Comparison of the Effect of Posterior Tibial Nerve Electrical Stimulation with Conventional Treatments on Improving the Control of Functional Retentive Fecal Incontinence in Children
To determine and compare the effect of posterior tibial nerve electrical stimulation with conventional treatments on improving the control of functional retentive fecal incontinence in children
Design
Two parallel group, Simple Randomized, Not blinded clinical trial, 30 patients
Settings and conduct
This study will be conducted voluntarily in Zahedan, at the Physiotherapy Clinic of Khatam Hospital, on children with retentive fecal incontinence. Patients will be randomly assigned to one of the routine treatment group or the posterior tibial nerve stimulation group. No blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 4 years; having at least two of the Rome IV criteria; receiving pharmacological treatment and dietary therapy for at least 3 months.
Exclusion criteria: Patient's unwillingness to receive treatment, Having organic diseases, Having a history of intestinal surgery, Having urinary incontinence concomitant with fecal incontinence.
Intervention groups
Control group: routine treatment, including a daily bowel evacuation program, pelvic floor muscle exercises, diaphragmatic breathing exercises, and dietary management; Intervention group: Posterior tibial nerve stimulation (PTNS) in addition to the routine treatment
Main outcome variables
Severity of fecal incontinence; Resting anal sphincter pressure; Maximum anal sphincter squeeze pressure; First rectal sensation; First urge to defecate; Strong urge to defecate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180714040466N10
Registration date:2026-07-09, 1405/04/18
Registration timing:prospective
Last update:2026-07-09, 1405/04/18
Update count:0
Registration date
2026-07-09, 1405/04/18
Registrant information
Name
Fateme Ghiasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 6708
Email address
f_ghiasi_p@zaums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-07-23, 1405/05/01
Expected recruitment end date
2027-05-22, 1406/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Posterior Tibial Nerve Electrical Stimulation with Conventional Treatments on Improving the Control of Functional Retentive Fecal Incontinence in Children
Public title
The effect of electrical stimulation on fecal incontinence in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 4 years
Having at least two of the Rome IV Criteria
Having been Under Drug Therapy and a Dietary Regimen for at least 3 months
Exclusion criteria:
Patient's unwillingness to continue participation
Having any Organic Disease
Having a history of Intestinal Surgery
Having Urinary Incontinence Concomitant with Fecal Incontinence
Age
From 4 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization as follows: Based on the number of patients in each group, the particular sort of treatment (the conventional treatment group and the posterior tibial nerve electrical stimulation group) is written on a piece of paper. Each paper is placed in a sealed envelope. One envelope will be chosen randomly by the therapist at the first session of the patient treatment and the patient's treatment technique is selected based on that. If any of the patients is omitted from the study, one envelope related to the excluded patient treatment group will be replaced and they will mixed again.
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
Ethics committee of Zahedan University of Medical Sciences
Street address
Dr. Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2026-05-04, 1405/02/14
Ethics committee reference number
IR.ZAUMS.REC.1405.038
Health conditions studied
1
Description of health condition studied
Functional Retentive Fecal Incontinence
ICD-10 code
R15
ICD-10 code description
Fecal incontinence
Primary outcomes
1
Description
Intensity of fecal incontinence
Timepoint
Before and after the intervention
Method of measurement
Rintala questionnaire
2
Description
Anal sphincter resting pressure
Timepoint
Before and after the intervention
Method of measurement
The pressure biofeedback
3
Description
Maximum anal sphincter squeeze pressure
Timepoint
Before and after the intervention
Method of measurement
The pressure biofeedback
4
Description
First rectal sensation
Timepoint
Before and after the intervention
Method of measurement
The pressure biofeedback
5
Description
First urge of defecate
Timepoint
Before and after the intervention
Method of measurement
The pressure biofeedback
6
Description
Strong urge to defecate
Timepoint
Before and after the intervention
Method of measurement
The pressure biofeedback
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the posterior tibial nerve stimulation group, patients will receive treatment three times per week for 8 weeks, for a total of 24 sessions. The procedure is performed with the patient lying in the supine position. The positive electrode is placed 1.5 inches above the medial malleolus, and the negative electrode is placed below the same malleolus. The current intensity is increased until flexion of the great toe and abduction of the other toes are observed, then reduced to a level at which the patient experiences only tingling or pins-and-needles sensation. Each treatment session lasts 20 minutes. Diaphragmatic breathing exercises, a daily bowel evacuation program, and adherence to a high-fiber diet will also be taught to the patients.
Category
Rehabilitation
2
Description
Control group: Patients in the routine treatment group will receive diaphragmatic breathing exercises, a daily bowel evacuation program, and adherence to a high-fiber diet three times per week for 8 weeks, for a total of 24 sessions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Al-Anbia Hospital
Full name of responsible person
Haniye Shoorooei
Street address
Khatam Ai-Anbia Hosp, Jame jam Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
haniyeh.shoorooei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Alireza Ansarifard
Street address
Dr. Hesabi Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3112 5000
Email
info@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Ghiasi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Khatam Al-Anbia Hops, Jame jam Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
f_ghiasi_p@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Ghiasi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Khatam Al-Anbia Hops, Jame jam Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
f_ghiasi_p@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Ghiasi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Khatam Al-Anbia Hops, Jame jam Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
f_ghiasi_p@zaums.ac.ir
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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