Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience

Not Applicable

Completed

• Conditions: Fecal Incontinence
• Interventions: Device: Transcutanous Posterior Tibial Nerve Stimulation; Device: Sham Transcutanous Posterior Tibial Nerve Stimulation

• Registration Number: NCT04478799
• Lead Sponsor: Batterjee Medical College

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.

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2020-05-01
• Status Verified: 2020-07
• Study Completion: 2020-07-15
• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-16
• Last Update Submitted: 2020-07-20
• Study First Posted: 2020-07-21
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (Transcutanous Posterior Tibial Nerve Stimulation)	Transcutanous Posterior Tibial Nerve Stimulation	Patients belonging to the group A received Transcautanoues posterior tibial nerve stimulation plus diet and Kegel exercises
Group B (Sham Control)	Sham Transcutanous Posterior Tibial Nerve Stimulation	Patients belonging to the group B received Sham Transcautanoues posterior tibial nerve stimulation plus diet and Kegel exercises

Primary Outcome Measures

Name	Time	Method
Number of incontinence episodes	24 months	Change in the number of incontinence episodes
Incontinence Score using Vaizey incontinence score	24 months	Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).

Secondary Outcome Measures

Name	Time	Method
First Urge (volume of the balloon by cm water)	3 months	The patient is trying to hold defecation and he can
Fecal Incontinence Quality of life Score	24 months	Change in quality of life score measured on a scale between 1 and 4, where 1 is very affected and 4 is not affected
First sensation (volume of the balloon by cm water)	3 months	First sensation of the stool in the rectum
Resting pressure (mm hg)	3 months	Pressure during relaxation of the anal sphincter
Squeeze pressure (mm hg)	3 months	Pressure during contraction of the anal sphincter

Trial Locations

Locations (1)

Benha University; 🇪🇬 Banhā, Al Qalyubia Governorate, Egypt