Sacral Neuromodulation for Overactive Bladder

Overseen By Yike Liu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Areflexive bladder, Pregnant, Neurogenic bladder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how electrical stimulation of the sacral nerve, known as Sacral Neuromodulation, can improve symptoms of an overactive bladder, a condition causing frequent urges to urinate. Researchers aim to determine how different stimulation settings, based on either movement responses or nerve signals, affect bladder function. Participants will try two different approaches, each for four weeks, to identify which works better. This trial may suit individuals diagnosed with an overactive bladder who are already eligible for a sacral nerve implant as part of their regular care. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance treatment options for overactive bladder.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the research team to get a clear answer.

What prior data suggests that sacral neuromodulation is safe for overactive bladder?

Research shows that sacral neuromodulation (SNM), which uses gentle electrical pulses on the sacral nerve, is generally safe for managing overactive bladder and other urinary problems. Studies have found it to be an effective non-surgical option, often preferred before surgery. Reports from various studies indicate that patients tolerate it well, with few serious side effects.

For the treatment based on sacral evoked responses (SER), detailed studies have confirmed its safety in large trials, with no major negative effects directly linked to the procedure. Used since the 1990s, it has demonstrated reliability over time.

The visual-motor response (VMR) method, another form of SNM, also has a similar safety record. It effectively reduces symptoms like frequent urination and sudden urges to urinate, without causing significant harm to patients.

Overall, extensive research supports both methods of sacral neuromodulation, showing they are safe and generally well-tolerated by patients with bladder issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Sacral Neuromodulation (SNM) for overactive bladder because it offers a more personalized approach compared to traditional treatments like medications or behavioral therapies. Unlike standard options that typically involve oral drugs or lifestyle changes, SNM targets the sacral nerves directly, which are crucial in bladder control. The unique aspect of this trial is its exploration of two different ways to adjust SNM settings—based on either visual-motor responses (VMRs) or sacral evoked responses (SERs). This could lead to more effective, tailored treatments for patients by optimizing neuromodulation settings to individual responses.

What evidence suggests that this trial's treatments could be effective for overactive bladder?

Research has shown that sacral neuromodulation (SNM) effectively treats overactive bladder symptoms. This treatment stimulates a nerve in the lower back, aiding bladder control and reducing pelvic pain. Studies have found SNM to be a safe option for those whose bladder issues haven't improved with other treatments. In this trial, participants will experience two different SNM methods. The sacral evoked responses (SERs) method suggests that SNM alters pelvic floor muscle function, offering new insights into its mechanism. Meanwhile, the visual-motor responses (VMRs) method examines changes in brain activity during stimulation, showing promise for improving bladder symptoms. Both methods rely on the idea that electrical stimulation can help manage challenging bladder conditions. ^{1 3 6 7 8}

Who Is on the Research Team?

Tim Bruns, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals with overactive bladder issues. Participants should be suitable candidates for sacral neuromodulation (SNM) therapy, which involves electrical stimulation of the sacral nerve to improve bladder function and reduce pelvic pain.

Inclusion Criteria

I am approved for a sacral nerve implant for my overactive bladder.

Capable of speaking, reading, and understanding English, as all study questionnaires are standardized assessments only available in English

Exclusion Criteria

Areflexive or atonic bladder

I have a condition affecting bladder control due to nerve issues.

I am not pregnant nor planning to become pregnant if I wish to join the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SNM implants with parameters based on VMR for four weeks followed by SER for four weeks, or vice versa

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sacral Neuromodulation based on sacral evoked responses (SERs)
• Sacral Neuromodulation based on visual-motor responses (VMRs)

Trial Overview The study compares two methods of setting SNM parameters: one based on visual-motor responses (VMRs) and another on sacral evoked responses (SERs). It aims to understand how these different parameter selections affect changes in bladder function.

How Is the Trial Designed?

Group I: VMR followed by SER Experimental Treatment 2 Interventions

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.

Group II: SER followed by VMR Experimental Treatment 2 Interventions

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 Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3398598/

Sacral neuromodulation and refractory overactive bladder SNM is considered as an effective and safe noninvasive therapy for refractory OAB patients. It should be considered before irreversible surgical treatment.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1094715923007031

Sensing in Sacral Neuromodulation: A Feasibility Study ... The purpose of this study was to measure and characterize sacral evoked responses (SERs) resulting from sacral nerve stimulation using a commercial, tined SNM ...

3. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(23)00703-1/pdf

Sensing in Sacral Neuromodulation Sacral neuromodulation changes pelvic floor activity in overactive bladder patients—possible new insights in mechanism of action: a pilot study.

4. withpower.com withpower.com/trial/sacral-neuromodulation-for-overactive-bladder-78551

Sacral Neuromodulation for Overactive Bladder Electrical stimulation of the sacral nerve can help with bladder problems and pelvic pain but researchers don't understand exactly how the stimulation helps ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9153358/

Predictive Factors in Sacral Neuromodulation: A Systematic ... Sacral neuromodulation (SNM) is an effective treatment in patients with overactive bladder syndrome or nonobstructive urinary retention when conservative ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1566070225000992

Sacral neuromodulation for low urinary tract dysfunction Sacral neuromodulation (SNM) is widely used since the 1990's for overactive bladder (OAB) and non-obstructive urinary retention (NOUR) with good clinical ...

7. mdpi.com mdpi.com/2077-0383/14/3/1031

Early Sacral Neuromodulation: A Promising Opportunity or ... In summary, SNM is a safe and effective option in incomplete SCI patients [3,4,10]. Concerning complete SCI, SNM could not improve nLUTD once the typical ...

8. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(21)06461-8/pdf

Reprogramming Sacral Neuromodulation for Sub-Optimal ... Detailed analysis of adverse events and surgical interventions in a large prospective trial of sacral neuromodulation therapy for overactive bladder patients.