Effect of Anorectal Biofeedback on Encopresis in School Aged Girls After Sexual Assault

Fecal Incontinence Clinical Trial

Official title:

Effect of Anorectal Biofeedback on Encopresis in School Aged Girls After Sexual Assault

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04652024
• Other study ID #: hana4
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: September 2021
• Source: Badr University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 5 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Encopresis
• Fecal Incontinence

Intervention

Device:
• Anorectal manometry
, 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.

Locations

Country	Name	City	State
Egypt	Hanaa	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Badr University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anorectal manometrey	measure four variables, anal squeeze and resting pressure , first sensation and maximum tolarble volume	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