Hu, Yiqun

Abstract Introduction Peyronie’s disease (PD) is a connective tissue disorder associated with the formation of fibrotic plaques in the tunica albuginea, leading to penile curvature. PD is underdiagnosed, and this may be related to the reluctance of some men to seek consultation with a health care provider (HCP). Objective The aim was to develop an English-language digital application (app) to increase PD awareness, give men concerned about penile curvature a self-screening tool, and provide a link for locating HCPs with expertise in PD. Methods The Peyronie’s Disease Self-Assessment App is Android- and iOS-compatible. It was developed as a self-assessment tool for screening purposes only. It is not intended to diagnose, treat, cure, or prevent any medical condition, disease, or health problem and should not be considered a replacement for a consultation with a physician. The app provides instructional videos on general features and how to perform a penile scanning procedure. Results The PD Self-Assessment App includes a questionnaire related to penile curvature, penetration difficulty, degree of bother for partner, and impact on sexual activity. An innovative feature of the app is a live scanning technology, which uses the phone’s camera to detect the contours of the penis from multiple angles and applies an algorithm that determines the degree of curvature. The resulting image is a 3D penile simulation in the app, which allows the user to mark the location of any “lumps.” The app will also produce a 2D outline to determine the maximum curvature. External links are provided to a PD education website and to locate an HCP. The patient can share both the questionnaire responses and penile curvature simulation with his HCP via the user’s native email. This tool has password protection features and encrypts sensitive data. The scan images are representations of the penis, not photographs. Images are stored in the app library and are not stored in the user’s photo gallery. To enhance security, all data are erased when the app is uninstalled. The app is adaptable and scalable as needed for future updates. Conclusions The PD Self-Assessment App will help improve patient knowledge of the condition, document penile deformity, and facilitate consultation with an HCP. For men with PD, the app will help ease their journey with PD. The app will assist HCPs with evaluation and diagnosis. Sequential documentation of penile curvature during medical treatment, during mechanical traction protocols, or following surgery will provide an evidence basis for tracking long-term outcomes in PD. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals Inc. Clarification Industry initiated, executed and funded study Any of the authors act as a consultant, employee or shareholder of an industry for: Endo Pharmaceuticals Inc.

ABSTRACT Introduction The efficacy and safety of collagenase clostridium histolyticum (CCH) for the treatment of Peyronie's disease (PD) were demonstrated in two phase 3, randomized, double-blind, placebo-controlled studies. CCH injections were administered in up to 4 treatment cycles at 6-week intervals; each cycle included two injections 1-3 days apart. Objective To evaluate incremental changes in penile curvature over the course of CCH treatment in men with PD. Methods A post hoc analysis was conducted using pooled data from the 2 placebo-controlled trials. Change from baseline and from the previous penile curvature measurement were calculated after each of the 4 treatment cycles (Weeks 6, 12, 18, and 24). For all patients, treatment included penile plaque modeling. For CCH vs placebo, mean percentage change in penile curvature was compared using a two-sample t-test; percentage of patients classified as treatment responders (defined as curvature reduction ≥20%) was compared using Fisher's exact test. Results The population included 832 adult men (CCH [n=551]; placebo [n=281]) who received ≥1 injection of study medication. At baseline, mean ± standard deviation (SD) penile curvature was 50.6±14.7 degrees in the CCH group and 50.4±14.1 degrees in the placebo group. Compared with baseline, the mean ± SD percentage change in penile curvature was -12.8±20.3% for CCH vs -6.2±18.8% for placebo after the first treatment cycle, -22.6±23.5% vs -10.6±23.1% after the second, -29.9±25.0% vs -14.6±24.0% after the third, and -33.1±28.0% vs -16.6±25.5% after the fourth (all P<0.001 vs placebo; Figure 1A). Comparing change from the previous measurement (ie, incremental change from previous treatment cycle [eg, between first and second; second and third, etc]), mean ± SD percentage reduction in penile curvature was 11.1±21.8% vs 5.0±16.4% after the second treatment cycle (P<0.001 vs placebo), 9.6±21.8% vs 3.9±17.0% after the third (P<0.001) and 6.3±23.0% vs 2.0±17.2% after the fourth (P=0.009; Figure 1B). The percentage of patients with ≥20% reduction in penile curvature since the previous measurement (cycle) was 29.9% for CCH group vs 18.3% for the placebo group after the first treatment cycle (P=0.0003), 29.1% vs 16.9% after the second (P=0.0002), 25.2% vs 12.8% after the third (P<0.0001), and 20.2% vs 10.9% after the fourth (P=0.001). For patients with a response after 2 treatment cycles (CCH [n=219]; placebo [n=77]), 40.2% of the CCH-treated patients vs 19.5% of the placebo-treated patients had an additional reduction of ≥20% after completing 4 treatment cycles (P=0.001). In patients with <20% reduction after the initial 2 treatment cycles (CCH [n=205]; placebo [n=168]), 29.8% of patients in the CCH group were classified as treatment responders after completing the fourth injection cycle (versus 20.8% of placebo-treated patients; P=0.057). Conclusions Data support that incremental benefits were obtained from each of the 4 CCH treatment cycles administered to men with Peyronie's disease. Results would suggest benefits with performing a full series of 4 CCH injections, even among men who are initial non-responders. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals Inc. Clarification Industry initiated, executed and funded study Any of the authors act as a consultant, employee or shareholder of an industry for: Endo Pharmaceuticals Inc.

Abstract 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.

Objectives: To determine patient preference for treating opioid-induced constipation (OIC) using naloxegol or polyethylene glycol (PEG) 3350 in patients receiving opioids for noncancer pain. Methods: This crossover study included two 2-week active treatment periods, each preceded by a 1-week washout period (NCT03060512). Individuals with baseline Bowel Function Index scores ≥30 were randomized to 1 of 2 treatment sequences (naloxegol/PEG 3350 or PEG 3350/naloxegol). Patient preference (primary end point) was measured at the end of the second treatment period. Results: Of 276 patients randomized, 246 completed both treatment periods and reported preference (per protocol). Similar proportions of patients reported overall preference for naloxegol (50.4%) or PEG 3350 (48.0%; P = 0.92); 1.6% reported no preference. Medication characteristics influencing preference were similar for both treatments, except convenience and working quickly, which were strong influences of preference for higher proportions of patients preferring naloxegol (69.9% and 39.0%, respectively) vs those preferring PEG 3350 (29.9% and 27.4%, respectively). Patients aged <50 years or receiving laxatives within the previous 2 weeks generally preferred naloxegol. Changes from baseline in overall Bowel Function Index and Patient Global Impression of Change scores were similar between treatments, but analyses according to treatment preference revealed clinical improvement aligned with reported preference. Safety profiles were generally consistent with known medication profiles. Conclusions: Almost equal proportions of patients with OIC reported similar preference for daily naloxegol or PEG 3350 treatment, and their preference was generally supported by clinically relevant and measurable improvements in OIC symptoms.