Fecal Incontinence in ChildrenNCT06053879
Biofeedback Intervention in Rehabilitation of Adolescence With Posterior Sagittal Anorectoplasty
A study testing Biofeedback electrical stimulation in people with Fecal Incontinence in Children, run by Badr University at 1 site in Egypt.
Trial summary
most of children undergo Posterior Sagittal Anorectoplasty Complain from faecal incontinence and faecal soiling which negatively impacts the social life of these children prohibiting their participation with their bears. Read more about this study
- Who is it for?
- Ages 10 to 13 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fecal Incontinence in Children
- What is being tested?
- Biofeedback electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2023to 5 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 13 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Age from 10-13 years old
- Reliable females
- Able to understand verbal commands
- Normal vision and hearing
Who cannot join
- Neuromuscular or musculoskeletal disorders
- Behavioural disorders
- Psychological disorders
Trial locations and contacts
1 site in 1 country.
About this study
most of children undergo Posterior Sagittal Anorectoplasty Complain from faecal incontinence and faecal soiling which negatively impacts the social life of these children prohibiting their participation with their bears.
Read the detailed description
most of children undergo Posterior Sagittal Anorectoplasty Complain from faecal incontinence and faecal soiling which negatively impacts the social life of these children prohibiting their participation with their bears so this study aims prevent faecal incontinence so continue life time without any interference with social life and activities
- Conditions
- Fecal Incontinence in Children
- Being tested
- Biofeedback electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback electrical stimulationOther
Also called Biofeedback
biofeedback stimulation for faecal incontinence post Posterior Sagittal Anorectoplasty
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback electrical stimulation | Experimental | Biofeedback electrical stimulation Receives: Other: Biofeedback electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG biofeedback assessment for contraction of anus and puborectalis muscle
EMG biofeedback assessment for degree ofanal contraction in cases with faecal incontinence post Posterior Sagittal Anorectoplasty
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start10 May 2023
- Primary completion5 Sep 2023
- Study completion5 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal Incontinence in ChildrenStudies 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
- Not applicable
- Intervention model
- Sequential
- Model description
- pretest post test
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Ahmed Fouad Abd-Elrahman, Badr University
- Investigators
- Reham A Elkalla, PHD, Principal investigator, Lecturer of PT for surgery and burnMostafa S Ali, PHD, Principal investigator, Ass.Prof. of PT for paediatricRadwa S Mahmoud, PHD, Principal investigator, Ass.Prof. of PT for paediatricNoha A Abd el rahman, PHD, Principal investigator, lecturer of PT for women health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053879
- Sponsor's protocol ID
- BUC-IACUC-230507-20
- Status last verified
- Apr 2024
- First submitted
- 11 Sep 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofeedback Intervention in Rehabilitation of Adolescence With Posterior Sagittal Anorectoplasty
- ClinicalTrials.gov ID
- NCT06053879
- Acronym / sponsor ID
- BUC-IACUC-230507-20
- Conditions
- Fecal Incontinence in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 26 Sep 2023 (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.
most of children undergo Posterior Sagittal Anorectoplasty Complain from faecal incontinence and faecal soiling which negatively impacts the social life of these children prohibiting their participation with their bears.
Detailed description
most of children undergo Posterior Sagittal Anorectoplasty Complain from faecal incontinence and faecal soiling which negatively impacts the social life of these children prohibiting their participation with their bears so this study aims prevent faecal incontinence so continue life time without any interference with social life and activities
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pretest post test
| Arm | Type | Receives |
|---|---|---|
| Biofeedback electrical stimulation | Experimental | Other: Biofeedback electrical stimulationBiofeedback electrical stimulation |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age from 10-13 years old
- Reliable females
- Able to understand verbal commands
- Normal vision and hearing
Key exclusion criteria (3 listed)
- Neuromuscular or musculoskeletal disorders
- Behavioural disorders
- Psychological disorders
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 |
|---|---|---|
| Biofeedback electrical stimulationAlso: Biofeedbackbiofeedback stimulation for faecal incontinence post Posterior Sagittal Anorectoplasty | Other | Biofeedback electrical stimulation |
Primary outcome
EMG biofeedback assessment for contraction of anus and puborectalis muscle
Time frame: 12 weeks
EMG biofeedback assessment for degree ofanal contraction in cases with faecal incontinence post Posterior Sagittal Anorectoplasty
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Reham A Elkalla, PHD principal investigator
Lecturer of PT for surgery and burn
Mostafa S Ali, PHD principal investigator
Ass.Prof. of PT for paediatric
Radwa S Mahmoud, PHD principal investigator
Ass.Prof. of PT for paediatric
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback electrical stimulation in people with Fecal Incontinence in Children, run by Badr 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 17 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EMG biofeedback assessment for contraction of anus and puborectalis muscle (time frame: 12 weeks). 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 17 Apr 2024.