Clinical trial NCT02597764: Diaphragmatic Breathing as an Adjunctive Therapy in the Management of Children With Bladder and Bowel Disorders
Official title: Use of Diaphragmatic Breathing (DB) in the Management of Bladder and Bowel Disorders in Children: A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder and Bowel Disorder, Pediatric
Keywords: Diaphragmatic breathing (DB)
Bladder and bowel disorders (BBD)
Autonomic nervous system (ANS)
Heart rate variability (HRV)
Deep breathing
Randomized controlled trial (RCT)
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 23
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 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:

1. 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.
2. Current use of medication or treatments which affects bladder or ANS function. These include anti-cholinergics, anti-psychotics, anti-depressants, and neuromodulators.
3. Any conditions or disorders that would affect the cardiovascular system or the activity of the ANS.
4. Serious pulmonary issues or diaphragmatic problems that would interfere with the practice of diaphragmatic breathing technique.
5. Psychological/behavioral abnormalities severe enough to prevent the cooperation of the child with the study coordinator or the urologist.
6. Inability to provide consent.
7. Inability to speak and/or understand in English.

Primary outcomes:
measure: Proportion of participants with resolved incontinence at the end of the trial in each group (SU+DB vs. SU only).
timeFrame: 3 months
Secondary outcomes:
measure: Number of withdrawals during the treatment period.
timeFrame: 3 months
measure: Number of children adhering to the diaphragmatic breathing schedule that is given to them.
timeFrame: 3 months
measure: Treatment acceptability of the proposed intervention (diaphragmatic breathing).
timeFrame: 3 months
measure: Change in High Frequency (HF) variation of HRV from baseline to end of treatment period for both study groups.
timeFrame: Baseline and 3 months
measure: Change in Total Power from baseline to end of treatment period for both study groups.
timeFrame: Baseline and 3 months
measure: Change in heart rate from baseline to end of treatment period for both study groups.
timeFrame: Baseline and 3 months
measure: Change in Pre-ejection Period (PEP) from baseline to end of treatment period for both study groups.
timeFrame: Baseline and 3 months
measure: Change in BBD score from baseline to end of treatment period for both study groups.
timeFrame: Baseline and 3 months
measure: Change in Pediatric Incontinence Questionnaire (PinQ) scores from baseline to end of treatment period for both study groups.
timeFrame: Baseline and 3 months
measure: Change in average urinary flow rate (a uroflowmetry parameter) from baseline to end of treatment period for both study groups.
timeFrame: Baseline and 3 months
measure: Change in peak urinary flow rate (a uroflowmetry parameter) from baseline to end of treatment period for both study groups.
timeFrame: Baseline and 3 months
measure: Change in post-void residual volume from baseline to end of treatment period for both study groups.
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's and Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Kourosh Afshar, MD, MHSc, FAAP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Mir Sohail Fazeli, MD, PhD(c)
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Jean-Paul Collet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: