Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT06983470
Status
Recruiting
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Conditions

  • Overactive Bladder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SNM based on visual-motor responses (VMRs) — DEVICE
    SNM using parameters that elicited the best VMRs in the stage-1 implant procedure
  • SNM based on sacral evoked responses (SERs) — DEVICE
    SNM using parameters that elicited the best SERs in the stage-1 implant procedure

Study Details

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.

Key Dates

Start date
Oct 16, 2025
Status verified
Dec 2025
Primary completion
Sep 30, 2028
Completion
Oct 31, 2029

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Yike Lui
[email protected]
734-763-7104
Tim Bruns, PhD (PRINCIPAL_INVESTIGATOR)
Priyanka Gupta, MD (SUB_INVESTIGATOR)

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