Group Versus Individual Urotherapy for Children
Condition: Lower Urinary Tract Symptoms
MeSH terms: Lower Urinary Tract Symptoms
Study type: Interventional

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 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.
    

Intervention name(s): Group urotherapy; Individual Urotherapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Children in this arm will receive group urotherapy in small groups with other children.; Children will receive standard individual urotherapy in regular pediatric urology clinic.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: quality of life; urinary bladder; symptoms; children