Fecal Incontinence (FI)NCT07099339
Effect of Pudendal Nerve Electrical Stimulation on Fecal Incontinence in Children With Repaired Anorectal Malformation
A study testing Behavioral Therapy, Kegel Exercise and Pudendal Nerve Electrical Stimulation in people with Fecal Incontinence (FI) and Anorectal Malformations, run by Sinai University at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial aims to evaluate the effect of pudendal nerve electrical stimulation on fecal incontinence in children with repaired anorectal malformation. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Fecal Incontinence (FI), Anorectal Malformations
- What is being tested?
- Behavioral Therapy, Kegel Exercise and Pudendal Nerve 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
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Nov 2024to 3 Jun 2025
- 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children ages ranged from 6 to 9 years and complain of involuntary leakage of feces with a history of anorectal surgical repair MRI revealed the degree of muscle development "Fair/Hypoplastic" identifiable but less developed or asymmetrical muscles
- they can do minimal palpable voluntary contraction of anal sphincter muscle
- they were able to follow instructions during the testing and treatment procedures.
Who cannot join
- with severe hypoplasia or complete agenesis/absence of parts of the sphincter complex "Poor/Barely Identifiable/Absent", evidenced by MRI,
- children with post-colon surgery other than ARM, neurologic/neuropathic disorder, spinal cord lesion, sensory or hearing deficits.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
General Organization for Teaching Hospitals and Institutes
Cairo, Cairo Governorate, 11562
About this study
Official title: Effect of Pudendal Nerve Electrical Stimulation on Fecal Incontinence in Children With Repaired Anorectal Malformation: A Randomized Controlled Clinical Trial
This randomized controlled clinical trial aims to evaluate the effect of pudendal nerve electrical stimulation on fecal incontinence in children with repaired anorectal malformation. Ithe investigators are hypothesized that PNES will significantly improve continence scores, reduce the frequency of fecal incontinent episodes, and enhance the overall quality of life in this vulnerable pediatric population, thereby addressing a critical unmet need in their long-term care.
Children with repaired anorectal malformation may benefit more from combined pudendal nerve electrical stimulation with behavioral therapy and pelvic floor muscles training in improving fecal incontinence.
Read the detailed description
Anorectal malformation (ARM), commonly known as imperforate anus, represent a spectrum of congenital anomalies where the anus and rectum do not form properly during fetal development, these malformations vary widely in severity, from a simple membrane covering the anal opening to complex defects cloacal malformations involving abnormal connections (fistulas) to the urinary or genital tracts.
Fecal incontinence in this population can stem from various factors, including impaired anorectal sensation, compromised sphincter function, and abnormal bowel motility, severely impacting a child's quality of life, psychosocial development, and integration into social activities.
Current management strategies for FI in children with repaired ARM typically involve a multi-faceted approach, including dietary modifications, laxatives, enemas, and bowel management programs.
Exercises such as Kegels, where children are taught to contract and relax these muscles, are commonly employed to enhance voluntary control and improve the ability to hold stool.
The pudendal nerve plays a vital role in maintaining fecal continence by innervating the external anal sphincter EAS bilaterally by the somatic fibers of the 2nd, 3rd, and 4th sacral roots through its connections to the sacral reflex arc, contributing to rectal sensation, and coordinating pelvic floor muscle function.
All children treated by Behavioral Therapy and Kegel Exercise, and by Pudendal Nerve Electrical Stimulation for the study group.
Outcome Measures: All children were evaluated before the commencement (pretreatment) and after 3 successive months of treatment (posttreatment). The anal sphincter muscle activity peak was assessed by anal pressure sensor and bowel diary was used for tracking defecation frequency and fecal leakage episodes daily.
- Conditions
- Fecal Incontinence (FI), Anorectal Malformations
- Being tested
- Behavioral Therapy, Kegel Exercise, Pudendal Nerve Electrical Stimulation, Anal Sphincter Muscle Activity Peak, Bowel Diary Documentation
- Keywords
- Pudendal Nerve Electrical Stimulation, Fecal Incontinence, Children, Repaired, Anorectal Malformation
- 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
Also called Cognitive-Behavioral Therapy, Behavioral Modifications
Behavioral Therapy in form of: Learning and advices, Dietary modifications, Toilet pattern modification, Motivational rewarding system, and Diary documentation.
Kegel ExerciseOther
Also called Pelvic Floor Muscles Training
Kegel Exercise done by contracting and relaxing pelvic floor muscles for seconds with hold and repetitions.
Pudendal Nerve Electrical StimulationDevice
Also called Anal Electrical Stimulation, Anorectal Electrical Stimulation, Intra-anal Electrical Stimulation
Pudendal Nerve Electrical Stimulation applied bilateral to the right and left pudendal by inserting rectal stimulator electrode anally with the other surface electrode at sacral region.
Anal Sphincter Muscle Activity PeakDiagnostic test
Also called Pelvic Floor Muscles Activity, Anorectal Manometer
Anal Sphincter Muscle Activity Peak was evaluated using anal pressure sensor (in mmHg) = anal squeeze pressure during maximum voluntary contraction - resting anal pressure at rest or resting tone as baseline activity
Bowel Diary DocumentationDiagnostic test
Defecation Frequency and Fecal Leakage Episodes collected from the Bowel Diary that documenting bowel events daily through a period of time "a week".
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Control Group children treated by Behavioral Therapy and Kegel Exercise, evaluated by assessing Anal Sphincter Muscle Activity Peak by anal pressure sensor and tracking Defecation Frequency and Fecal Leakage Episodes from the bowel diary. Receives: Behavioral: Behavioral Therapy; Other: Kegel Exercise; Diagnostic Test: Anal Sphincter Muscle Activity Peak; Diagnostic Test: Bowel Diary Documentation |
| Study Group | Experimental | Study Group children treated by Behavioral Therapy, Kegel Exercise, and Pudendal Nerve Electrical Stimulation, evaluated by assessing Anal Sphincter Muscle Activity Peak by anal pressure sensor and tracking Defecation Frequency and Fecal Leakage Episodes from the bowel diary. Receives: Behavioral: Behavioral Therapy; Other: Kegel Exercise; Device: Pudendal Nerve Electrical Stimulation; Diagnostic Test: Anal Sphincter Muscle Activity Peak; Diagnostic Test: Bowel Diary Documentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anal Sphincter Muscles Activity Peak
Anal Sphincter Muscle Activity Peak was evaluated using anal pressure sensor (in mmHg) = anal squeeze pressure during maximum voluntary contraction - resting anal pressure at rest or resting tone as baseline activity.
Measured: Baseline and after three months
Secondary outcomes (2)
Defecation Frequency
Defecation Frequency collected from the bowel diary that documenting bowel events daily through a period of time "a week".
Measured: Baseline and after three months
Fecal Leakage Episodes
Fecal Leakage Episodes collected from the bowel diary that documenting bowel events daily through a period of time "a week".
Measured: Baseline and after three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start2 Nov 2024
- Primary completion20 Mar 2025
- Study completion3 Jun 2025
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 Controlled Clinical Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinai University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Endocrinology, Egypt, El Galaa Teaching Hospital, Benha Children Hospital, Benha University
- Responsible party
- Principal investigator, Amany Gomaa Atiaa, Sinai University
- Investigators
- GOTHI, Study chair, National Institute for Teaching Hospitals and Institutes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099339
- Sponsor's protocol ID
- HB000145
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pudendal Nerve Electrical Stimulation on Fecal Incontinence in Children With Repaired Anorectal Malformation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07099339
- Acronym / sponsor ID
- HB000145
- Conditions
- Fecal Incontinence (FI), Anorectal Malformations
- Keywords
- Pudendal Nerve Electrical Stimulation, Fecal Incontinence, Children, Repaired, Anorectal Malformation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Sinai UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Endocrinology, Egypt, El Galaa Teaching Hospital, Benha Children Hospital, Benha University
- Study start
- 2 Nov 2024 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 1 Aug 2025 (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 randomized controlled clinical trial aims to evaluate the effect of pudendal nerve electrical stimulation on fecal incontinence in children with repaired anorectal malformation. Ithe investigators are hypothesized that PNES will significantly improve continence scores, reduce the frequency of fecal incontinent episodes, and enhance the overall quality of life in this vulnerable pediatric population, thereby addressing a critical unmet need in their long-term care.
Children with repaired anorectal malformation may benefit more from combined pudendal nerve electrical stimulation with behavioral therapy and pelvic floor muscles training in improving fecal incontinence.
Detailed description
Anorectal malformation (ARM), commonly known as imperforate anus, represent a spectrum of congenital anomalies where the anus and rectum do not form properly during fetal development, these malformations vary widely in severity, from a simple membrane covering the anal opening to complex defects cloacal malformations involving abnormal connections (fistulas) to the urinary or genital tracts.
Fecal incontinence in this population can stem from various factors, including impaired anorectal sensation, compromised sphincter function, and abnormal bowel motility, severely impacting a child's quality of life, psychosocial development, and integration into social activities.
Current management strategies for FI in children with repaired ARM typically involve a multi-faceted approach, including dietary modifications, laxatives, enemas, and bowel management programs.
Exercises such as Kegels, where children are taught to contract and relax these muscles, are commonly employed to enhance voluntary control and improve the ability to hold stool.
The pudendal nerve plays a vital role in maintaining fecal continence by innervating the external anal sphincter EAS bilaterally by the somatic fibers of the 2nd, 3rd, and 4th sacral roots through its connections to the sacral reflex arc, contributing to rectal sensation, and coordinating pelvic floor muscle function.
All children treated by Behavioral Therapy and Kegel Exercise, and by Pudendal Nerve Electrical Stimulation for the study group.
Outcome Measures: All children were evaluated before the commencement (pretreatment) and after 3 successive months of treatment (posttreatment). The anal sphincter muscle activity peak was assessed by anal pressure sensor and bowel diary was used for tracking defecation frequency and fecal leakage episodes daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Behavioral: Behavioral Therapy, Other: Kegel Exercise, Diagnostic Test: Anal Sphincter Muscle Activity Peak, Diagnostic Test: Bowel Diary DocumentationControl Group children treated by Behavioral Therapy and Kegel Exercise, evaluated by assessing Anal Sphincter Muscle Activity Peak by anal pressure sensor and tracking Defecation Frequency and Fecal Leakage Episodes from the bowel diary. |
| Study Group | Experimental | Behavioral: Behavioral Therapy, Other: Kegel Exercise, Device: Pudendal Nerve Electrical Stimulation, Diagnostic Test: Anal Sphincter Muscle Activity Peak, Diagnostic Test: Bowel Diary DocumentationStudy Group children treated by Behavioral Therapy, Kegel Exercise, and Pudendal Nerve Electrical Stimulation, evaluated by assessing Anal Sphincter Muscle Activity Peak by anal pressure sensor and tracking Defecation Frequency and Fecal Leakage Episodes from the bowel diary. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children ages ranged from 6 to 9 years and complain of involuntary leakage of feces with a history of anorectal surgical repair MRI revealed the degree of muscle development "Fair/Hypoplastic" identifiable but less developed or asymmetrical muscles
- they can do minimal palpable voluntary contraction of anal sphincter muscle
- they were able to follow instructions during the testing and treatment procedures.
Key exclusion criteria (2 listed)
- with severe hypoplasia or complete agenesis/absence of parts of the sphincter complex "Poor/Barely Identifiable/Absent", evidenced by MRI,
- children with post-colon surgery other than ARM, neurologic/neuropathic disorder, spinal cord lesion, sensory or hearing deficits.
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 TherapyAlso: Cognitive-Behavioral Therapy, Behavioral ModificationsBehavioral Therapy in form of: Learning and advices, Dietary modifications, Toilet pattern modification, Motivational rewarding system, and Diary documentation. | Behavioural | Control Group, Study Group |
| Kegel ExerciseAlso: Pelvic Floor Muscles TrainingKegel Exercise done by contracting and relaxing pelvic floor muscles for seconds with hold and repetitions. | Other | Control Group, Study Group |
| Pudendal Nerve Electrical StimulationAlso: Anal Electrical Stimulation, Anorectal Electrical Stimulation, Intra-anal Electrical StimulationPudendal Nerve Electrical Stimulation applied bilateral to the right and left pudendal by inserting rectal stimulator electrode anally with the other surface electrode at sacral region. | Device | Study Group |
| Anal Sphincter Muscle Activity PeakAlso: Pelvic Floor Muscles Activity, Anorectal ManometerAnal Sphincter Muscle Activity Peak was evaluated using anal pressure sensor (in mmHg) = anal squeeze pressure during maximum voluntary contraction - resting anal pressure at rest or resting tone as baseline activity | Diagnostic test | Control Group, Study Group |
| Bowel Diary DocumentationDefecation Frequency and Fecal Leakage Episodes collected from the Bowel Diary that documenting bowel events daily through a period of time "a week". | Diagnostic test | Control Group, Study Group |
Primary outcome
Anal Sphincter Muscles Activity Peak
Time frame: Baseline and after three months
Anal Sphincter Muscle Activity Peak was evaluated using anal pressure sensor (in mmHg) = anal squeeze pressure during maximum voluntary contraction - resting anal pressure at rest or resting tone as baseline activity.
2 secondary outcomes
Defecation Frequency
Time frame: Baseline and after three months
Fecal Leakage Episodes
Time frame: Baseline and after three months
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 Aug 2025.
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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.
GOTHI study chair
National Institute for Teaching Hospitals and Institutes
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, Kegel Exercise and Pudendal Nerve 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 3 inclusion and 2 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 Aug 2025. 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?
Anal Sphincter Muscles Activity Peak (time frame: Baseline and after three months). 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 Aug 2025.