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

NCT01915004 | Completed

• 1 other identifier: Bladder Training Video
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonneurogenic Lower Urinary Tract Dysfunction; Dysfunctional Elimination Syndrome

Keywords

Pediatric Urology; Urotherapy; Nonneurogenic Lower Urinary Tract Dysfunction; Dysfunctional Elimination Syndrome; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assess the Quality of Life of children with Nonneurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome.

  Up to 12 weeks

Study Arms (2)

Standard Invididual Urotherapy

OTHER

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

Other: Educational Intervention

Bladder Training Video

EXPERIMENTAL

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

Other: Educational Intervention

Interventions

Educational Intervention OTHER

Bladder Training Video

Bladder Training Video; Standard Invididual Urotherapy

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Canadian Urological Association: collaborator

Study Sites (1)

McMaster University Medical Centre

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Luis Braga, MD, FRCSC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: August 2, 2013
• Study Start: November 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 9, 2018

Record last verified: 2017-08

Locations

CA (1)