Group Versus Individual Urotherapy for Children

NCT01570673 | Completed

• 1 other identifier: 12-089
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Urinary Tract Symptoms

Keywords

quality of life; urinary bladder; symptoms; children

Outcome Measures

Primary Outcomes (1)

• lower urinary tract symptoms

  incontinence, urgency, frequency, dysuria, hesitancy, straining and constipation

  3 months

Secondary Outcomes (1)

• quality of life

  3 months

Study Arms (2)

Group Urotherapy

EXPERIMENTAL

Children in this arm wil receive group urotherapy in small groups with other children.

Behavioral: Group urotherapy

Individual urotherapy

ACTIVE COMPARATOR

Children will receive standard individual urotherapy in regular pediatric urology clinic.

Behavioral: Individual Urotherapy

Interventions

Group urotherapy BEHAVIORAL

Children in this arm will receive group urotherapy in small groups with other children.

Group Urotherapy

Individual Urotherapy BEHAVIORAL

Children will receive standard individual urotherapy in regular pediatric urology clinic.

Individual urotherapy

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children aged 6-10 years of age with a diagnosis of NLUTD or DES based on history and physical examination.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: April 4, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 12, 2015

Record last verified: 2015-06

Locations

CA (1)