Citations

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

Abstract Introduction Medical policy bulletins (also known as clinical policy bulletins) are insurance company guidelines for administering plan benefits. These documents purport to summarize current research, evidence-based guidelines, regulatory status, and physician opinion to determine whether insurers consider procedures and services to be medically necessary. These bulletins, along with member benefit plans, determine which services are covered. We have previously explored the lack of uniformity that exists for insurance payer coverage for penile prostheses. Here, we sought to expand this investigation to determine insurance coverage criteria for medical and surgical management of common men’s health conditions. Objective To determine covered benefits for sexual medicine conditions among the top United States healthcare insurers. Methods A list of common sexual medicine conditions was generated, including Peyronie’s disease, hypogonadism, erectile dysfunction, premature ejaculation, incontinence, and buried penis. The most common treatment modalities for each condition were identified (see Table I). Securities and Exchange Commission (SEC) filings were used to identify the top ten largest private insurers in the United States by member enrollment. This list was cross-referenced with the National Association of Insurance Commissioners (NAIC) 2020 Market Share Report (ref 1). The following list of the largest private US health insurers was thus developed: United, Anthem, Centene, Kaiser, Humana, CVS, Healthcare Service Corporation (HCSC), Cigna, Molina, and Independence Health Group (IBX). Kaiser and Centene were excluded due to lack of nationwide medical policy bulletins. We reviewed medical policy bulletins from the remaining 8 insurers to determine whether the specific treatments were identified as medically necessary, experimental/investigational, or cosmetic. Services and procedures deemed medically necessary were coded as “covered,” and those listed as investigational, or cosmetic were coded as “not covered.” If information about a specific condition or treatment modality was not found in a company’s policy bulletin, it was coded as “unknown.” Results In total, we recorded 143 data points, across the 8 insurance providers. Our review of medical policy bulletins yielded 60 (41.9%) instances where services were considered medically necessary and/or “covered”, 18 (12.6%) non-covered or investigational/cosmetic services, and 65 (45.5%) services with unknown coverage (Table I; covered=1, non-covered=0, unknown=2). Conclusions We encountered substantial difficulty in navigating and interpreting insurance coverage for various sexual medicine treatments and conditions based on review of policy bulletins from the topic insurance providers in the US. There was no readily identifiable coverage information for >45% of the data points that we collected, and instances of “unknown” coverage exceeded covered services across the collective of the largest private insurers. While 76.9% of conditions for which there was available data were covered, we are unable to draw generalizable conclusions for most conditions as there are significant deficits in the availability of policy information from online insurance sources. Further challenges in determining coverage include the additional layers of limitations in member plan benefits (i.e. plan exclusions), which could compound confusion for both physicians and patients. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast.

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

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

Abstract Introduction Peyronie’s disease (PD), estimated to affect around 10% of the male population, is an acquired disorder of penile fibrotic tissue. The only FDA approved medical treatment for PD is Intralesional Collagenase Clostridium Histolyticum (CCh). CCh is a mixture of AUX1 and AUXII, two different forms of collagenase that cleave collage type I and type III, leading to plaque degradation. PD plaques, however, also contain fibrin and calcium which CCh is unable to digest. It is unknown if plaque calcification prevents collagenolysis with CCh. Objective To determine if calcification prevents collageolysis of PD plaques with CCh. Methods Calcified PD plaques were collected from five males undergoing excision and grafting for PD. Control tissue was collected from five males undergoing penile implant surgery for erectile dysfunction, with no known history of PD. Tissue samples were then divided into equal weights and incubated with CCh or PBS for 24 hours. The CCh or PBS was injected into the tissue (control or plaque) to mimic administration of CCH for treatment of PD. Following incubation, the fluid (CCh or PBS) was measured for soluble collagen amount and tissue was subjected to Picrosirius Red and H&E staining. Results There was a higher concentration of soluble collagen in the tissue (control and plaque) incubated in CCh (301ug, SD 21.1) compared to the issue incubated in PBS (32.5ug, SD 3.7) (p=0.02). Additionally, there was less type 1 and 3 collagen present in the CCh condition (mean 0.12, SD=0.08), when compared to the PBS condition (0.44, SD=0.17) (p=0.002). However, when comparing within the CCh condition to look at differences between tissue types (calcified vs. control) no differences were found. There was a similar amount of soluble collagen in the CCh control condition (316ug, SD 35) and the CCh calcified condition (286ug, SD 11) (p=0.06). Similarly, the PBS control condition (30ug, SD17) and the PBS calcified condition (35ug, SD 48) were found to have no significant differences in collagen concentration (p=0.4). Finally, there were no significant differences found in type I/III collagen staining between tissues in the CCh condition, with control (0.08, SD=0.02) and calcified (0.17, SD=0.09) demonstrating no significant difference (p=0.08). Tissues in the PBS condition, control (0.5, SD=0.23) and calcified (0.39, SD=0.39), similarly were not significant (p=0.2) (table 1). Conclusions CCh is capable of breaking down collagen in calcified plaques. Further research into CCh as a treatment option for PD calcified plaques is necessary. 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: Acerus Pharmaceuticals, Boston Scientific, Coloplast, Endo Pharmaceuticals, Empower Pharmacy, Nestle Health, Olympus, Hims, Inc.

Abstract Introduction Independently performed procedures by well-trained advanced practice providers (APP) facilitate access to specialized care. We sought to compare outcomes between physicians and APPs with intralesional collagenase clostridium histolyticum (CCH). Objective Compare outcomes of CCH injections based on injection provider. Outcomes included curvature improvement and adverse events. Methods Men receiving CCH between 2014-2021 at our institution by four physicians and four APPs were included in an IRB-approved database. CCH was delivered as a series of 8 injections per protocol. Patient demographics, procedural-related adverse events, and curvature changes were recorded. The “APP-ratio” is defined as percentage of total injections administered by an APP per patient. Results After excluding patients who did not complete the entire CCH course or return for final assessment, 150/406 patients were analyzed. Mean baseline penile curvature was 66.2° (SD 23). Mean absolute and percent improvements in curvature were 21.7° (SD 18) and 33% (SD 27). The mean APP ratio was 69%, and 133 patients (89%) had at least 25% of their injections performed by an APP. There was no significant difference (p=0.65, p=0.39) in absolute or relative curvature improvement based on the APP-ratio [Figure 1]. There was also no difference in adverse events (pain, swelling, and hematoma). Conclusions In our high-volume CCH practice, APPs achieve the same outcomes and safety compared to physicians. Greater training efforts expand access to care for patients with PD. Disclosure No

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

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 reported outcomes of men undergoing a more aggressive protocol for CCH injections. 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, aggressive 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 are randomized 3:1 to receive either CCH + traction (RestoreX) + sildenafil (treatment) up front or initial observation followed by treatment (controls). Outcomes are subsequently compared between treatment and control groups. Key measures include 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 11/40 men have been randomized to date, with one having completed four series of CCH injections, three completing one series, and three completing two series. The average age of the cohort is 64.4 years, with a mean PD duration of 28.1 months. Mean baseline curvature was 82.9 degrees (composite curve). The average estimated improvement with prior CCH injections (before enrollment in the current study) was 10%. Preliminary outcomes of men who had completed one series and had a follow-up curve assessment available (n=3) demonstrated an absolute improvement of 28.3 degrees (42%). Of the one patient who completed four full series, the absolute curve improvement was 55 degrees (65%). The overall range of improvement among the four men was 20 to 55 degrees or 31 to 65%, with no patients failing to experience improvements thus far. Conclusions Preliminary data suggests that a repeat course of CCH using a previously described more aggressive administration protocol is effective at improving penile curvature in the majority of men. It is unclear if the improvements are due to the difference in administration protocol, or due to the repeat course of CCH alone. Given the very preliminary nature of the current results, additional data, including external validation, are warranted. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceutical Clarification Industry funding only - investigator initiated and executed study