Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents is Effective for the Treatment of Fecal Incontinence in Women - a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Biofeedback
- Conditions
- Fecal Incontinence
- Sponsor
- University Hospital, Linkoeping
- Locations
- 1
- Primary Endpoint
- symptom diary
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Jenny Sjödahl
PhD
University Hospital, Linkoeping
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
Arms & Interventions
Biofeedback
Intervention: Biofeedback
medical treatment
Intervention: Loperamide
medical treatment
Intervention: Stool bulking agent (stericulia or isphagula husk)
combination of the two treatments
Intervention: Combination of biofeedback and medical treatment
Outcomes
Primary Outcomes
symptom diary
Time Frame: Up to eight months