Diaphragmatic Breathing as an Adjunctive Therapy in the Management of Children With Bladder and Bowel Disorders

NCT02597764 | Completed

• 1 other identifier: H14-03205
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with resolved incontinence at the end of the trial in each group (SU+DB vs. SU only).

  3 months

Secondary Outcomes (12)

• Number of withdrawals during the treatment period.

  3 months

• Number of children adhering to the diaphragmatic breathing schedule that is given to them.

  3 months

• Treatment acceptability of the proposed intervention (diaphragmatic breathing).

  3 months

• Change in High Frequency (HF) variation of HRV from baseline to end of treatment period for both study groups.

  Baseline and 3 months

• Change in Total Power from baseline to end of treatment period for both study groups.

  Baseline and 3 months

Study Arms (2)

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.

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.

Behavioral: Diaphragmatic Breathing; Behavioral: Standard Urotherapy

Interventions

Diaphragmatic Breathing BEHAVIORAL

Standard Urotherapy (SU) + Diaphragmatic Beathing (DB)

Standard Urotherapy BEHAVIORAL

Standard Urotherapy (SU); Standard Urotherapy (SU) + Diaphragmatic Beathing (DB)

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's and Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: November 5, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

CA (1)