Phase 3
N=300
Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe)
Fecal Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT02008565 ↗Enrolled (actual)
300
Serious AEs
8.0%
Results posted
Nov 2018
Primary outcome: Primary: Change From Baseline St. Mark's (Vaizey) Score — -5.5; -4.4; -4.5; -3.4 units on a scale — p=0.092
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Loperamide (Drug); Placebo (Drug); Anal exercises with biofeedback (Behavioral); Usual Care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- NICHD Pelvic Floor Disorders Network
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline St. Mark's (Vaizey) Score |
-5.5; -4.4; -4.5; -3.4; -9.7; -5.9 | 0.092 |
| SECONDARY Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI) |
-16.3; -13.1; -16.9; -4.6; -21.5; -15.7 | — |
| SECONDARY Change in Colorectal-Anal Subscale of the Pelvic Floor Impact Questionnaire Short Form (CRAIQ) Score |
-12.5; -10.8; -15.8; -12.3; -41.3; -32.4 | — |
| SECONDARY Change From Baseline Accident-free Days at 12 and 24 Weeks |
1.8; 1.9; 1.7; 1.4; 2.5; 1.9 | — |
| SECONDARY Change From Baseline Pad-change Leaks Per Day at 12 and 24 Weeks |
-0.4; -0.2; -0.3; -0.2; -0.5; -0.1 | — |
| SECONDARY Change From Baseline Pad-change Leaks Per Week at 12 and 24 Weeks |
-2.7; -1.1; -1.3; -1.7; -3.3; -0.7 | — |
| SECONDARY Change From Baseline Total Number of Leaks Per Day at 12 and 24 Weeks |
-1.1; -0.7; -0.9; -1.0; -1.3; -0.7 | — |
| SECONDARY Change in Fecal Incontinence Severity Index (FISI) Score |
-12.4; -10.6; -14.4; -7.8; -19.1; -15.0 | — |
| SECONDARY Participants With Improvement in Patient Global Impression of Improvement (PGI-I) Score |
68; 57; 61; 26; 67; 59 | — |
| SECONDARY Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks |
52.6; 49.4; 51.1; 46.3; 47.7; 47.8 | — |
| SECONDARY Change From Baseline Volume of Air (mL) at First Sensation for Perception of Rectal Distention at 12 and 24 Weeks |
19.0; 22.7; 21.6; 25.1; 20.1; 24.5 | — |
| SECONDARY Change From Baseline Volume of Air (mL) at Urge to Defecate at 12 and 24 Weeks |
69.3; 66.9; 73.0; 71.8; 76.0; 78.4 | — |
| SECONDARY Change From Baseline Maximum Anal Pressures During Squeeze With the Catheter at the HPZ at 12 and 24 Weeks |
83.0; 76.3; 73.6; 73.1; 83.0; 74.6 | — |
Summary
The study is a multi-center, randomized, placebo controlled trial with participants randomized into one of four groups:
1. placebo/usual care (educational pamphlet)
2. loperamide/usual care (educational pamphlet)
3. placebo/anal exercises with biofeedback
4. loperamide/anal exercises with biofeedback
The primary outcome, change from baseline in St. Marks (Vaizey) Score at 24 weeks, will be compared between treatment groups using linear regression.
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years
- Fecal incontinence defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment
Exclusion Criteria
- Stool consistency over the last 3 months that includes items 1 or 7 based on the Bristol Stool form scale
- Current or past diagnosis of colorectal or anal malignancy
- Diagnosis of inflammatory bowel disease
- Current or history of rectovaginal fistula or cloacal defect
- Rectal prolapse (mucosal or full thickness)
- Prior removal or diversion of any portion of colon or rectum
- Prior pelvic floor or abdominal radiation
- Refusal or inability to provide written consent
- Inability to conduct telephone interviews conducted in English or Spanish
- Fecal impaction by exam
- Untreated pelvic organ prolapse beyond the hymen; Patients with prolapse beyond the hymen who are currently using a pessary are eligible
- Incontinence only to flatus
- Has taken any loperamide (Imodium®) or diphenoxylate plus atropine (Lomotil®) in the last 30 days
- Previously received and failed treatment of fecal incontinence using loperamide (Imodium®) or diphenoxylate plus atropine (Lomotil®) over the last 3 months
- Current supervised anal sphincter exercise/pelvic floor muscle training with biofeedback
- Previously received and failed treatment of fecal incontinence using supervised anal sphincter exercise/pelvic floor muscle training with biofeedback
- Previous allergy or intolerance to loperamide
- Pregnant, nursing, or planning to become pregnant before the end of the study follow-up period.
- Childbirth within the last 3 months
- Currently taking anti-retroviral drugs
- Neurological disorders known to affect continence, including spinal cord injury, advanced multiple sclerosis or Parkinson's disease and debilitating stroke
- Known diagnosis of hepatic impairment
- Chronic abdominal pain in the absence of diarrhea
Data sourced from ClinicalTrials.gov (NCT02008565). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.