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Shockingly simple: wearable zaps aim to end bladder leaks for paralyzed men

NCT ID NCT07668063

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests a wearable device that delivers mild electrical stimulation to a nerve near the genitals, aiming to improve bladder control in men with spinal cord injury. The study will enroll 12 participants and measure changes in bladder capacity and device usability. If successful, it could lead to a noninvasive, drug-free way to manage incontinence and urgency.

What this could mean

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

Active substance
noninvasive electrical stimulation device (genital nerve stimulator)
What this could lead to
If it works, this could offer a drug-free, wearable option to help men with spinal cord injury gain better bladder control and reduce accidents.
What could go wrong
This is a very small early-phase trial with only 12 participants, so results may not apply widely. The device may not work for everyone, and skin irritation or discomfort is possible.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 12 people

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

Expected to start

Jun 2028

An estimate. Start dates often move.

Expected to finish

Dec 2029

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.

Ages

18 years and older

Sex

Male participants only

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 SCI * Neurologically stable * Skeletally mature * Presence of reflex bladder contractions * At least 12 months post SCI Exclusion Criteria: * Active sepsis * Open pressure sores on or around pelvis * Bleeding diathesis * Significant urethral trauma, erosion, or stricture * Indwelling catheter for over 1 year AND bladder capacity less than 100 mL * Significant history of autonomic dysreflexia

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Conditions

The condition(s) this trial relates to.

spinal cord injury Urinary Bladder, Neurogenic

As listed by the trial registrant

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

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

    Cleveland, Ohio, 44106-1702, United States

More trials for these conditions

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