Pilot Study on the Efficacy and Safety of FIBRORESTIL® as an Adjuvant Intralesional Treatment in Patients With Peyronie's Disease Receiving Standard Therapy

Peyronie's disease is a connective tissue disorder of the penis characterized by the formation of fibrous plaques in the tunica albuginea, leading to penile curvature, possible erectile dysfunction, and significant physical and psychological distress. While surgical correction is effective, it is invasive and associated with potential complications. Conservative treatments such as penile traction therapy and oral phosphodiesterase-5 inhibitors are commonly used but often provide limited improvement when used alone. This pilot, randomized, controlled, multicenter study was designed to evaluate the efficacy and safety of Fibrorestil®, an intralesional medical device combining hyaluronic acid with a proprietary enzymatic mixture, when used as an adjuvant to standard conservative treatment in men with stable-phase Peyronie's disease. The primary objective of the study was to assess the change in penile curvature from baseline to week 28. Secondary objectives included evaluation of safety, changes in disease-related symptoms and quality of life, erectile function, and patient satisfaction. Safety was assessed through the monitoring and reporting of adverse events throughout the study period.

NCT Number	NCT07341529
Lead Sponsor	Lyx Institute Collaborators: Lyx Institute of Urology, Lyx Institution
Conditions	Peyronie Disease
Enrollment	38 participants
Start Date	2023-06-15
Primary Completion	2026-03-15 (estimated)
Study Completion	2026-05-15 (estimated)
Updated on ClinicalTrials.gov	2026-01-14