Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation

NCT06983470 | Recruiting FDA Device

• 1 other identifier: HUM00222497
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change in bladder function score during SNM using visual-motor responses (VMR)-selected stimulation programs

  Bladder function score is assessed using the American Urological Association Symptom Index. The American Urological Association Symptom Index has a range of 0 (no dysfunction) to 35 (maximum dysfunction). A decrease in score indicates improvement.

  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

  Bladder function score is assessed using the American Urological Association Symptom Index. The American Urological Association Symptom Index has a range of 0 (no dysfunction) to 35 (maximum dysfunction). A decrease in score indicates improvement.

  Baseline through the conclusion of study participation, approximately 3 months

Study Arms (2)

VMR followed by SER

EXPERIMENTAL

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.

Device: SNM based on visual-motor responses (VMRs); Device: SNM based on sacral evoked responses (SERs)

SER followed by VMR

EXPERIMENTAL

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.

Device: SNM based on visual-motor responses (VMRs); Device: SNM based on sacral evoked responses (SERs)

Interventions

SNM based on visual-motor responses (VMRs) DEVICE

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

SER followed by VMR; VMR followed by SER

SNM based on sacral evoked responses (SERs) DEVICE

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

SER followed by VMR; VMR followed by SER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• Medtronic: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tim Bruns, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yike Liu

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Biomedical Engineering, Medical School

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 21, 2025
• Study Start: October 16, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)