Actively Recruiting
Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation
Led by University of Michigan · Updated on 2025-12-18
15
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
Y
Yike Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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