Biofeedback Vs Electrical Stimulation in Treatment of Fecal Incontinence

Not Applicable

Completed

• Conditions: Fecal Incontinence; Encopresis; Fecal Soiling

• Registration Number: NCT04380571
• Lead Sponsor: Cairo University

Brief Summary

Fecal incontinence is one of the most psychological frustrating problems. It occurs in children due to many causes. There is a wide range of non-invasive therapeutic approaches like Kegel exercise, Biofeedback, and posterior tibial nerve stimulation. However, up till now, there are no established guidelines for treatment.

the objective of this study is to evaluate and compare the early effect of Biofeedback therapy versus bilateral transcutaneous posterior tibial nerve stimulation (TPNS) as non-invasive methods in the treatment of functional non-retentive fecal incontinence (FNRFI) in children.

Detailed Description

Functional non-retentive fecal incontinence (FNRFI) requires prolonged treatment with a wide range of non-invasive therapeutic approaches like Kegel exercise, Biofeedback, and posterior tibial nerve stimulation (PTNS). However, up till now, there are no established guidelines for treatment.1 The aim of this study is to evaluate and compare the early effect of Biofeedback therapy versus bilateral transcutaneous posterior tibial nerve stimulation (TPTNS) as non-invasive methods in the treatment of (FNRFI) in children.

Methodology: The current prospective randomized controlled study included 93 children with FNRFI who were randomly divided and allocated into three groups. Group A treated by conventional methods through dietetic regulation and Kegal exercises. Group B treated by biofeedback therapy while group C received bilateral (TPTNS). Initial manometric findings including resting pressure, squeeze pressure, 1st sensation, 1st urge, and intense urge were recorded and repeated after 3 and 6 months together with incontinence score recorded in using St' Mark's (Varizey) with the primary endpoint of improvement of the incontinence score more than 50%.

Study Timeline

• Study Start: 2018-03-04
• Primary Completion: 2018-12-27
• Study Completion: 2019-02-28
• Study First Submitted: 2020-04-29
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-05
• Last Update Submitted: 2020-05-05
• Study First Posted: 2020-05-08
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• FecaI incontinence
• Normal defecation frequency,
• Normal bowel habits and
• Normal stool consistency

Exclusion Criteria

• Children who are not cooperative,
• Children with traumatic sphincter injury,
• Children with fecal impaction,
• Children with spinal diseases causing incontinence,
• Children with anorectal malformation,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incontinence score using St' Mark's (Vaiszey)	3 months after intervention	Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).
incontinence score using St' Mark's (Vaiszey)	6 months after intervention	Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).

Secondary Outcome Measures

Name	Time	Method
Resting pressure (mm hg)	6 months after intervention	Pressure during relaxation of the anal sphincter
First sensation (volume of the balloon by cm water)	6 months after intervention	First sensation of the stool in the rectum
Intense urge (volume of the balloon by cm water)	6 months after intervention	the Patent can no longer control the defecation
First Urge(volume of the balloon by cm water)	6 months after intervention	The patient is trying to hold defecation and he can
Squeeze pressure (mm hg)	6 months after intervention	Pressure during contraction of the anal sphincter

Trial Locations

Locations (1)

Banha University; 🇪🇬 Banhā, Banha, Egypt