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Completed

NCT Number: NCT02597764

Diaphragmatic Breathing as an Adjunctive Therapy in the Management of Children With Bladder and Bowel Disorders

Urination is a result of a complex neuro-muscular coordination which involves the action and arrangement of different parts of nervous systems as well as the muscular structure of the lower part of the urinary system. When there is an abnormal pattern in bladder and bowel habits without any known neuronal lesions, the condition is called bladder and bowel disorder (BBD). The symptoms can range from the feeling of rushing to the toilet, urinary accidents to urinating much less than expected during the day.

The standard treatment for most cases of BBD starts with Standard Urotherapy (SU) which is a beneficial basic and harmless form of treatment widely used for all children with BBD. SU involves explaining of the problem to the children and their parents by the doctors and educating them on proper voiding mechanisms, sitting, and standing positions as well as how and when to void.

The purpose of this study is to explore the possibility of testing the additive effectiveness of Diaphragmatic Breathing exercise (DB) as an alternative and harmless additional treatment to SU in children with BBD.

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Key information

Conditions

Bladder and Bowel Disorder, Pediatric Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BC Children's and Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children with bladder and bowel disorders (BBD) will be diagnosed by the attending pediatric urologists via a combination of thorough clinical history, physical examination, BBD Questionnaire, uroflowmetric evaluation, and voiding and stool diary.

Exclusion criteria

  • Known anatomic or neurological lower urinary tract abnormalities such as posterior urethral valve, urethral obstruction or stricture, ectopic ureters, congenital abnormalities of the spinal cord, or any previous surgery of the lower urinary tract.
  • Current use of medication or treatments which affects bladder or ANS function. These include anti-cholinergics, anti-psychotics, anti-depressants, and neuromodulators.
  • Any conditions or disorders that would affect the cardiovascular system or the activity of the ANS.
  • Serious pulmonary issues or diaphragmatic problems that would interfere with the practice of diaphragmatic breathing technique.
  • Psychological/behavioral abnormalities severe enough to prevent the cooperation of the child with the study coordinator or the urologist.
  • Inability to provide consent.
  • Inability to speak and/or understand in English.

Treatment and study plan

Diaphragmatic breathing

Behavioral

Standard urotherapy

Behavioral

Primary outcomes

  1. Proportion of participants with resolved incontinence at the end of the trial in each group (SU+DB vs. SU only).

    Time frame: 3 months

Secondary outcomes

  1. Number of withdrawals during the treatment period.

    Time frame: 3 months

  2. Number of children adhering to the diaphragmatic breathing schedule that is given to them.

    Time frame: 3 months

    This will be measured by the information obtained from the mobile application used during the study period.

  3. Treatment acceptability of the proposed intervention (diaphragmatic breathing).

    Time frame: 3 months

    This outcome will be reported based on the participants and their parents' response to the Treatment Acceptability Questionnaires.

  4. Change in High Frequency (HF) variation of HRV from baseline to end of treatment period for both study groups.

    Time frame: Baseline and 3 months

    This outcome will be measured using state-of-the-art machine for recording heart rate variability.

  5. Change in Total Power from baseline to end of treatment period for both study groups.

    Time frame: Baseline and 3 months

    This outcome will be calculated from the measurements obtained from state-of-the-art machine for recording heart rate variability.

  6. Change in heart rate from baseline to end of treatment period for both study groups.

    Time frame: Baseline and 3 months

  7. Change in Pre-ejection Period (PEP) from baseline to end of treatment period for both study groups.

    Time frame: Baseline and 3 months

    This outcome will be measured using state-of-the-art machine for recording heart rate variability.

  8. Change in BBD score from baseline to end of treatment period for both study groups.

    Time frame: Baseline and 3 months

    This outcome will be reported based on participants' response to a validated 5-point Likert scale questionnaire for diagnosing BBD.

  9. Change in Pediatric Incontinence Questionnaire (PinQ) scores from baseline to end of treatment period for both study groups.

    Time frame: Baseline and 3 months

  10. Change in average urinary flow rate (a uroflowmetry parameter) from baseline to end of treatment period for both study groups.

    Time frame: Baseline and 3 months

    Average urinary flow rate will be measured using top-notch equipment for measuring uroflowmetry parameters. Average urinary flow rate will be reported in mL/sec.

  11. Change in peak urinary flow rate (a uroflowmetry parameter) from baseline to end of treatment period for both study groups.

    Time frame: Baseline and 3 months

    Peak urinary flow rate will be measured using top-notch equipment for measuring uroflowmetry parameters. Peak urinary flow rate will be reported in mL/sec.

  12. Change in post-void residual volume from baseline to end of treatment period for both study groups.

    Time frame: Baseline and 3 months

    A hand-held ultrasound device will be used for the measurement of the post-void residual volume.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Use of Diaphragmatic Breathing (DB) in the Management of Bladder and Bowel Disorders in Children: A Pilot Randomized Trial

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 5, 2015
Registry last updated
Feb 23, 2017

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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