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Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents

Sponsor
University Hospital, Linkoeping (Other)
Overall Status
Completed
CT.gov ID
NCT02165475
Collaborator
(none)
1
Location
3
Arms

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Biofeedback
  • Drug: Loperamide
  • Drug: Stool bulking agent (stericulia or isphagula husk)
  • Other: Combination of biofeedback and medical treatment
 N/A

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
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 Start Date :
May 1, 2002
Actual Primary Completion Date :
Mar 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Experimental: Biofeedback

Behavioral: Biofeedback
Experimental: medical treatment

Drug: Loperamide

Drug: Stool bulking agent (stericulia or isphagula husk)
Experimental: combination of the two treatments

Other: Combination of biofeedback and medical treatment

Outcome Measures

Primary Outcome Measures

  1. symptom diary [Up to eight months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pelvic floor unit, University hospital of Linköping Linköping Sweden 58185

Sponsors and Collaborators

  • University Hospital, Linkoeping

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jenny Sjödahl, PhD, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT02165475
Other Study ID Numbers:
  • Dnr 02-220
First Posted:
Jun 17, 2014
Last Update Posted:
Jun 18, 2014
Last Verified:
Jun 1, 2014
Additional relevant MeSH terms:
Fecal Incontinence
Loperamide
Antidiarrheals

Study Results

No Results Posted as of Jun 18, 2014