Efficacy of Penile Traction Therapy Using a Novel Device: A Controlled, Single-blinded, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Adverse Events at 3 Months
研究概览
简要总结
This clinical trial is designed to assess the safety, dosing, and preliminary efficacy of a novel penile traction device on correcting deformities relating to Peyronie's disease, a condition which results in penile curvature and length loss. The trial is designed as a randomized, placebo-controlled study with men randomized to receiving no therapy or penile traction therapy 30 minutes once, twice, or three times daily. The study will occur over a 3 month period, after which an open label phase for 3 months will be conducted. Final assessments for adverse effects will also be assessed at 9 months.
详细描述
Peyronie's disease (PD) is a fibrotic condition of the penis, affecting 1-13% of the US male population. The disease results in penile curvature and significant psychosocial bother. Current preferred therapies for PD include repeated penile injections with bacterial enzymes and surgery. However, these therapies are expensive and in some cases result in permanent reductions in penile length and sensation. Penile traction therapy (PTT) is a relatively newer treatment which has been proposed as a treatment for PD with preliminary data suggesting a potential role. However, currently available PTT devices are primarily designed for penile lengthening and have many significant limitations including a requirement of use for 9 hours daily and significant difficulties in personal application. Given these limitations, a new penile traction device (RestoreX® ) was created and funded through Mayo Ventures and was specifically designed to treat men with PD. The primary objective of the current study is to evaluate safety of the device using various dosing schedules, with secondary endpoints designed to assess efficacy and subjective outcomes. To accomplish the study, a population of men from Mayo Clinic with PD will be enrolled and will be randomized to utilize the device for varying amounts of time. Outcomes will be assessed at 3, 6, and 9 months, and results are to be used with the intent to publish in a scientific journal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Objective outcomes including penile length and curvature will be masked for the investigator and outcome assessor by obtaining photographs of the penis in the lateral and dorsal planes. Curvatures will also be assessed by a clinician in the case where photographs are not able to be obtained or if the participant refuses photographs. These will be assessed without any knowledge as to which grouping the patient is located by two independent reviewers. If there are differences >5 degrees (curvature), or 0.5 cm (length), a 3rd individual will mediate the difference.
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
- •Diagnosis of Peyronie's disease
- •Current 30 degree curvature in a single plane (i.e. 20 degrees up, 15 degrees left would not be a candidate)
- •Not undergoing other therapies for PD currently
排除标准
- •Stretched penile length <7 cm
- •Prisoners
- •Erectile dysfunction unresponsive to phosphodiesterase-5 inhibitors or intracavernosal injection therapies
- •Diabetes mellitus with evidence of end-organ damage (peripheral neuropathy, retinopathy, chronic kidney disease stage III or higher)
结局指标
主要结局
Adverse Events at 3 Months
时间窗: 3 months
Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other
Adverse Events at 9 Months
时间窗: 9 months
Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other
Adverse Events at Baseline
时间窗: Baseline
Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other
Adverse Events at 6 Months
时间窗: 6 months
Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other
次要结局
- Overall Treatment Satisfaction(3 months)
- Change in Penile Length to Corona(3 months, 6 months)
- Ability to Achieve Sexual Intercourse(6 months)
- Change in Penile Length to Tip(3 months, 6 months)
- Change in Penile Curvature(3 months, 6 months)
- Change Erectile Function(3 months, 6 months)
- Change in Peyronie's Disease Psychological and Physical Domain on Peyronie's Disease Questionnaire (PDQ)(Baseline, 3 months)
- Change in Peyronie's Disease Penile Pain Domain on Peyronie's Disease Questionnaire (PDQ)(Baseline, 3 months)
- Change in Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)(Baseline, 3 month)
- Satisfaction With the RestoreX® Device to Alternative Forms of PTT(3 months)
- Satisfaction With the RestoreX® Device to Alternative PD Therapies(3 months)
研究者
Landon W. Trost
Principal Investigator
Mayo Clinic