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Completed

NCT Number: NCT04652024

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

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.

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Key information

Age range

5 year–11 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hanaa

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anorectal manometry

Device

, 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 outcomes

  1. anorectal manometrey

    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

    measure four variables, anal squeeze and resting pressure , first sensation and maximum tolarble volume

Sponsors and collaborators

Lead sponsor

Badr University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 3, 2020
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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