Lower Urinary Tract SymptomsNCT05146258
Voiding Class Study for Symptom Reduction and Quality of Life in Children With LUTS
An observational study of Lower Urinary Tract Symptoms, run by University Hospital, Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Lower Urinary Tract Symptoms
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Apr 2021to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with Lower Urinary Tract Dysfunctions attending the group urotherapy, the voiding school
Who may be able to join
- children (5-12 years old)
- children with LUTS
- children who follow voiding school, with or without previously failed training
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Ghent University Hospital/Ghent University
Ghent, East Flanders, 9000
About this study
Official title: The Effectivity of the Voiding School for Symptom Reduction and Quality of Life in Children With Lower Urinary Tract Symptoms
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.
Read the 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
- Keywords
- Voiding class, Quality of Life, Children
- Medical subject headings
- Lower Urinary Tract Symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: through study completion, average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start14 Apr 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bieke Samijn, dr., Principal investigator, Ghent University Hospital/Ghent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146258
- Sponsor's protocol ID
- BC-10501/10502/10504
- Status last verified
- Jul 2023
- First submitted
- 19 Oct 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectivity of the Voiding School for Symptom Reduction and Quality of Life in Children With Lower Urinary Tract Symptoms
- ClinicalTrials.gov ID
- NCT05146258
- Acronym / sponsor ID
- BC-10501/10502/10504
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Voiding class, Quality of Life, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with Lower Urinary Tract Dysfunctions attending the group urotherapy, the voiding school
Key inclusion criteria (3 listed)
- children (5-12 years old)
- children with LUTS
- children who follow voiding school, with or without previously failed training
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bieke Samijn, dr. principal investigator
Ghent University Hospital/Ghent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Urinary Tract Symptoms - VVSDES (time frame: through study completion, average of 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.