Biofeedback Training Fecal Incontinence in Children
NCT04472923 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2020-07-16
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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