Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe)
CAPABLe
10 other identifiers
interventional
300
1 country
9
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2014
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2013
CompletedFirst Posted
Study publicly available on registry
December 11, 2013
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedResults Posted
Study results publicly available
November 20, 2018
CompletedNovember 20, 2018
October 1, 2018
2.2 years
December 6, 2013
February 16, 2018
October 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline St. Mark's (Vaizey) Score
The primary outcome measure for all study arms is the change from baseline in St. Mark's (Vaizey) Score 24 weeks after treatment initiation to compare the marginal outcomes of anal exercise with biofeedback to usual care and loperamide to placebo. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent.
12 and 24 weeks
Secondary Outcomes (12)
Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI)
12 and 24 weeks
Change in Colorectal-Anal Subscale of the Pelvic Floor Impact Questionnaire Short Form (CRAIQ) Score
12 and 24 weeks
Change From Baseline Accident-free Days at 12 and 24 Weeks
12 and 24 weeks
Change From Baseline Pad-change Leaks Per Day at 12 and 24 Weeks
12 and 24 weeks
Change From Baseline Pad-change Leaks Per Week at 12 and 24 Weeks
12 and 24 weeks
- +7 more secondary outcomes
Study Arms (4)
Placebo - Exercise plus Biofeedback
PLACEBO COMPARATORPlacebo and biofeedback intervention. Placebo doses range from 2mg every other day to 8mg per day. Capsules are taken by mouth once a day for 24 weeks. Anal exercises with biofeedback intervention is a total of six sessions with trained personnel occurring every 2 weeks over a 12-week period. Sessions are held at the following study visits: baseline, 2, 4, 6, 9, and 12 week visits.
Loperamide - Exercise plus Biofeedback
EXPERIMENTALLoperamide and biofeedback intervention. Loperamide doses range from 2mg every other day to 8mg per day. Capsules are taken by mouth once a day for 24 weeks. Anal exercises with biofeedback intervention is a total of six sessions with trained personnel occurring every 2 weeks over a 12-week period. Sessions are held at the following study visits: baseline, 2, 4, 6, 9, and 12 week visits.
Placebo - Education Only
PLACEBO COMPARATORPlacebo and education (usual care). Placebo doses range from 2mg every other day to 8mg per day. Capsules are taken by mouth once a day for 24 weeks. Participants receive education and a NIDDK Bowel Control Educational pamphlet.
Loperamide - Education Only
EXPERIMENTALLoperamide and education (usual care). Loperamide doses range from 2mg every other day to 8mg per day. Capsules are taken by mouth once a day for 24 weeks. Participants receive education and a NIDDK Bowel Control Educational pamphlet.
Interventions
Participants randomized to the loperamide group will begin with 2mg of loperamide/day. The participant will be administered the Patient Global Symptom Control rating scale (PGSC) to determine dose escalation. Participants who report inadequate control of stool leakage on the PGSC will be instructed to increase the daily dose of loperamide by 2 mg up to a maximum of 8 mg per day (1-4 capsules). Bothersome adverse events and resulting dose reduction will be based exclusively on the result of the Patient Global Tolerability Scale (PGTS). The daily dose will be decreased by 2mg to a minimum of 2mg every other day. If a PGSC score indicates inadequate control of stool leakage combined with a PGTS score indicating bothersome side effects, the participant will discontinue the study medication.
Participants randomized to the placebo arm will begin the a dose of one capsule per day and will be dose increased or dose decreased using the same algorithm described for the loperamide arm.
Participants will receive a formal anal exercises training program that can be easily applied in an office setting with minimal participant burden. Participants will attend six anal exercises with biofeedback sessions with trained personnel over a 12-week period for the 24-week study. Sessions will include introduction, standard patient education, and exercises using anal manometry-assisted biofeedback introducing concepts such as shaping, generalization and termination. The protocol uses strength and sensory training including urge resistance training. During the final twelve weeks, participants will perform anal exercises on their own. The sessions with interventionists will occur every other week for 12 weeks (total 6 supervised sessions).
Usual care consists of patients receiving an educational pamphlet on fecal incontinence created by the National Institute of Diabetes and Digestive and Kidney Diseases.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NICHD Pelvic Floor Disorders Networklead
- The Cleveland Cliniccollaborator
- University of Alabama at Birminghamcollaborator
- University of California, San Diegocollaborator
- Duke Universitycollaborator
- National Institutes of Health (NIH)collaborator
- University of New Mexicocollaborator
- Women and Infants Hospital of Rhode Islandcollaborator
- RTI Internationalcollaborator
- University of Pennsylvaniacollaborator
- University of Pittsburghcollaborator
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
Study Sites (9)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of California at San Diego
La Jolla, California, 92037-0974, United States
Kaiser San Diego
San Diego, California, 92110, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Duke University
Durham, North Carolina, 27707, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19118, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Brown/Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02903, United States
Related Publications (1)
Jelovsek JE, Markland AD, Whitehead WE, Barber MD, Newman DK, Rogers RG, Dyer K, Visco AG, Sutkin G, Zyczynski HM, Carper B, Meikle SF, Sung VW, Gantz MG; National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Controlling faecal incontinence in women by performing anal exercises with biofeedback or loperamide: a randomised clinical trial. Lancet Gastroenterol Hepatol. 2019 Sep;4(9):698-710. doi: 10.1016/S2468-1253(19)30193-1. Epub 2019 Jul 15.
PMID: 31320277DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marie Gantz
- Organization
- RTI International
Study Officials
- STUDY CHAIR
J E Jelovsek
The Cleveland Clinic
- STUDY CHAIR
Matthew Barber
The Cleveland Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2013
First Posted
December 11, 2013
Study Start
February 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
November 20, 2018
Results First Posted
November 20, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share