67%, p=0.02. No patients discontinued prednisone due to side effects. Conclusions Prednisone taper protocols appear to reduce the likelihood for pregnancy following vasectomy reversal. Use of low-dose prednisone results in non-statistically higher rates of patency at 6- and 12-months, mean sperm concentration at 6- and 12-months, and pregnancy at 6-months. Overall results suggest superiority of either no prednisone post-vasectomy reversal or a low dose protocol but argue against the use of higher dosages at any time due to its negative impacts on pregnancy rates despite maintained sperm counts. Disclosure No.
Significant Geographic Variation in Access to Certified Collagenase
Clostridium histolyticum
Injectors for Peyronie’s Disease Throughout the United States
Abstract Glans hypermobility (GH) is a well-described clinical entity that can have significant implications for cosmesis and function, resulting in sexual dissatisfaction, penile pain, and early device erosion, with an estimated incidence of 0.04–10%. We developed a novel grading scale to assess GH severity intraoperatively during primary inflatable penile prosthesis (IPP) placement and describe a modified glanspexy technique to correct GH when encountered during IPP placement. A total of 530 patients underwent primary device implantation. Of these, 139 (26%) had hypermobility. Employing our new scaling system, grade 1, 2, and 3 GH was seen in 86 (16%), 29 (5.5%), and 24 (4.5%) cases, respectively. Increased implant size correlated with decreased likelihood of GH incidence. Each increase in implant size by 1 cm decreased the incidence of detecting GH by 11% (OR = 0.89; p = 0.015). 11 patients underwent primary GH repair using our described technique. At one-year follow-up, one patient required repeat glanspexy for recurrent bothersome GH and a second patient developed a suture granuloma at the glanspexy incision requiring unilateral cylinder explant. Our modified glanspexy technique can be used to correct GH in any direction and is a useful tool for the prosthetic surgeon’s armamentarium.
(546) Outcomes of Two Novel Techniques for Low Submuscular Reservoir Placement: Thalia Stich and Transfacial Fixation
Abstract Introduction Penile Implant reservoir complications continue to drive surgical technique innovation to avoid catastrophic complication typically affiliated with theoretical placement in the space of Retzius. The high submuscular technique (versus initially described low submuscular) aimed to reduce migration/herniation. Most high submuscular technique complications are cosmetic, however, unintentional bowel injury and difficulty with extraction of these reservoirs has been reported. Furthermore, reservoirs left via drain and retain technique have been reported to cause significant bowel complications most typically when the reservoir or pressure regulating balloon unknowingly resides intraperitoneally. Objective We report outcomes of two surgeons who independently invented and published novel techniques allowing for low submuscular reservoir placement (and thus avoid blind puncture above the arcuate line) to help avoid reservoir complications. Methods Two surgeons’ technique outcomes were assessed. The first surgical technique (T1) involves suturing an additional implant connector collar to the pubic bone with a permanent stitch. This collar acts as a backstop to prevent reservoir herniation or migration into the scrotum. It can also be used to prevent upward migration of drain and retain reservoirs as the retained reservoir is capped. The second surgical technique (T2) involves placing a right angle outside in of the fascia after a pocket is cleared below the muscle and pulling the implant tubing through this defect. This approach stops the prb or reservoir at the puncture site. Results T1 was performed 55 times for reservoir fixation and 7 times for drain and retain fixation. Mean follow up is 11 months. One infection occurred necessitating reservoir removal (and cutting of permanent stitch) which was easily accomplished. No other complications or patient complaints from this technique have occurred. Average case time increase is 5-10 minutes. T2 has been performed 31 times for reservoir fixation with no complications or patient complaints. Average case time increase is < 5 minutes. Conclusions Although submuscular reservoir techniques decrease catastrophic complications and are widely adopted, they are not without risk. We report success of two independent techniques that demonstrate safety and feasibility with low reservoir placement. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Mayo Clinic – Rochester
(541) Health Care Provider Knowledge and Attitudes about Erectile Dysfunction and Penile Implants
Abstract Introduction Erectile dysfunction (ED) stems from a variety of etiologies and often requires a multidisciplinary approach to optimize patient care. Objective We sought to assess attitudes and confidence regarding the treatment of erectile dysfunction across different provider types. Methods Responses were obtained through an anonymous, email-based survey of our institution's providers in the disciplines of urology, internal medicine, and family medicine. We created a novel tool of 25 5-point Likert scale questions regarding ED treatment. Data were analyzed through descriptive statistics and Fisher’s exact test and sorted by respondent specialty. Ethical Committee approval was obtained before study. Results 138 health care providers returned surveys, including 58 internists (IM), 47 family physicians (FP), and 33 urologists (GU). FP and IM responses showed significant overlap with a few key statistically significant differences. In general, IM was much more positive in VED, penile implant as an option, penile implant satisfaction, and penile implant risk. 37% of IM agreed or strongly agreed inflatable penile prosthesis risk is low vs 6% FP (p = .0032). IM also more strongly supported team-based care and referral to specialists IM 71% vs. 51% FP (p = .0012). (Figures) When comparing GU versus FP + IM 24/25 questions revealed statistically significant differences revealing greater GU confidence and knowledge about ED with only the importance of a team-based approach not differing. Noteworthy points include 46% vs. 18% confidence for a detailed sexual history for GU vs. FP + IM (all other points % and same provider sequence). IIEF usage and familiarity were 61 vs. 3 and 88 vs. 18, respectively. 100 and 85 strongly/agreed that good options remained after pills failed. Regarding inflatable penile prosthesis, agreement or strong agreement for patient willingness to undergo surgery for ED 67 vs. 13; patient satisfaction 91 vs. 25, partner satisfaction 80 vs. 25; and would repeat surgery or recommend to a friend was 82 vs. 17. Finally, and perhaps most notably 83 vs. 11 of providers were aware that Medicare covered implants. (Figures). Conclusions Conclusions This survey reveals significant knowledge gaps for treatment options and outcomes for ED. Targeted provider education, particularly about penile prostheses, could optimize patient care. Disclosure No
(464) Impact of Training on Confronting Discrimination and Harassment by Patients and Peers
Abstract Introduction Discrimination and sexual harassment within the workplace have a negative impact on well-being and productivity and are often underreported due to lack of comfortability in confronting the offender. Objective We aim to assess the prevalence of these abusive behaviors within a urology department and the impact of a dedicated training session on comfortability reporting/confronting discrimination and harassment. Methods Employees within a urology department at a single institution were invited to take a survey regarding discrimination and harassment both before and after a dedicated training session on reporting and confronting these behaviors. Statistical analyses were performed between pre- and post-survey groups, genders, and roles within the department. Results A total of 166 employees completed the pre-training survey, while 79 (47.6%) completed the post-training survey. 116 (69.9%) respondents identified as female. Roles within the department included physician (48/166, 28.9%), advanced practice provider (21/166, 12.7%), nurse (42/166, 25.3%), and nonclinical staff (51/166, 30.7%). The training demonstrated a positive impact in respondent comfort level with addressing gender discrimination, where 19/23 (82.6%) people who answered neutral/ disagree/strongly disagree changed their answer to agree/strongly agree compared to 7/56 (12.5%) who changed their answers in the opposite way (p=0.02). More women reported experiencing sexual harassment at least once a year compared to men (38.6% vs. 16.7%, p<0.0001). Patients were the most commonly reported offenders of abusive behaviors towards staff. Conclusions Specific training on strategies for addressing abusive behaviors can help employees feel empowered to confront gender discrimination by both patients and their peers. Disclosure No