Nonneurogenic Lower Urinary Tract DysfunctionNCT01915004
The Effectiveness of a Bladder Training Video for Management of Lower Urinary Tract Symptoms.
A study testing Educational Intervention in people with Nonneurogenic Lower Urinary Tract Dysfunction and Dysfunctional Elimination Syndrome, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Nonneurogenic Lower Urinary Tract Dysfunction, Dysfunctional Elimination Syndrome
- What is being tested?
- Educational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-10 years old
- Bladder Dysfunction (Diagnosis of NLUTD or DES)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bladder Training Video Versus Individual Urotherapy for Children With Non-neurogenic Lower Urinary Tract Dysfunction.
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.
- Being tested
- Educational Intervention
- Keywords
- Pediatric Urology, Urotherapy, Nonneurogenic Lower Urinary Tract Dysfunction, Dysfunctional Elimination Syndrome, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Bladder Training Video
| Study group | Role | What they receive |
|---|---|---|
| Standard Invididual Urotherapy | Other | Educational Intervention. Standard individual urotherapy (bladder re-training) occurs in the pediatric urology clinic. Receives: Other: Educational Intervention |
| Bladder Training Video | Experimental | Experimental Educational Intervention. Participants will watch a 7 minute animated bladder training video. Receives: Other: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 12 weeks
Secondary outcomes (1)
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
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startNov 2014
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonneurogenic Lower Urinary Tract DysfunctionStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Urological Association
- Responsible party
- Sponsor
- Investigators
- Luis Braga, MD, FRCSC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915004
- Sponsor's protocol ID
- Bladder Training Video
- Status last verified
- Aug 2017
- First submitted
- 26 Jul 2013
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Training Video Versus Individual Urotherapy for Children With Non-neurogenic Lower Urinary Tract Dysfunction.
- ClinicalTrials.gov ID
- NCT01915004
- Acronym / sponsor ID
- Bladder Training Video
- Keywords
- Pediatric Urology, Urotherapy, Nonneurogenic Lower Urinary Tract Dysfunction, Dysfunctional Elimination Syndrome, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Urological Association
- Study start
- Nov 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 2 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Invididual Urotherapy | Other | Other: Educational InterventionEducational Intervention. Standard individual urotherapy (bladder re-training) occurs in the pediatric urology clinic. |
| Bladder Training Video | Experimental | Other: Educational InterventionExperimental Educational Intervention. Participants will watch a 7 minute animated bladder training video. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 6-10 years old
- Bladder Dysfunction (Diagnosis of NLUTD or DES)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionBladder Training Video | Other | Bladder Training Video, Standard Invididual Urotherapy |
Primary outcome
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)
1 secondary outcome
Assess the Quality of Life of children with Nonneurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome.
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Braga, MD, FRCSC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Nonneurogenic Lower Urinary Tract Dysfunction and Dysfunctional Elimination Syndrome, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Nonneurogenic Lower Urinary Tract Dysfunction symptoms (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.