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Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation

RecruitingNAAges 18 Years - anyAllUniversity of Michigan
NCT06983470 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • SNM based on visual-motor responses (VMRs)
  • SNM based on sacral evoked responses (SERs)
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Where

1 site
University of Michigan
Ann Arbor, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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