Lower Urinary Tract Symptoms Clinical Trial
Official title:
Group Versus Individual Urotehrapy in Children With Non-neurogenic Lower Urinary Tract Dysfunction
Verified date | June 2015 |
Source | Hamilton Health Sciences Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
What are we doing? A pilot research study is planned to take place within the Pediatric
Urology program at McMaster Children's hospital starting this spring/summer 2012. The pilot
study will compare standard individual teaching that occurs in pediatric urology clinic
about bladder re-training and achieving healthy bladder and bowel habits to a group teaching
session. The group teaching session will be one hour in length and include the same content
taught in pediatric urology clinic and provide more time for the children to ask questions,
demonstrate and practice different exercises and talk about some of the challenges
associated with having problems with their bladder. The group teaching session will be
approximately one hour in length and occur weekly in the evenings for 12 to 15 weeks. Study
participants will be asked to attend either one group teaching session or one individual
teaching session which will occur in regular pediatric urology clinic. Parents will be asked
to complete a demographics questionnaire at the start of the study and child participants
will be asked to complete 2 short questionnaires about symptoms and quality of life before
and after either individual or group teaching sessions. At the 3 month follow up, parents
and child participants will also be asked to fill out an evaluation form of the session
received. Children between the ages of 6 and 10 years old and a diagnosis of nonneurogenic
lower urinary tract dysfunction will be asked if they would like to participate.
Why are we doing it? Some of the symptoms of bladder dysfunction include incontinence
(wetting), recurrent urinary tract infections, frequency (having to pee a lot) and urgency
(having sudden urges to pee). These symptoms can affect a child's physical and
emotional/mental well-being. Treatment includes improving bladder habits through bladder
re-training and improving bowel habits through treatment and management of constipation as
well as establishing a bowel routine. Children are taught about their urinary tract system
and what they need to do to improve and maintain its health. Children are asked to void
(pee) every 2 hours, double void and drink more water. Sometimes they also need to take
medications. Often in a busy clinic, parents are taught what the child needs to do and
expected to return home and implement the bladder re-training instructions. Participation of
the child during these visits varies. However, participation and engagement of the child in
bladder re-training is crucial for success. Also, little time is spent on the impact of
bladder dysfunction on the lives of these children. Many children do not want to follow the
instructions on bladder re-training because they are worried about what their peers may say.
What do we hope to accomplish? The purpose of this study is to assess the feasibility of a
group teaching session and evaluate the preliminary effectiveness of the session.
Questionnaire results will be compared before and after the teaching sessions and between
the individual and group teaching groups. Evaluation forms will provide feedback about the
teaching sessions which will help determine the strengths of the sessions and improvements
that could be made to improve the quality and effectiveness of future treatment. Outcomes
that will be measured include symptoms and quality of life. This pilot study will also
provide important information related to symptoms and quality of life for these children.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 10 Years |
Eligibility |
Inclusion Criteria: - children aged 6-10 years of age with a diagnosis of NLUTD or DES based on history and physical examination. Exclusion Criteria: - grade 3 or 4 hydronephrosis; grade 3, 4, 5 vesicoureteral reflux; other diagnosis which affects bladder/bowel function (i.e. Spina Bifida); English as a second language; diagnosed learning disability (i.e. Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder), mental health condition (i.e. anxiety, depression) and cannot have received urotherapy within the past 24 months. |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | McMaster Children's Hospital | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Hamilton Health Sciences Corporation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | lower urinary tract symptoms | incontinence, urgency, frequency, dysuria, hesitancy, straining and constipation | 3 months | No |
Secondary | quality of life | quality of life related to bladder/bowel health | 3 months | No |
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