Comparison of the effectiveness of treatment with transcutaneous functional electrical stimulation and biofeedback in improving of functional non-retentive fecal incontinence in children
To evaluate the effects of transcutaneous functional electrical stimulation with or without biofeedback on functional non-retentive fecal incontinence in children.
Design
Forty five children with functional non-retentive fecal incontinence were enrolled in the study. Patients were randomly allocated into three equal treatment groups in a balanced randomization study using random block
sizes of 4 (ratio; 1:1).
Settings and conduct
This study was performed in the Children's Medical Center , Tehran University of Medical Sciences, Tehran, Iran
Participants/Inclusion and exclusion criteria
Participants including major eligibility criteria: Inclusion criteria including: age 5 years old or more, at least once fecal incontinence episodes per week . Exclusion criteria including: neuropathic bowel dysfunction, inflammatory bowel disease and metabolic disease.
Intervention groups
Intervention: Group 1 comprised of 15 patients who underwent transcutaneous functional electrical stimulation (20 minutes on the anal region) and pelvic floor muscles training by biofeedback for 10 treatment sessions. Group 2 comprised of 15 patients who underwent transcutaneous functional electrical stimulation (20 minutes on the anal region ) for 10 treatment sessions. Control group including 15 patients who underwent only medical treatment. All patients ( cases and controls) were evaluated at the end of treatment sessions and 6 months later by bowel habit diary and then results were compared between groups.
Main outcome variables
Primary outcome is a decrease in fecal soiling episodes per week . Secondary outcomes are changing in defecation frequency per week, stool form and pain score.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140527017876N4
Registration date:2018-03-16, 1396/12/25
Registration timing:registered_while_recruiting
Last update:2018-03-16, 1396/12/25
Update count:0
Registration date
2018-03-16, 1396/12/25
Registrant information
Name
Lida Sharifi Rad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6147 2090
Email address
l-sharifirad@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research of Tehran University of Medical Sciences
Expected recruitment start date
2018-02-04, 1396/11/15
Expected recruitment end date
2019-02-04, 1397/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of treatment with transcutaneous functional electrical stimulation and biofeedback in improving of functional non-retentive fecal incontinence in children
Public title
Effects of transcutaneous functional electrical stimulation with or without biofeedback on functional non-retentive fecal incontinence in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 5 years old or more
Presence of fecal incontinence episode at least once a week
No history of previous constipation
Patients were randomly allocated in a balanced randomization study using random block sizes of 4 (ratio; 1:1) into three equal treatment groups. A computer-generated list of random numbers was used to allocate the participants.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods st., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
14194 33151
Approval date
2018-02-03, 1396/11/14
Ethics committee reference number
IR.TUMS.CHMC.REC.1396.4427
Health conditions studied
1
Description of health condition studied
Fecal incontinence
ICD-10 code
F98.1
ICD-10 code description
Fecal incontinence
Primary outcomes
1
Description
Number of fecal incontinence episodes
Timepoint
At the end of treatment sessions and 6 months later
Method of measurement
Filling out of bowel habit diary by parents
Secondary outcomes
1
Description
Defecation frequency per week
Timepoint
At the end of treatment sessions and 6 months later
Method of measurement
Filling out a bowel habit diary by parents
2
Description
Stool form
Timepoint
At the end of treatment sessions and 6 months later
Method of measurement
Filling out a bowel habit diary by parents
3
Description
Pain
Timepoint
At the end of treatment sessions and 6 months later
Method of measurement
Pain scoring system
Intervention groups
1
Description
Children in group 1 ( n=15) underwent 10 treatment sessions, two times per week. In each session, patients underwent pelvic floor muscle exercise by biofeedback for 10 minutes and transcutanues functional electrical stimulation of anal region. Functional electrical stimulation was performed for 20 minutes with frequency of 40 Hz and hold and rest time of 3 seconds.
Category
Rehabilitation
2
Description
Children in group 2 ( n=15) underwent 10 treatment sessions, two times per week. In each session, patients underwent transcutanues functional electrical stimulation of anal region. Functional electrical stimulation was performed for 20 minutes with frequency of 40 Hz and hold and rest time of 3 seconds.
Category
Rehabilitation
3
Description
Control group: Patients in control group (n=15) only underwent medical treatment.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Lida Sharifi Rad
Street address
No. 62, Dr. Qarib St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
14194 33151
Phone
+98 21 6147 2090
Email
l-sharifirad@farabi.tums.ac
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research of Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohamma-Ali Sahraeian
Street address
6th floor, Central of Organization, Ghods St, Keshavarz Bolv.
City
Tehran
Province
Tehran
Postal code
14194 33151
Phone
+98 21 8163 3698
Email
sahraian1350@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyedeh-Sanam Ladi-Seyedian
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 62, Dr. Qarib St, Keshavarz Blvd, Children's Medical Center
City
Tehran
Province
Tehran
Postal code
14194 33151
Phone
+98 21 6147 2090
Fax
Email
ladiseyedian.sanam@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Lida Sharifi Rad
Position
Head of Physical Therapy Department
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 62, Dr. Qarib St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
14194 33151
Phone
+98 21 6147 2090
Email
l-sharifirad@farabi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyedeh-Sanam Ladi-Seyedian
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 62, Dr. Qarib’s St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
14194 33151
Phone
+98 21 6147 2090
Fax
Email
ladiseyedian.sanam@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Unrecognized individual data of patients
When the data will become available and for how long
After ending of the study
To whom data/document is available
For staff in academic institutions
Under which criteria data/document could be used
In comparison with other therapeutic methods
From where data/document is obtainable
No. 62, Dr. Qarib St, Keshavarz Blvd , Children's Medical Center, Tehran,Iran Lida Sharifi Rad
E-mail : l-sharifirad@farabi.tums.ac.ir
Telephone:982161472090
What processes are involved for a request to access data/document
The application will be sent to the project manager through the Research Vice-Chancellor of the Tehran University of Medical Sciences