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Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents

NCT02165475 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL

Last updated 2014-06-18

No results posted yet for this study

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.

Conditions

  • Fecal Incontinence

Interventions

BEHAVIORAL

Biofeedback

DRUG

Loperamide

DRUG

Stool bulking agent (stericulia or isphagula husk)

OTHER

Combination of biofeedback and medical treatment

Sponsors & Collaborators

  • University Hospital, Linkoeping

    lead OTHER

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2005-03-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02165475 on ClinicalTrials.gov