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Battle of the bowel: biofeedback vs. injections for incontinence

NCT ID NCT03811821

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compared two treatments for severe fecal incontinence: biofeedback (exercises to strengthen muscles) and injections of a bulking agent into the rectal wall. 275 adults with frequent accidents took part. After a month of basic care, those who didn't improve were randomly assigned to one of the treatments. The goal was to see which reduced accidents more, and if it was safe and cost-effective.

What this could mean

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

Active substance
biofeedback and injectable bulking agents (Solesta)
What this could lead to
If successful, this could show which treatment works better for severe fecal incontinence, improving quality of life for many patients.
What could go wrong
The trial is completed but results may not apply to everyone. Treatments may not work for all, and there are risks like pain or infection from injections.

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

275 people

The number who actually took part.

Started

Feb 2019

Finished

Jan 2026

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: * Physician diagnosis of FI (R15) for the past 6 months or longer. * Able to ambulate independently on level surfaces. Patient may use assistive devices other than parallel bars. * Average \>2 staining, solid or liquid FI episodes per week by self-report and during the two-week baseline * Meets criteria for dextranomer treatment except an internal anal sphincter defect of 180 degrees or less is acceptable. * Less than 75% reduction in the number of FI episodes after 4 weeks of conservative treatment. * Age \>=18 years Exclusion Criteria: * Dementia, assessed using the Six-Item Screener to Identify Cognitive Impairment. * Obstetrical injuries including third and fourth degree tears in the anal sphincter within the past 6 months. * Pregnant or planning pregnancy in next 2 years * Internal anal sphincter separation \>180 degrees on ultrasound or magnetic resonance imaging * Spinal cord injury or spina bifida * Congenital malformation of anus or rectum * Complete rectal prolapse or grade III/IV hemorrhoids * History of ileoanal pouch; history of anal sphincteroplasty, rectopexy, or rectocele repair within the past 6 months; or history of pelvic surgery with synthetic graft and suspected graft erosion into the anus, rectum, or skin or if the graft ends less than approximately 1" above the upper limit of the anal canal. * Established diagnosis of inflammatory bowel disease * Intestinal stoma present * History of pelvic radiation within previous 12 months or presence of active radiation proctitis. * Patients who cannot expel the rectal balloon during the balloon expulsion test and who have constipation most of the time. * Anatomic limitations to placement of dextranomer injections. * Presence of existing implant in the anal or rectal region * Allergy to hyaluronic acid-based products * Active anal or rectal conditions in the last 6 months including abscess, fissures, sepsis, significant bleeding, proctitis, colovaginal and rectovaginal fistulas, anal or rectal tumors, or other infections. * The patient's physician believes it is unsafe for the patient to temporarily stop anticoagulants for any test procedures and treatments associated with the study. * Patients who have 4 or more days with 4 or more bowel movements classed as a 6 or 7 on the Bristol Stool Scale per day in either (any) week bowel movements classed as a 6 or 7 during the Baseline will be excluded. * Patients with Parkinson's disease, multiple sclerosis, severe diabetic neuropathy documented by electromyography (EMG), and neurodegenerative disorder. * Patients currently receiving immunotherapy or chemotherapy. * Significant anal pain in the last 6 months. * Unwillingness of participant to stop using over-the-counter medications, herbal supplements, or prescribed medications for the purpose of modifying stool consistency, that are not included in the approved medications list (loperamide, laxatives, fiber supplements, and Questran are approved medications), for the duration of the research study. Medical history will be documented to test for predictors of response.

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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.

Contacts and locations

Locations

  • Augusta University Medical College of Georgia

    Augusta, Georgia, 30912, United States

  • Colon and Rectal Surgery Associates, Ltd.

    Saint Paul, Minnesota, 55114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35801, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

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