Shockingly simple: wearable zaps aim to end bladder leaks for paralyzed men
NCT ID NCT07668063
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2028
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New catheter design aims to make Self-Catheterization easier and more comfortable
- Bladder wash could cut infections and hospital visits for catheter users
- Decades of data: does this bladder surgery stand the test of time for spinal cord injury?
- New registry tracks Real-Life catheter experiences to improve bladder care
- Antibiotics after bladder botox may cut infection risk
- Double transplant: kidney and bladder together for the first time