McMaster University Medical Centre
Hamilton, Ontario, L8S 4K1, Canada
Completed
NCT Number: NCT01915004
The Effectiveness of a Bladder Training Video for Management of Lower Urinary Tract Symptoms.
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.
Completed
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Notify MeKey information
Age range
5 year–10 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Educational Intervention
OtherBladder Training Video
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.
Time frame: 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
Sponsors and collaborators
Lead sponsor
McMaster University
Other
Collaborators
- Canadian Urological Association
Registry information
Official study title
Bladder Training Video Versus Individual Urotherapy for Children With Non-neurogenic Lower Urinary Tract Dysfunction.
Important dates
- Study start
- 2014
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Aug 2, 2013
- Registry last updated
- Mar 9, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.