Real-world study explores effectiveness of Peyronie's disease treatments

The first patient has been enrolled in a non-interventional study (NCT05873595) that is examining real-world data to assess the efficacy of available treatments for patients with Peyronie's disease, according to Endo Pharmaceuticals, the sponsor of the study.¹

"Because Peyronie's disease is not a life-threatening disease and due to embarrassment about the condition, many people with Peyronie's may not seek medical attention, which has led to insufficient data on the condition," said Mohit Khera, MD.

The study is officially titled, “Clinical Understanding through Real-world data to Validate Effectiveness of treatments in Peyronie's disease” (CURVE-PD). It is an observational (patient registry) trial that has a targeted enrollment of 1000 patients with Peyronie's disease who have started to receive therapy no more than 2 weeks prior to enrollment or at any time point after enrollment.

Patients will be accrued from 15 sites and study follow-up will last for up to 1 year. The study investigators will be collecting data from the patients, as well as from their partners and healthcare providers.

According to the official website for the CURVE-PD trial on ClinicalTrials.gov, the following are the key outcome measures for the study.²

• Change from baseline in Peyronie's Disease Questionnaire (PDQ) score (Time frame: Up to 12 months)
• Change from baseline in International Index of Erectile Function (IIEF) score (Time frame: Up to 12 months)
• Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) score (Time Frame: Up to 12 months)
• Change from baseline in Beck Anxiety Inventory (BAI) Scale score (Time Frame: Up to 12 months)
• Participant Satisfaction Questionnaire (Time frame: Up to 12 months)
• Number of participants receiving post-procedural care by the treating physician (Time frame: Up to 12 months)

The CURVE-PD trial is being run by a steering committee comprised of these individuals:

1. Mohit Khera, MD, President of the Sexual Medicine Society of North America and Professor of Urology at Baylor College of Medicine
2. Jesse Mills, MD, Director of Urology at UCLA Santa Monica Medical Center
3. Ranjith Ramasamy, MD, Director of Reproductive Urology and Associate Professor of Clinical Urology at University of Miami
4. Representatives from Endo and Pulse Infoframe

"Because Peyronie's disease is not a life-threatening disease and due to embarrassment about the condition, many people with Peyronie's may not seek medical attention, which has led to insufficient data on the condition," Mohit Khera, MD, President of the Sexual Medicine Society of North America, stated in the press release.¹ "This landmark registry will facilitate more comprehensive knowledge of treatment and management using real-world evidence."

The estimated study completion date is May 2025.

"We're pleased to help advance knowledge of Peyronie's disease and treatments so that, in the future, patients can benefit from a fuller understanding of their options," Gregory Kaufman, MD, Vice President, Medical Affairs and Chief Medical Officer at Endo, stated in the press release.¹ "Along with our study steering committee partners, Endo is committed to supporting the Peyronie's patient community."

According to Endo, approximately 1 in every 10 men in the United States experiences Peyronie’s disease.¹

References

1. Endo Announces First Patient Enrolled in Registry of Peyronie's Disease. Published online July 20, 2023. Accessed July 20, 2023. https://www.prnewswire.com/news-releases/endo-announces-first-patient-enrolled-in-registry-of-peyronies-disease-301881303.html

2. NIH US National Library of Medicine ClinicalTrials.gov. Real-World Data Study to Understand Effectiveness of Treatments in Peyronie's Disease (CURVE-PD). Updated May 24, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT05873595