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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
University Hospital, Linkoeping
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
June 11, 2014
Last Updated
June 17, 2014
Sponsor
University Hospital, Linkoeping
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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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