NCT05804552已完成不适用
The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure
Thea Christoffersen2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年3月28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
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Effect of burst dorsal genital nerve stimulation compared to baseline
研究概览
简要总结
This study aims to investigate the effect of electrical stimulation of the dorsal genital nerve on the urethral pressure in healthy women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal weight (Body weight 50 kg or more, Body Mass Index 18-5-30 kg/m2)
- •Signed an informed consent
排除标准
- •Any history of clinically significant diseases, unless regarded irrelevant and/or stable by the investigator
- •Any history or evidence of clinically significant urinary incontinence, urinary retention, overactive bladder, or other voiding dysfunction
- •Known or suspected nerve injuries or paraesthesia in the pelvic area
- •Pregnancy within six months before enrolment
- •Breastfeeding within three months before enrolment
- •Smoking or other regular use of any form of nicotine product during the study period and the previous 3 months
- •Current or prior participation (within 3 months before screening) in other clinical trials that might affect the results of this study (judged by the investigator)
- •Any systemic drug use within 2 weeks before the first study day (prescription drugs, over-the-counter drugs, herbal drugs, and/or illicit drugs), except for occasional use of paracetamol (up to 4 g/day), ibuprofen, or antihistamine, hormonal contraceptives and hormone replacement therapy.
结局指标
主要结局
Effect of burst dorsal genital nerve stimulation compared to baseline
时间窗: Baseline and during dorsal genital nerve stimulation
The difference in mean opening urethral pressure (in cmH20) measured with urethral pressure reflectometry during electrical burst stimulation of dorsal genital nerve (reflex-induced pelvic floor contraction) compared to mean baseline opening urethral pressure during squeezing condition
次要结局
- Effect of continuous dorsal genital nerve stimulation on resting pressure compared to baseline(Baseline and during dorsal genital nerve stimulation)
- Effect of continuous dorsal genital nerve stimulation on squeezing pressure compared to baseline(Baseline and during dorsal genital nerve stimulation)
研究者
Thea Christoffersen
Medical Doctor, Principal Investigator
University Hospital Bispebjerg and Frederiksberg
研究点 (2)
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