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Could a TENS device stop bowel accidents in spinal injury?

NCT ID NCT06836739

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This study tests whether using a small electrical stimulation device on the skin near the genitals can help people with spinal cord injury control bowel accidents. Twelve participants will use the device at home for 6-8 hours daily over 4 weeks. The goal is to see if this approach is practical and worth studying further.

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 via a TENS device
What this could lead to
If it works, this could offer a non-invasive, drug-free way to manage bowel accidents for people with spinal cord injury.
What could go wrong
This is a very small feasibility study with only 12 participants. It is too early to know if the stimulation actually works, and the device is being used off-label.

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 12 people

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

Started

Mar 2025

Expected to finish

Sep 2026

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: 1. Traumatic SCI. 2. Minimum of 6 months' post-injury. 3. Aged 18 years and older. 4. Neurological level of injury T12 or higher and AIS grade A-D, as defined by the ISNCSCI. 5. Score of 14 or higher on the ISCI BF BDS v2.1. 6. Response to genital nerve stimulation able to be elicited upon screening. 7. Able to understand and provide informed consent. Exclusion Criteria: 1. Currently enrolled in another functional electrical stimulation (FES) research trial. 2. Females who are pregnant or planning to become pregnant in the duration of the trial (identified by self-report). 3. Presence of a cardiac pacemaker, implanted defibrillator, or other implanted functional electrical stimulation device if, upon clinical evaluation, it may have an interaction with GNS. 4. In the judgment of the PI and 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.

Spinal cord injury

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 Center for Rehabilitation Research

    RECRUITING

    Cleveland, Ohio, 44109, United States

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