Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 11, 2014
CompletedFirst Posted
Study publicly available on registry
June 17, 2014
CompletedJune 18, 2014
June 1, 2014
2.8 years
June 11, 2014
June 17, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
symptom diary
Up to eight months
Study Arms (3)
Biofeedback
EXPERIMENTALmedical treatment
EXPERIMENTALcombination of the two treatments
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pelvic floor unit, University hospital of Linköping
Linköping, 58185, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
June 11, 2014
First Posted
June 17, 2014
Study Start
May 1, 2002
Primary Completion
March 1, 2005
Last Updated
June 18, 2014
Record last verified: 2014-06