Penile Lengthening Pre-Penile Prosthesis Implantation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Length Assessment of Penile Prosthesis Implanted
研究概览
简要总结
This study is intended to utilize a novel, class I (ie. lowest risk, clinical studies not required) medical device to determine whether penile length can be increased in men prior to undergoing a penile prosthesis implantation procedure.
详细描述
Men with erectile dysfunction, unresponsive to conservative therapies, are recommended to undergo placement of an inflatable penile prosthesis (IPP); however, it is a common complaint post-operatively that their penis length is shorter than what it was previously.
Several attempts have been made by investigators to optimize penile length prior to placement of the penile prosthesis. Compared to other options, penile traction therapy (PTT) offers several potential advantages in that it is minimally-invasive, does not increase the morbidity of surgery, and has not been shown to result in any long-term side effects.
A new penile traction device (RestoreX® ) was created and funded through Mayo Ventures. Given the clinical issue of dissatisfaction with penile length post IPP, the potential role for PTT, and limited amount of data available, we sought to perform a clinical trial evaluating the effect of PTT on increasing the total length of prosthesis which can be inserted. We additionally sought to determine if PTT resulted in improved post-operative satisfaction on total penile length achieved.
To accomplish the study, a population of men from Mayo Clinic planning to undergo placement of an IPP will be enrolled and given the option to either join the control (no treatment) group or PTT group for 3 months prior to their procedure. Outcomes will be assessed prior to surgery and 3, 6, and 12 months post-procedure. 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
- Non Randomized
- 干预模型
- Parallel
- 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
- •Men undergoing placement of a penile prosthesis
- •Must be the first time a penile prosthesis is implanted
- •Undergoing implantation of a 3-piece inflatable penile prosthesis
排除标准
- •Prior ischemic priapism
- •Any prior penile prosthesis surgeries
- •Any prior penile surgeries other than circumcision
- •Undergoing malleable penile prosthesis or Ambicor device
研究组 & 干预措施
Group 1 - Control
No treatment will be administered and men will not have to delay their IPP procedure
干预措施: Control (Other)
Group 2 - PTT 3x daily x 3 months
Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP
干预措施: RestoreX (Device)
结局指标
主要结局
Length Assessment of Penile Prosthesis Implanted
时间窗: From baseline to 3 months
The primary objective is to assess the length of the penile prosthesis inserted into subjects following completion of RestoreX® traction therapy compared to the control group (no treatment)
次要结局
- Participant Compliance(From baseline to 3 months)
- Participant Satisfaction With Traction(From baseline to 3 months)
- Adverse Events With Use of Traction(From baseline to 3 months)
- Operative Complications(3, 6, 12 months post-operative)
- Stretched Penile Length(From baseline to 12 months)
- Participant Satisfaction Penile Length(Baseline to 12 months post-operative)