Effect of Anorectal Biofeedback on Encopresis in School Aged Girls After Sexual Assault
Primary Purpose
Fecal Incontinence
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Anorectal manometry
Sponsored by
About this trial
This is an interventional treatment trial for Fecal Incontinence
Eligibility Criteria
Inclusion Criteria:
- absent anal reflex,
- skin trifles around the anus,
- funnel shaped anus
- medically stable and able to follow instructions
Exclusion Criteria:
- sexual transmitted disease
- any medical condition that affect the anus potentially such as Crohn's disease,
- severe chronic constipation,
- myotonic dystrophy
Sites / Locations
- Hanaa
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
CONTROL GROUP
STUDY GROUP
Arm Description
Girls in the control group received pelvic floor muscle exercise (kegel exercise) daily in the outpatient clinic 12 weeks.
Girls in the study group received the same physical therapy program given to the control group in addition to anorectal biofeedback for six sessions per week. in addition to kegel exercise
Outcomes
Primary Outcome Measures
anorectal manometrey
measure four variables, anal squeeze and resting pressure , first sensation and maximum tolarble volume
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04652024
Brief Title
Effect of Anorectal Biofeedback on Encopresis in School Aged Girls After Sexual Assault
Official Title
Effect of Anorectal Biofeedback on Encopresis in School Aged Girls After Sexual Assault
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Badr University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Females who have been sexually abused anally, have a disturbed anorectal motility. They have an increased resting pressure at the lower part of the anal canal. When their rectum is suddenly distended, they tend not to have an initially increased pressure in the anal canal, and the recto-anal inhibitory reflex is markedly decreased amplitude which is caused by reflex contraction of the pelvic floor during the relaxation of the internal anal sphincter.
Detailed Description
The cause of fecal incontinence after sexual abuse is the improper functioning of anal sphincter muscles, as a result of their damage and/or neurological changes including the disturbance perception of sensory stimuli from the anal canal. Biofeedback therapy using visual and verbal feedback techniques has emerged as an useful option in managing fecal incontinence and levator ani syndrome. The goal of biofeedback training is to improve bowel function by restoring a normal pattern of defecation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CONTROL GROUP
Arm Type
No Intervention
Arm Description
Girls in the control group received pelvic floor muscle exercise (kegel exercise) daily in the outpatient clinic 12 weeks.
Arm Title
STUDY GROUP
Arm Type
Experimental
Arm Description
Girls in the study group received the same physical therapy program given to the control group in addition to anorectal biofeedback for six sessions per week. in addition to kegel exercise
Intervention Type
Device
Intervention Name(s)
Anorectal manometry
Intervention Description
, patients are instructed to isolate the anal sphincter and puborectalis muscles and improve its strength by using modified Kegel exercises in lying position with a probe in situ. Visual and verbal feedback techniques are used to reinforce the maneuvers, as they are being performed. The anal and rectal pressure changes displayed on the monitor provides visual feedback to the patient.
Primary Outcome Measure Information:
Title
anorectal manometrey
Description
measure four variables, anal squeeze and resting pressure , first sensation and maximum tolarble volume
Time Frame
pre and after 3 months of intervention, increase in the change in the mean of initial parameters of the anal and squeeze pressure indicate improvement while decreases in the mean of first sensation and maximum tolerable volume indicate improvement
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
absent anal reflex,
skin trifles around the anus,
funnel shaped anus
medically stable and able to follow instructions
Exclusion Criteria:
sexual transmitted disease
any medical condition that affect the anus potentially such as Crohn's disease,
severe chronic constipation,
myotonic dystrophy
Facility Information:
Facility Name
Hanaa
City
Cairo
Country
Egypt
12. IPD Sharing Statement
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Effect of Anorectal Biofeedback on Encopresis in School Aged Girls After Sexual Assault
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