Citations

Abstract Introduction Sleep disorders can negatively impact multiple facets of health including sexual function. In men undergoing fertility testing, optimization of general health is of utmost importance to maximize fertility outcomes. Objective To determine the relationship between sleep disturbance and sexual function in men undergoing fertility testing. Methods This study evaluated men undergoing fertility testing who completed an at-home semen analysis kit developed by Fellow Health, Inc. Men ≥18 years were included if they consented to participate in research and completed survey questionnaires on both their quality of life and sexual function. Sleep disturbance level (normal, mild, moderate, or severe) was derived using a validated survey assessment, developed by the Patient-Reported Outcomes Measurement Information System (PROMIS), which queried sleep quality, sleep depth, and restoration associated with sleep. The sexual function survey assessed libido, orgasmic and ejaculatory dysfunction, Erection Hardness Score, and IIEF-5 score. Descriptive statistics were reported and chi squared tests were used to test for independence of categorical variables with statistical significance reported at the 0.05 alpha level. Results Of the 1919 men included in this analysis, 7.7% were assessed to have a mild level of sleep disturbance and 4.4% had moderate to severe sleep disturbance. Compared to those with “normal” levels of sleep disturbance, those with mild to severe levels more often reported low libido (20.7% vs. 13.8%; p = 0.01), ejaculatory dysfunction (31.3% vs. 19.9%; p < 0.01), and orgasmic dysfunction (15.3% vs. 5.1%; p < 0.01). Of men with mild to severe sleep disturbance, 28.3% reported pursuing treatment for erectile dysfunction compared to those with normal levels of sleep disturbance (17.8%; p < 0.01). Further, only 57.2% of men with mild to severe sleep disturbance were assessed to have “No signs of ED” compared to 71.0% of men without elevated levels of sleep disturbance (p < 0.01). Conclusions Sleep disturbance is associated with reduced libido, ejaculatory, orgasmic, and erectile function in men undergoing fertility testing. Providers should assess for sleep-related symptoms during initial evaluation to optimize fertility potential. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Fellow Health.

Abstract Introduction Penile prosthesis (PP) implantation is associated with high patient satisfaction in patients with medically refractory erectile dysfunction (ED). There remains a paucity in the literature regarding the temporal evolution of patient satisfaction and well-being following PP surgery. Objective We aimed to identify factors responsible for patient satisfaction after 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 a survey at 6 months and 12 months. Patients who completed both items were included in the analysis. Results A total of 304 patients had a PP placement, of these 101 completed the initial surveys. Overall patient satisfaction was favorable and durable and 6- and 12-months (87% and 82% respectively, p = 0.11). Confidence with device use was reported by 92% at 6 months, without significant change at 1 year (vs. 95%, p = 0.91). At 6 months, 81% of patients reported that their PP met or exceeded expectations, 83% of patients reported that they would undergo the procedure again, and 80% would recommend to a friend/family member. [Figure 1] At 6 months, 78 patients (77%) reported a moderate to high improvement in their overall sense of well-being related to their PP. This percentage further increased to 91% at 12-months (p < 0.001). Additionally, 36% of patients reported that they had made significant improvements to their overall lifestyle since receiving the PP, and this increased to 48% by 12 months post-operatively (p = 0.082). Conclusions Penile prosthesis satisfaction is evident and durable as early as 6 months following surgery. Factors such as perceived overall well-being continued to significantly improve past 6 months, and nearly half of patients reported overall lifestyle improvement following surgery. Disclosure Yes, this is sponsored by industry/sponsor: Coloplast. Clarification: Industry funding only - investigator initiated and executed study.

Abstract Background Sexual Medicine Society of North America (SMSNA) fellowships offer variable experience in sexual health domains: erectile dysfunction, Peyronie’s disease, male infertility, male hypogonadism (low testosterone), reconstruction (including male incontinence), benign prostatic hyperplasia, gender affirmation surgery, sexual mental health, and female sexual dysfunction. Aim To evaluate baseline and postbootcamp understanding and trust in these domains. Methods In 2023, 28 of 31 urologists currently enrolled in SMSNA-endorsed fellowships participated in a 3.5-day training bootcamp in Minneapolis, Minnesota. Participants were asked to complete pre- and postbootcamp surveys. The bootcamp curriculum offered American Urological Association guidelines and case-based lectures, hands-on clinical training with cadavers (penile surgery) and models (collagenase training), and interaction with industry. Outcomes Changes in knowledge, independence, and trust in performing the procedures, as well as billing issues and feedback for future bootcamps. Results Prebootcamp surveys revealed vastly varied residency experience. Reported time with an expert faculty member was greatest for benign prostatic hyperplasia and least for female sexual dysfunction, gender affirmation surgery, and low testosterone. The lowest prebootcamp confidence in performing surgery independently was for penile grafting procedures and elevating the neurovascular bundle. Postbootcamp results revealed several areas of significant improvement in confidence (P ≤ .03): intralesional injections for Peyronie’s disease, manual modeling, penile plication, penile grafting procedures, and elevating the neurovascular bundle. There was a trend for improved confidence with the insertion of inflatable (P = .05) and semirigid (P = .08) penile prostheses. Nonsignificant improvement occurred in artificial urinary sphincter surgery (P = .12). Participants graded the bootcamp very highly and requested that next year’s bootcamp have more content on female sexual dysfunction, male incontinence, and low testosterone, as well as more hands-on skills sessions and case-based lecture formats. Clinical Implications Offering a bootcamp with hands-on instruction could significantly improve urologists’ knowledge and confidence. Strengths and Limitations As the main strength, this study was the first specialized bootcamp for urologists in the subject of men’s health, taking into account hands-on and cadaver laboratories, as well as highlighting industrial and pharmaceutical products. The small sample size was the major limitation. Conclusions Current SMSNA fellows present with varied levels of experience and confidence across sexual health domains. Notable confidence improvements were seen with topics that combined didactic lectures with hands-on trainings.

Abstract Introduction Limited data are available on the efficacy of collagenase clostridium histolyticum (CCH) on Peyronie’s disease (PD) in men with ventral curvatures. Our team previously published a limited series of outcomes of 25 men with ventral curvatures who underwent CCH. Given the paucity of data available, we sought to provide an updated series of outcomes in this important cohort. Objective To report outcomes of men undergoing CCH injections for PD based on initial direction of curvature, including absolute and percent improvement in curvature, adverse events (AE), and other subjective outcomes. Methods A prospective registry has been maintained of all men undergoing CCH injections since 2014. All men underwent curvature assessments and subjective questioning at the time of initial evaluation and prior to each subsequent series of injections. The method of injection and subsequent protocol have changed in a stepwise fashion since 2014 and currently include injecting 0.9 mg (diluted to 0.8 mL) on back-to-back days, injecting into the point of max curve with an erection on day 1, performing in-office modeling on day 2, utilizing Restorex traction beginning on day 2, and wrapping for 4-8 days depending on results. To review outcomes, clinicopathologic data were abstracted from the registry including relevant history, exam, and data obtained at the time of penile ultrasound and curvature assessment. Outcomes are reported using a “Most Recent” definition (most recent data point used, regardless if the patient continues or finished treatment) and “Completed 8 or Satisfied” (only included if the patient indicated that they were done with treatment or had finished the full 8 injections). Results A total of 560 patients (mean age 57 years) were identified from March 2014 through Feb 2023 and comprise our study cohort. Overall, 85 men had a ventral component to their curvature and 475 non-ventral. Baseline demographics and clinical factors were similar between groups, with the exception of penile length (ventral 14.0 cm, non-ventral 12.0 cm, p<0.0001), Psych and Physical subdomain of the Peyronie’s Disease Questionnaire (10 vs 12, p=0.03), and prior treatment with CCH (3% vs 16%, p=0.03). Following treatment, men in the ventral cohort exhibited possibly greater improvements in curvature (Most Recent Definition: -25 degrees vs -24, p=0.08; 45% vs 34%, p=0.03; Completed 8 or Satisfied Definition: -35 vs -25, p<0.05, 48% vs 38%, p=0.11). However, all other outcomes were similar between cohorts, including differences in subdomains of the IIEF and PDQ, use of traction therapy, and adverse events including ecchymoses, hematomas, and popping sensations. Importantly, no urethral complications were experienced in the ventral group. Conclusions Men with ventral PD may be effectively treated with CCH with similar AEs compared to other directions. Ventral curvatures are likely associated with greater overall curvature improvements compared to other directions. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Endo - Matt Ziegelmann.

Abstract Introduction Semen parameters are a reflection of overall patient health and may fluctuate during times of physiologic stress. Autoimmune disease affects a number of aspects of health and may be exacerbated by disease flare-ups and/or medical therapy. Nearly 5 million men are living with an autoimmune disease, yet its effect on male fertility is not well defined. Objective The object of this study is to evaluate the effect of autoimmune disease and other health factors, such as smoking status, BMI, and age on semen parameters using a large institutional database. Methods We reviewed an institutional database of all patients who underwent as semen analysis for any reason between 2013 and 2019. In addition to autoimmune disease status, patient age, smoking status, and body mass index were noted. Chi-Squared analysis was performed to evaluate the effects of autoimmune disease and smoking status on semen analysis. Univariate analysis was performed to evaluate the effect of age and body mass index on semen analysis. Results Of the 1127 patients in the cohort, 44 patients had a diagnosis of autoimmune disease at the time of semen analysis. Mean age of patients with and without autoimmune disease was noted to be the same at 34 years. No significant difference was noted in semen parameters (motility, pH, concentration, volume, morphology) when comparing patients with autoimmune disease to those without. When looking at factors aside from having an autoimmune disease, smoking status had a significant difference on sperm morphology (p = 0.043) but did not have any significant effect on other semen parameters. Sperm motility (p = <0.01) and volume (p = 0.03) declined with increasing age. Increasing body mass index was associated with increased semen pH (p = 0.03), but otherwise did not impact semen parameters. Conclusions This single center, large retrospective analysis shows no significant impact of autoimmune disease on semen parameters. Smoking and patient age were the only significant factors that influenced semen parameters, while patient age only caused a slight increase in semen pH. Disclosure No.

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 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.

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 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.