Bladder and Bowel Disorder, PediatricNCT02597764
Diaphragmatic Breathing as an Adjunctive Therapy in the Management of Children With Bladder and Bowel Disorders
A study testing Diaphragmatic Breathing and Standard Urotherapy in people with Bladder and Bowel Disorder, Pediatric, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Bladder and Bowel Disorder, Pediatric
- What is being tested?
- Diaphragmatic Breathing and Standard Urotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Children's and Women's Hospital
Vancouver, British Columbia, V6H 3N1
About this study
Official title: Use of Diaphragmatic Breathing (DB) in the Management of Bladder and Bowel Disorders in Children: A Pilot Randomized Trial
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.
- Conditions
- Bladder and Bowel Disorder, Pediatric
- Being tested
- Diaphragmatic Breathing, Standard Urotherapy
- Keywords
- Diaphragmatic breathing (DB), Bladder and bowel disorders (BBD), Autonomic nervous system (ANS), Heart rate variability (HRV), Deep breathing, Randomized controlled trial (RCT)
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic BreathingBehavioural
Standard UrotherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Standard Urotherapy |
| 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. Receives: Behavioral: Diaphragmatic Breathing; Behavioral: Standard Urotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with resolved incontinence at the end of the trial in each group (SU+DB vs. SU only).
Measured: 3 months
Secondary outcomes (12)
Number of withdrawals during the treatment period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months
Change in heart rate from baseline to end of treatment period for both study groups.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months
Change in Pediatric Incontinence Questionnaire (PinQ) scores from baseline to end of treatment period for both study groups.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder and Bowel Disorder, PediatricStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kourosh Afshar, University of British Columbia
- Investigators
- Kourosh Afshar, MD, MHSc, FAAP, Principal investigator, University of British ColumbiaMir Sohail Fazeli, MD, PhD(c), Principal investigator, University of British ColumbiaJean-Paul Collet, MD, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597764
- Sponsor's protocol ID
- H14-03205
- Status last verified
- Feb 2017
- First submitted
- 27 Aug 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Diaphragmatic Breathing (DB) in the Management of Bladder and Bowel Disorders in Children: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT02597764
- Acronym / sponsor ID
- H14-03205
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Urotherapy (SU) | Active comparator | Behavioral: Standard UrotherapyStandard 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. |
| Standard Urotherapy (SU) + Diaphragmatic Beathing (DB) | Experimental | Behavioral: Diaphragmatic Breathing, Behavioral: Standard UrotherapyStandard 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic Breathing | Behavioural | Standard Urotherapy (SU) + Diaphragmatic Beathing (DB) |
| Standard Urotherapy | Behavioural | Standard Urotherapy (SU), Standard Urotherapy (SU) + Diaphragmatic Beathing (DB) |
Primary outcome
Proportion of participants with resolved incontinence at the end of the trial in each group (SU+DB vs. SU only).
Time frame: 3 months
12 secondary outcomes
Number of withdrawals during the treatment period.
Time frame: 3 months
Number of children adhering to the diaphragmatic breathing schedule that is given to them.
Time frame: 3 months
Treatment acceptability of the proposed intervention (diaphragmatic breathing).
Time frame: 3 months
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
Change in Total Power from baseline to end of treatment period for both study groups.
Time frame: Baseline and 3 months
Change in heart rate from baseline to end of treatment period for both study groups.
Time frame: Baseline and 3 months
Change in Pre-ejection Period (PEP) from baseline to end of treatment period for both study groups.
Time frame: Baseline and 3 months
Change in BBD score from baseline to end of treatment period for both study groups.
Time frame: Baseline and 3 months
Change in Pediatric Incontinence Questionnaire (PinQ) scores from baseline to end of treatment period for both study groups.
Time frame: Baseline and 3 months
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
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
Change in post-void residual volume from baseline to end of treatment period for both study groups.
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kourosh Afshar, MD, MHSc, FAAP principal investigator
University of British Columbia
Mir Sohail Fazeli, MD, PhD(c) principal investigator
University of British Columbia
Jean-Paul Collet, MD, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic Breathing and Standard Urotherapy in people with Bladder and Bowel Disorder, Pediatric, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with resolved incontinence at the end of the trial in each group (SU+DB vs. SU only). (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.