Biofeedback Training Fecal Incontinence in Children

NCT04472923 | Completed

• 1 other identifier: BatterjeeMC
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fecal incontinence; Biofeedback; long-term; Children

Outcome Measures

Primary Outcomes (2)

• Number of incontinence episodes

  Change in the number of incontinence episodes

  24 months

• Incontinence Score using Vaizey incontinence score

  Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).

  24 months

Secondary Outcomes (6)

• Fecal Incontinence Quality of life Score

  24 months

• Resting pressure (mm hg)

  3 months

• Squeeze pressure (mm hg)

  3 months

• First sensation (volume of the balloon by cm water)

  3 months

• First Urge (volume of the balloon by cm water)

  3 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Patients belonging to the control group received conventional physical therapy program in the form of diet and Kegel exercises.

Procedure: Traditional Treatment

Study group

EXPERIMENTAL

Patients belonging to the study group were subjected to the same conventional physical therapy program in addition to biofeedback training

Device: Biofeedback

Interventions

Traditional Treatment PROCEDURE

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.

Also known as: Diet and exercises

Control group

Biofeedback DEVICE

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.

Study group

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age ranged from (5-14 years) with FNRFI with normal bowel habits
• Children with normal defecation frequency and normal stool consistency
• Children with incontinence score ranging from 6-24 according to Vaizey score

You may not qualify if:

• Children who have traumatic sphincter injury.
• Children who have Fecal impaction
• Children who have Spinal diseases causing incontinence
• Children who have Anorectal malformation
• Children who were not cooperative

Sponsors & Collaborators

• Batterjee Medical College: lead
• Benha University: collaborator

Study Sites (1)

Benha University

Banhā, Al Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Diet; Exercise; Biofeedback, Psychology

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Emad M Abdelrahman, M.D.

  Bnha University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Therapy

Model Details: The present study included 100 children of both sexes that were included with an age ranged from (5-14 years) with FNRFI with normal bowel habits, normal defecation frequency, and normal stool consistency with incontinence score ranging from 6-24 according to Vaizey score 12. Exclusion criteria included; children who have traumatic sphincter injury, fecal impaction, spinal diseases causing incontinence, anorectal malformation, and children who were not cooperative. Patients included in this study were randomly divided and allocated into two groups Control group and Study group. Written informed consent was obtained from parents of all included children. A detailed history was taken including bowel habits, duration history of trauma. Complete physical examination to exclude patients requiring surgical correction

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 16, 2020
• Study Start: May 5, 2018
• Primary Completion: June 4, 2020
• Study Completion: July 5, 2020
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication
• Access Criteria: Not available now

Locations

EG (1)