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

NCT ID: NCT05146258

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-14
• Study Completion Date: 2023-06-30

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.

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.

Conditions

Lower Urinary Tract Symptoms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bieke Samijn, dr.

Role: PRINCIPAL_INVESTIGATOR

Ghent University Hospital/Ghent University

Locations

Ghent University Hospital/Ghent University

Ghent, East Flanders, Belgium

Countries

Belgium

Other Identifiers

BC-10501/10502/10504

Identifier Type: -

Identifier Source: org_study_id