Transcutaneous Electrical Nerve Stimulation of Penile Nerves for Treatment of Delayed Ejaculation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- International Index of Erectile Function (IIEF) Scale Score
研究概览
简要总结
The aim of this clinical trial is to test the safety and feasibility of using transcutaneous electrical nerve stimulation (TENS) of the penile nerves to reduce intra-vaginal ejaculatory latency time in men with delayed ejaculation (DE). We hypothesize that this type of stimulation, either before or during sexual activity, will reduce latency time. The primary objective of this study is to determine if TENS of the penile nerve helps men with DE subjectively reduce their ejaculatory latency time. The secondary objective is to determine whether their International Index of Erectile Function (IIEF) score improves with treatment.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Sexually active
- •Diagnosed with delayed ejaculation
排除标准
- •Less than 18 years old
- •Any condition effecting the participant that would make them unable to operate the interventional device
研究组 & 干预措施
TENS penile nerve stimulation group
The electrode pads of the transcutaneous electrical nerve stimulation (TENS 7000) will be placed at the base of the penis (and perineum). Participants will be able to use the device prior to sexual activity (immediately before sexual encounter for 10 minutes or daily for up to 14 days prior) to "prime" their system or during sexual activity. Each participant will use the device these three separate ways for 6 weeks each (total of 18 weeks of use).
干预措施: TENS penile nerve stimulation (Device)
结局指标
主要结局
International Index of Erectile Function (IIEF) Scale Score
时间窗: Baseline and 12 weeks
Participants were surveyed before testing the device and then at the conclusion of the trial using the International Index of Erectile Function (IIEF) which is a validated multidimensional scale for erectile function and ejaculatory function in men. The questionnaire consists of 3 questions with a scale for each from 0-5 (highest overall score 15, lowest score 0). The higher the score, the better the outcome and vice versa.
次要结局
- Count of Participants With Treatment-related Adverse Events as Assessed by Survey(Up to 12 weeks)
研究者
Michael Eisenberg
Associate Professor of Urology
Stanford University