Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation

University of Michigan

Status: Enrolling

Conditions: Overactive Bladder

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06983470

HUM00222497

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

15 participants in 2 patient groups

VMR followed by SER

Experimental group

Description:

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.

Treatment:

Device: SNM based on visual-motor responses (VMRs)

Device: SNM based on sacral evoked responses (SERs)

SER followed by VMR

Experimental group

Description:

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.

Treatment:

Device: SNM based on visual-motor responses (VMRs)

Device: SNM based on sacral evoked responses (SERs)