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Could a TENS unit stop bowel accidents after spinal injury?

NCT ID NCT05626816

Symptom relief Sponsor: MetroHealth Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether gentle electrical stimulation of a nerve in the genital area can improve bowel control in people with spinal cord injury. Researchers will measure how the rectum and anus respond to the stimulation using a small balloon. The goal is to see if this non-invasive approach could reduce fecal incontinence, a common and life-limiting problem after spinal cord injury.

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 using a TENS unit with surface electrodes
What this could lead to
If it works, this could point toward a non-invasive, drug-free way to reduce fecal incontinence and improve quality of life for people with spinal cord injury.
What could go wrong
This is a small, early-phase study (52 people) testing only short-term effects. It may not translate to real-world benefit, and not everyone responds to the 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

About 52 people

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

Started

Mar 2023

Expected to finish

Dec 2025

An estimate. End dates often move.

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

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: * Traumatic SCI * Minimum 6 months post-injury * Aged 18 years or older * Neurological level of injury T12 or higher AIS grade A-D defined by ISNCSCI * Response to genital nerve stimulation upon screening * Able to understand and provide informed consent Exclusion Criteria: * Currently enrolled in another functional electrical stimulation (FES) research trial * Females who are pregnant or planning to become pregnant during the trial * Presence of cardiac pacemaker, implanted defibrillator or other implanted FES device if, upon clinical exam, it may have an interaction with GNS. * In the judgement of the PI or Co-Investigators, presence of medical complications that may interfere with the execution of the study.

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Conditions

The condition(s) this trial relates to.

Fecal Incontinence neurogenic bowel palsy paraplegia quadriplegia spinal cord injury

As listed by the trial registrant

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

Fecal 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

  • MetroHealth Medical System Old Brooklyn Campus

    RECRUITING

    Cleveland, Ohio, 44109, United States

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