Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional Platelet Rich Plasma for Peyronie's Disease
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of Treatment Related Adverse Events
研究概览
简要总结
The purpose of this study is to learn about the safety and side effects of intralesional collagenase clostridium histolyticum (CCH) injected into the Peyronies Disease (PD) plaque after receiving prior treatment with intralesional Platelet Rich Plasma (PRP) injections.
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Be able to provide written informed consent
- •Have a diagnosis of PD with evidence of stable disease as determined by the investigator
- •Patient must have palpable penile plaque
- •Penile curvature deformity of >30° to <90°
- •Agree to comply with all study related tests/procedures.
- •Prior intralesional platelet rich plasma treatment within the past 18 months and desire secondary treatment of penile curvature
排除标准
- •Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting, penile prosthesis.
- •Previous intralesional injection therapy with CCH for PD within six months. Patients with failed therapy greater than six months ago may be included.
- •Previous history of priapism or penile fracture
- •PD characterized by a ventral plaque
- •Severe erectile dysfunction as characterized with an IIEF score ≤ 12
- •Hour-glass deformity
- •Unwilling to participate
- •Medically unfit for sexual intercourse as deemed by the principal investigator
- •Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with autologous PRP injection therapy.
- •Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
研究组 & 干预措施
Collagenase Clostridium Histolyticum (CCH) Group
There will be 8 total treatments. These will follow the manufacturer protocol of 2 injections 24-72 hours apart (one cycle), followed by a 6-week break. This will total a maximum of 4 cycles.
干预措施: Collagenase Clostridium Histolyticum (CCH) (Drug)
结局指标
主要结局
Number of Treatment Related Adverse Events
时间窗: up to 6 months (post-intervention)
To determine number of treatment related adverse events. Safety will be evaluated via the incidence of adverse events as assessed by treating physician
Percent change of penile curvature in degrees.
时间窗: Baseline up to 6 months
Treatment efficacy of CCH will be assessed via the percentage of participants achieving degree change in penile curvature from baseline. Degree of curvature will be measured using a goniometer with the aid of injection of vasoactive substance into the penis.
次要结局
- Changes in International Index of Erectile Function - Erectile Function (IIEF-EF) scores(Baseline, 6 months)
- Change in Peyronie's Disease Questionnaire (PDQ) sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).(Baseline, 6 months.)
研究者
Manuel Molina Leyba
Staff Physician
University of Miami