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Clinical Trials/NCT01915004
NCT01915004
Completed
Not Applicable

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

McMaster University1 site in 1 country150 target enrollmentNovember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nonneurogenic Lower Urinary Tract Dysfunction
Sponsor
McMaster University
Enrollment
150
Locations
1
Primary Endpoint
Improvement of Nonneurogenic Lower Urinary Tract Dysfunction symptoms
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
November 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Improvement of Nonneurogenic Lower Urinary Tract Dysfunction symptoms

Time Frame: 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 Outcomes

  • Assess the Quality of Life of children with Nonneurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome.(Up to 12 weeks)

Study Sites (1)

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