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

Sponsor
Badr University (Other)
Overall Status
Completed
CT.gov ID
NCT04652024
Collaborator
(none)
30
1
2
3.9
7.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Anorectal manometry
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Anorectal Biofeedback on Encopresis in School Aged Girls After Sexual Assault
Actual Study Start Date :
Nov 1, 2020
Actual Primary Completion Date :
Mar 1, 2021
Actual Study Completion Date :
Mar 1, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: CONTROL GROUP

Girls in the control group received pelvic floor muscle exercise (kegel exercise) daily in the outpatient clinic 12 weeks.

Experimental: STUDY GROUP

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

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.

Outcome Measures

Primary Outcome Measures

  1. anorectal manometrey [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 11 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hanaa Cairo Egypt

Sponsors and Collaborators

  • Badr University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
hanaa mohsen, lecturer in the deparment of pediatrics and peditaric surgery , faculty of phyical therapy, Badr University
ClinicalTrials.gov Identifier:
NCT04652024
Other Study ID Numbers:
  • hana4
First Posted:
Dec 3, 2020
Last Update Posted:
Sep 14, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2021