The Effectiveness of a Bladder Training Video for Management of Lower Urinary Tract Symptoms.

Bladder Training Video Versus Individual Urotherapy for Children With Non-neurogenic Lower Urinary Tract Dysfunction.

Children with non-neurogenic lower urinary tract dysfunction (NLUTD) represent a significant subgroup of pediatric urology patients, comprising up to 30 percent of some out-patient clinics. These children present with urinary tract infections (UTIs), abnormal voiding habits and various other lower urinary tract symptoms (LUTs) such as incontinence, urinary urgency and urinary frequency. Furthermore, the effects of NLUTD on a child's physical health, mental health and its potential negative clinical sequelae, which includes upper or lower urinary tract damage, must be taken into account when treating these children. These patients have complex needs requiring a significant amount of health teaching and it is imperative to determine the effectiveness of the various modes of delivering urotherapy. To determine the best modality to deliver urotherapy, this trial will compare the effectiveness of a 7 minute bladder training video to the effectiveness of standard urotherapy provided at a pediatric urology clinic at improving NLUTD/DES symptoms and quality of life in children between 5-10 years of age.

Study Overview

• Status: Completed
• Conditions: Nonneurogenic Lower Urinary Tract Dysfunction; Dysfunctional Elimination Syndrome
• Intervention / Treatment: Other: Educational Intervention

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • McMaster University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children aged 6-10 years old
• Bladder Dysfunction (Diagnosis of NLUTD or DES)

Exclusion Criteria:

• Grade 3 or 4 hydronephrosis
• Grade 3, 4 or 5 vesicoureteral reflux
• Other diagnoses which affect bladder bowel function (i.e. Spina Bifida)
• English as a second language
• Diagnosed learning disability (i.e. ADD or ADHD)
• Mental health condition (i.e. anxiety or depression)
• Received intensive urotherapy and biofeedback in past 12 months
• Child is diagnosed with primary nocturnal enuresis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard Invididual Urotherapy; Educational Intervention. Standard individual urotherapy (bladder re-training) occurs in the pediatric urology clinic.	Other: Educational Intervention; Bladder Training Video
Experimental: Bladder Training Video; Experimental Educational Intervention. Participants will watch a 7 minute animated bladder training video.	Other: Educational Intervention; Bladder Training Video

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of Nonneurogenic Lower Urinary Tract Dysfunction symptoms	Determine improvement of Nonneurogenic Lower Urinary Tract Dysfunction symptoms according to the Vancouver NLUTD/DES questionnaire after administration of either intervention (Bladder Training Video or standard urotherapy)	up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the Quality of Life of children with Nonneurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome.	The secondary outcome is to assess the QOL of children with NLUTD/DES. QOL will be measured by a validated QOL tool specific to children with bladder dysfunction called the PinQ	Up to 12 weeks

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Canadian Urological Association
• Investigators: Principal Investigator: Luis Braga, MD, FRCSC, McMaster University

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: July 26, 2013
• First Submitted That Met QC Criteria: July 31, 2013
• First Posted (Estimate): August 2, 2013

Study Record Updates

• Last Update Posted (Actual): March 9, 2018
• Last Update Submitted That Met QC Criteria: March 8, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Pediatric Urology; Urotherapy; Nonneurogenic Lower Urinary Tract Dysfunction; Dysfunctional Elimination Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: Bladder Training Video