Fecal Incontinence (FI), Anorectal Malformations
Conditions
Keywords
fecal incontinence, anorectal malformation, biofeedback, anal electrical stimulation, pelvic floor muscles training
Brief 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.
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.
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
exercises to reeducate pelvic floor muscles control
Sponsors
Sinai University
El Galaa Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
who run the randomization process
Intervention model description
randomized comparative clinical trial
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
No
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| anal sphincter muscle activity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fecal soiling frequency | a weak before treatment and the last weak of treatment | 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 |
Countries
Egypt
Contacts
CONTACTAmany G Atiaa, PhD
CONTACTSeham M Abd El-Moghny, PhD
PRINCIPAL_INVESTIGATORRabab S Mohamed, PhD
El Galaa Teaching Hospital
Outcome results
None listed