Battle of the bowel: biofeedback vs. injections for incontinence

NCT ID NCT03811821

Completed Disease control Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

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.

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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.

BOWEL INCONTINENCE FECAL INCONTINENCE

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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