Effects of an Anal Insert Device in Fecal Incontinence

NCT03898778 | Completed Results FDA Device

• 1 other identifier: 18-004642
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to test the effects of an inserted anal device on fecal incontinence (accidental bowel leakage) in patients who have persistent symptoms despite other conservative therapy.

Conditions

Fecal Incontinence

Keywords

bowel incontinence; accidental bowel leakage; rectal diseases; intestinal diseases; gastrointestinal diseases; digestive system diseases; diarrhea; loose stool; stool leakage; watery stool; involuntary bowel leakage

Outcome Measures

Primary Outcomes (1)

• Primary Effectiveness Endpoint

  Percent treatment responders (proportion of subjects with percent relative change of Accidental Bowel Leakage (ABL) ≥ 50%) for the modified Intent to Treat (mITT) population.

  Baseline (Weeks 1-4) through Treatment period (Weeks 9-12)

Study Arms (1)

Subjects with fecal incontinence

EXPERIMENTAL

Male and female subjects aged 18 years and older with a diagnosis of fecal incontinence who have failed conservative medical therapy (i.e., the use of bulking agents, anti-diarrheal agents (e.g., loperamide and biofeedback therapy as appropriate) for fecal incontinence will be treated with an anal insert device.

Device: Minnesota Medical Technologies Anal Insert Device

Interventions

Minnesota Medical Technologies Anal Insert Device DEVICE

Non-sterile soft, flexible, liquid-filled anal insert either 10 mm size or 13 mm size, meant for single use only

Subjects with fecal incontinence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide signed (written) informed consent
• Diagnosis of fecal incontinence, with duration of symptoms six months or longer with a history of at least one fecal incontinence (FI) episode per week or at least four episodes per month
• Subject comprehends study meaning and is capable of carrying out study duties
• Patient is fluent in English as study questionnaires have been validated using English
• If female and of childbearing potential, patient has had a negative urine pregnancy test within 21 days of the first day of the baseline visit
• If applicable, patient agrees to use acceptable birth control (surgical sterilization, abstinence, approved hormonal contraceptives such as birth control pills, barrier methods such as condom or diaphragm used with a spermicide, or an intrauterine device (IUD)). If not applicable, the reason why shall be documented on the screening log.
• Subject is at least 18 years of age at time of consent
• Patients has failed conservative medical therapy (i.e., the use of bulking agents, anti-diarrheal agents (e.g., loperamide) and biofeedback therapy as appropriate) for Fecal Incontinence

You may not qualify if:

• Unable or unwilling to provide informed consent or to comply with study procedures
• History of anorectal pathology in the past 6 months (perianal abscess or fistula, fecal impaction, or clinically significant rectocele).
• History of inflammatory bowel disease with active proctosigmoiditis
• History of rectal surgery in past 6 months where the Investigator determines that the use of the study device may be associated with an increased risk of complications.
• Patient has known clinically-significant immune deficiency state (e.g., HIV infection).
• Patient is taking drugs with a low therapeutic index, such as warfarin, digoxin, and anti-seizure medications
• If patient has clinically suspected upper or lower gastrointestinal (GI) obstruction, they must be excluded or have been evaluated per standard of care and obstruction ruled out before screening. Determination of obstruction shall be documented on the screening log.
• History of fecal impaction with overflow diarrhea in the past 6 months
• History of Ileo-anal pouch
• History of allergy to silicone or one of its components
• Patient is pregnant and/or nursing
• Any other reason, which in the opinion of the Investigator, would confound proper interpretation of the study
• Patient whom, after training from a healthcare provider, cannot insert or expel the device themself or with assistance from a caregiver
• History of anal or rectal pain and/or rectal bleeding in the past month
• Subject cannot retain either device (10 or 13 mm) while ambulating at the screening visit

Sponsors & Collaborators

• Minnesota Medical Technologies: lead
• Mayo Clinic: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Fecal Incontinence; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: VP of Regulatory Affairs
• Organization: Minnesota Medical Technologies Corporation

rmanglin@mnmedicaltechnologies.com

507-533-0366

Study Officials

• Adil E Bharucha, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2019
• First Posted: April 2, 2019
• Study Start: May 16, 2019
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)