Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in bladder function score during SNM using visual-motor responses (VMR)-selected stimulation programs
研究概览
简要总结
Electrical stimulation of the sacral nerve can help with bladder problems and pelvic pain but researchers don't understand exactly how the stimulation helps. The goal of this study is to examine signals evoked during sacral neuromodulation (SNM or electrical stimulation of the sacral nerve) and their relationship to the selection of stimulation parameters that improve pelvic function symptoms. This study uses SNM parameters based on visual-motor responses (VMR) or sacral evoked responses (SER). It is investigating how the parameter selection impacts change in bladder function.
详细描述
Some surgical procedures will be conducted at the Chealsea Hospital (75 S Main St, Chelsea, MI 48118) and all others will be done at Michigan Medicine facilities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Determined by the research team to be fully eligible to receive a sacral neuromodulation implant at a sacral nerve as part of their normal clinical care for overactive bladder (OAB).
- •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.
排除标准
- •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, sacral nerve damage, lower motor dysfunction, or other conditions that would affect the neural circuits involved in micturition.
研究组 & 干预措施
VMR followed by SER
SNM implants will use parameters selected based on visual-motor responses (VMRs) for four weeks followed by parameters selected based on sacral evoked responses (SERs) for four weeks.
干预措施: SNM based on visual-motor responses (VMRs) (Device)
VMR followed by SER
SNM implants will use parameters selected based on visual-motor responses (VMRs) for four weeks followed by parameters selected based on sacral evoked responses (SERs) for four weeks.
干预措施: SNM based on sacral evoked responses (SERs) (Device)
SER followed by VMR
SNM implants will use parameters selected based on sacral evoked responses (SERs) for four weeks followed by parameters selected based on visual-motor responses (VMRs) for four weeks.
干预措施: SNM based on visual-motor responses (VMRs) (Device)
SER followed by VMR
SNM implants will use parameters selected based on sacral evoked responses (SERs) for four weeks followed by parameters selected based on visual-motor responses (VMRs) for four weeks.
干预措施: SNM based on sacral evoked responses (SERs) (Device)
结局指标
主要结局
Change in bladder function score during SNM using visual-motor responses (VMR)-selected stimulation programs
时间窗: Baseline through the conclusion of study participation, approximately 3 months
Bladder function score is assessed using the American Urological Association Symptom Index. The American Urological Association Symptom Index has a range of 0 (no dysfunction) to 35 (maximum dysfunction). A decrease in score indicates improvement.
Change in bladder function score during SNM using sacral evoked responses (SER)-selected stimulation programs
时间窗: Baseline through the conclusion of study participation, approximately 3 months
Bladder function score is assessed using the American Urological Association Symptom Index. The American Urological Association Symptom Index has a range of 0 (no dysfunction) to 35 (maximum dysfunction). A decrease in score indicates improvement.
次要结局
未报告次要终点
研究者
Timothy Bruns
Associate Professor of Biomedical Engineering, Medical School
University of Michigan