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

NCT ID: NCT01915004

Last Updated: 2018-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-11-30

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.

Detailed Description

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Conditions

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Nonneurogenic Lower Urinary Tract Dysfunction Dysfunctional Elimination Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Invididual Urotherapy

Educational Intervention. Standard individual urotherapy (bladder re-training) occurs in the pediatric urology clinic.

Group Type OTHER

Educational Intervention

Intervention Type OTHER

Bladder Training Video

Bladder Training Video

Experimental Educational Intervention. Participants will watch a 7 minute animated bladder training video.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Bladder Training Video

Interventions

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Educational Intervention

Bladder Training Video

Intervention Type OTHER

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
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Urological Association

INDUSTRY

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luis Braga, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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McMaster University Medical Centre

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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Bladder Training Video

Identifier Type: -

Identifier Source: org_study_id

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