Clinical trial NCT04478799: Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience
Official title: Long Term Outcome of Transcutaneous Posterior Tibial Nerve Stimulation in Treatment of Functional Non-Retentive Fecal Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Keywords: Posterior Tibial Nerve Stimulation
Fecal Incontinence
Long Term Effect
Lead sponsor: Batterjee Medical College
Sponsor class: OTHER
Collaborators: name: Benha University
First posted: 2020-07-21
Enrollment: 102
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The current single-blind randomized controlled study included 102 children with FNRF who were randomly allocated into two groups. Group 1, Bilateral transcutaneous posterior tibial nerve stimulation and group B, Sham TPTNS. Inclusion criteria included those with FI and normal defecation frequency, normal bowel habits and stool consistency. Children younger than 4 years or those who are not cooperative, or those with traumatic sphincter injury, fecal impaction, spinal diseases causing incontinence, anorectal malformation, were excluded from the study.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of incontinence episodes
timeFrame: 24 months
measure: Incontinence Score using Vaizey incontinence score
timeFrame: 24 months
Secondary outcomes:
measure: Fecal Incontinence Quality of life Score
timeFrame: 24 months
measure: Resting pressure (mm hg)
timeFrame: 3 months
measure: Squeeze pressure (mm hg)
timeFrame: 3 months
measure: First sensation (volume of the balloon by cm water)
timeFrame: 3 months
measure: First Urge (volume of the balloon by cm water)
timeFrame: 3 months
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University
state: Al Qalyubia Governorate
Study officials:
affiliation: faculty of medicine, Benha university
name: Mohamed S Kharoub, MD
role: STUDY_DIRECTOR
References: