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Standard Urotherapy (SU) + Diaphragmatic Beathing (DB) for Pediatric Bladder and Bowel Disorder

N/A
Waitlist Available
Led By Kourosh Afshar, MD, MHSc, FAAP
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

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.

Eligible Conditions
  • Pediatric Bladder and Bowel Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in BBD score from baseline to end of treatment period for both study groups.
Change in High Frequency (HF) variation of HRV from baseline to end of treatment period for both study groups.
Change in Pre-ejection Period (PEP) from baseline to end of treatment period for both study groups.
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard Urotherapy (SU) + Diaphragmatic Beathing (DB)Experimental Treatment2 Interventions
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.
Group II: Standard Urotherapy (SU)Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diaphragmatic Breathing
2015
N/A
~340
Standard Urotherapy
2019
N/A
~60

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,451 Previous Clinical Trials
2,483,167 Total Patients Enrolled
Kourosh Afshar, MD, MHSc, FAAPPrincipal InvestigatorUniversity of British Columbia
Mir Sohail Fazeli, MD, PhD(c)Principal InvestigatorUniversity of British Columbia
~2 spots leftby Sep 2025