Penile Length Maintenance Post-Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Change in Penile Length
研究概览
简要总结
The objective of the current study is to evaluate the efficacy of a novel, class I (ie. lowest risk, clinical studies not required) medical penile traction device in preventing loss of penile length in men undergoing robotic-assisted prostatectomy.
详细描述
The treatment of prostate cancer results in several known sexual dysfunctions, including erectile dysfunction, orgasmic dysfunction, ejaculatory dysfunction, penile curvature (Peyronie's disease), and reduced penile length. Among the dysfunctions, loss of penile length is often one that results in significant distress and bother to patients. Beyond the esthetic concerns, reduced penile length may lead to inability to participate in sexual intercourse, difficulty with future interventions to restore erectile function, and lead to worsened urinary hygiene.
Penile traction therapy (PTT) is currently the best available treatment to maintain or restore lost penile length due to conditions that reduce length. To date, no studies have evaluated the benefits of using PTT in this clinical setting. The objective of the current study is to evaluate the efficacy of a novel penile traction device (RestoreX®), created and funded through Mayo Ventures, in maintaining or restoring reduced penile length.
To accomplish the study, a population of men from Mayo Clinic who have undergone a prostatectomy will be enrolled and randomized to utilize the device for varying amounts of time. Outcomes will be assessed at 6 and 9 months post-prostatectomy 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
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Undergoing robotic prostatectomy
- •Seen in the post-prostatectomy rehab clinic
排除标准
- •Urethral complications from prostatectomy at the time of baseline visit
结局指标
主要结局
Change in Penile Length
时间窗: Baseline, 6 months
Stretched penile length measured in centimeters from pubic symphysis to glanular corona
次要结局
- Change in Overall Satisfaction Domain of International Index of Erectile Function (IIEF)(Baseline, 6 months)
- Change in Erectile Function Domain of International Index of Erectile Function (IIEF)(baseline, 6 months)
- Intracavernosal Injections(6 months)
- Erectogenic Therapy Use(6 months)
- Change in Intercourse Satisfaction Domain of International Index of Erectile Function (IIEF)(Baseline, 6 months)
研究者
Matthew (Matt) J. Ziegelmann
Principal Investigator
Mayo Clinic
