Recruiting

SNM

Sponsor:

University of Michigan

Code:

NCT06983470

Conditions

Overactive Bladder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SNM based on visual-motor responses (VMRs)

SNM based on sacral evoked responses (SERs)

Study Details

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 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.

Conditions

Overactive Bladder

Study ID

NCT06983470

Start date

Oct 16, 2025

Status verified date

Dec, 2025

Completion date

Oct, 2029

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VMR followed by SER

SNM implants will use parameters selected based on visual-motor responses (VMRs) for four weeks followed by parameters selected based on sacral evoked responses (SERs) for four weeks.

experimental: SER followed by VMR

SNM implants will use parameters selected based on sacral evoked responses (SERs) for four weeks followed by parameters selected based on visual-motor responses (VMRs) for four weeks.

Interventions

SNM based on visual-motor responses (VMRs)

SNM using parameters that elicited the best VMRs in the stage-1 implant procedure

SNM based on sacral evoked responses (SERs)

SNM using parameters that elicited the best SERs in the stage-1 implant procedure

Primary outcome measure

  • Change in bladder function score during SNM using visual-motor responses (VMR)-selected stimulation programs [ Time Frame: Baseline through the conclusion of study participation, approximately 3 months ]
  • Change in bladder function score during SNM using sacral evoked responses (SER)-selected stimulation programs [ Time Frame: Baseline through the conclusion of study participation, approximately 3 months ]

Central Contacts and Locations

Central contacts

Yike Liu

734-763-7104yikel@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Yike Lui

734-763-7104yikel@med.umich.edu

Principal Investigator:

Tim Bruns, PhD

More Information

Sponsor

University of Michigan

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2025-12-18.