Biofeedback Vs Electrical Stimulation in Treatment of Fecal Incontinence

Study Overview
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Brief Summary
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Fecal incontinence is one of the most psychological frustrating problems. It occurs in children due to many causes. There is a wide range of non-invasive therapeutic approaches like Kegel exercise, Biofeedback, and posterior tibial nerve stimulation. However, up till now, there are no established guidelines for treatment. the objective of this study is to evaluate and compare the early effect of Biofeedback therapy versus bilateral transcutaneous posterior tibial nerve stimulation (TPNS) as non-invasive methods in the treatment of functional non-retentive fecal incontinence (FNRFI) in children.

Detailed Description
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Functional non-retentive fecal incontinence (FNRFI) requires prolonged treatment with a wide range of non-invasive therapeutic approaches like Kegel exercise, Biofeedback, and posterior tibial nerve stimulation (PTNS). However, up till now, there are no established guidelines for treatment.1 The aim of this study is to evaluate and compare the early effect of Biofeedback therapy versus bilateral transcutaneous posterior tibial nerve stimulation (TPTNS) as non-invasive methods in the treatment of (FNRFI) in children. Methodology: The current prospective randomized controlled study included 93 children with FNRFI who were randomly divided and allocated into three groups. Group A treated by conventional methods through dietetic regulation and Kegal exercises. Group B treated by biofeedback therapy while group C received bilateral (TPTNS). Initial manometric findings including resting pressure, squeeze pressure, 1st sensation, 1st urge, and intense urge were recorded and repeated after 3 and 6 months together with incontinence score recorded in using St' Mark's (Varizey) with the primary endpoint of improvement of the incontinence score more than 50%.

Official Title
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Biofeedback Versus Bilateral Transcutaneous Electrical Nerve Stimulation in the Treatment of Functional Non-retentive Fecal Incontinence

Conditions
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Fecal Incontinence, Encopresis, Fecal Soiling

Intervention / Treatment
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* Device: Biofeedback
* Device: Electrical stimulation
* Other: Traditional treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: FecaI incontinence Normal defecation frequency, Normal bowel habits and Normal stool consistency Exclusion Criteria: Children who are not cooperative, Children with traumatic sphincter injury, Children with fecal impaction, Children with spinal diseases causing incontinence, Children with anorectal malformation,

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The current prospective randomized controlled study included 93 children with FNRFI who were randomly divided and allocated into 3 groups. were managed by conventional methods through Kegal exercises and dietetic regulation where they had received bulky food including vegetables, fruits bran and cereals. Fast foods, spicy drinks and caffeine should be limited in child's diet. Local hygiene and zinc oxide application to the perianal skin were advised to prevent skin excoriation.Biofeedback group treated by biofeedback therapy in addition to traditional treatment, while the third group is the electrical stimulation group received bilateral (TPTNS) in addition to the traditional treatment. Initial manometric findings including resting pressure (mm hg), squeeze pressure (mm hg), 1st sensation (cm water), 1st urge (cm water), and intense urge (cm water) were recorded and repeated after 3 and 6 months together with incontinence score recorded in using St' Mark's (Varizey).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biofeedback<br>Biofeedback therapy in addition to the conventional measures done in the control Group. It was performed in the same position used for baseline manometry. The used protocol included strength and sensory training, twice weekly for 3 months. Strength training was performed by a double-lumen rectal PVC balloon clothed catheter (MMS U-72210). | Device: Biofeedback<br>* Biofeedback therapy in addition to the conventional measures done in the control Group. It was performed in the same position used for baseline manometry. The used protocol included strength and sensory training, twice weekly for 3 months. Strength training was performed by a double-lumen rectal PVC balloon clothed catheter (MMS U-72210).<br>|
| Experimental: Electrical Stimulation<br>Bilateral (TPTNS); was applied with an electrode above the medial malleolus A second electrode) was applied just below the same malleolus. Electrical stimulation with a low-frequency current (10 Hz), and adjustable intensity. The procedure was done for 20-30 minutes, three times per week for 3 months together with the conventional maneuvers applied in the control group. | Device: Electrical stimulation<br>* A positive auto adhesive electrode was applied above the medial malleolus over the S3 dermatome. A second negative electrode was applied just below the same malleolus. Both electrodes were linked to an electrical stimulation device ( EMS physio Ltd, OX129 F, England) with a low frequency current (10 Hz), and adjustable intensity.<br>* Other names: Posterior tibial nerve stimulation;|
| Active Comparator: Control group<br>were managed by conventional methods through Kegal exercises and dietetic regulation where they had received bulky food including vegetables, fruits bran and cereals. Fast foods, spicy drinks and caffeine should be limited in child's diet. Local hygiene and zinc oxide application to the perianal skin were advised to prevent skin excoriation. | Other: Traditional treatment<br>* Conventional treatment through Kegal exercises and dietetic regulation where they had received bulky food including vegetables, fruits bran and cereals. Fast foods, spicy drinks and caffeine should be limited in child's diet. Local hygiene and zinc oxide application to the perianal skin were advised to prevent skin excoriation.<br>* Other names: Exercises;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incontinence score using St' Mark's (Vaiszey) | Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence). | 3 months after intervention | 
| incontinence score using St' Mark's (Vaiszey) | Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence). | 6 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting pressure (mm hg) | Pressure during relaxation of the anal sphincter | 3 months after intervention | 
| Resting pressure (mm hg) | Pressure during relaxation of the anal sphincter | 6 months after intervention | 
| Squeeze pressure (mm hg) | Pressure during contraction of the anal sphincter | 3 months after intervention | 
| Squeeze pressure (mm hg) | Pressure during contraction of the anal sphincter | 6 months after intervention | 
| First sensation (volume of the balloon by cm water) | First sensation of the stool in the rectum | 3 months after intervention | 
| First sensation (volume of the balloon by cm water) | First sensation of the stool in the rectum | 6 months after intervention | 
| First Urge(volume of the balloon by cm water) | The patient is trying to hold defecation and he can | 3 months after intervention | 
| First Urge(volume of the balloon by cm water) | The patient is trying to hold defecation and he can | 6 months after intervention | 
| Intense urge (volume of the balloon by cm water) | The Patent can no longer control the defecation | 3 months after intervention | 
| Intense urge (volume of the balloon by cm water) | the Patent can no longer control the defecation | 6 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal incontinence, Biofeedback, Transcutaneous posterior tibial nerve stimulation, Childern