Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience

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

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.

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence
• Intervention / Treatment: Device: Transcutanous Posterior Tibial Nerve Stimulation; Device: Sham Transcutanous Posterior Tibial Nerve Stimulation

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 Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al Qalyubia Governorate
    • Banhā, Al Qalyubia Governorate, Egypt, 13511
      • Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A (Transcutanous Posterior Tibial Nerve Stimulation); Patients belonging to the group A received Transcautanoues posterior tibial nerve stimulation plus diet and Kegel exercises	Device: Transcutanous Posterior Tibial Nerve Stimulation; children were managed by bilateral TPTNS following the procedure described in 2006 by Queralto et al(11). A positive auto-adhesive electrode was applied 1.5 inch above the medial malleolus over the S3 dermatome. A second negative electrode was applied just below the same malleolus. Electrical stimulation device (EMS physio Ltd, OX129 F, England) was connected to both electrodes. This device delivers a low frequency current (10 Hz), and the intensity was gradually increased till flexion of the big toe or spread out of the other toes in a fan shape occurred. Then the intensity was lowered to (10 Hz) again to avoid the motor response of the toes. Intensity was determined by the child's sensitivity. The procedure was done for 20-30 minutes and repeated2 times per week for 3 months
SHAM_COMPARATOR: Group B (Sham Control); Patients belonging to the group B received Sham Transcautanoues posterior tibial nerve stimulation plus diet and Kegel exercises	Device: Sham Transcutanous Posterior Tibial Nerve Stimulation; Sham transcutaneous stimulation Patients also had twice-weekly 20-30-min sessions for 3 months. The same self-adhesive electrodes as used for group A were employed, placed in a similar position. The stimulator was briefly switched on for 30 s to induce only a minor electrical sensation in the skin, and was then turned off for the rest of the treatment. This short duration was given for only for a few seconds to avoid lower limb stimulation. Patients in all TWO groups were told that they may or may not have any perception of the electrical stimulation. Without prior knowledge of what to expect from treatment, this enabled the sham group to act as a control. In order to improve on the blinding effect of the study, the electronic display window of the stimulators was shielded from the patients in the TWO groups. All patients underwent therapy in individual screened cubicles to prevent comparison between patients of the treatment being administered.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Batterjee Medical College
• Collaborators: Benha University
• Investigators: Study Director: Mohamed S Kharoub, MD, Faculty of Medicine- Benha University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): May 1, 2020
• Study Completion (ACTUAL): July 15, 2020

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (ACTUAL): July 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Fecal Incontinence; Posterior Tibial Nerve Stimulation; Long Term Effect
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: Banha University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After Publication, investigators would like to share the data with other researchers who interested in this topic
• IPD Sharing Time Frame: After Publication
• IPD Sharing Access Criteria: Not available now
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No