Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04478799
• Other study ID #: Banha University
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: July 15, 2020

Study information

• Verified date: July 2020
• Source: Batterjee Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 15, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

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 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.

Locations

Country	Name	City	State
Egypt	Benha University	Banha	Al Qalyubia Governorate

Sponsors (2)

Lead Sponsor	Collaborator
Batterjee Medical College	Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of incontinence episodes	Change in the number of incontinence episodes	24 months
Primary	Incontinence Score using Vaizey incontinence score	Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).	24 months
Secondary	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
Secondary	Resting pressure (mm hg)	Pressure during relaxation of the anal sphincter	3 months
Secondary	Squeeze pressure (mm hg)	Pressure during contraction of the anal sphincter	3 months
Secondary	First sensation (volume of the balloon by cm water)	First sensation of the stool in the rectum	3 months
Secondary	First Urge (volume of the balloon by cm water)	The patient is trying to hold defecation and he can	3 months