Overactive Bladder
Conditions
Brief 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.
Interventions
DEVICESNM based on visual-motor responses (VMRs)
SNM using parameters that elicited the best VMRs in the stage-1 implant procedure
DEVICESNM based on sacral evoked responses (SERs)
SNM using parameters that elicited the best SERs in the stage-1 implant procedure
Sponsors
Medtronic
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in bladder function score during SNM using visual-motor responses (VMR)-selected stimulation programs | Baseline through the conclusion of study participation, approximately 3 months | Bladder function score is assessed using the American Urological Association Symptom Index. The American Urological Association Symptom Index has a range of 0 (no dysfunction) to 35 (maximum dysfunction). A decrease in score indicates improvement. |
| Change in bladder function score during SNM using sacral evoked responses (SER)-selected stimulation programs | Baseline through the conclusion of study participation, approximately 3 months | Bladder function score is assessed using the American Urological Association Symptom Index. The American Urological Association Symptom Index has a range of 0 (no dysfunction) to 35 (maximum dysfunction). A decrease in score indicates improvement. |
Countries
United States
Contacts
Primary ContactYike Liu
Outcome results
None listed