Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience

Batterjee Medical College

Status: Completed

Conditions: Fecal Incontinence

Treatments: Device: Sham Transcutanous Posterior Tibial Nerve Stimulation; Device: Transcutanous Posterior Tibial Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04478799

Banha University

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups

Group A (Transcutanous Posterior Tibial Nerve Stimulation)

Experimental group

Description:

Patients belonging to the group A received Transcautanoues posterior tibial nerve stimulation plus diet and Kegel exercises

Treatment:

Device: Transcutanous Posterior Tibial Nerve Stimulation

Group B (Sham Control)

Sham Comparator group

Description:

Patients belonging to the group B received Sham Transcautanoues posterior tibial nerve stimulation plus diet and Kegel exercises

Treatment:

Device: Sham Transcutanous Posterior Tibial Nerve Stimulation