Dysfunctional Elimination Syndrome Clinical Trial
Official title:
Bladder Training Video Versus Individual Urotherapy for Children With Non-neurogenic Lower Urinary Tract Dysfunction.
| Verified date | August 2017 |
| Source | McMaster University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | November 2017 |
| Est. primary completion date | November 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 5 Years to 10 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | McMaster University Medical Centre | Hamilton | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| McMaster University | Canadian Urological Association |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |