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New device aims to strengthen muscles and ease fecal incontinence

NCT ID NCT06532123

Symptom relief Sponsor: Medical College of Wisconsin 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a device called c-RED, which uses a balloon to provide resistance during anal muscle contractions. The goal is to see if this exercise can strengthen muscles and improve fecal incontinence. Researchers will measure anal and vaginal pressure, incontinence severity, and quality of life in 340 healthy volunteers and patients.

What this could mean

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

Active substance
continence muscles resistance device (c-RED)
What this could lead to
If successful, this could provide a non-surgical way to strengthen anal muscles and reduce fecal incontinence severity.
What could go wrong
This is an early-stage study focused on muscle fatigue mechanisms, not a proven treatment. The device may not lead to lasting improvement for all participants.

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 340 people

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

Started

Jul 2025

Expected to finish

Mar 2030

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

Accepted

You do not need to have the condition being studied to take part.

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: * Healthy volunteers without past or present history of fecal incontinence * Patients age 18 years and older with reduced anal resting and or squeeze pressure, reflecting weakness of the anal sphincters who can perform the study Exclusion Criteria: * Any one less than 18 years old * Neurological disorders like dementia, cerebrovascular diseases * Muscle diseases like muscular dystrophy, myopathies * Inflammatory bowel disease or celiac disease * Neuro-muscular junction disorders/myasthenia gravis, Eaton-Lambert syndrome * Organ prolapse, large rectocele(\>2cm), rectal intussusception * Hip dysplasia or recent hip surgery and immobile patients. * Patients with complete normal anal resting and squeeze pressure * Impaired rectal evacuation (dyssynergy defecation) * Fecal incontinence completely due to loss of rectal sensation * Subjects unable to contract their external anal sphincter at all

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Conditions

The condition(s) this trial relates to.

Fecal Incontinence

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

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53086, United States

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