Status:
RECRUITING
Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Medtronic
Conditions:
Overactive Bladder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 signa...
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06983470
Start Date
October 16 2025
End Date
October 1 2029
Last Update
December 18 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109