Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents
NCT ID: NCT02165475
Last Updated: 2014-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
2002-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Study Groups
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Biofeedback
Biofeedback
medical treatment
Loperamide
Stool bulking agent (stericulia or isphagula husk)
combination of the two treatments
Combination of biofeedback and medical treatment
Interventions
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Biofeedback
Loperamide
Stool bulking agent (stericulia or isphagula husk)
Combination of biofeedback and medical treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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University Hospital, Linkoeping
OTHER
Responsible Party
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Jenny Sjödahl
PhD
Locations
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Pelvic floor unit, University hospital of Linköping
Linköping, , Sweden
Countries
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Other Identifiers
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Dnr 02-220
Identifier Type: -
Identifier Source: org_study_id
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