Study Stopped
Low enrollment led sponsor to terminate study early.
Educational-Medical-Behavioral Treatment of Fecal Incontinence
FIX
Conservative Treatment of Fecal Incontinence: Community-Based Effectiveness Trial
2 other identifiers
interventional
31
1 country
1
Brief Summary
In previous studies at a university referral center the investigators demonstrated that a multicomponent conservative treatment for fecal incontinence was effective. The treatment combines patient education with medical management of diarrhea and constipation plus behavioral training. The purpose of this study is to determine whether this treatment is effective when delivered by home health care nurses to frail elderly patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2012
CompletedFirst Posted
Study publicly available on registry
October 30, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
February 17, 2017
CompletedFebruary 17, 2017
February 1, 2017
2.2 years
September 15, 2012
May 16, 2016
February 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Fecal Incontinence Severity Index (FISI) at End of Treatment
At the end of treatment, the FISI requires the patient to report the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range of scores is 0-61. Higher scores show more severe fecal incontinence.
End of Treatment (Week 6)
Fecal Incontinence Severity Index (FISI) at Follow-Up (FU)
At follow up 6 months after the end of treatment, the subject reports the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range is 0-61. No data is available to interpret the scale as mild, moderate, or severe fecal incontinence.
6 months after (6-Week) treatment ends
Secondary Outcomes (23)
Adequate Relief of Fecal Incontinence at End of Treatment
End of Treatment (Week 6)
Adequate Relief of Fecal Incontinence at Follow Up
6 months after (6-Week) treatment ends
MHQ Severity Scale at End of Treatment
End of Treatment (Week 6)
MHQ Severity Scale at Follow Up
6 months after (6-Week) treatment ends
Zarit Caregiver Burden Scale at End of Treatment
End of Treatment (Week 6)
- +18 more secondary outcomes
Other Outcomes (7)
Cognitive Status at End of Treatment
End of Treatment (Week 6)
Change in Ambulation From Baseline to End of Treatment
Baseline, End of Treatment (Week 6)
Ability to Reach Toilet at End of Treatment
End of Treatment (Week 6)
- +4 more other outcomes
Study Arms (2)
Educational-Medical-Behavioral
ACTIVE COMPARATOREducational-Medical-Behavioral intervention includes education, fiber supplements \[Metamucil 1-4 packets (3.4-13.6 g)/day\], laxatives or anti-diarrheals \[Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day\], pelvic floor muscle exercises \[100 10-second squeezes/day\], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments \[as needed\].
Standard Care
PLACEBO COMPARATORStandard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day\], daily diary, and protective pads or garments \[as needed\].
Interventions
Patient and caregiver will be taught which muscles are used in continence and defecation through the use of a training manual and anatomical drawings.
Patients and caregivers will be taught to use fiber supplements to normalize stool consistency if patient reports diarrhea or constipation. Fiber supplements will be in the form of Metamucil beginning with 3.4 grams per day and increasing up to 13.6 grams per day if needed to control stool consistency.
Miralax at a dose of one packet (17 grams) daily may be used for constipation if unresponsive to fiber. Dose may be titrated up to two packets (34 grams) daily if needed. Imodium at a starting dose of 2 mg/day may be used for diarrhea if unresponsive to fiber. Dose of Imodium may be titrated down to 1 mg or up to 4 mg if needed.
Patients will be taught how to perform pelvic floor muscle contractions during digital rectal examination by a nurse. They will be asked to squeeze 100 times daily.
Examples of behavioral tips are "Walk, don't run to the toilet" and "Squeeze before you lift objects or sneeze".
Both groups will keep a daily diary, but amount of detail differs: Active comparator group records bowel accidents, bowel movements, Bristol Stool ratings of stool consistency, number of times they do pelvic floor exercises, study medications, and comments for the nurse to read. Placebo comparator group records only bowel accidents, bowel movements, and Bristol Stool scores.
In both groups, patients will be permitted to use pads or protective garments to avoid embarrassment. They will be told that fecal leakage that is stopped by a pad or protective garment should still be recorded as fecal incontinence.
Eligibility Criteria
You may qualify if:
- Self-reported fecal incontinence at least once a month
- Family caregiver available and willing to participate in treatment sessions and willing to assist patient with study procedures
- Patients and caregivers willing to be interviewed by a research assistant in their home on three occasions
- Onset of fecal incontinence more than 3 months previously (i.e., not transient fecal incontinence)
You may not qualify if:
- Has a stoma or fecal incontinence status is unknown
- Has fecal incontinence less than monthly
- Severe cognitive impairment (response of 4 on OASIS question M1700)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7080, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Early termination leading to small numbers of subjects analyzed.
Results Point of Contact
- Title
- William E. Whitehead, PhD, Professor of Medicine
- Organization
- University of North Carolina at Chapel Hill
Study Officials
- PRINCIPAL INVESTIGATOR
William E Whitehead, PhD
University of North Carolina, Chapel Hill
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine and Adjunct Professor of OBGYN
Study Record Dates
First Submitted
September 15, 2012
First Posted
October 30, 2012
Study Start
January 1, 2013
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
February 17, 2017
Results First Posted
February 17, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share
Insufficient data to be analyzed by an outside investigator.