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Clinical Trials/NCT04380571
NCT04380571
Completed
Not Applicable

Biofeedback Versus Bilateral Transcutaneous Electrical Nerve Stimulation in the Treatment of Functional Non-retentive Fecal Incontinence

Cairo University1 site in 1 country93 target enrollmentMarch 4, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fecal Incontinence
Sponsor
Cairo University
Enrollment
93
Locations
1
Primary Endpoint
Incontinence score using St' Mark's (Vaiszey)
Status
Completed
Last Updated
5 years ago

Overview

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%.

Registry
clinicaltrials.gov
Start Date
March 4, 2018
End Date
February 28, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Olfat Ibrahim Ali

Assistant professor

Cairo University

Eligibility Criteria

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,

Outcomes

Primary Outcomes

Incontinence score using St' Mark's (Vaiszey)

Time Frame: 3 months after intervention

Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).

incontinence score using St' Mark's (Vaiszey)

Time Frame: 6 months after intervention

Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).

Secondary Outcomes

  • Resting pressure (mm hg)(6 months after intervention)
  • First sensation (volume of the balloon by cm water)(6 months after intervention)
  • Intense urge (volume of the balloon by cm water)(6 months after intervention)
  • First Urge(volume of the balloon by cm water)(6 months after intervention)
  • Squeeze pressure (mm hg)(6 months after intervention)

Study Sites (1)

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