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

NCT ID: NCT07341529

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2026-05-15

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.

Detailed Description

This study is a prospective, randomized, controlled, open-label, multicenter pilot clinical investigation designed to evaluate the efficacy and safety of intralesional Fibrorestil® as an adjuvant treatment to standard conservative therapy in patients with stable-phase Peyronie's disease.

Following the withdrawal of collagenase Clostridium histolyticum from the European market, there is a significant unmet need for effective, minimally invasive intralesional therapies. Fibrorestil® is a Class III medical device composed of hyaluronic acid combined with a proprietary enzymatic mixture intended to facilitate remodeling of fibrotic tissue while providing anti-inflammatory and antioxidant effects.

Eligible participants were adult men (≥18 years) with stable Peyronie's disease, defined as stable symptoms for at least three months, a palpable penile plaque, and penile curvature between 30 and 90 degrees. Patients with prior surgical treatment for Peyronie's disease or significant comorbid conditions affecting wound healing or safety were excluded.

A total of 38 patients were randomized in a 1:1 allocation to one of two parallel groups. The experimental group received three intralesional Fibrorestil® treatment sessions administered at four-week intervals using a percutaneous tunneling technique under local anesthesia, in addition to standard conservative treatment. The control group received standard conservative treatment alone. Standard treatment in both groups consisted of daily use of a penile traction device for a minimum of four hours and daily oral tadalafil at the maximum tolerated dose (up to 5 mg).

Penile curvature was assessed at baseline and at week 28 using standardized self-photography and goniometric measurement. When adequate rigidity could not be achieved naturally, intracavernosal alprostadil was administered according to the Kelami test protocol.

The primary outcome measure was the change in penile curvature from baseline to week 28, expressed in degrees and as a percentage change. Secondary outcome measures included safety and tolerability assessed by adverse event reporting, changes in erectile function measured by the International Index of Erectile Function erectile function domain (IIEF-EF), disease-specific quality of life assessed using the Peyronie's Disease Questionnaire (PDQ), and patient-reported treatment satisfaction.

This pilot study was designed to assess feasibility, safety, and preliminary efficacy, and to inform the design of future larger-scale controlled trials.

Conditions

Peyronie Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Treatment Plus Intralesional Fibrorestil®

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.

Group Type: EXPERIMENTAL

Intralesional hyaluronic acid-based enzymatic medical device

Intervention Type: 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

Intervention Type: 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.

Standard Conservative Treatment Alone

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.

Group Type: ACTIVE_COMPARATOR

Standard conservative treatment for Peyronie's disease

Intervention Type: 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.

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Fibrorestil®; Intralesional Fibrorestil®; Penile traction therapy; Daily Tadalafil

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Lyx Institute of Urology

UNKNOWN

Sponsor Role: collaborator

Lyx Institution

UNKNOWN

Sponsor Role: collaborator

Lyx Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan Ignacio Martínez-Salamanca, Full Professor

Role: PRINCIPAL_INVESTIGATOR

Lyx Institute of Urology

Locations

Lyx Institute of Urology

Madrid, Madrid, Spain

Hospital Universitario La Paz (HULP)

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

FIBRONIE1.3

Identifier Type: -

Identifier Source: org_study_id