Clinical Trials

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 dextranomer treatment expert; an internal 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 limitation to placement of 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.