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Wireless bladder sensor could help veterans regain control

NCT ID NCT05141487

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new type of nerve stimulation to help Veterans with bladder control problems caused by nerve damage. A small wireless sensor is placed in the bladder to detect when it is filling and trigger stimulation to prevent leakage. The goal is to see if this approach works better than standard 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.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Oct 2026

An estimate. End dates often move.

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.

Who is studied

The study will enroll 16 patients undergoing treatment at the VANEOHS (US Veterans). Participants will have a diagnosis of neurogenic bladder with a recent (within one year) multi-channel UDS evaluation. Participants will be selected as those with neurogenic bladder symptoms most likely to respond to SNM treatment based on evidence-based recommendations (i.e reasonable bladder capacity, non-catheter dependent, ability to identify and manage bladder needs - as based upon assessment by clinical experts / co-investigators). Participants will be screened to meet inclusion/exclusion criteria. Implantation of bilateral percutaneous stimulating electrodes, setting of SNM stimulation waveforms, and the use of an external continuous SNM stimulator will follow clinical standard of care for prospective evaluation for Medtronic Interstim treatment.

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: * Diagnosis of neurogenic lower urinary tract dysfunction consistent with International Continence Society definition which includes all bladder/urinary sphincter dysfunction related to any neurological disease or injury * Male or female * If SCI, time from injury \> 6 months to allow for recovery from the acute phase * Can tolerate lying prone \> 1 hour * Functional bladder capacity \> 100 mL confirmed by urodynamics examination * Low risk of upper urinary tract deterioration * Over 18 years of age, able to speak and understand English, capacity for consent Exclusion Criteria: * Active urinary tract infection * Chronic indwelling or suprapubic catheter usage * Severe or rapidly progressive neurologic disease * Abnormal sacral anatomy * Anticipated need for MRI of body parts below the head * Pelvic organ prolapse beyond the hymen * Pregnancy * Treatment with Botox injection within last six months * Current treatment with percutaneous tibial nerve stimulation or other forms of neuromodulation * History of sacral neuromodulation treatment or presence of sacral neuromodulation leads or implant * Interstitial cystitis/bladder pain syndrome * Benign prostatic hyperplasia preventing catheterization to empty * History of anatomically relevant pelvic or anti-incontinence surgery

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Conditions

The condition(s) this trial relates to.

Urinary Bladder, Neurogenic Urinary Incontinence

As listed by the trial registrant

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

Urinary bladder, neurogenic Urinary incontinence

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Louis Stokes VA Medical Center, Cleveland, OH

    RECRUITING

    Cleveland, Ohio, 44106-1702, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.