Trial Outcomes & Findings for Fecal Incontinence Treatment (FIT) Study (NCT NCT03811821)
NCT ID: NCT03811821
Last Updated: 2026-04-06
Results Overview
FI episodes will be assessed using a validated symptom diary at Baseline and at three months follow-up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
275 participants
Primary outcome timeframe
3-month follow-up
Results posted on
2026-04-06
Participant Flow
275 enrolled participants were treated with enhanced medical management (EMM). Those who did not respond to EMM (defined as a 75% or greater reduction from baseline in fecal incontinence episodes) were eligible for randomization. Of the 275: 16 were not evaluated for treatment response, 39 responded to EMM, 220 did not respond. Of the 220: 201 were randomized to BIO or INJ (1 of whom was ineligible), 8 discontinued, and 11 were randomized to SNS before it was removed as a randomized treatment.
Participant milestones
| Measure |
Biofeedback (BIO)
Participants will receive biofeedback intervention during five (5) required weekly 1-hour sessions. A 6th treatment session will be made available for participants if it is shown through anorectal manometry that they are having trouble understanding directions given during the first five sessions.
Biofeedback: The participant will learn how to improve strength and rectal sensation during five (5) - six (6) visits each lasting 60 minutes.
|
Injection (INJ)
Bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.
Injection: The participant will have a bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
101
|
|
Overall Study
COMPLETED
|
91
|
88
|
|
Overall Study
NOT COMPLETED
|
8
|
13
|
Reasons for withdrawal
| Measure |
Biofeedback (BIO)
Participants will receive biofeedback intervention during five (5) required weekly 1-hour sessions. A 6th treatment session will be made available for participants if it is shown through anorectal manometry that they are having trouble understanding directions given during the first five sessions.
Biofeedback: The participant will learn how to improve strength and rectal sensation during five (5) - six (6) visits each lasting 60 minutes.
|
Injection (INJ)
Bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.
Injection: The participant will have a bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Contraindication for treatment
|
0
|
1
|
|
Overall Study
Tolerability
|
0
|
3
|
|
Overall Study
Comorbidities
|
0
|
2
|
Baseline Characteristics
Fecal Incontinence Treatment (FIT) Study
Baseline characteristics by cohort
| Measure |
Biofeedback (BIO)
n=99 Participants
Participants will receive biofeedback intervention during five (5) required weekly 1-hour sessions. A 6th treatment session will be made available for participants if it is shown through anorectal manometry that they are having trouble understanding directions given during the first five sessions.
Biofeedback: The participant will learn how to improve strength and rectal sensation during five (5) - six (6) visits each lasting 60 minutes.
|
Injection (INJ)
n=101 Participants
Bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.
Injection: The participant will have a bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
69 years
n=5 Participants
|
67 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
89 Participants
n=5 Participants
|
176 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=5 Participants
|
24 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
98 Participants
n=5 Participants
|
100 Participants
n=5 Participants
|
198 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
13 Participants
n=5 Participants
|
24 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=5 Participants
|
86 Participants
n=5 Participants
|
168 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
99 participants
n=5 Participants
|
101 participants
n=5 Participants
|
200 participants
n=10 Participants
|
|
Weekly number of fecal incontinence events (accidental bowel leakages)
|
7 Events per week
n=5 Participants
|
6.5 Events per week
n=5 Participants
|
6.5 Events per week
n=10 Participants
|
PRIMARY outcome
Timeframe: 3-month follow-upPopulation: Analysis population is all eligible participants randomized to Biofeedback or Injection
FI episodes will be assessed using a validated symptom diary at Baseline and at three months follow-up.
Outcome measures
| Measure |
Biofeedback (BIO)
n=99 Participants
Participants will receive biofeedback intervention during five (5) required weekly 1-hour sessions. A 6th treatment session will be made available for participants if it is shown through anorectal manometry that they are having trouble understanding directions given during the first five sessions.
Biofeedback: The participant will learn how to improve strength and rectal sensation during five (5) - six (6) visits each lasting 60 minutes.
|
Injection (INJ)
n=101 Participants
Bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.
Injection: The participant will have a bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.
|
|---|---|---|
|
Treatment Response Defined as a 75% or Greater Change in Number of Average Weekly FI Episodes at Month 3 Follow-Up Compared to Baseline
|
29 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: 3-month follow-upPopulation: The analysis population is all participants who received the treatment to which they were randomized, regardless of eligibility.
Adverse events of pelvic pain of grade II or higher based on Common Terminology Criteria for AE (CTCAE) criteria, treatment site infection, or serious adverse events (SAEs) requiring hospitalization.
Outcome measures
| Measure |
Biofeedback (BIO)
n=93 Participants
Participants will receive biofeedback intervention during five (5) required weekly 1-hour sessions. A 6th treatment session will be made available for participants if it is shown through anorectal manometry that they are having trouble understanding directions given during the first five sessions.
Biofeedback: The participant will learn how to improve strength and rectal sensation during five (5) - six (6) visits each lasting 60 minutes.
|
Injection (INJ)
n=90 Participants
Bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.
Injection: The participant will have a bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.
|
|---|---|---|
|
Proportion of Participants With Specified Adverse Events at Month 3 Follow-Up
|
2 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 3-month follow-upPopulation: The analysis population is all eligible participants who received the treatment to which they were randomized.
Costs will be measured in three categories: (a) Procedure costs based on number of treatment visits and Medicare reimbursement rates. (b) Patient direct costs for travel and parking for visits. (c) Indirect costs of time losses resulting from attending visits. These costs will be combined to establish overall societal costs.
Outcome measures
| Measure |
Biofeedback (BIO)
n=92 Participants
Participants will receive biofeedback intervention during five (5) required weekly 1-hour sessions. A 6th treatment session will be made available for participants if it is shown through anorectal manometry that they are having trouble understanding directions given during the first five sessions.
Biofeedback: The participant will learn how to improve strength and rectal sensation during five (5) - six (6) visits each lasting 60 minutes.
|
Injection (INJ)
n=90 Participants
Bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.
Injection: The participant will have a bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.
|
|---|---|---|
|
Treatment Costs at Month 3 Follow-Up
|
756 dollars
Interval 721.0 to 792.0
|
2335 dollars
Interval 2221.0 to 2449.0
|
SECONDARY outcome
Timeframe: up to 24 monthsTreatment effect on the severity of FI at 3-month follow-up, compared to baseline, will be assessed using the Fecal Incontinence Severity Scale, a validated FI severity scale which incorporates the frequency of different types of stool loss (solid, liquid, staining and a combination), the circumstances surrounding FI (urgency, passive, combined, or neither), and volume of leakage. Higher scores indicate more severe fecal incontinence. Assessed at Baseline, Months 6, 12, and 24.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 monthsTreatment effect on the impact of FI on quality of life will be assessed using the Fecal Incontinence Quality of Life Scale which contains 29 items and is scored for four subscales: Lifestyle, Coping/Behavior, Depression/Self-Perception, and Embarrassment. Scores for each item range from 1 - 4 with 1 indicating a lower functional status of quality of life. Scale scores are the average (mean) response to all items after adjusting for missing and not applicable items. Assessed at Baseline, Months 6, 12, and 24.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 monthsOne of the measures of psychological distress is the 7-item PROMIS Anxiety Scale for which higher scores indicate higher levels of anxiety. The Anxiety Scale (SF 7a) has a score range of 5 - 35. Assessed at Baseline, Months 6, 12, and 24.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 monthsOne of the measures of psychological distress is the 8-item PROMIS Depression Scale for which higher scores indicate higher levels of depression. The Depression Scale (SF 8a) has a score range of 5 - 40. Assessed at Baseline, Months 6, 12, and 24.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 monthsOne of the measures of psychological distress is the 8-item PROMIS Self-Efficacy Symptom Management Scale for which higher scores indicate higher levels of self-efficacy. The Self-Efficacy for Managing Symptoms Scale (SF 8a) has a score range of 5 - 40. Assessed at Baseline, Months 6, 12, and 24.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 monthsAssessed at Baseline, Months 6, 12, and 24.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 monthsAssessed at Baseline, Months 6, 12, and 24.
Outcome measures
Outcome data not reported
Adverse Events
Biofeedback (BIO)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Injection (INJ)
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Biofeedback (BIO)
n=93 participants at risk
Participants will receive biofeedback intervention during five (5) required weekly 1-hour sessions. A 6th treatment session will be made available for participants if it is shown through anorectal manometry that they are having trouble understanding directions given during the first five sessions.
Biofeedback: The participant will learn how to improve strength and rectal sensation during five (5) - six (6) visits each lasting 60 minutes.
|
Injection (INJ)
n=90 participants at risk
Bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.
Injection: The participant will have a bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/93 • Adverse event data were collected from the time of randomization through 3 months.
Adverse events were analyzed in the population of participants who underwent the treatment to which they were assigned (93 for BIO including 1 participant who was randomized and treated but ineligible, 90 for INJ).
|
1.1%
1/90 • Number of events 1 • Adverse event data were collected from the time of randomization through 3 months.
Adverse events were analyzed in the population of participants who underwent the treatment to which they were assigned (93 for BIO including 1 participant who was randomized and treated but ineligible, 90 for INJ).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/93 • Adverse event data were collected from the time of randomization through 3 months.
Adverse events were analyzed in the population of participants who underwent the treatment to which they were assigned (93 for BIO including 1 participant who was randomized and treated but ineligible, 90 for INJ).
|
1.1%
1/90 • Number of events 1 • Adverse event data were collected from the time of randomization through 3 months.
Adverse events were analyzed in the population of participants who underwent the treatment to which they were assigned (93 for BIO including 1 participant who was randomized and treated but ineligible, 90 for INJ).
|
|
Ear and labyrinth disorders
Vertigo
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected from the time of randomization through 3 months.
Adverse events were analyzed in the population of participants who underwent the treatment to which they were assigned (93 for BIO including 1 participant who was randomized and treated but ineligible, 90 for INJ).
|
0.00%
0/90 • Adverse event data were collected from the time of randomization through 3 months.
Adverse events were analyzed in the population of participants who underwent the treatment to which they were assigned (93 for BIO including 1 participant who was randomized and treated but ineligible, 90 for INJ).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/93 • Adverse event data were collected from the time of randomization through 3 months.
Adverse events were analyzed in the population of participants who underwent the treatment to which they were assigned (93 for BIO including 1 participant who was randomized and treated but ineligible, 90 for INJ).
|
1.1%
1/90 • Number of events 1 • Adverse event data were collected from the time of randomization through 3 months.
Adverse events were analyzed in the population of participants who underwent the treatment to which they were assigned (93 for BIO including 1 participant who was randomized and treated but ineligible, 90 for INJ).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/93 • Adverse event data were collected from the time of randomization through 3 months.
Adverse events were analyzed in the population of participants who underwent the treatment to which they were assigned (93 for BIO including 1 participant who was randomized and treated but ineligible, 90 for INJ).
|
1.1%
1/90 • Number of events 1 • Adverse event data were collected from the time of randomization through 3 months.
Adverse events were analyzed in the population of participants who underwent the treatment to which they were assigned (93 for BIO including 1 participant who was randomized and treated but ineligible, 90 for INJ).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected from the time of randomization through 3 months.
Adverse events were analyzed in the population of participants who underwent the treatment to which they were assigned (93 for BIO including 1 participant who was randomized and treated but ineligible, 90 for INJ).
|
0.00%
0/90 • Adverse event data were collected from the time of randomization through 3 months.
Adverse events were analyzed in the population of participants who underwent the treatment to which they were assigned (93 for BIO including 1 participant who was randomized and treated but ineligible, 90 for INJ).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/93 • Adverse event data were collected from the time of randomization through 3 months.
Adverse events were analyzed in the population of participants who underwent the treatment to which they were assigned (93 for BIO including 1 participant who was randomized and treated but ineligible, 90 for INJ).
|
1.1%
1/90 • Number of events 1 • Adverse event data were collected from the time of randomization through 3 months.
Adverse events were analyzed in the population of participants who underwent the treatment to which they were assigned (93 for BIO including 1 participant who was randomized and treated but ineligible, 90 for INJ).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected from the time of randomization through 3 months.
Adverse events were analyzed in the population of participants who underwent the treatment to which they were assigned (93 for BIO including 1 participant who was randomized and treated but ineligible, 90 for INJ).
|
0.00%
0/90 • Adverse event data were collected from the time of randomization through 3 months.
Adverse events were analyzed in the population of participants who underwent the treatment to which they were assigned (93 for BIO including 1 participant who was randomized and treated but ineligible, 90 for INJ).
|
Other adverse events
| Measure |
Biofeedback (BIO)
n=93 participants at risk
Participants will receive biofeedback intervention during five (5) required weekly 1-hour sessions. A 6th treatment session will be made available for participants if it is shown through anorectal manometry that they are having trouble understanding directions given during the first five sessions.
Biofeedback: The participant will learn how to improve strength and rectal sensation during five (5) - six (6) visits each lasting 60 minutes.
|
Injection (INJ)
n=90 participants at risk
Bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.
Injection: The participant will have a bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
5.4%
5/93 • Number of events 6 • Adverse event data were collected from the time of randomization through 3 months.
Adverse events were analyzed in the population of participants who underwent the treatment to which they were assigned (93 for BIO including 1 participant who was randomized and treated but ineligible, 90 for INJ).
|
0.00%
0/90 • Adverse event data were collected from the time of randomization through 3 months.
Adverse events were analyzed in the population of participants who underwent the treatment to which they were assigned (93 for BIO including 1 participant who was randomized and treated but ineligible, 90 for INJ).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place