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Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation

NCT06983470 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-18

No results posted yet for this study

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

Interventions

DEVICE

SNM based on visual-motor responses (VMRs)

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

DEVICE

SNM based on sacral evoked responses (SERs)

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

Sponsors & Collaborators

Principal Investigators

  • Tim Bruns, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-16
Primary Completion
2028-09-30
Completion
2029-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06983470 on ClinicalTrials.gov