FIBRONIE: ESTUDIO PILOTO SOBRE EFICACIA Y SEGURIDAD DE FIBRORESTIL® COMO TRATAMIENTO INTRALESIONAL COADYUVANTE EN PACIENTES CON ENFERMEDAD DE PEYRONIE CON TRATAMIENTO ESTÁNDAR
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in penile curvature
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This was an open-label study with no masking of participants, care providers, investigators, or outcome assessors.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Intralesional hyaluronic acid-based enzymatic medical device (Device)
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.
干预措施: Standard conservative treatment for Peyronie's disease (Other)
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.
干预措施: Standard conservative treatment for Peyronie's disease (Other)
结局指标
主要结局
Change in penile curvature
时间窗: 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
时间窗: 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.
次要结局
- 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)