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

Lower Urinary Tract Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05146258
• Other study ID #: BC-10501/10502/10504
• Status: Completed
• Start date: April 14, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Locations

Country	Name	City	State
Belgium	Ghent University Hospital/Ghent University	Ghent	East Flanders

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower Urinary Tract Symptoms - VVSDES	Amount of LUTS before and after the voiding class measured by the Vancouver symptom score for dysfunctional elimination syndrome (VSSDES)	through study completion, average of 3 months
Primary	Well-being of the child - PinQ	The effect of the voiding class on the QoL measured by the Paediatric incontinence questionnaire	through study completion, average of 3 months