Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SNM based on visual-motor responses (VMRs), SNM based on sacral evoked responses (SERs).
- Who it may be relevant to
- Registry conditions: Overactive Bladder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Change in bladder function score during SNM using visual-motor responses (VMR)-selected stimulation programs [Time frame: Baseline through the conclusion of study participation, approximately 3 months]
- Change in bladder function score during SNM using sacral evoked responses (SER)-selected stimulation programs [Time frame: Baseline through the conclusion of study participation, approximately 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT06983470 · HUM00222497