Trial Outcomes & Findings for Effects of an Anal Insert Device in Fecal Incontinence (NCT NCT03898778)
NCT ID: NCT03898778
Last Updated: 2025-08-22
Results Overview
Percent treatment responders (proportion of subjects with percent relative change of Accidental Bowel Leakage (ABL) ≥ 50%) for the modified Intent to Treat (mITT) population.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
124 participants
Primary outcome timeframe
Baseline (Weeks 1-4) through Treatment period (Weeks 9-12)
Results posted on
2025-08-22
Participant Flow
Recruitment for the study was initiated in May 2019 and completed in October 2023. Potential subjects were approached by advertising, letter, phone, in person, or by e-mail.
Participant milestones
| Measure |
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.
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
|
|---|---|
|
Overall Study
STARTED
|
124
|
|
Overall Study
COMPLETED
|
59
|
|
Overall Study
NOT COMPLETED
|
65
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of an Anal Insert Device in Fecal Incontinence
Baseline characteristics by cohort
| Measure |
Subjects With Fecal Incontinence
n=59 Participants
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.
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Weeks 1-4) through Treatment period (Weeks 9-12)Population: modified Intent to Treat (mITT)
Percent treatment responders (proportion of subjects with percent relative change of Accidental Bowel Leakage (ABL) ≥ 50%) for the modified Intent to Treat (mITT) population.
Outcome measures
| Measure |
Subjects With Fecal Incontinence
n=58 Participants
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.
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
|
|---|---|
|
Primary Effectiveness Endpoint
|
75.9 percentage of treatment responders
Interval 62.83 to 86.13
|
Adverse Events
Subjects With Fecal Incontinence
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subjects With Fecal Incontinence
n=124 participants at risk
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.
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
|
|---|---|
|
Cardiac disorders
Diastolic dysfunction and relative chronotropic insufficiency
|
0.81%
1/124 • Number of events 1 • Through study completion, an average of 16 weeks.
|
Other adverse events
| Measure |
Subjects With Fecal Incontinence
n=124 participants at risk
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.
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
|
|---|---|
|
Injury, poisoning and procedural complications
Leg pain
|
0.81%
1/124 • Number of events 1 • Through study completion, an average of 16 weeks.
|
|
Infections and infestations
Cough and nasal congestion
|
0.81%
1/124 • Number of events 1 • Through study completion, an average of 16 weeks.
|
|
Gastrointestinal disorders
Anorectal irritation, pain, soreness
|
0.81%
1/124 • Number of events 1 • Through study completion, an average of 16 weeks.
|
|
Gastrointestinal disorders
Perianal irritation and anorectal discomfort (worsening)
|
0.81%
1/124 • Number of events 1 • Through study completion, an average of 16 weeks.
|
|
Gastrointestinal disorders
Nausea and vomiting
|
0.81%
1/124 • Number of events 1 • Through study completion, an average of 16 weeks.
|
|
Gastrointestinal disorders
Perianal pruritus and soreness
|
0.81%
1/124 • Number of events 1 • Through study completion, an average of 16 weeks.
|
|
Gastrointestinal disorders
Device over-insertion or device migration into anal canal or rectum
|
0.81%
1/124 • Number of events 1 • Through study completion, an average of 16 weeks.
|
|
Injury, poisoning and procedural complications
chest and extremity pain
|
0.81%
1/124 • Number of events 1 • Through study completion, an average of 16 weeks.
|
|
Gastrointestinal disorders
Dysuria
|
0.81%
1/124 • Number of events 1 • Through study completion, an average of 16 weeks.
|
|
Gastrointestinal disorders
Abdominal cramping
|
0.81%
1/124 • Number of events 1 • Through study completion, an average of 16 weeks.
|
|
Gastrointestinal disorders
Perianal pain and bleeding related to flair of lichen sclerosis
|
0.81%
1/124 • Number of events 1 • Through study completion, an average of 16 weeks.
|
|
Musculoskeletal and connective tissue disorders
Herniated disc
|
0.81%
1/124 • Number of events 1 • Through study completion, an average of 16 weeks.
|
|
Gastrointestinal disorders
Diarrhea and vomiting
|
0.81%
1/124 • Number of events 1 • Through study completion, an average of 16 weeks.
|
|
Hepatobiliary disorders
Abnormal liver function tests
|
0.81%
1/124 • Number of events 1 • Through study completion, an average of 16 weeks.
|
Additional Information
VP of Regulatory Affairs
Minnesota Medical Technologies Corporation
Phone: 507-533-0366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place