Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience
Primary Purpose
Fecal Incontinence
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Transcutanous Posterior Tibial Nerve Stimulation
Sham Transcutanous Posterior Tibial Nerve Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Fecal Incontinence focused on measuring Posterior Tibial Nerve Stimulation, Fecal Incontinence, Long Term Effect
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
Sites / Locations
- Benha University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Group A (Transcutanous Posterior Tibial Nerve Stimulation)
Group B (Sham Control)
Arm Description
Patients belonging to the group A received Transcautanoues posterior tibial nerve stimulation plus diet and Kegel exercises
Patients belonging to the group B received Sham Transcautanoues posterior tibial nerve stimulation plus diet and Kegel exercises
Outcomes
Primary Outcome Measures
Number of incontinence episodes
Change in the number of incontinence episodes
Incontinence Score using Vaizey incontinence score
Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).
Secondary Outcome Measures
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
Resting pressure (mm hg)
Pressure during relaxation of the anal sphincter
Squeeze pressure (mm hg)
Pressure during contraction of the anal sphincter
First sensation (volume of the balloon by cm water)
First sensation of the stool in the rectum
First Urge (volume of the balloon by cm water)
The patient is trying to hold defecation and he can
Full Information
NCT ID
NCT04478799
First Posted
July 16, 2020
Last Updated
July 20, 2020
Sponsor
Batterjee Medical College
Collaborators
Benha University
1. Study Identification
Unique Protocol Identification Number
NCT04478799
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
July 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Batterjee Medical College
Collaborators
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
Posterior Tibial Nerve Stimulation, Fecal Incontinence, Long Term Effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A (Transcutanous Posterior Tibial Nerve Stimulation)
Arm Type
Experimental
Arm Description
Patients belonging to the group A received Transcautanoues posterior tibial nerve stimulation plus diet and Kegel exercises
Arm Title
Group B (Sham Control)
Arm Type
Sham Comparator
Arm Description
Patients belonging to the group B received Sham Transcautanoues posterior tibial nerve stimulation plus diet and Kegel exercises
Intervention Type
Device
Intervention Name(s)
Transcutanous Posterior Tibial Nerve Stimulation
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Sham Transcutanous Posterior Tibial Nerve Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of incontinence episodes
Description
Change in the number of incontinence episodes
Time Frame
24 months
Title
Incontinence Score using Vaizey incontinence score
Description
Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Fecal Incontinence Quality of life Score
Description
Change in quality of life score measured on a scale between 1 and 4, where 1 is very affected and 4 is not affected
Time Frame
24 months
Title
Resting pressure (mm hg)
Description
Pressure during relaxation of the anal sphincter
Time Frame
3 months
Title
Squeeze pressure (mm hg)
Description
Pressure during contraction of the anal sphincter
Time Frame
3 months
Title
First sensation (volume of the balloon by cm water)
Description
First sensation of the stool in the rectum
Time Frame
3 months
Title
First Urge (volume of the balloon by cm water)
Description
The patient is trying to hold defecation and he can
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed S Kharoub, MD
Organizational Affiliation
Faculty of Medicine- Benha University
Official's Role
Study Director
Facility Information:
Facility Name
Benha University
City
Banhā
State/Province
Al Qalyubia Governorate
ZIP/Postal Code
13511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience
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