Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Number of Participants With Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During the Stage-4 Test
研究概览
简要总结
This study is to map the pudendal nerve. In this study the researchers will examine subjects who are already receiving an implanted stimulator at their pudendal nerve as part of their normal clinical care.
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 problems and pelvic pain. Researchers do not understand how the nerve anatomy is different between people. Successfully mapping the pudendal nerve may help improve the medical care for future patients with bladder problems, pelvic pain, bowel problems, and 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
- •Clinically referred as having bladder problems that have not responded to conservative treatment. Normal clinical care includes referral to implant of Medtronic Interstim neurostimulator at the pudendal nerve. Fully eligible to receive an Interstim implant.
- •Adult (18 or older), capable of providing own informed consent and communicating clearly with research team
- •Capable of speaking, reading, and understanding English, as all study questionnaires are standardized assessments only available in English
- •Capable of attending all experimental sessions (Visit 1: pre-stage-1 imaging, Visit 2: stage-1 surgery, Visit 3: CT after stage-2 surgery, Visit 3: cystometrogram test)
- •Implanted materials that prohibit magnetic imaging
- •Any medical problems that prevent an individual from laying flat in an MRI or CT scanner, are are claustrophobic.
- •Areflexive or atonic bladder
- •Pregnant or planning to become pregnant. If a woman of child-bearing potential wishes to participate in this study, they will be pre-screened with a test to detect pregnancy.
- •Diagnosed neurogenic bladder, pudendal nerve damage, lower motor dysfunction, or other conditions that would affect the neural circuits involved in micturition.
- •Unwilling to allow de-identified data to be stored for future use or shared with other researchers.
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During the Stage-4 Test
时间窗: Visit 4, approximately 10 weeks after consent
The primary outcome measure in this study was an evoked bladder contraction of at least 20 centimeters of water (cmH2O) during the cystometrogram. These bladder contractions were evoked by applying nerve stimulation to the pudendal nerve through testing of the participant's implanted stimulator. Measure reflects number of participants who experienced an evoked bladder contraction of at least 20 centimeters of water during nerve stimulation.
次要结局
- Selectivity Index (SI) for Selective Stimulation of Pudendal Nerve Branches for Simulated Model Stimulation(Approximately one year and four months after consent)
- Selectivity Index (SI) for Selective Stimulation of Pudendal Nerve Branches for Participant Stimulation(Visit 2: Stage-1 (approximately 3 weeks after consent))
- Measurement of Effect of Pudendal Nerve Stimulation on Urethral Leak Point Pressure During the Stage-4 Test(Visit 4, approximately 10 weeks after consent)
研究者
Timothy Bruns
Associate Professor of Biomedical Engineering
University of Michigan