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

Study Overview
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Brief Summary
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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.

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

Conditions
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Nonneurogenic Lower Urinary Tract Dysfunction, Dysfunctional Elimination Syndrome

Intervention / Treatment
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* Other: Educational Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Urology, Urotherapy, Nonneurogenic Lower Urinary Tract Dysfunction, Dysfunctional Elimination Syndrome, Randomized Controlled Trial