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Not yet recruitingNCT07366476Updated Aug 4, 2026

Effectiveness of Electrical Stimulation and Biofeedback on Fecal Incontinence in Children With Repaired Anorectal Malformation

An interventional study of behavioral therapy and biofeedback in Fecal Incontinence (FI) and Anorectal Malformations, sponsored by Sinai University. Not yet recruiting at 1 site in Egypt. Open to participants aged 6 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by Sinai University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
6 Years to 10 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Fecal Incontinence with a site in Egypt — 4 open to participants now, 4 under way, none of them phase 3. Fecal Incontinence · Egypt.

Planned enrollment
7th of 12
30 · median 35
Started
2026
with 1 other
No phase
11 of 12
4 open now
Registered
11th of 12
by date
Lead sponsor
2 of 12
Sinai University

Among the 12 studies in Fecal Incontinence with a site in Egypt, this one is the 7th largest by planned enrollment, is one of 2 that started in 2026, is one of 11 with no phase, and was the 11th registered.

Fecal Incontinence

283 studies on the registry are indexed under Fecal Incontinence; 52 are open to participants now.

Browse Fecal Incontinence studies →

Open to participants now

4 of the 12 studies in Fecal Incontinence with a site in Egypt are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 38 Fecal Incontinence studies recruiting now, 25 (66%) set no upper age limit and 9 (24%) stop at 75 or younger; 6 take children under 18; 3 take healthy volunteers.

This study: 6 Years to 10 Years · all sexes · no healthy volunteers.

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02

Study summary

This study aimed to investigate and compare the effect of electrical stimulation and biofeedback with electrical stimulation alone on fecal incontinence in children with repaired imperforate anus, with ages from 6 to 10 years.

Read the detailed description

A comparative, randomized, clinical trial regarding children who complain of fecal incontinence after operative repair of imperforate anus, to evaluate the effect of biofeedback assisted pelvic floor muscles training through animated games combined with anal electrical stimulation and anal electrical stimulation with pelvic floor muscles training through measuring anal muscles activity and implementing a bowel diary.

03

Conditions studied

  • Fecal Incontinence (FI)
  • Anorectal Malformations

Keywords

  • fecal incontinence
  • anorectal malformation
  • biofeedback
  • anal electrical stimulation
  • pelvic floor muscles training
04

Who can participate

Ages eligible
6 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • children with repaired anorectal malformation
  • evident spared anal sphincter muscles by MRI
  • the age range from 6 to 10 years
  • able to follow instructions
  • Faecal symptoms will be evaluated for a month to confirm study eligibility.

Exclusion criteria

Exclusion Criteria:

  • children with absent anal sphincter muscles by MRI
  • children with post-colon surgery other than ARM
  • neurologic/neuropathic disorder
  • sensory or hearing deficits
  • psychological disturbances.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    ES group

    receive anal electrical stimulation, pelvic floor muscles training, and behavioral therapy

    Behavioral: behavioral therapy · Device: electrical stimulation · Other: pelvic floor muscles training

  • Experimental
    Combined group

    receive animated biofeedback in combination with anal electrical stimulation and behavioral therapy

    Behavioral: behavioral therapy · Device: biofeedback · Device: electrical stimulation

Interventions

  • Behavioralbehavioral therapy

    instructions, diet and toilet modification, motivation and reinforcement

  • Devicebiofeedback

    animated biofeedback for pelvic floor muscles training

  • Deviceelectrical stimulation

    anal electrical stimulation to stimulate pelvic floor muscles

  • Otherpelvic floor muscles training

    exercises to reeducate pelvic floor muscles control

06

What researchers measure

Primary outcomes

  1. anal sphincter muscle activity

    The anal sphincter muscles, comprising the internal and external sphincters, play a critical role in maintaining continence and regulating the release of feces. In the context of fecal incontinence in children with repaired anorectal malformation, the activity of these muscles is crucial for understanding their functional restoration post-surgery. Electrical stimulation and biofeedback therapies aim to enhance the tone and coordination of these muscles, improving their ability to control defecation. By assessing the activity of the anal sphincter muscles through method like pressure measurement, the study will determine how these interventions influence muscle function and whether they contribute to a reduction in fecal incontinence episodes. The analysis of sphincter muscle activity is key in evaluating the effectiveness of these therapies in strengthening the muscles and improving overall bowel control.

    Time frame: before and after 3 months of treatment

Secondary outcomes

  1. fecal soiling frequency

    Fecal soiling refers to the involuntary leakage of small amounts of stool or mucus, which can result in stains or marks on clothing or bedding. This condition is often associated with fecal incontinence, where individuals are unable to control the release of stool. Fecal soiling frequency refers to how often these incidents occur within a given timeframe, typically measured over a day, week, or month. The frequency of fecal soiling can vary significantly from one individual to another, depending on the severity of incontinence, the functionality of the anal sphincters, and other factors such as diet, bowel habits, and the effectiveness of any treatments or interventions. It is often used as a key indicator in clinical studies to assess the effectiveness of treatments for fecal incontinence, such as biofeedback, electrical stimulation, or pelvic floor rehabilitation. Tracking fecal soiling frequency helps clinicians understand the patient's condition, determine the severity of their

    Time frame: a weak before treatment and the last weak of treatment

07

Study locations

1 site
  • El-Galaa Teaching Hospital
    Cairo, Qalyubia Governorate 11698, Egypt
    • Rabab S Mohamed, PhD · ContactDr.RababSalaheldin@gothi.gov.eg · +201146101160
    • Seham M Abd El-Moghny, PhD · Contactdr.siham@gothi.gov.eg · +201006920495
    • Seham M Abd El-Moghny, PhD · Sub investigator
    • Rabab S Mohamed, PhD · Principal investigator
    • Amany G Atiaa, PhD · Sub investigator
    • Mohamed I Elsepaee, PhD · Sub investigator
    • Mohammad A Seada, PhD · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Aug 2027, 11 months later.

Of 70 non-industry interventional studies with no phase under Fecal Incontinence, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 57. This study's planned 11 months is below that.

Counting every sponsor, half of 86 studies reached it within 36 months; a quarter within 20 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 17, 2025
First posted
Jan 26, 2026
StartEst.
Aug 3, 2026
Primary completionEst.
Aug 1, 2027
CompletionEst.
Nov 1, 2027
Last update
Aug 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07366476
Lead sponsor
Sinai University
Collaborators
El Galaa Teaching Hospital
Responsible party
Amany Gomaa Atiaa (Lecturer, Sinai University) — Principal investigator
First posted
Jan 26, 2026
Start date
Aug 3, 2026 (estimated)
Primary completion
Aug 1, 2027 (estimated)
Completion
Nov 1, 2027 (estimated)
Last update
Aug 4, 2026

Study contacts

Amany G Atiaa, PhD
Contact
amany.atia@su.edu.eg
+201100120004
Seham M Abd El-Moghny, PhD
Contact
dr.siham@gothi.gov.eg
+201006920495
Rabab S Mohamed, PhD
principal investigator · El Galaa Teaching Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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