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

Sponsor
University Hospital, Ghent (Other)
Overall Status
Recruiting
CT.gov ID
NCT05146258
Collaborator
(none)
83
1
26.5
3.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    83 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Effectivity of the Voiding School for Symptom Reduction and Quality of Life in Children With Lower Urinary Tract Symptoms
    Actual Study Start Date :
    Apr 14, 2021
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Jun 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Lower Urinary Tract Symptoms - VVSDES [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)

    2. Well-being of the child - PinQ [through study completion, average of 3 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ghent University Hospital/Ghent University Ghent East Flanders Belgium 9000

    Sponsors and Collaborators

    • University Hospital, Ghent

    Investigators

    • Principal Investigator: Bieke Samijn, dr., Ghent University Hospital/Ghent University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Ghent
    ClinicalTrials.gov Identifier:
    NCT05146258
    Other Study ID Numbers:
    • BC-10501/10502/10504
    First Posted:
    Dec 6, 2021
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Ghent
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 8, 2022