NCT03811821

Fecal Incontinence Treatment (FIT) Study

Completed NA Results posted Last updated 6 April 2026

What this trial tests

NA trial testing Biofeedback in Fecal Incontinence in 275 participants. Completed in 27 January 2026.

Timeline

1 February 2019

Primary endpoint
16 May 2024

27 January 2026

Quick facts

Lead sponsor	Mayo Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	275
Start date	1 February 2019
Primary completion	16 May 2024
Estimated completion	27 January 2026
Sites	6 locations across United States

Drugs / interventions tested

• Biofeedback
• Injection

Conditions studied

• Fecal Incontinence — all drugs for Fecal Incontinence →
• Bowel Incontinence — all drugs for Bowel Incontinence →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Fecal Incontinence or Bowel Incontinence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

FI episodes will be assessed using a validated symptom diary at Baseline and at three months follow-up.

Group	Value	95% CI
Biofeedback (BIO)	29
Injection (INJ)	28

Proportion of Participants With Specified Adverse Events at Month 3 Follow-Up Primary · 3-month follow-up

Adverse events of pelvic pain of grade II or higher based on Common Terminology Criteria for AE (CTCAE) criteria, treatment site infection, or serious adverse events (SAEs) requiring hospitalization.

Group	Value	95% CI
Biofeedback (BIO)	2
Injection (INJ)	5

Treatment Costs at Month 3 Follow-Up Primary · 3-month follow-up

Costs will be measured in three categories: (a) Procedure costs based on number of treatment visits and Medicare reimbursement rates. (b) Patient direct costs for travel and parking for visits. (c) Indirect costs of time losses resulting from attending visits. These costs will be combined to establish overall societal costs.

Group	Value	95% CI
Biofeedback (BIO)	756	721 – 792
Injection (INJ)	2335	2221 – 2449

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected from the time of randomization through 3 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Biofeedback (BIO)

Serious: 2/93 (2%)

Deaths: 0/93

Injection (INJ)

Serious: 3/90 (3%)

Deaths: 0/90

Serious adverse events (8 terms)

Reaction	System	Biofeedback (BIO)	Injection (INJ)
Atrial fibrillation	Cardiac disorders	—	—
Cardiac failure congestive	Cardiac disorders	—	—
Vertigo	Ear and labyrinth disorders	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—
Pyelonephritis	Infections and infestations	—	—
Diabetic ketoacidosis	Metabolism and nutrition disorders	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Biofeedback (BIO)	Injection (INJ)
Urinary tract infection	Infections and infestations	—	—

Most-reported serious reactions: Atrial fibrillation, Cardiac failure congestive, Vertigo, Gastrointestinal haemorrhage, Pyelonephritis, Diabetic ketoacidosis, Breast cancer, Abortion spontaneous.

Data from ClinicalTrials.gov NCT03811821 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comparative effectiveness of biofeedback and injectable bulking agents for treatment of fecal incontinence: Design and methods.
   Bharucha AE, Gantz MG, Rao SS, Lowry AC, et al · · 2021 · cited 8× · PMID 34139357 · DOI 10.1016/j.cct.2021.106464
2. Cluster Analysis of Fecal Incontinence Symptoms: Associations With Anorectal Physiology and Quality of Life.
   Butt MF, Rao SSC, Meyer I, Chey WD, et al · · 2025 · cited 2× · PMID 41297739 · DOI 10.1016/j.cgh.2025.11.015
3. Translumbosacral Neuromodulation Therapy Is a Promising Option for Fecal Incontinence.
   Bharucha AE, Oblizajek NR. · · 2021 · cited 2× · PMID 33273260 · DOI 10.14309/ajg.0000000000001069
4. When to Order Anorectal Function Testing.
   Bharucha AE. · · 2023 · PMID 36865821