A Study to Compare Effectiveness of Biofeedback, Nerve Stimulation, and Injectable Bulking Agents for Fecal Incontinence Treatment

Overview

About this study

The objectives of this study are effectiveness in reducing the frequency of fecal incontinence (FI) per week, safety measured by the number of adverse events, and cost of delivering each of the treatments (Biofeedback, Sacral Nerve Stimulation, and Injectable Bulking Agents).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 not including staining by self-report and during the two-week baseline.
  • Meets criteria for SNS and 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.

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 >120 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 previous anorectal surgery, such as stapled transanal rectal resection (STARR) or stapled hemorrhoidectomy. The FENIX procedure, artificial anal sphincter or transposed gracilis; surgical hemorrhoidectomy, and sphincteroplasty are permitted if performed more than 6 months previously and the patient meets inclusion criteria. 
  • Established diagnosis of inflammatory bowel disease.
  • Intestinal stoma present.
  • History of pelvic radiation within previous 12 months or presence of active radiation proctitis. 
  • Patients who have overflow diarrhea with rectal impaction with stool or an abnormal balloon expulsion test plus predominant symptoms of constipation.
  • Anatomic limitations to placement of SNS or dextranomer injections. 
  • Previously failed an adequate (1-2 weeks) trial of SNS.
  • Presence or history of any medical disorder likely to require follow-up with MRI of the body (not head or neck), diathermy, microwave, or RF energy therapy.
  • Presence of existing implant in the anal or rectal region.
  • Allergy to hyaluronic acid-based products. 
  • Active anal or rectal conditions in the last 6 months including abscess, fissures, sepsis, significant bleeding, proctitis, colovaginal and rectovaginal fistulas, anal or rectal tumors, or other infections. 
  • The patient's physician believes it is unsafe for the patient to temporarily stop anticoagulants for any test procedures and treatments associated with the study.
  • Watery diarrhea that is not managed by diet or drugs is an exclusion. Patients who have 4 or more days of Bristol Stool Scale bowel movements classed as a 6 or 7 during the Baseline will be excluded.
  • Patients with Parkinson's disease, multiple sclerosis, severe diabetic neuropathy documented by EMG, and neurodegenerative disorder.
  • Immunotherapy or chemotherapy in the last 12 months. 
  • Significant anal pain in the last 6 months. 
  • Unwillingness of participant to stop using over-the-counter medications, herbal supplements, or prescribed medications for the purpose of modifying stool consistency, that are not included in the approved medications list (loperamide, laxatives, fiber supplements, and Questran are approved medications), for the duration of the research study. 
  • Participant feels urgency to have a bowel movement, but is able to reach a toilet in time without leaking stool/feces. Patients with clinically evident diabetic neuropathy, Parkinson's disease, multiple sclerosis, other neurological disorders, and obstetric injuries with or without previous sphincter repair who have less than 1/3 external anal sphincter (EAS) separation, and patients with rectal reconstructions or ileoanal pouches, will be permitted. Medical history will be documented to test for predictors of response.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Adil Bharucha, M.B.B.S., M.D.

Open for enrollment

Contact information:

Kelly Feuerhak CCRP

(507)255-6802

Feuerhak.Kelly@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available