Previously Implanted Pudendal Nerve Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During Cystometrogram
研究概览
简要总结
This study seeks to examine the response of the bladder to different pudendal nerve stimulation frequencies, by studying patients who have been previously-implanted with pudendal nerve neurostimulators.
详细描述
The pudendal nerve goes to the urethra, anus, and other areas of the pelvic floor. Electrical stimulation of this nerve can help with bladder, bowel, and sexual problems, and pelvic pain. Researchers do not fully understand how the nerve helps with these functions or how the anatomy is different between people. Successful stimulation of the pudendal nerve may help improve medical care for future patients with bladder problems, pelvic pain, bowel problems, and/or sexual problems.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously received an implanted neurostimulator at the pudendal nerve
- •Adult (18 or older), capable of providing own informed consent and communicating clearly with the research team
- •Capable of speaking, reading, and understanding English, as all study questionnaires are standardized assessments only available in English.
- •Capable of attending the experimental session
排除标准
- •Pregnant or planning to become pregnant during study. If a woman of child- bearing potential wishes to participate in this study, they will be pre-screened with a test to detect pregnancy
- •Currently has a urinary tract infection (UTI)
- •Currently has or tested positive in the last 14 days for COVID-19, or is symptomatic for COVID-19
- •Unwilling to allow de-identified data to be stored for future use or shared with other researchers
结局指标
主要结局
Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During Cystometrogram
时间窗: Visit 1, approximately 1 week after consent
The results reflects the number of participants who experienced an evoked bladder contraction of at least 20 centimeters of water during stimulation of the pudendal nerve. Bladder contractions were evoked by applying nerve stimulation to the pudendal nerve through testing of the participant's implanted stimulator.
次要结局
- Selective Stimulation of Pudendal Nerve Branches(2 hours)
- Measurement of Effect of Selective Pudendal Nerve Stimulation (PNS) on Urethral Leak Point Pressure (ULPP)(2 hours)
研究者
Timothy Bruns
Associate Professor of Biomedical Engineering, Medical School
University of Michigan