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Completed

NCT Number: NCT04472923

Biofeedback Training Fecal Incontinence in Children

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.

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Key information

Conditions

Fecal Incontinence in Children Digestive System Diseases Fecal Incontinence Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

5 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University

Banhā, Al Qalyubia Governorate, 13511, Egypt

About this study

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.

It is an extremely embarrassing and psychologically frustrating shameful problem with a bad impact on children3. It can lead to social isolation, loss of self-confidence, depression, and behavioral problems4. The underlying mechanism of functional non-retentive fecal incontinence is largely unknown. The pathophysiology seems to be complex and it is considered to be a multifactorial disorder5. Approximately 95% of the children had no organic cause and these children are considered to have a functional defecation disorder. Of this, in approximately 80% of these children FI is results of constipation and is treated with laxatives, the remaining 20% without signs of fecal retention is classified as FNRFI6 The negative psychological and social impact for these children is high, however, and requires adequate intervention7. Biofeedback therapy is a feasible option that has been used for fecal incontinence over several decades8. The underlying premise of biofeedback, as with learning any physical activity, is that "practice makes perfect" if the learner is provided with accurate feedback to make adjustments to optimize performance 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.

Methods:

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Traditional treatment

Procedure

Patients belonging to the control group received conventional physical therapy program in the form of:

  • Dietetic Regulation: The diet was given in the form of the bulk-forming diet, fruits, vegetables, cereals, and bran.
  • 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.

Other names: Diet and exercises

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.

Primary outcomes

  1. Number of incontinence episodes

    Time frame: 24 months

    Change in the number of incontinence episodes

  2. Incontinence Score using Vaizey incontinence score

    Time frame: 24 months

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

Secondary outcomes

  1. Fecal Incontinence Quality of life Score

    Time frame: 24 months

    Change in quality of life score measured on a scale between 1 and 4, where 1 is very affected and 4 is not affected

  2. Resting pressure (mm hg)

    Time frame: 3 months

    Pressure during relaxation of the anal sphincter

  3. Squeeze pressure (mm hg)

    Time frame: 3 months

    Pressure during contraction of the anal sphincter

  4. First sensation (volume of the balloon by cm water)

    Time frame: 3 months

    First sensation of the stool in the rectum

  5. First Urge (volume of the balloon by cm water)

    Time frame: 3 months

    The patient is trying to hold defecation and he can

  6. Intense urge (volume of the balloon by cm water)

    Time frame: 3 months

    The Patent can no longer control the defecation

Sponsors and collaborators

Lead sponsor

Batterjee Medical College

Other

Collaborators

  • Benha University

Registry information

Official study title

Effect of Biofeedback Training on Functional Non-Retentive Fecal Incontinence in Children

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 16, 2020
Registry last updated
Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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