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

NCT04652024 | Completed

• 1 other identifier: hana4
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

CONTROL GROUP

NO INTERVENTION

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

STUDY GROUP

EXPERIMENTAL

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

Interventions

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.

STUDY GROUP

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• absent anal reflex,
• skin trifles around the anus,
• funnel shaped anus
• medically stable and able to follow instructions

You may not qualify if:

• sexual transmitted disease
• any medical condition that affect the anus potentially such as Crohn's disease,
• severe chronic constipation,
• myotonic dystrophy

Sponsors & Collaborators

• Badr University: lead

Study Sites (1)

Hanaa

Cairo, Egypt

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in the deparment of pediatrics and peditaric surgery , faculty of phyical therapy

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 3, 2020
• Study Start: November 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

EG (1)