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 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 previous anorectal surgery, such as stapled transanal rectal resection
(STARR). Stapled hemorrhoidectomy is not an exclusion if performed more than 12 months
previously. The FENIX® procedure, artificial anal sphincter or transposed gracilis;
surgical hemorrhoidectomy (other than stapled), sphincteroplasty, rectal
reconstructions and ileoanal pouches 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 cannot expel the rectal balloon during the balloon expulsion test and who
have constipation most of the time.

- Anatomic limitations to placement of dextranomer injections.

- 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.

- Patients who have 4 or more days with 4 or more bowel movements classed as a 6 or 7 on
the Bristol Stool Scale per day in either (any) week 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 electromyography (EMG), and neurodegenerative disorder.

- Patients currently receiving immunotherapy or chemotherapy.

- 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.

Medical history will be documented to test for predictors of response.

Eligibility last updated 6/16/22. Questions regarding updates should be directed to the study team contact.

 

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
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CLS-20455982

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