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Pilot Study on the Efficacy and Safety of FIBRORESTIL® as an Adjuvant Intralesional Treatment in Patients With Peyronie's Disease Receiving Standard Therapy
Sponsor: Lyx Institute
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.
Official title: FIBRONIE: ESTUDIO PILOTO SOBRE EFICACIA Y SEGURIDAD DE FIBRORESTIL® COMO TRATAMIENTO INTRALESIONAL COADYUVANTE EN PACIENTES CON ENFERMEDAD DE PEYRONIE CON TRATAMIENTO ESTÁNDAR
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
38
Start Date
2023-06-15
Completion Date
2026-05-15
Last Updated
2026-01-14
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (2)
Lyx Institute of Urology
Madrid, Madrid, Spain
Hospital Universitario La Paz (HULP)
Madrid, Madrid, Spain