Sacral Neuromodulation for Overactive Bladder

Overseen By Yike Liu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Areflexive bladder, Pregnant, Neurogenic bladder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Tim Bruns, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for individuals with overactive bladder issues. Participants should be suitable candidates for sacral neuromodulation (SNM) therapy, which involves electrical stimulation of the sacral nerve to improve bladder function and reduce pelvic pain.

Inclusion Criteria

I am approved for a sacral nerve implant for my overactive bladder.

Capable of speaking, reading, and understanding English, as all study questionnaires are standardized assessments only available in English

Exclusion Criteria

Areflexive or atonic bladder

I have a condition affecting bladder control due to nerve issues.

I am not pregnant nor planning to become pregnant if I wish to join the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SNM implants with parameters based on VMR for four weeks followed by SER for four weeks, or vice versa

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sacral Neuromodulation based on sacral evoked responses (SERs)
• Sacral Neuromodulation based on visual-motor responses (VMRs)

Trial Overview The study compares two methods of setting SNM parameters: one based on visual-motor responses (VMRs) and another on sacral evoked responses (SERs). It aims to understand how these different parameter selections affect changes in bladder function.

Participant Groups

Group I: VMR followed by SER Experimental Treatment 2 Interventions

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.

Group II: SER followed by VMR Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc