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Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents

Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents is Effective for the Treatment of Fecal Incontinence in Women - a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02165475
Enrollment
Unknown
Registered
2014-06-17
Start date
2002-05-31
Completion date
Unknown
Last updated
2014-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fecal Incontinence

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.

Interventions

BEHAVIORALBiofeedback
DRUGLoperamide
DRUGStool bulking agent (stericulia or isphagula husk)
OTHERCombination of biofeedback and medical treatment

Sponsors

University Hospital, Linkoeping
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
symptom diaryUp to eight months

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026