CompletedNot Applicable

Fecal Incontinence Treatment (FIT) Study

United States275 participantsStarted 2019-02-01

Plain-language summary

Patients with severe fecal incontinence (FI), defined as two or more episodes of staining, solid or liquid FI per week, and who meet the inclusion criteria for Injection of Solesta (INJ; an inert bulking agent), or Biofeedback (BIO) will be enrolled. The baseline rate of FI will be assessed using a 2-week daily stool diary. All participants will initially be enrolled into a 4-week trial of Enhanced Medical Management (EMM; education, pelvic floor exercises, and use of non-prescription drugs to normalize stool consistency). Those who demonstrate at least a 75% reduction in FI frequency will not be randomized to one of the two treatment groups but will be followed-up for two years. Those not showing a 75% reduction in FI frequency will be randomized to BIO or INJ and will be evaluated three months later with respect to efficacy for reducing the frequency of fecal incontinence, safety of the interventions, and cost of providing care. All participants who experience a 75% decrease in FI after three months of treatment, compared to baseline, will be followed-up for a further 21 months, for a total of 24 months from the time of treatment initiation. To assess the long-term response to treatment, those who improve less than 75% in FI episodes will be offered an additional treatment with either the treatment to which they were not randomized or sacral nerve stimulation (SNS). Anorectal manometry and Magnetic Evoked Potentials will be used to subtype the physiological basis for FI. Quality of life and psychological factors will be used to assess outcomes.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 p…

What they're measuring

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

Timeframe: 3-month follow-up

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

Timeframe: 3-month follow-up

Treatment Costs at Month 3 Follow-Up

Timeframe: 3-month follow-up

Trial details

NCT IDNCT03811821

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-16

Results submitted2025-04-11

View on ClinicalTrials.gov More Fecal Incontinence trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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