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Can a nerve pacemaker that takes breaks still tame an overactive bladder?

NCT ID NCT06170450

Symptom relief Sponsor: University Hospitals Cleveland Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This trial tests whether a sacral neuromodulation device programmed to cycle on and off (8 hours on, 16 hours off) works as well as continuous stimulation for women with overactive bladder. Participants who have already had a successful trial of the device will be randomly assigned to one of the two settings. The study measures changes in bladder symptoms and quality of life over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sacral neuromodulation (SNM) device programmed either cyclically (8 hours on, 16 hours off) or continuously
What this could lead to
If cycling works as well as continuous stimulation, patients could enjoy better battery life and less frequent device replacements.
What could go wrong
This is a small, early-stage trial with only 50 participants, so results may not apply to everyone. Cycling might not control symptoms as effectively as continuous stimulation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

50 people

The number who actually took part.

Started

Apr 2024

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients 18 years of age or older * Female * English Speaking * Diagnosis of urinary urge incontinence or overactive bladder * Meet criteria for and are planning permanent SNM (ie. successful stage I or office PNE trial of SNM with 50% or more reduction in UUI episodes) * Willing and able to complete all study related items Exclusion Criteria: * Patients less than 18 years of age * Unable to provide consent * Non-English speaking * Relevant neurologic diseases (multiple sclerosis, Parkinson Disease, myasthenia gravis, - - - Charcot-Marie-Tooth disease, complete spinal cord injury) * Current or prior bladder malignancy

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Conditions

The condition(s) this trial relates to.

overactive bladder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Overactive bladder syndrome

Contacts and locations

Locations

  • MetroHealth

    Cleveland, Ohio, 44109, United States

  • University Hospitals

    Cleveland, Ohio, 44106, United States

  • University of Louisville

    Louisville, Kentucky, 40202, United States

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