Fecal Incontinence
Conditions
Keywords
fecal incontinence, adults, diarrhea
Brief summary
The purpose of this study is to evaluate and compare treatment with fiber and loperamide for fecal incontinence.
Detailed description
Fecal incontinence (FI) affects 4-24% adults in the community and greatly impacts quality of life. Both fiber and loperamide are common, first-line treatments for diarrhea-associated FI in primary care. No known studies exist that compare fiber and loperamide for diarrhea-predominant FI. Further knowledge is needed to define which treatment is more effective and to compare drug tolerability (side effects) for FI. This study will also look at changes in quality of life with treatment and potential mechanisms of drug treatment.
Interventions
DRUGPsyllium powder
2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose)
DRUGLoperamide
1 capsule daily for 28 days (weekly adjusted dose)
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* weekly fecal incontinence
Exclusion criteria
* fecal impaction * inability to complete a baseline 1-week bowel diary * rectal prolapse * any prior radiation to the pelvis * colo-rectal cancer * rectal fistula * inflammatory bowel disease * neurological diseases (spinal cord injury, multiple sclerosis, Parkinson's disease) * constipation (\<2 bowel movements/week) or total colectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-day Bowel Diary, Number of Fecal Incontinence Episodes | 6 weeks and 12 weeks | After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). The mean number of total fecal incontinence episodes from a 7-day bowel diary from each time point was compared between the groups. |
| Percentage of Bowel Movements With Incontinence | 4 weeks | After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). We compared the percentage of the total number of fecal incontinence episodes over the total number of bowel movements from a 7-day bowel diary from each time point between the groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal Incontinence Severity Index Score, FISI | baseline, 4 week and 12 weeks | The patient-reported symptoms severity score, the Fecal Incontinence Severity Index (FISI), has 4 questions about the frequency of gas, mucus, liquid stool, and solid stool incontinence. Responses are weighted based on the patient rating of severity and a total score is calculated (range 0-61) with higher scores indicating a greater severity of symptoms. |
Countries
United States
Participant flow
Recruitment details
Outpatient medical clinic
Participants by arm
| Arm | Count |
|---|---|
| P1L2 (Psyllium First, Then Loperamide) Fiber (psyllium) powder with loperamide placebo first
Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 2 mg placebo daily with weekly dose adjustments for side-effects and/or efficacy | 37 |
| L1P2 (Loperamide First, Then Pysllium) Fiber (psyllium) powder placebo with loperamide 2mg pill
Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy | 43 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (4-weeks) | Lost to Follow-up | 1 | 2 |
| First Intervention (4-weeks) | Withdrawal by Subject | 2 | 1 |
| Second Intervention (4-weeks) | Death | 1 | 0 |
| Second Intervention (4-weeks) | Lost to Follow-up | 0 | 1 |
| Second Intervention (4-weeks) | Withdrawal by Subject | 0 | 2 |
| Wash-out (2-weeks) | Lost to Follow-up | 3 | 1 |
| Wash-out (2-weeks) | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | L1P2 (Loperamide First, Then Pysllium) | P1L2 (Psyllium First, Then Loperamide) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 22 Participants | 47 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 15 Participants | 33 Participants |
| Age, Continuous | 59.2 years STANDARD_DEVIATION 9.2 | 62.3 years STANDARD_DEVIATION 10.9 | 60.8 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment United States | 43 participants | 37 participants | 80 participants |
| Sex: Female, Male Female | 14 Participants | 12 Participants | 26 Participants |
| Sex: Female, Male Male | 29 Participants | 25 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 34 | 6 / 40 | 3 / 29 | 4 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 40 | 1 / 29 | 0 / 34 |
Outcome results
Primary
7-day Bowel Diary, Number of Fecal Incontinence Episodes
After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). The mean number of total fecal incontinence episodes from a 7-day bowel diary from each time point was compared between the groups.
Time frame: 6 weeks and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| P1L2 (Psyllium First, Then Loperamide) | 7-day Bowel Diary, Number of Fecal Incontinence Episodes | Baseline | 7.3 Fecal incontinence episodes | Standard Deviation 6.2 |
| P1L2 (Psyllium First, Then Loperamide) | 7-day Bowel Diary, Number of Fecal Incontinence Episodes | End of First Intervention | 4.8 Fecal incontinence episodes | Standard Deviation 4.8 |
| P1L2 (Psyllium First, Then Loperamide) | 7-day Bowel Diary, Number of Fecal Incontinence Episodes | End of Wash-out Period | 4.3 Fecal incontinence episodes | Standard Deviation 4.2 |
| P1L2 (Psyllium First, Then Loperamide) | 7-day Bowel Diary, Number of Fecal Incontinence Episodes | End of Second Intervention | 3.5 Fecal incontinence episodes | Standard Deviation 6.6 |
| L1P2 (Loperamide First, Then Pysllium) | 7-day Bowel Diary, Number of Fecal Incontinence Episodes | End of Second Intervention | 4.7 Fecal incontinence episodes | Standard Deviation 5.7 |
| L1P2 (Loperamide First, Then Pysllium) | 7-day Bowel Diary, Number of Fecal Incontinence Episodes | Baseline | 7.9 Fecal incontinence episodes | Standard Deviation 7.5 |
| L1P2 (Loperamide First, Then Pysllium) | 7-day Bowel Diary, Number of Fecal Incontinence Episodes | End of Wash-out Period | 5.0 Fecal incontinence episodes | Standard Deviation 6.2 |
| L1P2 (Loperamide First, Then Pysllium) | 7-day Bowel Diary, Number of Fecal Incontinence Episodes | End of First Intervention | 4.1 Fecal incontinence episodes | Standard Deviation 5.1 |
Primary
Percentage of Bowel Movements With Incontinence
After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). We compared the percentage of the total number of fecal incontinence episodes over the total number of bowel movements from a 7-day bowel diary from each time point between the groups.
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| P1L2 (Psyllium First, Then Loperamide) | Percentage of Bowel Movements With Incontinence | Baseline | 30.5 percentage of incontinent bowel movement | Standard Deviation 18 |
| P1L2 (Psyllium First, Then Loperamide) | Percentage of Bowel Movements With Incontinence | End of First Intervention | 23.4 percentage of incontinent bowel movement | Standard Deviation 22.1 |
| P1L2 (Psyllium First, Then Loperamide) | Percentage of Bowel Movements With Incontinence | End of Wash-out Period | 23.0 percentage of incontinent bowel movement | Standard Deviation 22.2 |
| P1L2 (Psyllium First, Then Loperamide) | Percentage of Bowel Movements With Incontinence | End of Second Intervention | 15.9 percentage of incontinent bowel movement | Standard Deviation 19.3 |
| L1P2 (Loperamide First, Then Pysllium) | Percentage of Bowel Movements With Incontinence | End of Second Intervention | 18.8 percentage of incontinent bowel movement | Standard Deviation 21 |
| L1P2 (Loperamide First, Then Pysllium) | Percentage of Bowel Movements With Incontinence | Baseline | 32.3 percentage of incontinent bowel movement | Standard Deviation 23.4 |
| L1P2 (Loperamide First, Then Pysllium) | Percentage of Bowel Movements With Incontinence | End of Wash-out Period | 18.8 percentage of incontinent bowel movement | Standard Deviation 20.2 |
| L1P2 (Loperamide First, Then Pysllium) | Percentage of Bowel Movements With Incontinence | End of First Intervention | 21.3 percentage of incontinent bowel movement | Standard Deviation 22.7 |
Secondary
Fecal Incontinence Severity Index Score, FISI
The patient-reported symptoms severity score, the Fecal Incontinence Severity Index (FISI), has 4 questions about the frequency of gas, mucus, liquid stool, and solid stool incontinence. Responses are weighted based on the patient rating of severity and a total score is calculated (range 0-61) with higher scores indicating a greater severity of symptoms.
Time frame: baseline, 4 week and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| P1L2 (Psyllium First, Then Loperamide) | Fecal Incontinence Severity Index Score, FISI | Baseline | 29.1 units on a scale | Standard Deviation 11 |
| P1L2 (Psyllium First, Then Loperamide) | Fecal Incontinence Severity Index Score, FISI | End of First Intervention | 24.9 units on a scale | Standard Deviation 12.2 |
| P1L2 (Psyllium First, Then Loperamide) | Fecal Incontinence Severity Index Score, FISI | End of Second Intervention | 22.0 units on a scale | Standard Deviation 17.1 |
| L1P2 (Loperamide First, Then Pysllium) | Fecal Incontinence Severity Index Score, FISI | Baseline | 31.9 units on a scale | Standard Deviation 13.5 |
| L1P2 (Loperamide First, Then Pysllium) | Fecal Incontinence Severity Index Score, FISI | End of First Intervention | 24.9 units on a scale | Standard Deviation 13.3 |
| L1P2 (Loperamide First, Then Pysllium) | Fecal Incontinence Severity Index Score, FISI | End of Second Intervention | 23.2 units on a scale | Standard Deviation 12.7 |