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Clinical Trials/NCT04478799
NCT04478799
Completed
Not Applicable

Long Term Outcome of Transcutaneous Posterior Tibial Nerve Stimulation in Treatment of Functional Non-Retentive Fecal Incontinence

Batterjee Medical College1 site in 1 country102 target enrollmentSeptember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fecal Incontinence
Sponsor
Batterjee Medical College
Enrollment
102
Locations
1
Primary Endpoint
Number of incontinence episodes
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Shafik and colleagues were the first to report the use of posterior tibial nerve stimulation (PTNS) for FI, and they documented improved continence after 4 weeks course. Subsequent studies documented percutaneous and transcutaneous PTNS as effective methods for treatment of FI, with a short term reduction in incontinence episode by 50-80 %. Percutaneous PTNS (PPTNS) showed a greater effect than transcutaneous PTNS (TPTNS) and this may be assumed due to the presence of the stimulating electrode very close to the posterior tibial nerve. However, TPTNS is more preferable to percutaneous PTNS because of the concern about the insertion of a needle may result in stimulation that is sufficient to produce a neuromodulatory effect.

Detailed Description

Treatment of FNRFI is often difficult and requires prolonged therapies with unexpected responses and frequent relapses. The corner-stones in treatment of FNRFI are education, positive motivation, and toilet training. Preparation of children and their parents for a long-lasting treatment is mandatory with the expectation of many ups and downs. The main goal is to have regular bowel movements and normal continence and this can be achieved by teaching the child the importance of regular toilet use and avoid urges. Many previous studies, reported the short term effect of TPTNS in treatment of FNRFI. However, there are sufficient studies evaluating the long term effect of TPNS and this has motivated the authors to conduct of this study The aim of this study is to evaluate the Long term outcome and quality of life in children with Functional non-retentive fecal incontinence and received Bilateral Transcutaneous posterior tibial nerve stimulation therapy.

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
July 15, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed A. Abdel Ghafar

Associate Professor

Batterjee Medical College

Eligibility Criteria

Inclusion Criteria

  • Age ranged from (6-14 years) with FNRFI with normal bowel habits
  • Children with normal defecation frequency and normal stool consistency
  • Children with incontinence score ranging from 8-22 according to Vaizey score

Exclusion Criteria

  • Children who have traumatic sphincter injury.
  • Children who have Fecal impaction
  • Children who have Spinal diseases causing incontinence
  • Children who have Anorectal malformation
  • Children who were not cooperative

Outcomes

Primary Outcomes

Number of incontinence episodes

Time Frame: 24 months

Change in the number of incontinence episodes

Incontinence Score using Vaizey incontinence score

Time Frame: 24 months

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

Secondary Outcomes

  • First Urge (volume of the balloon by cm water)(3 months)
  • Fecal Incontinence Quality of life Score(24 months)
  • First sensation (volume of the balloon by cm water)(3 months)
  • Resting pressure (mm hg)(3 months)
  • Squeeze pressure (mm hg)(3 months)

Study Sites (1)

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