Effects of an Anal Insert Device in Fecal Incontinence

Effects of the Minnesota Medical Technologies Anal Insert Device in Fecal Incontinence

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.

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence
• Intervention / Treatment: Device: Minnesota Medical Technologies Anal Insert Device

Detailed Description

This is a prospective, open label study designed to evaluate the efficacy, safety, and tolerability of the Minnesota Medical Technologies Anal Insert Device in participants with Fecal Incontinence (FI).

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• History of acute or chronic illness or history of illness or any other reason which in the opinion of the Investigator, could pose a threat or harm to the subject or obscure interpretation of laboratory test results or interpretation of study data such as frequent angina, Class III or IV congestive heart failure, etc. The reason for exclusion of any enrolled subject shall be documented on the screening log.
• 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
• Post baseline anoscopy examination, presence of an anal fissure, Grade III-IV internal hemorrhoids, or thrombosed external hemorrhoids.

In addition, subjects will not be eligible to participate in the Treatment Period if during the baseline period or at the anorectal manometry visit:

• Used rescue medications beyond those allowed by the protocol
• demonstrated lack of compliance (for e.g., did not complete bowel diaries for 3 days in any week during the baseline diary period).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects with fecal incontinence; 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; Non-sterile soft, flexible, liquid-filled anal insert either 10 mm size or 13 mm size, meant for single use only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Minnesota Medical Technologies
• Collaborators: Mayo Clinic
• Investigators: Principal Investigator: Adil E Bharucha, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2019
• Primary Completion (Actual): February 20, 2024
• Study Completion (Actual): February 20, 2024

Study Registration Dates

• First Submitted: March 30, 2019
• First Submitted That Met QC Criteria: March 30, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: diarrhea; accidental bowel leakage; bowel incontinence; gastrointestinal diseases; digestive system diseases; stool leakage; intestinal diseases; rectal diseases; loose stool; watery stool; involuntary bowel leakage
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: 18-004642

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes