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

Condition(s) studied

Investigational drug(s) / intervention(s)

Intralesional hyaluronic acid-based enzymatic medical device: Fibrorestil® is a Class III intralesional medical device composed of hyaluronic acid combined with a proprietary enzymatic mixture. It was administered using a percutaneous tunneling technique under local anesthesia. Participants received three intralesional treatment sessions at 4-week intervals. The intervention was used as an adjuvant to standard conservative treatment, which included daily penile traction therapy and daily oral tadalafil.

Standard conservative treatment for Peyronie's disease: Standard conservative treatment consisted of daily penile traction therapy using a penile extender device for a minimum of 4 hours per day and daily oral tadalafil at the maximum tolerated dose (up to 5 mg). This intervention was administered throughout the study period in both study arms.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in penile curvature — From baseline to 28 weeks
  Change in penile curvature measured in degrees from baseline to week 28. Penile curvature was assessed using standardized self-photography with goniometric measurement. When adequate natural erection was not achieved, curvature was assessed using the Kelami test following intracavernosal injection of alprostadil.
• Patient-reported treatment satisfaction — At 28 weeks
  Patient-reported satisfaction with treatment assessed using a categorical satisfaction questionnaire with the following response options: very satisfied, fairly satisfied, neutral, fairly dissatisfied, or very dissatisfied.

Trial sites (2)