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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

NCT07341529 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-01-14

No results posted yet for this 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.

Conditions

  • Peyronie Disease

Interventions

OTHER

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.

DEVICE

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.

Sponsors & Collaborators

  • Lyx Institute of Urology

    collaborator UNKNOWN

  • Lyx Institution

    collaborator UNKNOWN

  • Lyx Institute

    lead OTHER

Principal Investigators

  • Juan Ignacio Martínez-Salamanca, Full Professor · Lyx Institute of Urology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-15
Primary Completion
2026-03-15
Completion
2026-05-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07341529 on ClinicalTrials.gov