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

Not Applicable

Completed

• Conditions: Dysfunctional Elimination Syndrome; Nonneurogenic Lower Urinary Tract Dysfunction
• Interventions: Other: Educational Intervention

• Registration Number: NCT01915004
• Lead Sponsor: McMaster University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-26
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-02
• Study Start: 2014-11
• Status Verified: 2017-08
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Improvement of Nonneurogenic Lower Urinary Tract Dysfunction symptoms	up to 12 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Assess the Quality of Life of children with Nonneurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome.	Up to 12 weeks	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

Trial Locations

Locations (1)

McMaster University Medical Centre; 🇨🇦 Hamilton, Ontario, Canada