Bladder and Bowel Disorder, Pediatric Clinical Trial
Official title:
Use of Diaphragmatic Breathing (DB) in the Management of Bladder and Bowel Disorders in Children: A Pilot Randomized Trial
| Verified date | February 2017 |
| Source | University of British Columbia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 23 |
| Est. completion date | February 2017 |
| Est. primary completion date | February 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 5 Years to 18 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | BC Children's and Women's Hospital | Vancouver | British Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| University of British Columbia |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of participants with resolved incontinence at the end of the trial in each group (SU+DB vs. SU only). | 3 months | ||
| Secondary | Number of withdrawals during the treatment period. | 3 months | ||
| Secondary | Number of children adhering to the diaphragmatic breathing schedule that is given to them. | This will be measured by the information obtained from the mobile application used during the study period. | 3 months | |
| Secondary | Treatment acceptability of the proposed intervention (diaphragmatic breathing). | This outcome will be reported based on the participants and their parents' response to the Treatment Acceptability Questionnaires. | 3 months | |
| Secondary | Change in High Frequency (HF) variation of HRV from baseline to end of treatment period for both study groups. | This outcome will be measured using state-of-the-art machine for recording heart rate variability. | Baseline and 3 months | |
| Secondary | Change in Total Power from baseline to end of treatment period for both study groups. | This outcome will be calculated from the measurements obtained from state-of-the-art machine for recording heart rate variability. | Baseline and 3 months | |
| Secondary | Change in heart rate from baseline to end of treatment period for both study groups. | Baseline and 3 months | ||
| Secondary | Change in Pre-ejection Period (PEP) from baseline to end of treatment period for both study groups. | This outcome will be measured using state-of-the-art machine for recording heart rate variability. | Baseline and 3 months | |
| Secondary | Change in BBD score from baseline to end of treatment period for both study groups. | This outcome will be reported based on participants' response to a validated 5-point Likert scale questionnaire for diagnosing BBD. | Baseline and 3 months | |
| Secondary | Change in Pediatric Incontinence Questionnaire (PinQ) scores from baseline to end of treatment period for both study groups. | Baseline and 3 months | ||
| Secondary | Change in average urinary flow rate (a uroflowmetry parameter) from baseline to end of treatment period for both study groups. | 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. | Baseline and 3 months | |
| Secondary | Change in peak urinary flow rate (a uroflowmetry parameter) from baseline to end of treatment period for both study groups. | 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. | Baseline and 3 months | |
| Secondary | Change in post-void residual volume from baseline to end of treatment period for both study groups. | A hand-held ultrasound device will be used for the measurement of the post-void residual volume. | Baseline and 3 months |