Phase 3
Completed N=300
Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe)
Source: ClinicalTrials.gov NCT02008565 ↗Enrolled (actual)
300
Serious AEs
8.0%
Results posted
Nov 2018
Primary outcomePrimary: Change From Baseline St. Mark's (Vaizey) Score — -5.5; -4.4; -4.5; -3.4 units on a scale — p=0.092
◆ Published Evidence
Established
65citations · ~9 / year
Controlling faecal incontinence in women by performing anal exercises with biofeedback or loperamide: a randomised clinical trial.
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.
Linked Publications
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Controlling faecal incontinence in women by performing anal exercises with biofeedback or loperamide: a randomised clinical trial.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.