Outcomes related to penile prosthesis reservoir removal: a 7-year multi-institutional experience.

BACKGROUND: The 3-piece inflatable penile prosthesis (IPP) is the most widely used device for erectile dysfunction refractory to medications, containing a reservoir inserted into the retropubic space (RPS) or an alternative/ectopic space (AES). Indications for removal of the reservoir include malfunction, malposition, or infection. In revision cases without infection, reservoir removal is sometimes optional. AIM: We reviewed outcomes and complications related to reservoir removal from a large multi-institutional series. METHODS: We retrospectively reviewed databases at 6 institutions over 7 years. Patients with artificial urethral sphincter, urethral sling, or mini-jupette were excluded. OUTCOMES: Outcomes and complications related to IPP reservoir removal were analyzed. Data were collected, but only reservoir-related complications at surgery were included. Data were compared between the RPS and AES cohorts to evaluate differences with a χ2 test, with significance at P < .05. RESULTS: Of 215 cases, there were 172 RPS and 43 AES reservoirs. The mean patient age was 65.3 years. An overall 131 procedures were due to malfunction and 49 to malposition of an IPP component; 35 were secondary to infection. Among those retained (n = 44), reasons included reuse, avoiding surrounding structure damage, and difficult dissection. Among those removed (n = 171), 15 required a counterincision. To determine the statistical difference between those removed from the RPS and an AES, the χ2 test result was P = .00059, indicating a significant difference in the need for a counterincision between the groups. Complications included bladder perforation (n = 1) in the RPS group and an avulsion of the epigastric vessels requiring abdominal exploration (n = 1) in the AES group. To determine the statistical difference between RPS and AES complications, the χ2 test result was P = .365, indicating no significant difference between the groups. STRENGTHS AND LIMITATIONS: Strengths include being a multi-institutional study with high-volume skilled implanters. Limitations include being a retrospective review, with implanters exclusively performing penoscrotal incisions and not utilizing an infrapubic approach. Last, there was a lack of long-term follow-up with these patients. CONCLUSIONS: Removal of an IPP reservoir remains safe, with few intraoperative complications. Surgeons should be aware of the inferior epigastric vessels during removal in an AES or be willing to perform a counterincision to avoid injury to surrounding structures. Surgeons should also obtain preoperative imaging to identify the specific location of the reservoir and adjacent anatomy. This is the first multi-institutional study reviewing outcomes related to reservoir removal during IPP revision or removal surgery.

Lessons learned from the Sexual Medicine Society of North America fellowship bootcamp.

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.

Creation of a Novel Classification System (PTNM) for Peyronie's Disease and Penile Curvature Using Evidence-Based Criteria.

PURPOSE: Our goal was to identify new Peyronie's disease (PD) subtypes, non-PD penile curvature classifications, and define active (acute) vs stable (chronic) phases of disease using evidence-based analyses. MATERIALS AND METHODS: A retrospective review was performed of 1098 men who presented with penile deformity, including subjective standardized and nonstandardized questionnaires and objective measures. A second cohort of 719 men who were sent a mailed survey was also utilized for the relapsing/remitting subtype. Statistical analyses were performed to identify clusters of disease characteristics representative of distinct PD and non-PD categorizations, including sensitivity/specificity analyses and subtype comparisons. RESULTS: Comparative analyses identified 4 distinct subtypes of PD: (1) classical and nonclassical, (2) calcifying-moderate/severe calcification, (3) progressive-subjective worsening following disease onset, and (4) relapsing/remitting-reactivation following ≥ 6 months of stability. Additional, non-PD categorizations included congenital (lifelong), maturational (developed around puberty), and trauma induced. Statistical analyses demonstrated unique profiles among each category. Penile pain was not found to be a reliable predictor for disease progression or stability. Stable phase disease (historically "chronic") was variably defined by subtype: classical (≥3 months); progressive, calcifying, or trauma induced (≥12 months + ≥3 months stable OR ≥6 months stable). Similarly, PD subtypes may be assigned at ≥ 3 months following disease onset. A PTNM staging system is proposed to help communicate disease states, in which P = PD component (Ca-calcifying, Cl-classical, P-progressive, R-relapsing/remitting, U-undifferentiated), T = trauma component (0-absent, 1-present), N = non-PD component (C-congenital, M-maturational, U-undifferentiated), and M = mode (0-stable, 1-active); for example, PClT1N0M0 = stable classical PD with prior trauma. CONCLUSIONS: The current study provides an evidence-based proposal for the establishment of new PD subtypes and non-PD curvature categorizations as well as a standardized definition for active vs stable phases of disease.

Cosmetic penile enhancement procedures: an SMSNA position statement.

BACKGROUND: Penile cosmetic enhancement procedures have been performed for many years with varying success. However, they have historically been relegated to niche areas of sexual medicine, with limited data, and have not achieved mainstream adoption. More recently, the topic has been increasingly discussed within academic congresses due to availability of novel techniques, therapies, and procedures. Given their distinctive nature, the Sexual Medicine Society of North America (SMSNA) felt that it was pertinent to develop formal position statements to help guide both patients and sexual medicine providers on the current state of the scientific literature and to give recommendations for future research. AIM: The study sought to provide an evidence-based set of recommendations for injection and surgical procedures designed to lengthen, augment, or otherwise cosmetically enhance the penis. METHODS: A review was performed of all scientific literature listed in PubMed from inception through December 2023 relating to penile cosmetic enhancement procedures. Only invasive (injection/surgery) therapies were included due to their distinct risk-benefit profile compared with more conservative treatments (eg, vacuum erection devices, penile traction devices). Similar therapies were categorized, with pertinent data summarized and used to help create relevant position statements. All statements were expert opinion only and were based on analyses of the potential risks and benefits of the specific therapies. OUTCOMES: A total of 6 position statements were issued relating to 5 distinct sexual medicine cosmetic enhancement procedures. RESULTS: A consensus opinion was reached by SMSNA leadership on the state of injection/surgical penile cosmetic enhancement procedures as of 2024. Key topic areas addressed included injectable soft tissue fillers, suspensory ligament division, graft-and-flap procedures, silicone sleeve implants, and sliding/slicing techniques. Distinct recommendations were tailored to each therapy and were based solely on the current state of the literature. It is anticipated that future studies will further inform position statements and will lead to ongoing modifications. CLINICAL IMPLICATIONS: The current position statements provide both patients and clinicians evidence-based, expert recommendations on best practices relating to penile cosmetic enhancement procedures. STRENGTHS AND LIMITATIONS: Strengths include the use of an expert panel of sexual medicine clinicians, consensus design, and summary of existing literature. Limitations include expert opinion and limited research on the topic. CONCLUSION: The current SMSNA position statements provide evidence-based, consensus opinions on the appropriate role for penile augmentation and cosmetic procedures in 2024.

The Utilization of Fine-Needle Vasography to Localize Obstruction of the Male Reproductive Tract.

OBJECTIVE: To report our experience using fine-needle vasography (FNV) to identify a site of obstruction and determine candidacy for reconstructive procedures in patients presenting with suspected obstructive azoospermia (OA) or cryptozoospermia. METHODS: We report a multi-institutional case series of patients with suspected complete or partial OA. Patients that were included had azoospermia or cryptozoospermia, presence of palpable vasa, testicles ≥12 mL, and FSH <7.6 IU/L. All patients underwent testicular biopsy prior to or at the time of FNV to confirm spermatogenesis. FNV was performed using a 25-gauge angiocatheter, with radio-opaque dye visualized under fluoroscopy. Descriptive statistics are reported as median and interquartile range (IQR). RESULTS: A total of 16 patients underwent vasography from 2014 to 2022 with 3 surgeons. Twelve patients presented with azoospermia, and 4 with cryptozoospermia. A total of 7 (44%) men were found to have distal obstruction on FNV. Of the 8 men with prior inguinal hernia repairs, 2 were confirmed to have an obstruction at the level of the inguinal canal. Of the 6 patients with a history of genitourinary infection, 4 had an obstruction at the level of the epididymis (with normal FNV), while 2 had atresia of the vas deferens in the pelvis. CONCLUSION: FNV is an effective, minimally invasive way to identify the site of complete or partial obstruction in patients presenting with suspected OA/cryptozoospermia. It additionally permits identification of men who are candidates for epididymovasostomy reconstruction and helps to differentiate between ejaculatory duct obstruction (EDO) and other causes of blockage.

Changes in Point of Maximal Curvature During Collagenase Clostridium Histolyticum Injections for Peyronie's Disease.

OBJECTIVE: To determine change in the point of maximal curvature (POMC) during Collagenase Clostridium histolyticum (CCH) injections for Peyronie's disease (PD). METHODS: A prospective database has been maintained of all men undergoing CCH injections since March 2014. For the current study, data were abstracted on the POMC with each curve assessment and correlated with demographic and clinical factors. Maximal changes were defined as the largest change in POMC from baseline. RESULTS: Six hundred and eighteen men underwent ≥1 series of CCH, with 313 having a baseline and subsequent POMC measurements available. Median baseline curvature was 60.0° and POMC 2.8 cm. Among 189 men who were satisfied or completed 8 CCH injections, the median improvement in penile curvature was -27.5° (40.9%). The median maximal change in POMC during CCH treatment was 1.0 cm (interquartile range, 0.5, 1.8). Overall, 55.6% had changes in POMC of ≥1 cm, 23.6% ≥2 cm, 8.9% ≥3 cm, and 3.8% ≥4 cm. Multivariate logistic regression identified ventral curvature as a predictor of larger change in POMC, after controlling for other variables. Study limitations included the observational, non-randomized study design and potential for intra- and inter-individual measurement variability. Strengths are the inclusion of an all-comer population, large series, prospective database, and routine objective assessments. CONCLUSION: Approximately half of men with PD undergoing CCH experience ≥1 cm of change in POMC during the treatment course, with nearly 1/4 experiencing ≥2 cm. Findings suggest that patients may benefit from repeat curvature assessments with each CCH series to optimize accuracy of drug administration.

Outcomes of collagenase Clostridium histolyticum in men with ventral curvatures: an updated series.

BACKGROUND: The efficacy and safety of collagenase Clostridium histolyticum (CCH) have been demonstrated in the treatment of men with Peyronie's disease (PD); however, the pivotal clinical trials excluded men with ventral penile curvature. AIM: The study sought to evaluate outcomes of CCH treatment in men with ventral curvatures secondary to PD. METHODS: Men with PD treated with CCH were identified from a prospective database. Patients received up to 4 series of CCH injections using a progressively modified protocol over time. Results were compared between those with baseline ventral vs nonventral penile curvatures. OUTCOMES: Changes in penile curvature, Peyronie's Disease Questionnaire scores, International Index of Erectile Function scores, nonstandardized assessments, and adverse events. RESULTS: A total of 560 men with PD (85 ventral curvature, 475 nonventral curvature) were included in the analysis. Baseline median curvature was 60.0° (interquartile range, 48.8°-75.0°) in the ventral cohort and 65.0° (interquartile range, 45.0°-80.0°) in the nonventral cohort. Median change from baseline penile curvature was -25.0° in the ventral cohort vs -24.0° in the nonventral cohort (P = .08, between-group comparison), which corresponded to curvature reductions of 44.7% and 33.6%, respectively (P = .03). In the subset of patients who completed CCH treatment (ie, received 8 injections or discontinued early because of patient satisfaction with curvature reduction), median change from baseline was -35.0° in the ventral cohort vs -25.0° in the nonventral cohort (P < .05); median percent improvement was 48.3% and 37.5%, respectively (P = .11). Median change from baseline in Peyronie's Disease Questionnaire and International Index of Erectile Function domain scores and adverse events were similar between cohorts, with the exception of possibly higher hematoma rates in the nonventral group (50% vs 37%; P = .05). No urethral injuries were sustained in either cohort. CLINICAL IMPLICATIONS: Data support the use of CCH for the treatment of ventral as well as nonventral penile curvatures in men with PD. STRENGTHS AND LIMITATIONS: Study strengths are the inclusion of a general clinical population of men with PD, the prospective design, and the relatively large series of men with ventral curvature. Limitations include the single-center and observational nature of the study. CONCLUSION: CCH was safe and effective in the treatment of both ventral and nonventral penile curvatures in men with PD.

Comparison of Collagenase Clostridium histolyticum to Surgery for the Management of Peyronie's Disease: A Randomized Trial.

PURPOSE: Since Food and Drug Administration approval of collagenase Clostridium histolyticum for Peyronie's disease, there has been significant debate regarding its role and comparable efficacy to surgery. MATERIALS AND METHODS: A randomized, controlled trial was performed of Peyronie's disease men treated with either collagenase C histolyticum + RestoreX penile traction therapy + sildenafil or penile surgery + RestoreX penile traction therapy + sildenafil, with 3-month data presented. Primary objectives were overall satisfaction, subjective changes in erectile function, penile sensation, penile length, and changes in the International Index of Erectile Function-Erectile Function Domain score. Secondary outcomes included objective changes in length, curve, adverse events, and other standardized and nonstandardized questionnaires. RESULTS: A total of 40 men were enrolled, with 38 (collagenase C histolyticum group = 19, surgery group = 19) completing treatment and having 3-month data available. All demographic and clinicopathological variables were similar between groups. Following treatment, 50% of men in the collagenase C histolyticum group reported being very satisfied (vs 21% in the surgery group, P = .08) and noted better subjective erectile function (100% vs 68%, P = .03) and penile length (88% vs 16%, P < .0001), lesser impacts on penile sensation (75% vs 11% no change, P < .001), and similar International Index of Erectile Function-Erectile Function Domain changes (+1.5 vs +2.5, P = .91). Objectively, men in the surgery group had greater curve improvements (84% vs 54%, P < .01) and higher rates of adverse events (50 vs 13 events, P < .001) but decreased penile length (-0.5 cm vs +1.0 cm, P < .01). CONCLUSIONS: At 3 months posttreatment, collagenase C histolyticum + RestoreX penile traction therapy + sildenafil results in lesser curve improvements but greater penile length and fewer adverse events, including impacts on subjective erectile function and sensation, than men treated with surgery.

Incremental Treatment Response by Cycle With Collagenase Clostridium Histolyticum for Peyronie's Disease: A Pooled Analysis of Two Phase 3 Trials.

OBJECTIVE: To evaluate cumulative and incremental changes in penile curvature after each treatment cycle of collagenase clostridium histolyticum (CCH) in men with Peyronie's disease (PD). METHODS: Data from 2 phase 3, randomized, placebo-controlled trials were analyzed post hoc. Treatment was administered in up to 4 treatment cycles (per cycle: 2 injections, 1-3 days apart, of CCH 0.58 mg or placebo; subsequent penile modeling) at 6-week intervals. Penile curvature was measured at baseline and after each treatment cycle (weeks 6, 12, 18, and 24). Successful response was defined as ≥20% reduction from baseline penile curvature. RESULTS: Overall, 832 men (CCH, n = 551; placebo, n = 281) were included in the analysis. After each cycle, mean cumulative percent reduction from baseline penile curvature was significantly greater with CCH vs placebo (P <.001). Following one cycle, 29.9% of CCH recipients exhibited a successful response. Among nonresponders, additional cycles of injections led to further successful responses: 60.8% of first cycle failures achieved response after fourth cycle (8 injections), 42.7% of cycle 1-2 failures achieved response after fourth cycle, and 23.5% of cycle 1-3 failures achieved response after fourth cycle. CONCLUSION: Data showed incremental benefits from each of the 4 CCH treatment cycles. Completion of a full series of 4 CCH treatment cycles may optimize improvements in penile curvature in men with PD, including among those who did not clinically respond to previous treatment cycles.

Efficacy of collagenase Clostridium histolyticum in men with congenital penile curvature.

BACKGROUND: Collagenase Clostridium histolyticum (CCH) has been proven effective in multiple subpopulations of PD men; however, no studies have evaluated its role with congenital penile curvature (CPC). AIM: To evaluate the safety and efficacy of CCH in men with CPC. METHODS: A prospective registry was queried of men undergoing CCH injections at our institution. Beginning in 2016, CCH was administered to CPC men using a similar protocol to PD. A comparative analysis was performed between cohorts to evaluate the safety and efficacy of therapy. OUTCOMES: Objective measures included penile length and curvature, while subjective outcomes included standardized (International Index of Erectile Function and Peyronie's Disease Questionnaire) and non-standardized assessments. Curvature outcomes were categorized as follows: 1 - included all men, with the most recent assessment considered final, and 2 - only men who had completed eight CCH injections or stopped early due to satisfaction. RESULTS: From 2014 to Oct 2021, a total of 453 men (408 PD, 45 CPC) underwent one or more CCH injections. In comparing cohorts, CPC men were younger (33 vs 58 years, p<0.0001), had lesser baseline curvatures (52.5 vs 65°, p<0.01), more ventral curves (25.7 vs 9.2%, p<0.01), and longer penile lengths (12.5 vs 12.0 cm, p=0.04). Following treatment, both cohorts experienced similar curvature improvements. Specifically, PD men experienced 20-25° or 33-35% improvements depending on definition compared to 25-30° or 40-50% in CPC men (all p-values >0.05). CPC and PD men also demonstrated similar changes on standardized questionnaires, with the exception of the Psychological and Physical subdomain, which was more improved in CPC men (-11 vs -4, p<0.01). Baseline curvature was positively correlated with greater absolute (degree) and relative (percent) improvements. Adverse events were similar between groups after controlling for confounders. CLINICAL IMPLICATIONS: CCH may be safely and effectively administered in men with CPC. These data provide the first evidence for the efficacy of a non-surgical therapeutic option in this cohort. STRENGTHS AND LIMITATIONS: Strengths - large, prospective series with standardized assessments; Limitations - non-randomized study, short-term follow-up, and lack of standardized method to differentiate CPC from PD. CONCLUSIONS: CCH may be safely and effectively administered to men with CPC, with similar success rates compared to PD. Increasing curvature was associated with greater absolute (degree) and relative (percent) improvements, supporting the role for CCH in men with mild, moderate, or severe curvatures. External validation is warranted prior to routine implementation.

Penile surgery for patients with Peyronie's disease initially treated with collagenase clostridium histolyticum or surgery: a claims database analysis.

Collagenase clostridium histolyticum (CCH) is an injectable therapy targeting collagen present in penile plaques in Peyronie's disease (PD). Data comparing CCH to penile surgery are limited, and long-term therapeutic outcomes are unknown. This retrospective analysis used a US claims database (January 2014-June 2017) to determine the percentage of men with subsequent penile surgery among those who initially received CCH (n = 1227) or surgery (index treatment; n = 620) for PD. Eligible patients were aged ≥18 years with continuous enrollment ≥6 months before and ≥12 months after index treatment date. During 12 months of post-index treatment follow-up, fewer patients with PD initially treated with CCH (4.6% [56/1227]) had subsequent penile surgery versus those initially treated with penile surgery (10.3% [64/620]; p < 0.0001). Mean ± SD time to first subsequent surgery after initial PD treatment was longer in the CCH versus surgery cohort (7.7 ± 3.0 vs 1.7 ± 3.2 months). The likelihood of subsequent surgery varied by initial surgery type: 18.2% after plaque incision or excision with grafting; 11.6% after penile implant; and 8.2% after tunical plication. Patients with PD who received CCH first were less likely to undergo subsequent surgery compared with those who received surgery first within a 12-month post-treatment follow-up.

Guidelines for Sexual Health Care for Prostate Cancer Patients: Recommendations of an International Panel.

BACKGROUND: Patients with prostate cancer suffer significant sexual dysfunction after treatment which negatively affects them and their partners psychologically, and strain their relationships. AIM: We convened an international panel with the aim of developing guidelines that will inform clinicians, patients and partners about the impact of prostate cancer therapies (PCT) on patients' and partners' sexual health, their relationships, and about biopsychosocial rehabilitation in prostate cancer (PC) survivorship. METHODS: The guidelines panel included international expert researchers and clinicians, and a guideline methodologist. A systematic review of the literature, using the Ovid MEDLINE, Scopus, CINAHL, PsychINFO, LGBT Life, and Embase databases was conducted (1995-2022) according to the Cochrane Handbook for Systematic Reviews of Interventions. Study selection was based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Each statement was assigned an evidence strength (A-C) and a recommendation level (strong, moderate, conditional) based on benefit/risk assessment, according to the nomenclature of the American Urological Association (AUA). Data synthesis included meta-analyses of studies deemed of sufficient quality (3), using A Measurement Tool to Assess Systematic Reviews (AMSTAR). OUTCOMES: Guidelines for sexual health care for patients with prostate cancer were developed, based on available evidence and the expertise of the international panel. RESULTS: The guidelines account for patients' cultural, ethnic, and racial diversity. They attend to the unique needs of individuals with diverse sexual orientations and gender identities. The guidelines are based on literature review, a theoretical model of sexual recovery after PCT, and 6 principles that promote clinician-initiated discussion of realistic expectations of sexual outcomes and mitigation of sexual side-effects through biopsychosocial rehabilitation. Forty-seven statements address the psychosexual, relationship, and functional domains in addition to statements on lifestyle modification, assessment, provider education, and systemic challenges to providing sexual health care in PC survivorship. CLINICAL IMPLICATIONS: The guidelines provide clinicians with a comprehensive approach to sexual health care for patients with prostate cancer. STRENGTHS & LIMITATIONS: The strength of the study is the comprehensive evaluation of existing evidence on sexual dysfunction and rehabilitation in prostate cancer that can, along with available expert knowledge, best undergird clinical practice. Limitation is the variation in the evidence supporting interventions and the lack of research on issues facing patients with prostate cancer in low and middle-income countries. CONCLUSION: The guidelines document the distressing sexual sequelae of PCT, provide evidence-based recommendations for sexual rehabilitation and outline areas for future research. Wittmann D, Mehta A, McCaughan E, et al. Guidelines for Sexual Health Care for Prostate Cancer Patients: Recommendations of an International Panel. J Sex Med 2022;19:1655-1669.

Improved Peyronie's Disease Curvature Outcomes Using a Novel Collagenase Administration Protocol.

OBJECTIVE: To report outcomes of a novel collagenase clostridium histolyticum (CCH) injection protocol. METHODS: A prospective, sequential database was maintained of all Peyronie's men undergoing CCH injections since 2015. Our protocol has evolved to include changes with injection technique, timing, aggressive modeling/traction, and wrapping. Results of the "traditional" and "novel" techniques were compared using two definitions: "most recent" assessment and final assessments among men who "completed eight (injections) or were satisfied." RESULTS: A total of 509 men underwent greater than or equal to 1 CCH series (traditional, n = 280; novel n = 229). Baseline demographic/clinicopathologic characteristics were similar between groups. Results demonstrated significantly greater curve improvements with the novel technique ("most recent" median 30° vs 20° or 46% vs 28%; "completed eight or satisfied" 34° vs 20° or 58% vs 30%). Using the "completed eight or satisfied" definition, 94% vs 66% of men achieved greater than or equal to 20% improvement (odds ratio 7.6), and 60% vs 24% achieved greater than or equal to 50% improvements (odds ratio 5.0) in the novel cohort (all P < .0001). Importantly, the International Index of Erectile Function Erectile Function Domain score was unchanged, and subjective erectile function (50% vs 5%, P < .0001) and sensation improved (17% vs 8% improved, P = .01) with the new protocol. The novel cohort also reported higher rates of surgery prevention (53% vs 18%), restored/facilitated penetration (57% vs 21%), and hematomas (56% vs 26%), necessitating changes to wrapping procedures (all P < .0001). CONCLUSIONS: Use of the novel CCH protocol results in significant improvements with curvature without negatively impacting erectile function or sensation. Given its specialized nature, it is not recommended for low-volume CCH injectors.

Conservative management of suspected fractures in men undergoing collagenase clostridium histolyticum for Peyronie's Disease is not associated with worsening of erectile function.

The optimal management of suspected penile fractures post collagenase clostridium histolyticum (CCH) remains indeterminate, with some advocating for observation and others surgical repair. To address this issue, the current study sent surveys to 158 men with Peyronie's Disease (PD) who completed four CCH injection series. The survey included the Erectile Function Domain from the International Index of Erectile Function (IIEF-EFD) and questions regarding potential symptoms of corporal rupture (hematoma, popping, and detumescence). Men were categorized as having a suspected fracture (SF+) if they reported a popping sensation or rapid detumescence. All SF(+) men were managed conservatively without surgical intervention. Results were compared statistically against baseline IIEF-EFD values and between SF(+) and SF(-) groups. The key study objective was to determine whether erectile function was negatively impacted by conservative management of suspected fractures. Of the 53 returned surveys, 45 had complete data for review. The sample was statistically representative of the broader cohort of 158 men, except being older (60.0 vs 57.1 [SD 6.0 vs 9.0], p = 0.01) with shorter durations of PD (median 9 [IQR 5, 19] mo vs 13 [IQR 8, 24], p = 0.01). Overall, 7/45 (16%) of men were defined as SF(+), with all fractures occurring within 6 weeks of CCH administration. No demographic or pathophysiologic characteristics predicted SF(+). Importantly, SF(+) men did not experience worsened erectile function compared to SF(-), with a median IIEF-EFD change of +2 vs +1, p = 0.16, respectively. Curvatures were improved to a greater degree among SF(+) men (primary: median -30 [IQR -20, -32.5] vs -15 [-5, -26], p = 0.04; composite: -35 [-25, -40] vs -25 [-7, -30], p = 0.15). We concluded that suspected penile fractures in PD men undergoing CCH may be reasonably managed without surgical intervention and portend greater improvements in curvature correction.

Continuing Collagenase Clostridium Histolyticum Injections Among Initial Nonresponders Results in Significant Curvature Improvements in the Majority of Peyronie's Disease Men.

BACKGROUND: It is currently unclear if men with Peyronie's Disease (PD) who achieve minimal benefits with the first 2 series of Collagenase Clostridium Histolyticum (CCH) injections should continue with additional injections. AIM: To analyze curvature improvements from the final two series of CCH injections based on amount of improvement during the first 2 series. METHODS: A prospective registry was analyzed of all men undergoing CCH injections for PD at a single institution. Men were included if they had completed a full 4 series (8 injections) of CCH and had baseline, interval (after 2 series), and/or final (after 4 series) curvature assessments available. Men were stratified into cohorts using baseline-to-interval assessments of ≤10° (or ≤20%) and >10° (or >20%), and improvements were compared using interval-to-final assessments. OUTCOMES: The primary outcome was interval-to-final curvature improvements stratified by ≤10°/>10° or ≤20%/>20% improvements achieved during the baseline-to-interval period. Secondary outcomes included analyses of demographic and pathophysiologic variables to determine associations with significant improvements during the final 2 CCH series. RESULTS: A total of 296 PD men were identified as receiving at least one CCH injection, of whom 175 had baseline-to-interval, 84 interval-to-final, and 115 with baseline-to-final measurements. Mean age was 56.6, PD duration 28.6 months, baseline curvature 63.4°, hourglass deformity 36.2%, and calcification 20%. Mean overall curve improvement was -21.5° (33.1%). Among men who experienced ≤20% improvements after 2 series, the mean subsequent curvature change was -24.6% during the final two series (vs +4.3% of those with >20% initial improvement, P< .001), and they were 2.7x more likely to experience >20% subsequent curve improvements. Thirty-one percent of those who achieved >10° during the first 2 series experienced benefits during the final 2 series compared to 70% of men who had ≤10° improvement initially. No demographic or pathophysiological variables predicted likelihood for improvements during the final 2 series of injections. CLINICAL IMPLICATIONS: Men who fail to achieve significant benefits with 2 series of CCH injections may benefit from completing the final 2 series. STRENGTHS AND LIMITATIONS: Strengths including a relatively large, prospective series. Limitations include a single center, nonrandomization, nonblinded assessments, and restriction to men who completed eight injections. CONCLUSIONS: In the current series, approximately 2/3 of men who fail to achieve >10° or 20% curve improvements with an initial 2 series of CCH injections achieved >10° or 20% improvements with the subsequent 2 series. Alom M, Burgon H, Ziegelmann M, et al. Continuing Collagenase Clostridium Histolyticum Injections Among Initial Nonresponders Results in Significant Curvature Improvements in the Majority of Peyronie's Disease Men. J Sex Med 2021;18:1092-1098.

Patient Attitudes Towards Surgical Management of Peyronie's Disease Prior to Men's Health Consultation.

OBJECTIVE: To evaluate clinical characteristics associated with patient attitudes toward surgical treatment of Peyronie's disease (PD) prior to consultation in a high-volume male sexual health clinic. METHODS: From 2014-2018 a prospective database was created of patients presenting to the sexual health clinic at our institution. Multivariable regression analysis was conducted to determine factors associated with pre-visit consideration of surgery. RESULTS: Of 1359 men presenting to clinic, 342 had a chief complaint of PD. Prior to consultation, 79% of patients (n = 270) stated they were willing to consider surgery to correct their PD symptoms. Factors associated with consideration of surgery included younger patient age (mean 55.8 vs 60.0 years; P = .008), history of depression/anxiety (21% vs 8%, P = .01), greater penile curvature (43.3 vs 34.6 degrees; P = .002), penile shortening (64% vs 44%; P = .003), pain with erections (46% vs 33%; P = .05) and decreased ability to have penetrative intercourse (51.9% vs 65.3%, P = .04). On multivariable analysis, age, history of depression, penile shortening, and mean curvature remained significantly associated. Symptom duration and relationship factors were not associated with a difference in the stated preference to consider surgery prior to consultation (P >.05 for all). CONCLUSION: Nearly 4 out of 5 patients reported willingness to consider surgical intervention for their PD-related symptoms prior to urologic consultation. On multivariable analysis, younger age, history of depression/anxiety, penile shortening, and curvature were associated with a greater likelihood of considering surgery. This information provides important insight into patient attitude toward undergoing surgery and will help drive patient counseling for men with PD.

Treatment Patterns and Healthcare Outcomes with Collagenase Clostridium Histolyticum vs Surgery in Peyronie's Disease: A Retrospective Claims Database Analysis.

INTRODUCTION: Treatments for Peyronie's disease (PD) include surgical management and collagenase clostridium histolyticum (CCH). AIMS: To evaluate PD treatment trends after CCH approval and compare clinical outcomes in CCH- and surgery-treated cohorts. METHODS: Patients newly diagnosed with PD between January 2011 and December 2017 were identified in a U.S. claims database. Cohorts initiating treatment with CCH or surgery between January 2014 and June 2017 were included. Patients were continuously enrolled ≥6 months before and ≥12 months after index date. Post-treatment penile complications and analgesic use were compared 1 year after procedure in propensity score-matched cohorts. MAIN OUTCOME MEASURES: The main outcome measures of this study were treatment patterns, penile complications, and analgesic use. RESULTS: In the newly diagnosed PD cohort, 1,609 patients received CCH and 1,555 patients had surgery. Overall CCH or surgery treatment rate/year increased from 9.8% in 2014 to 15.5% in 2017, with <1% receiving verapamil or interferon. Initial treatment ratios of CCH to surgery increased from approximately 1:1 (2014) to 2:1 (2017). In the unmatched CCH (n = 1,227) and surgery (n = 620) cohorts, more (P < .05) surgery-treated patients received analgesics (particularly opioids), oral PD therapies, vacuum erection devices, and phosphodiesterase-5 inhibitors before the index date. After propensity score matching (n = 620/cohort), newly occurring postprocedural complications during the follow-up period were higher in the surgery cohort (25.3% vs 18.4%, P = .003). The surgery cohort had significantly (P < .05) higher rates of erectile dysfunction (65.0% vs 44.8%), penile pain (17.9% vs 8.9%), and penile swelling (8.1% vs 5.2%) and was more likely to be prescribed opioids (93.3% vs 38.9%; P < .0001) or non-steroidal anti-inflammatory drugs (27.0% vs 20.3%; P = .006). CONCLUSION: CCH demonstrated fewer complications and less analgesic use than surgery and was used as the initial therapy for PD twice as often as surgery. L Trost, H Huang, X Han, et al. Treatment Patterns and Healthcare Outcomes with Collagenase Clostridium Histolyticum vs Surgery in Peyronie's Disease: A Retrospective Claims Database Analysis. Sex Med 2021;9:100321.

Predictors of Patient Willingness to Consider Surgery Prior to Consultation at Sexual Health Clinic.

OBJECTIVE: To identify factors associated with patient willingness to consider surgical treatment for erectile dysfunction (ED) prior to urologic consultation. METHODS: A prospective database of patients presenting to the sexual health clinic at our institution was created from 2014 to 2018, consisting of previsit patient questionnaires and clinical information. Univariable and multivariable logistic regression analysis was performed to determine factors associated with consideration of surgery and decision to undergo surgery. RESULTS: Of 1359 men presenting to the clinic, 991 men had a chief complaint of ED with 630 (63.6%) considering surgery. On multivariable analysis, factors significantly associated with previsit willingness for surgery included history of diabetes mellitus (P = .0009), increasing symptom bother (P <.0001), and decreasing relationship duration (P = .0005). Approximately 16% (162/991) patients considering surgery prior to consultation ultimately underwent penile implant insertion. Multivariable analysis demonstrated that older age (P = .003), history of diabetes mellitus (P = .03), lower international index of erectile function-EF domain (P = .0009) and history of intracavernosal injection therapy (P <.0001) were significantly associated with proceeding to ED surgery. Initial declaration of willingness to undergo ED surgery led to nearly 8-fold increased odds for surgery (P <.0001). CONCLUSION: Over 60% of patients presenting for ED consultation considered surgical intervention, of whom 25% underwent penile prosthesis. Both patient and relationship factors were predictors of surgical willingness. Previsit surgical willingness was associated with highest odds of eventual decision for surgery, suggesting that knowledge of ED treatment options in the general public may play a role. Our findings highlight opportunities for shared decision-making in a patient-centered model of care.