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

NCT07341529 | Active Not Recruiting

• 1 other identifier: FIBRONIE1.3
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Peyronie's Disease; Peyronie; Collagenase; Intralesional therapy; Hyaluronic acid; Enzymatic therapy; Medical device

Outcome Measures

Primary Outcomes (2)

• Change in penile curvature

  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.

  From baseline to 28 weeks

• Patient-reported treatment satisfaction

  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.

  At 28 weeks

Secondary Outcomes (4)

• Change in erectile function (IIEF-EF score)

  From baseline to 28 weeks

• Change in Peyronie's Disease Questionnaire (PDQ) total score

  From baseline to 28 weeks

• Change in PDQ symptom bother domain score

  From baseline to 28 weeks

• Incidence of adverse events

  From baseline to 28 weeks

Study Arms (2)

Standard Treatment Plus Intralesional Fibrorestil®

EXPERIMENTAL

Participants in this arm received standard conservative treatment plus intralesional Fibrorestil®. Standard treatment consisted of daily penile traction therapy using a penile extender for a minimum of 4 hours per day and daily oral tadalafil at the maximum tolerated dose (up to 5 mg). In addition, participants received three intralesional Fibrorestil® treatment sessions administered at 4-week intervals using a percutaneous tunneling technique under local anesthesia. Participants were instructed to perform penile modeling exercises between treatment sessions. Outcomes were assessed over a total follow-up period of 28 weeks.

Device: Intralesional hyaluronic acid-based enzymatic medical device; Other: Standard conservative treatment for Peyronie's disease

Standard Conservative Treatment Alone

ACTIVE COMPARATOR

Participants in this arm received standard conservative treatment alone. Standard treatment consisted of daily penile traction therapy using a penile extender for a minimum of 4 hours per day and daily oral tadalafil at the maximum tolerated dose (up to 5 mg). No intralesional treatment was administered. Outcomes were assessed over a total follow-up period of 28 weeks.

Other: Standard conservative treatment for Peyronie's disease

Interventions

Intralesional hyaluronic acid-based enzymatic medical device 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.

Also known as: Fibrorestil®, Intralesional Fibrorestil®

Standard Treatment Plus Intralesional Fibrorestil®

Standard conservative treatment for Peyronie's disease OTHER

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.

Also known as: Penile traction therapy, Daily Tadalafil

Standard Conservative Treatment Alone; Standard Treatment Plus Intralesional Fibrorestil®

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients aged 18 years or older
• Diagnosis of Peyronie's disease with stable symptoms for at least 3 months
• Penile curvature between 30 and 90 degrees, assessed by standardized self-photography or Kelami test
• Presence of a palpable penile plaque consistent with Peyronie's disease
• No prior surgical treatment for Peyronie's disease
• Willingness and ability to comply with study procedures, including use of penile traction therapy and completion of questionnaires
• Ability to provide written informed consent

You may not qualify if:

• Prior surgical treatment for Peyronie's disease
• Known hypersensitivity or allergy to hyaluronic acid or any component of the investigational medical device
• Active oncological disease or oncological treatment within the previous 6 months
• Systemic immunosuppression
• Severe hepatic or renal disease
• Medical conditions affecting wound healing or tissue repair (e.g., scleroderma, systemic lupus erythematosus, dermatomyositis)
• Active infection or infected scar tissue in the treatment area
• Use of other treatments for Peyronie's disease during the study period, including surgery
• Any medical condition that, in the investigator's judgment, could increase risk to the participant or interfere with study participation or outcome assessment

Sponsors & Collaborators

• Lyx Institute: lead
• Lyx Institute of Urology: collaborator
• Lyx Institution: collaborator

Study Sites (2)

Lyx Institute of Urology

Madrid, Madrid, 28006, Spain

Location

Hospital Universitario La Paz (HULP)

Madrid, Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Penile Induration

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Juan Ignacio Martínez-Salamanca, Full Professor

  Lyx Institute of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This was an open-label study with no masking of participants, care providers, investigators, or outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomly assigned in a 1:1 ratio to two parallel study arms. One arm received standard conservative treatment alone, while the other arm received standard conservative treatment plus intralesional Fibrorestil®. Participants remained in their assigned group for the entire study duration, with outcomes assessed over a 28-week follow-up period.

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 14, 2026
• Study Start: June 15, 2023
• Primary Completion: March 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

ES (2)