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NCT06983470NARecruiting

Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation

University of Michigan

Start Date

10/16/2025

Completion Date

10/1/2029

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 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.

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

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

SNM based on visual-motor responses (VMRs)

DEVICE

SNM based on sacral evoked responses (SERs)

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Conditions

Overactive Bladder

Locations

University of Michigan

Ann Arbor, Michigan 48109

United States