(372) Clinical Understanding Through Real-World Data to Validate Effectiveness of Treatments in Peyronie’s Disease (CURVE-PD): Registry Design
Authors: Davis J , Mills J , Henderson J , Mason M , Cronin A , Gwadry-Sridhar F , Hurley D , Kaufman G , Ramasamy R , Khera M 
Published: February 2024

Abstract

Introduction
Limited information is available on the treatment modalities, treatment choices and outcomes of patients with Peyronie’s disease (PD). Clinical Understanding through Real-world data to Validate Effectiveness of treatments in Peyronie’s Disease (CURVE-PD) is a prospective longitudinal, multi-center, web-based PD registry, built on the healthie™ platform, that collects relevant real-world information from treating sites, and individuals with PD and their partners and clinicians.

Objective
The overarching primary objective is two-fold. First, the registry aims to collect real-world data on treatments used for PD (including injectables and any surgical techniques) to understand treatment choice and variability in treatment delivery, and to assess treatment effectiveness. Secondly, to understand the impact of treatments on patient-reported outcomes (PROs) and their partners’ satisfaction as well. Furthermore, the registry also recognizes the importance of evaluating the natural progression of Peyronie’s disease (PD) in men who choose not to pursue active treatment and instead opt for observational approaches.

Methods
Eligible adults (≥18 years of age) with a confirmed clinical diagnosis of PD who received PD treatment starting at or within 2 weeks before enrollment (“treated”) or have never received PD treatment (“untreated”) are invited to participate by registry site personnel or their treating physician. Untreated patients who initiate PD treatment after enrollment may crossover into the treated group. Using a web-based portal, which is part of the registry, participants complete surveys at enrollment, and, for those who are treated, longitudinally at treatment initiation and at 3- 6-, 9- and 12-months post treatment initiation. Participant surveys include validated PROs such as the Peyronie’s disease questionnaire (PDQ) scale, Peyronie’s disease questionnaire for female sexual partners (PDQ-FSP), international index of erectile function (IIEF) for participants and male sexual partners, patient health questionnaire-9 (PHQ-9), and the Beck anxiety index (BAI). Additionally, participants are asked to provide details on sexual function, and reasons for treatment start and satisfaction with treatment. Designated site staff use the clinician web-based portal to enter information on demographics, medical history, and treatment history for up to 12 months before enrollment. Prospective data collected include information on PD treatments and clinical assessments as performed in routine clinical care (e.g., pre-treatment and post-treatment penile characteristics and PD symptoms) at enrollment, baseline, and each clinical visit. Currently, 15 sites in the United States are planned, with a possible future expansion to additional sites. The target for enrollment in the treated group is a minimum of 1,000 patients with PD.

Results
CURVE-PD enrollment opened in June 2023, with an anticipated 15 U.S. sites being enrolled over the next few months. Initial data for analysis are anticipated to be available in 2024.

Conclusions
CURVE-PD is a novel registry where participants with PD and their partners can provide information on quality-of-life impacts in a secure and private evidence generation web-based environment, that links both patient and clinician-reported treatments and assessments. This registry will provide the means for investigating real-world data (RWD) to attain real-world evidence (RWE) for more comprehensive knowledge and evaluation of the natural history, treatment patterns and modalities, and the comparative effectiveness of treatments for PD.

Disclosure
Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals Inc.
Clarification: Industry funding only - investigator initiated and executed study
Any of the authors act as a consultant, employee or shareholder of an industry for: Endo Pharmaceuticals Inc.