Overactive BladderNCT06983470
Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation
A study testing SNM based on visual-motor responses (VMRs) and SNM based on sacral evoked responses (SERs) in people with Overactive Bladder, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- SNM based on visual-motor responses (VMRs) and SNM based on sacral evoked responses (SERs)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2025to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Yike Lui, 734-763-7104, yikel@med.umich.edu
Tim Bruns, PhD
About this study
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.
Read the 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
- Being tested
- SNM based on visual-motor responses (VMRs), SNM based on sacral evoked responses (SERs)
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNM based on visual-motor responses (VMRs)Device
SNM using parameters that elicited the best VMRs in the stage-1 implant procedure
SNM based on sacral evoked responses (SERs)Device
SNM using parameters that elicited the best SERs in the stage-1 implant procedure
| Study group | Role | What they receive |
|---|---|---|
| VMR followed by SER | Experimental | 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. Receives: Device: SNM based on visual-motor responses (VMRs); Device: SNM based on sacral evoked responses (SERs) |
| SER followed by VMR | Experimental | 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. Receives: Device: SNM based on visual-motor responses (VMRs); Device: SNM based on sacral evoked responses (SERs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bladder function score during SNM using visual-motor responses (VMR)-selected stimulation programs
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.
Measured: 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
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.
Measured: Baseline through the conclusion of study participation, approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start16 Oct 2025
- Primary completionSep 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Timothy Bruns, University of Michigan
- Investigators
- Tim Bruns, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983470
- Sponsor's protocol ID
- HUM00222497
- Status last verified
- Dec 2025
- First submitted
- 9 May 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation
- ClinicalTrials.gov ID
- NCT06983470
- Acronym / sponsor ID
- HUM00222497
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VMR followed by SER | Experimental | Device: SNM based on visual-motor responses (VMRs), Device: SNM based on sacral evoked responses (SERs)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. |
| SER followed by VMR | Experimental | Device: SNM based on visual-motor responses (VMRs), Device: SNM based on sacral evoked responses (SERs)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNM based on visual-motor responses (VMRs)SNM using parameters that elicited the best VMRs in the stage-1 implant procedure | Device | SER followed by VMR, VMR followed by SER |
| SNM based on sacral evoked responses (SERs)SNM using parameters that elicited the best SERs in the stage-1 implant procedure | Device | SER followed by VMR, VMR followed by SER |
Primary outcome
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
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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tim Bruns, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SNM based on visual-motor responses (VMRs) and SNM based on sacral evoked responses (SERs) in people with Overactive Bladder, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yike Liu (734-763-7104, yikel@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.