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临床试验/NCT03500419
NCT03500419已完成不适用

Penile Length Maintenance Post-Prostatectomy

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2018年3月23日最近更新:
适应症

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

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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew (Matt) J. Ziegelmann

Principal Investigator

Mayo Clinic

研究点 (2)

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