NCT06983470

Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-10-16
• Primary completion: 2028-09-01
• Completion: 2029-10-01
• First posted: 2025-05-21
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study