Using sacral nerve responses to guide sacral neuromodulation for overactive bladder
Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation
This research will test whether choosing sacral nerve stimulation settings based on sacral evoked responses versus visual-motor responses helps adults with overactive bladder symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06983470 on ClinicalTrials.gov |
What this trial studies
This interventional study compares two ways of choosing sacral neuromodulation (SNM) settings—based on visual-motor responses (VMR) or on sacral evoked responses (SER)—to see how each approach changes bladder function. Participants who are already candidates for an SNM implant for overactive bladder will undergo implantation and parameter selection using one of the two methods, then be followed to measure changes in urinary symptoms and physiological signals. Some surgical procedures will take place at Chelsea Hospital while other visits and follow-up are conducted at Michigan Medicine facilities in Ann Arbor. Key eligibility includes adults able to consent and communicate in English and excludes people with areflexive or neurogenic bladders, sacral nerve damage, or pregnancy.
Who should consider this trial
Good fit: Adults (18+) who are medically eligible for a sacral neuromodulation implant for overactive bladder, can consent, and can complete English-language questionnaires are the ideal candidates.
Not a fit: Patients with an areflexive or atonic bladder, diagnosed neurogenic bladder, sacral nerve damage, lower motor dysfunction, or those who are pregnant or planning pregnancy are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could make SNM work better by personalizing stimulation settings to each patient's nerve responses, reducing urgency and incontinence for more people.
How similar studies have performed: Sacral neuromodulation itself is an established treatment for overactive bladder, but using sacral evoked responses to guide parameter selection is relatively novel and not yet widely proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Tim Bruns, PhD — University of Michigan
- Study coordinator: Yike Liu
- Email: yikel@med.umich.edu
- Phone: 734-763-7104
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.