Voiding Class Study for Symptom Reduction and Quality of Life in Children With LUTS

Lower urinary tract dysfunction (LUTD) is a common pathology within children and shows a wide spectrum of lower urinary tract symptoms (LUTS). These symptoms have a significant impact on a child's well-being. For the treatment of LUTS in children urotherapy, a non-medicamentous form of therapy, is implemented as standard therapy. It can be described as a bladder re-education and rehabilitation programme where the participants are informed on the anatomy and physiology of the normal and pathological urinary system. Urotherapy has been offered as individual therapy for a long time but is now also offered as group therapy (the voiding school). This is, as compared to the individual therapy, more cost-effective and gives the participants the feeling not to be alone in the situation. The effectiveness of the individual therapy for children with LUTD has already been determined, however little research has been done on the effectiveness of urotherapy in group (the voiding class). The present study wants to investigate the effect of the group therapy on the symptoms and quality of life of children with LUTD.

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Key information

Conditions

Lower Urinary Tract Symptoms Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University Hospital/Ghent University

Ghent, East Flanders, 9000, Belgium

About this study

The current study is a prospective cohort-study in which information of the impact of the voiding class on the symptoms and well-being of the children is obtained through two questionnaires, respectively the Vancouver Symptom Score for Dysfunctional Elimination Syndrome (VSSDES) and the Paediatric Incontinence Questionnaire (PinQ). Participants of this study are as well asked to complete drinking and voiding charts and nocturnal diaries. These questionnaires and documents are filled in before and after the voiding class. The collected data will be further analysed statistically trough Statistical Package for the Social Sciences (SPPS), to determine significant improvements in symptoms and quality of life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

children (5-12 years old)
children with LUTS
children who follow voiding school, with or without previously failed training

Exclusion criteria

children >12 years ol and <5 years old
children who suffer from solely faecal problems without lower urinary tract symptoms
children who are currently following a different kind of therapy concerning the LUTS, than VC
children with neurological disorders or anatomical variations of the bladder
children who underwent surgical intervention of the bladder

Treatment and study plan

Primary outcomes

Lower Urinary Tract Symptoms - VVSDES

Time frame: through study completion, average of 3 months

Amount of LUTS before and after the voiding class measured by the Vancouver symptom score for dysfunctional elimination syndrome (VSSDES)
Well-being of the child - PinQ

Time frame: through study completion, average of 3 months

The effect of the voiding class on the QoL measured by the Paediatric incontinence questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

The Effectivity of the Voiding School for Symptom Reduction and Quality of Life in Children With Lower Urinary Tract Symptoms

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Dec 6, 2021
Registry last updated: Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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