Fecal Incontinence (FI)NCT07366476
Effectiveness of Electrical Stimulation and Biofeedback on Fecal Incontinence in Children With Repaired Anorectal Malformation
A study testing behavioral therapy, biofeedback and electrical stimulation in people with Fecal Incontinence (FI) and Anorectal Malformations, run by Sinai University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Fecal Incontinence (FI), Anorectal Malformations
- What is being tested?
- behavioral therapy, biofeedback and electrical stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Aug 2026to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
El-Galaa Teaching Hospital
Cairo, Qalyubia Governorate, 11698
Rabab S Mohamed, PhD, +201146101160, Dr.RababSalaheldin@gothi.gov.eg
Seham M Abd El-Moghny, PhD, +201006920495, dr.siham@gothi.gov.eg
About this study
Official title: Effectiveness of Electrical Stimulation and Biofeedback on Fecal Incontinence in Children With Repaired Anorectal Malformation: A Comparative Randomized Clinical Trial
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.
- Conditions
- Fecal Incontinence (FI), Anorectal Malformations
- Being tested
- behavioral therapy, biofeedback, electrical stimulation, pelvic floor muscles training
- Keywords
- fecal incontinence, anorectal malformation, biofeedback, anal electrical stimulation, pelvic floor muscles training
- Medical subject headings
- Fecal Incontinence, Anorectal Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral therapyBehavioural
instructions, diet and toilet modification, motivation and reinforcement
biofeedbackDevice
animated biofeedback for pelvic floor muscles training
electrical stimulationDevice
anal electrical stimulation to stimulate pelvic floor muscles
pelvic floor muscles trainingOther
exercises to reeducate pelvic floor muscles control
| Study group | Role | What they receive |
|---|---|---|
| ES group | Experimental | receive anal electrical stimulation, pelvic floor muscles training, and behavioral therapy Receives: Behavioral: behavioral therapy; Device: electrical stimulation; Other: pelvic floor muscles training |
| Combined group | Experimental | receive animated biofeedback in combination with anal electrical stimulation and behavioral therapy Receives: Behavioral: behavioral therapy; Device: biofeedback; Device: electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: a weak before treatment and the last weak of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start3 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal Incontinence (FI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized comparative clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinai University
- Sponsor type
- University, hospital or other
- Collaborators
- El Galaa Teaching Hospital
- Responsible party
- Principal investigator, Amany Gomaa Atiaa, Sinai University
- Investigators
- Rabab S Mohamed, PhD, Principal investigator, El Galaa Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366476
- Sponsor's protocol ID
- HG000124
- Status last verified
- Aug 2026
- First submitted
- 17 Dec 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Electrical Stimulation and Biofeedback on Fecal Incontinence in Children With Repaired Anorectal Malformation: A Comparative Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07366476
- Acronym / sponsor ID
- HG000124
- Conditions
- Fecal Incontinence (FI), Anorectal Malformations
- Keywords
- fecal incontinence, anorectal malformation, biofeedback, anal electrical stimulation, pelvic floor muscles training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sinai UniversityUniversity, hospital or other
- Collaborators
- El Galaa Teaching Hospital
- Study start
- 3 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized comparative clinical trial
| Arm | Type | Receives |
|---|---|---|
| ES group | Experimental | Behavioral: behavioral therapy, Device: electrical stimulation, Other: pelvic floor muscles trainingreceive anal electrical stimulation, pelvic floor muscles training, and behavioral therapy |
| Combined group | Experimental | Behavioral: behavioral therapy, Device: biofeedback, Device: electrical stimulationreceive animated biofeedback in combination with anal electrical stimulation and behavioral therapy |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral therapyinstructions, diet and toilet modification, motivation and reinforcement | Behavioural | Combined group, ES group |
| biofeedbackanimated biofeedback for pelvic floor muscles training | Device | Combined group |
| electrical stimulationanal electrical stimulation to stimulate pelvic floor muscles | Device | Combined group, ES group |
| pelvic floor muscles trainingexercises to reeducate pelvic floor muscles control | Other | ES group |
Primary outcome
anal sphincter muscle activity
Time frame: before and after 3 months of treatment
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.
1 secondary outcome
fecal soiling frequency
Time frame: a weak before treatment and the last weak of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rabab S Mohamed, PhD principal investigator
El Galaa Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral therapy, biofeedback and electrical stimulation in people with Fecal Incontinence (FI) and Anorectal Malformations, run by Sinai University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amany G Atiaa, PhD (+201100120004, amany.atia@su.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anal sphincter muscle activity (time frame: before and after 3 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.