Biofeedback Training Fecal Incontinence in Children

NCT04472923 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2020-07-16

No results posted yet for this study

Summary

Fecal incontinence (FI) is the inability to control bowel movements, causing stool to leak from rectum it ranges from an occasional leakage of stool while passing gas to a complete loss of bowel control after the age of 4 years1. Functional non-retentive fecal incontinence (FNRFI) is fecal incontinence in a child with a mental age of more than 4 years with no evidence of metabolic, inflammatory, or anatomical cause2.

The long-term result of biofeedback therapy is one of the most important subjects of controversy, and few studies have extended to 2 years of follow-up 11. So, the purpose of this study was to evaluate quantitatively the short-term and long-term efficacy of biofeedback training as a treatment tool designed to control functional non-retentive fecal incontinence in children and its long term impact on the quality of life.

Conditions

  • Fecal Incontinence in Children

Interventions

PROCEDURE

Traditional Treatment

Patients belonging to the control group received conventional physical therapy program in the form of: 1. Dietetic Regulation: The diet was given in the form of the bulk-forming diet, fruits, vegetables, cereals, and bran. 2. Pelvic floor muscle exercises (Kegal exercises): The patient was instructed to lie crock lying position with knees bent. He/she was instructed to pull his/her pelvic muscles upward and inward and hold the contraction for 6 seconds as if to hold back a defecation movement, followed by relaxation for 6 seconds. The exercise was repeated 25 times. Gradually increase the time until reaching 10 seconds of contraction and relaxation for each with repetition up to 30 times. The exercises applied twice per week for 3 months.

DEVICE

Biofeedback

Patients belonging to the study group were subjected to the same conventional physical therapy program in addition to biofeedback training. Biofeedback was planned after full guardians' education. Local hygiene for perianal skin for soiling episodes and using zinc oxide cream to prevent excoriation. Biofeedback was done using two types of catheters; a 24-channel water-perfused catheter with latex balloon for sensory training and a double-lumen rectal PVC balloon clothed catheter (MMS U-72210) for strength training. Each biofeedback session took 30 minutes with two sessions per week for 3 months.

Sponsors & Collaborators

  • Benha University

    collaborator OTHER
  • Batterjee Medical College

    lead OTHER

Principal Investigators

  • Emad M Abdelrahman, M.D. · Bnha University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-05
Primary Completion
2020-06-04
Completion
2020-07-05

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04472923 on ClinicalTrials.gov