Lower Urinary Tract SymptomsNCT01570673
Group Versus Individual Urotherapy for Children
A study testing Group urotherapy and Individual Urotherapy in people with Lower Urinary Tract Symptoms, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- Group urotherapy and Individual Urotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to May 2014
- 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 6-10 years of age with a diagnosis of NLUTD or DES based on history and physical examination.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Group Versus Individual Urotehrapy in Children With Non-neurogenic Lower Urinary Tract Dysfunction
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.
Read the detailed description
Background Urotherapy has been the standard nonsurgical, nonpharmacologic treatment for children with nonneurogenic lower urinary tract dysfunction (NLUTD) and dysfunctional elimination syndrome (DES) for over two decades (Hoebeke, 2006). Children with NLUTD/DES represent a heterogenous group whose physical and mental health are affected (Afshar et al., 2009). There is no widely accepted diagnostic criteria (Afshar et al.) and urotherapy modalities that have been studied vary by setting, curriculum, length of treatment, outcome measurements and study participants. It is challenging to determine what modality of urotherapy is the most effective by reviewing the current literature. Furthermore, quality of life as an outcome measurement of urotherapy has not been reported in the literature.
Purpose The purpose of this study is to assess the feasibility of a group urotherapy session and evaluate the preliminary effectiveness of the group urotherapy session by measuring NLUTD/DES symptoms and quality of life and compare the group urotherapy session to standard urotherapy that takes place in pediatric urology clinics.
Methods Children aged 6-10 years old diagnosed with NLUTD/DES will be recruited from pediatric urology clinic at McMaster Children's Hospital over 12 to 15 weeks. The aim is to recruit at least 60 participants, 30 will be randomized to the control group and receive standard individual urotherapy in clinic and 30 will be randomized to the experimental group and receive a 1 hour group urotherapy session. Parents will be asked to complete a demographics questionnaire at the time of consent and children will be asked to complete 2 questionnaires at time of consent and again 3 months after receiving either individual or group urotherapy. At the 3 month follow up, parents and participants will be asked to complete an evaluation form to provide feedback about the teaching session received.
Outcome Measurements NLUTD/DES symptoms will be evaluated using the Vancouver NLUTD/DES questionnaire. This questionnaire assesses the following symptoms: incontinence, urgency, frequency, dysuria, hesitancy, straining and constipation. Quality of life (QOL) will be measured using the PinQ QOL measure. This questionnaire measures 6 domains of QOL: social, self-esteem, family, body image, independence and mental health. Both questionnaires have been deemed valid and reliable in children with the same diagnosis and age as the study population.
Impact This pilot study will provide new knowledge as a controlled trial comparing standard individual and group urotherapy which has not been reported on in the literature. Urotherapy is effective, but the search for the most effective program continues. This pilot study will provide information on the feasibility of the group urotherapy session as well as preliminary effectiveness. Furthermore, quality of life as an outcome measure has not been used to evaluate urotherapy. Again, this will provide new and valuable knowledge on the child's perception of their condition and the effect of urotherapy on their QOL.
References Afshar, K., Mirbagheri, A., Scott, H. \& MacNeily, A.E. (2009). Development of a syndrome score for dysfunctional elimination syndrome. The Journal of Urology, 182, 1939-1944.
Bower, W.F., Sit, F.K.Y., Bluyssen, N., Wong, E.M.C. \& Yeung, C.K. (2006). PinQ: A valid, reliable and reproducible quality-of-life measure in children with bladder dysfunction. Journal of Pediatric Urology, 2, 185-189.
Hoebeke, P. (2006). Twenty years of urotherapy in children: what have we learned? European Urology,49, 426-428.
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- Group urotherapy, Individual Urotherapy
- Keywords
- quality of life, urinary bladder, symptoms, children
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group urotherapyBehavioural
Children in this arm will receive group urotherapy in small groups with other children.
Individual UrotherapyBehavioural
Children will receive standard individual urotherapy in regular pediatric urology clinic.
| Study group | Role | What they receive |
|---|---|---|
| Group Urotherapy | Experimental | Children in this arm wil receive group urotherapy in small groups with other children. Receives: Behavioral: Group urotherapy |
| Individual urotherapy | Active comparator | Children will receive standard individual urotherapy in regular pediatric urology clinic. Receives: Behavioral: Individual Urotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
lower urinary tract symptoms
incontinence, urgency, frequency, dysuria, hesitancy, straining and constipation
Measured: 3 months
Secondary outcomes (1)
quality of life
quality of life related to bladder/bowel health
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570673
- Sponsor's protocol ID
- 12-089
- Status last verified
- Jun 2015
- First submitted
- 2 Apr 2012
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Versus Individual Urotehrapy in Children With Non-neurogenic Lower Urinary Tract Dysfunction
- ClinicalTrials.gov ID
- NCT01570673
- Acronym / sponsor ID
- 12-089
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- quality of life, urinary bladder, symptoms, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 4 Apr 2012 (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.
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.
Detailed description
Background Urotherapy has been the standard nonsurgical, nonpharmacologic treatment for children with nonneurogenic lower urinary tract dysfunction (NLUTD) and dysfunctional elimination syndrome (DES) for over two decades (Hoebeke, 2006). Children with NLUTD/DES represent a heterogenous group whose physical and mental health are affected (Afshar et al., 2009). There is no widely accepted diagnostic criteria (Afshar et al.) and urotherapy modalities that have been studied vary by setting, curriculum, length of treatment, outcome measurements and study participants. It is challenging to determine what modality of urotherapy is the most effective by reviewing the current literature. Furthermore, quality of life as an outcome measurement of urotherapy has not been reported in the literature.
Purpose The purpose of this study is to assess the feasibility of a group urotherapy session and evaluate the preliminary effectiveness of the group urotherapy session by measuring NLUTD/DES symptoms and quality of life and compare the group urotherapy session to standard urotherapy that takes place in pediatric urology clinics.
Methods Children aged 6-10 years old diagnosed with NLUTD/DES will be recruited from pediatric urology clinic at McMaster Children's Hospital over 12 to 15 weeks. The aim is to recruit at least 60 participants, 30 will be randomized to the control group and receive standard individual urotherapy in clinic and 30 will be randomized to the experimental group and receive a 1 hour group urotherapy session. Parents will be asked to complete a demographics questionnaire at the time of consent and children will be asked to complete 2 questionnaires at time of consent and again 3 months after receiving either individual or group urotherapy. At the 3 month follow up, parents and participants will be asked to complete an evaluation form to provide feedback about the teaching session received.
Outcome Measurements NLUTD/DES symptoms will be evaluated using the Vancouver NLUTD/DES questionnaire. This questionnaire assesses the following symptoms: incontinence, urgency, frequency, dysuria, hesitancy, straining and constipation. Quality of life (QOL) will be measured using the PinQ QOL measure. This questionnaire measures 6 domains of QOL: social, self-esteem, family, body image, independence and mental health. Both questionnaires have been deemed valid and reliable in children with the same diagnosis and age as the study population.
Impact This pilot study will provide new knowledge as a controlled trial comparing standard individual and group urotherapy which has not been reported on in the literature. Urotherapy is effective, but the search for the most effective program continues. This pilot study will provide information on the feasibility of the group urotherapy session as well as preliminary effectiveness. Furthermore, quality of life as an outcome measure has not been used to evaluate urotherapy. Again, this will provide new and valuable knowledge on the child's perception of their condition and the effect of urotherapy on their QOL.
References Afshar, K., Mirbagheri, A., Scott, H. \& MacNeily, A.E. (2009). Development of a syndrome score for dysfunctional elimination syndrome. The Journal of Urology, 182, 1939-1944.
Bower, W.F., Sit, F.K.Y., Bluyssen, N., Wong, E.M.C. \& Yeung, C.K. (2006). PinQ: A valid, reliable and reproducible quality-of-life measure in children with bladder dysfunction. Journal of Pediatric Urology, 2, 185-189.
Hoebeke, P. (2006). Twenty years of urotherapy in children: what have we learned? European Urology,49, 426-428.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Urotherapy | Experimental | Behavioral: Group urotherapyChildren in this arm wil receive group urotherapy in small groups with other children. |
| Individual urotherapy | Active comparator | Behavioral: Individual UrotherapyChildren will receive standard individual urotherapy in regular pediatric urology clinic. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children aged 6-10 years of age with a diagnosis of NLUTD or DES based on history and physical examination.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Group urotherapyChildren in this arm will receive group urotherapy in small groups with other children. | Behavioural | Group Urotherapy |
| Individual UrotherapyChildren will receive standard individual urotherapy in regular pediatric urology clinic. | Behavioural | Individual urotherapy |
Primary outcome
lower urinary tract symptoms
Time frame: 3 months
incontinence, urgency, frequency, dysuria, hesitancy, straining and constipation
1 secondary outcome
quality of life
Time frame: 3 months
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 12 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group urotherapy and Individual Urotherapy in people with Lower Urinary Tract Symptoms, run by Hamilton Health Sciences Corporation 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 1 inclusion and 1 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 12 Jun 2015. 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?
lower urinary tract symptoms (time frame: 3 months). 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 12 Jun 2015; AzTrials last refreshed its copy on 27 Oct 2026.