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| Name | Class |
|---|---|
| El Galaa Teaching Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ES group | Experimental | receive anal electrical stimulation, pelvic floor muscles training, and behavioral therapy |
|
| Combined group | Experimental | receive animated biofeedback in combination with anal electrical stimulation and behavioral therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| behavioral therapy | Behavioral | instructions, diet and toilet modification, motivation and reinforcement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | before and after 3 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amany G Atiaa, PhD | Contact | +201100120004 | amany.atia@su.edu.eg | |
| Seham M Abd El-Moghny, PhD | Contact | +201006920495 | dr.siham@gothi.gov.eg |
| Name | Affiliation | Role |
|---|---|---|
| Rabab S Mohamed, PhD | El Galaa Teaching Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| El-Galaa Teaching Hospital | Cairo | Qalyubia Governorate | 11698 | Egypt |
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randomized comparative clinical trial
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who run the randomization process
| biofeedback | Device | animated biofeedback for pelvic floor muscles training |
|
| electrical stimulation | Device | anal electrical stimulation to stimulate pelvic floor muscles |
|
| pelvic floor muscles training | Other | exercises to reeducate pelvic floor muscles control |
|
| a weak before treatment and the last weak of treatment |
| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| D000071056 | Anorectal Malformations |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D004065 | Digestive System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D001676 | Biofeedback, Psychology |
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D030141 | Feedback, Psychological |
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
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