Microneedle Treatment of Chronic Phase Peyronie's Disease: A Pilot Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
Peyronie's Disease (PD) is a disorder of the penis where scar tissue (composed of excessive and disorganized collagen) known as a "plaque," forms along the shaft of the penis. This plaque can lead to permanent penile deformity (curvature, narrowing, indentation, hinging), loss of penile length, erectile dysfunction, and pain during intercourse. Research has shown PD to negatively impact the quality of life and cause significant psychosocial distress for many men.
This study proposes the use of microneedle treatment of chronic phase PD. Microneedling is a minimally invasive technique that creates tiny injuries in scarred tissues, which encourages a controlled healing process.
This will be a pilot clinical trial evaluating the safety and feasibility of using microneedling treatment in the management of chronic phase PD. Enrolled study participants will undergo an initial clinical assessment of their PD which involves penile measurements at flaccid and erect states, a curvature assessment with duplex ultrasound, and will be asked to complete the International Index of Erectile Function Questionnaire (IIEF-5), and Peyronie's Disease Questionnaire (PDQ). They will then undergo 3-4 treatment sessions at 6-8 week intervals. This will then be followed by a short and long-term follow-up at 24 and 52-54 weeks, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Healthy males aged 18 or older in a stable relationship with a female partner/spouse (for at least 3 months and willing to have vaginal intercourse with their female partner/spouse).Non heterosexual men are also included; however they need not fill out the PDQ questionnaire as it pertains to those having intercourse with females.
- •Diagnosis of PD for at least 12 months with evidence of stable disease as determined by the investigator (i.e. no change in penile curve for at least 6 months and absence of pain).
- •Penile curvature of 30º-90º in the dorsal, lateral, or dorsal/lateral plane (must be possible to delineate the single plane of maximal curvature for evaluation)
- •Signed informed IRB-approved consent agreement; signed authorization form to allow disclosure of protected information.
- •Ability to read, complete, and understand the various rating instruments in English.
排除标准
- •Penile curvature of <30º or >90º
- •Any conditions affecting the penis such as a chordee in the presence or absence of hypospadias; thrombosis of the dorsal penile artery; infiltration by a benign or malignant mass or an infectious agent; ventral curvature from any cause; presence of an active sexually transmitted disease.
- •Failure to achieve a sufficient 8/10 erection (after prostaglandin E or Trimix administration), in the opinion of the investigator, to accurately measure the penile deformity.
- •Calcified plaque as evident by appropriate radiographic evaluation, i.e., penile ultrasound that would prevent treatment with microneedling.
- •Isolated hourglass deformity of the penis without curvature
- •Treatment or plans to undergo treatment for PD, including but not limited to any previous surgery, oral/topical agents within 3 months, intralesional medical therapies within 3 months, extracorporeal shock wave therapy within 6 months, or use of mechanical devices within 2 weeks before the start of the study
- •Use of or plans to use a mechanical device to induce a passive erection within 2 weeks before the start of study.
- •Erectile Dysfunction that was unresponsive to PDE5 inhibitors
- •Received an investigation drug or treatment within 30 days before start of the study.
- •At any time, received collagenase clostridium histolyticum (CCH) for the treatment of PD.
- •Currently on anti-coagulation medications.
- •History of HSV
结局指标
主要结局
Safety
时间窗: 52 weeks
Given that this is a pilot study, safety is a critical outcome alongside feasibility and efficacy. Adverse events (AEs) and serious adverse events (SAEs) related to microneedling will be collected, documented, and analyzed to evaluate the safety profile of the intervention. AEs will be assessed at every treatment and follow-up visit through direct questioning, physical examinations, and spontaneous participant reports. Investigators will use a standardized adverse event log to capture the nature, severity, duration, frequency, and outcome of all events. The incidence of AEs and SAEs will be summarized descriptively using counts and percentages. Events will be categorized by severity (mild, moderate, severe), expectedness (anticipated vs. unanticipated), and relationship to the intervention (definitely, probably, possibly, unlikely, unrelated).
次要结局
未报告次要终点
研究者
Luke Witherspoon
Urologist
Ottawa Hospital Research Institute