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Biofeedback + Injection for Bowel Incontinence

N/A

Waitlist Available

Led By William Whitehead, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Less than 75% reduction in the number of FI episodes after 4 weeks of conservative treatment

Age 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial is testing a new treatment for fecal incontinence. Patients will either receive injections of a bulking agent or biofeedback, and will be monitored for a 75% reduction in fecal incontinence episodes. If the treatment is successful, participants will be followed for an additional 21 months.

Who is the study for?

Adults with severe fecal incontinence, experiencing more than two episodes per week despite 4 weeks of conservative treatment. Participants must be able to walk independently and have had a physician's diagnosis for at least six months. Exclusions include significant anal pain or injuries, certain anatomic limitations, allergies to specific products, pregnancy plans within two years, and various medical conditions like inflammatory bowel disease or neurological disorders.Check my eligibility

What is being tested?

The FIT Study is testing the effectiveness of Biofeedback versus Injection of Solesta after initial Enhanced Medical Management fails to reduce fecal incontinence by 75%. Patients who don't improve sufficiently will be randomized into one of these treatments and followed up for efficacy, safety, and cost over a total period of 24 months.See study design

What are the potential side effects?

Potential side effects may include discomfort at the injection site for those receiving Solesta injections or muscle strain from biofeedback exercises. There could also be risks associated with not responding to treatment leading to continued episodes of incontinence.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My conservative treatment for FI didn't reduce episodes by 75% after 4 weeks.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of Participants with Specified Adverse Events at Month 3 Follow-Up

Treatment Costs at Month 3 Follow-Up

Treatment Response Defined as a 75% or Greater Change in Number of Average Weekly FI Episodes at Month 3 Follow-Up Compared to Baseline

Secondary outcome measures

Change in Psychological Distress as Assessed Using the 7-item Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale

Change in Psychological Distress as Assessed Using the 8-item PROMIS Depression Scale

Change in Psychological Distress as Assessed Using the 8-item PROMIS Self-Efficacy Symptom Management Scale

+4 more

Trial Design

2Treatment groups

Active Control

Group I: Biofeedback (BIO)Active Control1 Intervention

Participants will receive biofeedback intervention during five (5) required weekly 1-hour sessions. A 6th treatment session will be made available for participants if it is shown through anorectal manometry that they are having trouble understanding directions given during the first five sessions.

Group II: Injection (INJ)Active Control1 Intervention

Bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamOTHER

1,581 Previous Clinical Trials

2,277,758 Total Patients Enrolled

RTI InternationalOTHER

188 Previous Clinical Trials

875,693 Total Patients Enrolled

University of MichiganOTHER

1,794 Previous Clinical Trials

6,373,645 Total Patients Enrolled

Media Library

Biofeedback Clinical Trial Eligibility Overview. Trial Name: NCT03811821 — N/A

Bowel Incontinence Research Study Groups: Biofeedback (BIO), Injection (INJ)

Bowel Incontinence Clinical Trial 2023: Biofeedback Highlights & Side Effects. Trial Name: NCT03811821 — N/A

Biofeedback 2023 Treatment Timeline for Medical Study. Trial Name: NCT03811821 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are joining the experiment?

"Affirmative. According to clinicaltrials.gov, the investigation was first posted on February 1st 2019 and is presently enrolling 285 candidates from 5 clinics. Recent updates were made on January 13th 2022."

Answered by AI

What is the aim of this research endeavor?

"The primary aim of this trial, evaluated over a 3-month period is to assess Treatment Costs at Month 3 Follow-Up. Secondary objectives constitute modifications in Psychological Distress as Assessed Using the 8-item PROMIS Self-Efficacy Symptom Management Scale (SF 8a; score range 5 - 40) and 7-item Patient Reported Outcomes Measurement Information System Anxiety Scale (SF 7a; score range 5 - 35), alongside changes in Severity of FI assessed with Fecal Incontinence Severity Scale at Baseline, Months 6, 12 and 24."

Answered by AI

Is recruitment for this research endeavor still available?

"As evidenced on clinicaltrials.gov, this scientific experiment is presently searching for suitable participants. The initial post was made February 1st 2019 with the most recent amendment being done January 13th 2022."

Answered by AI

How many medical sites are participating in this investigation?

"This research endeavor is occurring at five different universities, including the University of Alabama at Birmingham in Birmingham, The University of Michigan in Ann Arbor and The University of North carolina at Chapel Hill in Chapel Hill. There are also 5 other sites being utilized to execute this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fecal Incontinence Treatment (FIT) Study

Adil Bharucha, MBBS, MD 2019. "Fecal Incontinence Treatment (FIT) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03811821.