Using sacral nerve responses to guide sacral neuromodulation for overactive bladder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.