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A 'Bladder Pacemaker'? nerve stimulation may curb incontinence after spinal injury

NCT ID NCT03472599

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether long-term electrical stimulation of the genital nerves can reduce bladder spasms and improve continence in people with neurogenic bladder dysfunction due to spinal cord injury, stroke, or multiple sclerosis. Participants will use a home-based stimulation system for up to a year, and researchers will track leakage episodes, urgency, and bladder capacity. The goal is to develop a practical 'bladder pacemaker' that enhances independence and quality of life.

What this could mean

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

Active substance
Genital nerve stimulation
What this could lead to
If effective, this could lead to a 'bladder pacemaker' that helps people with spinal cord injuries manage incontinence and improve quality of life.
What could go wrong
This is a small early-stage trial, and the approach has not been tested for long-term home use. Results may vary, and there is a risk of infection or discomfort.

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

17 people

The number who actually took part.

Started

Nov 2019

Finished

Sep 2023

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

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

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Suprasacral neurogenic bladder following spinal cord injury, stroke, or multiple sclerosis * Neurologically stable * Skeletally mature, over 18 years of age. * Reflex bladder contractions confirmed by cystometrogram * At least six (6) months post spinal cord injury, stroke, or multiple sclerosis diagnosis * Able to understand and comply with study requirements * Able to understand and give informed consent Exclusion Criteria: * Active sepsis * Open pressure sores on penis * Significant trauma, erosion or stricture of the urethra * Pregnancy * Individuals who do not speak English.

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Conditions

The condition(s) this trial relates to.

spinal cord injury Urinary Incontinence

As listed by the trial registrant

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

Neurogenic bladder dysfunction

Contacts and locations

Locations

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio, 44106-1702, United States

  • Syracuse VA Medical Center, Syracuse, NY

    Syracuse, New York, 13210, United States

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