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

NCT ID: NCT04652024

Last Updated: 2021-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-03-01

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.

Conditions

Fecal Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CONTROL GROUP

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Anorectal manometry

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Badr University

OTHER

Sponsor Role: lead

Responsible Party

hanaa mohsen

lecturer in the deparment of pediatrics and peditaric surgery , faculty of phyical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hanaa

Cairo, , Egypt

Countries

Egypt

Other Identifiers

hana4

Identifier Type: -

Identifier Source: org_study_id