Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience

NCT04478799 | Completed

• 1 other identifier: Banha University
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Fecal Incontinence

Keywords

Posterior Tibial Nerve Stimulation; Fecal Incontinence; Long Term Effect

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Fecal Incontinence Quality of life Score

  24 months

• Resting pressure (mm hg)

  3 months

• Squeeze pressure (mm hg)

  3 months

• First sensation (volume of the balloon by cm water)

  3 months

• First Urge (volume of the balloon by cm water)

  3 months

Study Arms (2)

Group A (Transcutanous Posterior Tibial Nerve Stimulation)

EXPERIMENTAL

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

Device: Transcutanous Posterior Tibial Nerve Stimulation

Group B (Sham Control)

SHAM COMPARATOR

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

Interventions

Transcutanous Posterior Tibial Nerve Stimulation DEVICE

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

Group A (Transcutanous Posterior Tibial Nerve Stimulation)

Sham Transcutanous Posterior Tibial Nerve Stimulation DEVICE

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.

Group B (Sham Control)

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Batterjee Medical College: lead
• Benha University: collaborator

Study Sites (1)

Benha University

Banhā, Al Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Mohamed S Kharoub, MD

  faculty of medicine, Benha university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 21, 2020
• Study Start: September 1, 2017
• Primary Completion: May 1, 2020
• Study Completion: July 15, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After Publication
• Access Criteria: Not available now

Locations

EG (1)