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

NCT05146258 | Completed

• 1 other identifier: BC-10501/10502/10504
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms

Keywords

Voiding class; Quality of Life; Children

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with Lower Urinary Tract Dysfunctions attending the group urotherapy, the voiding school

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital/Ghent University

Ghent, East Flanders, 9000, Belgium

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

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

Study Officials

• Bieke Samijn, dr.

  Ghent University Hospital/Ghent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: December 6, 2021
• Study Start: April 14, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

BE (1)