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Home › Conditions › Fecal Incontinence

Fecal Incontinence

Part of Rectal Diseases

2 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Fecal Incontinence

28 trials tracked for Fecal Incontinence: 4 in phase 3 or 4 and 1 with published results. The most-cited published study has 65 citations.

28Trials tracked
4Phase 3 & 4
0Recruiting
1With published results
Phase distribution
Phase 4 1 Phase 3 3 Phase 2 4 Phase 1 1 Other / NA 19
  1. Phase 3 Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe) Completed · 65 cited
  2. Phase 4 A Within Subjects Comparison of Two Antegrade Flushing Regimens in Children Completed
  3. Phase 3 A Study of Colesevelam in Fecal Incontinence Completed
  4. Phase 3 Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence Completed
  5. Phase 2 Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms Completed
  6. Phase 2 A Placebo-Controlled Study of Clonidine for Fecal Incontinence. Completed
Show 22 more trials
  1. Phase 2 Lidocaine Patches Prior to Percutaneous Nerve Evaluation Completed
  2. Phase 2 Autologous Cell Therapy for Treatment of Fecal Incontinence Completed
  3. Phase 1 Does Single Dose Imipramine Affect the Opening Pressure of the Urethral and Anal Sphincter? Completed
  4. N/A A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence Completed
  5. N/A Prevalence and Treatment of Anal Incontinence (AI) in Primiparous Women Completed
  6. N/A Fecal Incontinence Treatment (FIT) Study Completed
  7. N/A Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence Completed
  8. N/A The Use of an "Anal-Tape" in Patients With Fecal Incontinence Completed
  9. N/A Neuromodulation for Accidental Bowel Leakage Completed
  10. N/A Effects of an Anal Insert Device in Fecal Incontinence Completed
  11. N/A Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence Completed
  12. N/A Percutaneous Nerve Evaluation With Fluoroscopy Versus Without Completed
  13. N/A The Role of Biofeedback in Improving Continence After Anterior Resection Completed
  14. N/A A Colonic Tube to Improve Bowel Function in Spinal Cord Injury Completed
  15. N/A Utility of an Animated Bowel Biofeedback Training Routine to Improve Bowel Function in Individuals With SCI Completed
  16. N/A Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence Completed
  17. N/A A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women Completed
  18. N/A LIBERATE - PRO: Eclipse™ System Registry Completed
  19. N/A Axonics SacRal NeuromodulaTIon System RegisTRY Study Completed
  20. N/A Study to Evaluate Solesta for Treatment of Fecal Incontinence Completed
  21. N/A Feasibility Study of the Magnetic Anal Sphincter (FENIX System) Completed
  22. N/A A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE) Completed

Showing the 28 most-cited and recently-updated of 28 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found For clinicians

Fecal Incontinence: what the trials found

Clinical evidence for fecal incontinence management includes pharmacological and behavioral interventions. Loperamide was evaluated in a Phase 3 trial, showing a reduction in St. Mark's (Vaizey) scores (p=0.092) and an increase in accident-free days over 12 to 24 weeks 2.

Pharmacological management also includes colesevelam, which showed no statistically significant differences compared to placebo regarding the number of participants achieving a 50% reduction in weekly episodes (p=0.85), daily stool frequency (p=0.24), or stool consistency (p=0.44) 3.

Fiber supplementation with psyllium powder was evaluated, resulting in specific reported percentages for bowel movements with incontinence and Fecal Incontinence Severity Index (FISI) scores 4.

Biofeedback is an established intervention; however, a Phase 4 trial using NS and USP Glycerin did not show statistically significant changes in fecal soiling counts (p=0.69), dosing frequency for continence (p=0.172), or stool calprotectin levels (p=0.80) 1. Another study on biofeedback showed no significant change in Cleveland Clinic Incontinence (CCI) scores (p=0.54) 14.

Recent results — preliminary, needs further review

  • A trial evaluating a Minnesota Medical Technologies Anal Insert Device is currently listed as recent but lacks detailed outcome data for synthesis 10.

For the clinician treating this condition

  • Loperamide has been shown to reduce St. Mark's (Vaizey) scores and increase accident-free days, though the p-value for score reduction was 0.092 2.
  • Colesevelam did not demonstrate statistically significant improvements in stool frequency or consistency compared to placebo 3.
  • Biofeedback is an established intervention, but specific trials showed no significant change in Cleveland Clinic Incontinence (CCI) scores 14.

AI synthesis of 6 cited trials, updated Jun 21, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Review suggests automated stool management system may reduce costs and nursing time in ICU fecal incontinence
Dermatology Sys. Review
Review suggests automated stool management system may reduce costs and nursing time in ICU fecal incontinence New Device Cuts ICU Fecal Incontinence Costs By 90%
This narrative review synthesizes evidence on the Qoramatic Automated Stool Management system versus traditional methods for fecal incontine…
A new automated device could save hospitals thousands of dollars while keeping patients cleaner and safer.
Frontiers Apr 21, 2026
8-week home biofeedback system equivalent to 16-week for fecal incontinence in women
Physical Medicine & Rehab RCT
8-week home biofeedback system equivalent to 16-week for fecal incontinence in women For fecal incontinence, does 8 weeks of home therapy work as well as 16?
A single-blind equivalence RCT in 36 women with fecal incontinence compared 8-week versus 16-week durations of a home-based digital pelvic h…
An 8-week home therapy program works just as well as 16 weeks for reducing fecal incontinence symptoms in women.
Apr 2, 2026