Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents
Primary Purpose
Fecal Incontinence
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Biofeedback
Loperamide
Stool bulking agent (stericulia or isphagula husk)
Combination of biofeedback and medical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Fecal Incontinence
Eligibility Criteria
Inclusion Criteria:
- Patients older than 18 years of age
- Patients with at least one or more episodes of FI during a period of 2 weeks as recorded by bowel function diary
- Patients from whom written consent was obtained
Exclusion Criteria:
- Previous congenital or acquired spinal injury, spinal tumour or spinal surgery
- Presence of neurological diseases or peripheral vascular disease
- Uncontrolled diabetes mellitus
- Congenital anorectal malformations
- Recent colorectal or gastrointestinal surgery
- Presence of external full-thickness rectal prolapse
- Inflammatory bowel disease
- Chronic diarrhoea
- Use of tibial nerve or sacral nerve stimulations
- Ongoing pregnancy
- Any malignant disease
Sites / Locations
- Pelvic floor unit, University hospital of Linköping
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Biofeedback
medical treatment
combination of the two treatments
Arm Description
Outcomes
Primary Outcome Measures
symptom diary
Secondary Outcome Measures
Full Information
NCT ID
NCT02165475
First Posted
June 11, 2014
Last Updated
June 17, 2014
Sponsor
University Hospital, Linkoeping
1. Study Identification
Unique Protocol Identification Number
NCT02165475
Brief Title
Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents
Official Title
Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents is Effective for the Treatment of Fecal Incontinence in Women - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: Biofeedback and medical treatments have been extensively used for moderate fecal incontinence. There is limited data comparing and combining these two treatments.
Aim: To evaluate the effect of biofeedback and medical treatments, separately and in combination.
Methods: Sixty-five consecutive female patients, referred to a tertial center for fecal incontinence were included. The patients were randomized to start with either biofeedback (4-6 months) or medical treatment with loperamide and stool-bulking agents (2 months). Both groups continued with a combination treatments, i.e. medical treatment was added to biofeedback and vice versa. A two-week prospective bowel symptom diary and anorectal physiology were evaluated at baseline, after single- and combination treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
Biofeedback
Arm Type
Experimental
Arm Title
medical treatment
Arm Type
Experimental
Arm Title
combination of the two treatments
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback
Intervention Type
Drug
Intervention Name(s)
Loperamide
Intervention Type
Drug
Intervention Name(s)
Stool bulking agent (stericulia or isphagula husk)
Intervention Type
Other
Intervention Name(s)
Combination of biofeedback and medical treatment
Primary Outcome Measure Information:
Title
symptom diary
Time Frame
Up to eight months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients older than 18 years of age
Patients with at least one or more episodes of FI during a period of 2 weeks as recorded by bowel function diary
Patients from whom written consent was obtained
Exclusion Criteria:
Previous congenital or acquired spinal injury, spinal tumour or spinal surgery
Presence of neurological diseases or peripheral vascular disease
Uncontrolled diabetes mellitus
Congenital anorectal malformations
Recent colorectal or gastrointestinal surgery
Presence of external full-thickness rectal prolapse
Inflammatory bowel disease
Chronic diarrhoea
Use of tibial nerve or sacral nerve stimulations
Ongoing pregnancy
Any malignant disease
Facility Information:
Facility Name
Pelvic floor unit, University hospital of Linköping
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
12. IPD Sharing Statement
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Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents
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