Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe)
The goals of this trial are to compare the use of loperamide to oral placebo and to compare the use of anal sphincter exercise training with biofeedback to usual care (educational pamphlet) in the treatment of women suffering from fecal incontinence (FI). We will test the following null hypotheses:
- there is no difference in outcomes between women randomized to loperamide and women randomized to oral placebo for treatment of FI;
- there is no difference in outcomes between women randomized to anal sphincter exercises with biofeedback and women randomized to usual care (educational pamphlet) for FI treatment;
- there is no difference between women randomized to both treatments together and women randomized to either FI treatment alone; and
- there is no correlation between anal manometry measurements and digital anal squeeze strength or measures of FI severity and bother.
A supplemental study, Stool Metabolome and Microbiome in Women with Fecal Incontinence in CAPABLe, will evaluate the stool metabolome and microbiome in women with fecal incontinence and unaffected age matched controls.
Behavioral: Anal exercises with biofeedback
Behavioral: Usual Care
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe): a Randomized Placebo Controlled Trial|
- Change from baseline St. Mark's (Vaizey) Score [ Time Frame: 24 week visit ] [ Designated as safety issue: No ]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.
- Condition-specific and generalized quality of life [ Time Frame: 12 and 24 week visits ] [ Designated as safety issue: No ]Change in quality of life between those randomized to loperamide compared to placebo and between those randomized to anal sphincter exercises with biofeedback compared to usual care (educational pamphlet).
- Efficacy Measures [ Time Frame: 12 and 24 week visits ] [ Designated as safety issue: No ]Measures of efficacy include bowel diary measures, digital rectal tone, and anal manometry measures .
- Patient satisfaction [ Time Frame: 12 and 24 week visits ] [ Designated as safety issue: No ]Participants' satisfaction with FI treatment modality defined as a response that their condition is "much better" or "very much better" on the PGI-I.
- Cost-effectiveness of FI treatment [ Time Frame: 12 and 24 week visits ] [ Designated as safety issue: No ]Cos-effectiveness of FI treatment modalities will be assessed using the patient's and societal perspectives.
- Succes of masking the drug treatment arm [ Time Frame: 24 week visit ] [ Designated as safety issue: No ]The purpose of this outcome is to assess the extent to which masking of the drug treatment arm is successful with respect to both the patient and the study coordinator.
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
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.
|Experimental: Anal exercises with biofeedback||
Behavioral: Anal exercises with biofeedback
Subjects randomized to anal exercises with biofeedback will receive a formal anal exercises training program designed by experts in the use of manometry and biofeedback for fecal incontinence. The intent is to provide a simple program that can be easily applied in an office setting with minimal subject burden. Subjects will attend six separate 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 will include strength and sensory training including urge resistance training. During the final twelve weeks, subjects will perform anal exercises on their own. The sessions with interventionists will occur every other week for 12 weeks (total 6 supervised sessions).
|Placebo Comparator: Usual care||
Behavioral: Usual Care
Usual care consists of patients receiving an educational pamphlet on fecal incontinence created by the National Institute of Diabetes and Digestive and Kidney Diseases.
Participants randomized to the loperamide treatment group will begin with 2mg of loperamide per day. The participant will be administered the Patient Global Symptom Control rating scale (PGSC) to determine dose escalation. The participant will be instructed to either maintain the current drug dose if PGSC is 4 or 5, or dose escalate if PGSC is 1-3. 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 PGTS. The participant will be instructed to reduce the current drug dose if PGTS is 4 or 5. The daily dose will be decreased by 2mg to a minimum of 2mg every other day. If they have a PGSC score of 1-3 (inadequate control of stool leakage) combined with a PGTS score of 4-5 (bothersome side effects), the participant will discontinue the study medication.
Other Name: Imodium
Please refer to this study by its ClinicalTrials.gov identifier: NCT02008565
|Contact: J E Jelovsek, MDemail@example.com|
|Contact: Susan Meikle, MD|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35233|
|Contact: Velria Willis firstname.lastname@example.org|
|Principal Investigator: Alayne Markland, DO, MSc|
|United States, California|
|University of California at San Diego||Recruiting|
|La Jolla, California, United States, 92037-0974|
|Contact: JoAnn Columbo email@example.com|
|Principal Investigator: Charles W Nager, MD|
|Kaiser San Diego||Recruiting|
|San Diego, California, United States, 92110|
|Contact: Gisselle Zazueta- Damian Gisselle.Zazueta-Damian@kp.org|
|Contact: Linda Mackinnon Linda.firstname.lastname@example.org|
|Principal Investigator: Keisha Dyer|
|United States, New Mexico|
|University of New Mexico||Recruiting|
|Albuquerque, New Mexico, United States, 87131|
|Contact: Susan Lee email@example.com|
|Contact: Elizabeth Hervey ECHervey@salud.unm.edu|
|Principal Investigator: Rebecca Rogers, MD|
|United States, North Carolina|
|Durham, North Carolina, United States, 27707|
|Contact: Mary Raynor firstname.lastname@example.org|
|Principal Investigator: Anthony G Visco, MD|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Ly Pung email@example.com|
|Contact: Geetha Krishna KRISHNG@ccf.org|
|Principal Investigator: Matthew Barber, MD|
|Sub-Investigator: J E Jelovsek, MD|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19118|
|Contact: Michelle Kinglee firstname.lastname@example.org|
|Principal Investigator: Diane Newman|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Judy Gruss email@example.com|
|Principal Investigator: Gary Sutkin, MD|
|United States, Rhode Island|
|Brown/Women and Infants Hospital of Rhode Island||Recruiting|
|Providence, Rhode Island, United States, 02903|
|Contact: Ann Meers firstname.lastname@example.org|
|Principal Investigator: Vivian Sung, MD|
|Study Chair:||J E Jelovsek||The Cleveland Clinic|
|Study Chair:||Matthew Barber||The Cleveland Clinic|