Fecal IncontinenceNCT03898778
Effects of an Anal Insert Device in Fecal Incontinence
A study testing Minnesota Medical Technologies Anal Insert Device in people with Fecal Incontinence, run by Minnesota Medical Technologies at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Minnesota Medical Technologies Anal Insert Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2019to 20 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the 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).
- Conditions
- Fecal Incontinence
- Being tested
- Minnesota Medical Technologies Anal Insert Device
- 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
- Medical subject headings
- Fecal Incontinence, Rectal Diseases, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minnesota Medical Technologies Anal Insert DeviceDevice
Non-sterile soft, flexible, liquid-filled anal insert either 10 mm size or 13 mm size, meant for single use only
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Minnesota Medical Technologies Anal Insert Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Weeks 1-4) through Treatment period (Weeks 9-12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start16 May 2019
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minnesota Medical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Adil E Bharucha, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898778
- Sponsor's protocol ID
- 18-004642
- Status last verified
- Aug 2025
- First submitted
- 30 Mar 2019
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bharucha AE, Lamichhane R, Fletcher JG, Oblizajek NR, Gautam M, Bailey KR, Szarka LA. Clinical Trial: Effectiveness and Safety of a Novel Anal Insert Device for Treatment of Faecal Incontinence. Aliment Pharmacol Ther. 2026 Sep;64(5):603-614. doi: 10.1111/apt.70831. Epub 2026 Jul 21.
PubMed 42482523
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Minnesota Medical Technologies Anal Insert Device in Fecal Incontinence
- ClinicalTrials.gov ID
- NCT03898778
- Acronym / sponsor ID
- 18-004642
- Conditions
- Fecal Incontinence
- Keywords
- bowel incontinence, accidental bowel leakage, rectal diseases, intestinal diseases, gastrointestinal diseases, digestive system diseases, diarrhea, loose stool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Minnesota Medical TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Study start
- 16 May 2019 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Posted 22 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with fecal incontinence | Experimental | Device: Minnesota Medical Technologies Anal Insert DeviceMale 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minnesota Medical Technologies Anal Insert DeviceNon-sterile soft, flexible, liquid-filled anal insert either 10 mm size or 13 mm size, meant for single use only | Device | Subjects with fecal incontinence |
Primary outcome
Primary Effectiveness Endpoint
Time frame: Baseline (Weeks 1-4) through Treatment period (Weeks 9-12)
Percent treatment responders (proportion of subjects with percent relative change of Accidental Bowel Leakage (ABL) ≥ 50%) for the modified Intent to Treat (mITT) population.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42482523Bharucha AE, Lamichhane R, Fletcher JG, Oblizajek NR, Gautam M, Bailey KR, Szarka LA. Clinical Trial: Effectiveness and Safety of a Novel Anal Insert Device for Treatment of Faecal Incontinence. Aliment Pharmacol Ther. 2026 Sep;64(5):603-614. doi: 10.1111/apt.70831. Epub 2026 Jul 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adil E Bharucha, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minnesota Medical Technologies Anal Insert Device in people with Fecal Incontinence, run by Minnesota Medical Technologies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: Baseline (Weeks 1-4) through Treatment period (Weeks 9-12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03898778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.