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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Urotherapy (SU) | Active Comparator | Standard Urotherapy (SU): A non-invasive therapy combining cognitive, behavioral and physical therapy. The study team will explain the problem to the children and their parents and educate them on the following: proper voiding mechanics, sitting, standing positions, how and when to void, techniques on relaxing pelvic floor muscles, and avoiding straining. An assessment of bowel habits will be done and their diet and drinking/voiding habits will be modified to maintain proper hydration with timed voiding. Voiding diaries will be provided for the assessment of the bladder and bowel habits. |
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| Standard Urotherapy (SU) + Diaphragmatic Beathing (DB) | Experimental | Standard Urotherapy (SU) with the addition of Diaphragmatic Breathing (DB): A non-invasive breathing technique that is performed by a marked expansion of the abdomen (contracting diaphragm) rather than chest cavity during inspiration and tightening of the stomach muscles during expiration. Participants will lie on their back on a flat surface. Head is supported with a pillow and knees are bent forward supported by another pillow. Participants will place one hand on chest and the other on the abdomen, then start inhalation by moving their abdomen out against their hand, breathing in through their nose while keeping their chest and the other hand as still as possible. During expiration, the participants will tighten their abdominal muscles by forcing them inward and breathe out through pursed lips while keeping the hand on the chest as still as possible. Participants will be asked to perform this exercise for 10 minutes 3 times daily for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diaphragmatic Breathing | Behavioral |
| ||
| Standard Urotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with resolved incontinence at the end of the trial in each group (SU+DB vs. SU only). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of withdrawals during the treatment period. | 3 months | |
| 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. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Kourosh Afshar, MD, MHSc, FAAP | University of British Columbia | Principal Investigator |
| Mir Sohail Fazeli, MD, PhD(c) | University of British Columbia | Principal Investigator |
| Jean-Paul Collet, MD, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Children's and Women's Hospital | Vancouver | British Columbia | V6H 3N1 | Canada |
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| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Behavioral |
|
| 3 months |
| 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 |
| 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 |
| 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 |
| Change in heart rate from baseline to end of treatment period for both study groups. | Baseline and 3 months |
| 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 |
| 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 |
| Change in Pediatric Incontinence Questionnaire (PinQ) scores from baseline to end of treatment period for both study groups. | Baseline and 3 months |
| 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 |
| 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 |
| 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 |