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Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation

NCT ID: NCT06983470

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-16

Study Completion Date

2029-10-31

Brief Summary

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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.

Detailed Description

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Some surgical procedures will be conducted at the Chealsea Hospital (75 S Main St, Chelsea, MI 48118) and all others will be done at Michigan Medicine facilities.

Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SNM based on visual-motor responses (VMRs)

Intervention Type DEVICE

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

SNM based on sacral evoked responses (SERs)

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

SNM based on visual-motor responses (VMRs)

Intervention Type DEVICE

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

SNM based on sacral evoked responses (SERs)

Intervention Type DEVICE

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

Interventions

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SNM based on visual-motor responses (VMRs)

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

Intervention Type DEVICE

SNM based on sacral evoked responses (SERs)

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Timothy Bruns

Associate Professor of Biomedical Engineering, Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tim Bruns, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Yike Liu

Role: CONTACT

Phone: 734-763-7104

Email: [email protected]

Facility Contacts

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Yike Lui

Role: primary

Other Identifiers

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HUM00222497

Identifier Type: -

Identifier Source: org_study_id