Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience

NACompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

September 1, 2017

Primary Completion Date

May 1, 2020

Study Completion Date

July 15, 2020

Conditions
Fecal Incontinence
Interventions
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

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.

Trial Locations (1)

13511

Benha University, Banhā

All Listed Sponsors
collaborator

Benha University

OTHER

lead

Batterjee Medical College

OTHER

NCT04478799 - Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience | Biotech Hunter | Biotech Hunter