Plain English Summary
Background and study aims
Lower urinary tract dysfunction (LUTD) in childhood might affect both lower urinary tract function and psychosocial wellbeing later on in life. The long-term outcome and prognosis are largely unknown.
The aim of this study is to evaluate the long-term functional and psychosocial outcome of adolescents and young adults treated for childhood LUTD and compare these outcomes to healthy age-related controls and treatment outcome in the past.
Who can participate?
Former patients treated for childhood LUTD, currently aged 16-26 years, and a healthy control group
What does the study involve?
Both former patients and controls complete a four-part paper survey composed of validated questionnaires measuring LUTD, general- and disease-specific quality of life and mental health.
What are the possible benefits and risks of participating?
There are no benefits or risks involved in participation.
Where is the study run from?
January 2018 to June 2020
When is the study starting and how long is it expected to run for?
Radboud University Medical Center, Amalia's Children's Hospital (Netherlands)
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr LL de Wall
liesbeth.dewall@radboudumc.nl
Trial website
Contact information
Type
Public
Primary contact
Ms Liesbeth de Wall
ORCID ID
http://orcid.org/0000-0002-1704-6772
Contact details
Geert Grooteplein zuid 10
Nijmegen
6500 HB
Netherlands
+31 (0)24 3613735
liesbeth.dewall@radboudumc.nl
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
PANAMA 108187
Study information
Scientific title
Long-term functional and psychosocial outcome at adolescence and young adulthood of patients treated for lower urinary tract dysfunction in childhood
Acronym
LUCOS
Study hypothesis
A hypothesized 25% more lower urinary tract symptoms (LUTS) are expected in former patients versus healthy age-related controls.
Ethics approval
Approved 20/03/2018, local ethics committee (CMO Arnhem-Nijmegen, p/a Radboudumc, huispost 628, Postbus 9101, 6500 HB Nijmegen, The Netherlands; +31 (0)24 361 3154; tc@ccmo.nl), ref: NL 64311.091.17
Study design
Single-center observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet written in Dutch
Condition
Long term psychosocial and functional outcome of former patients treated for childhood lower urinary tract dysfunction
Intervention
After informed consent, a four-part paper survey is sent including questions about demographics, psychiatric co-morbidity, LUTS (Lower Urinary Tract Symptoms), general and disease-specific quality of life (DSQOL) and mental health. A healthy age-related control group receive the same survey. Validated existing questionnaires are used: the overactive bladder questionnaire to assess LUTS and DSQOL, the pediatric Quality of life Inventory (PedsQol) or Short Form-36 (SF-36) to determine quality of life and the Hospital and Depression Scale (HADS) to assess mental health.
The mean follow-up time for former patients is 8.8 +/- 4.4 years after treatment in childhood. The OAB-q score for controls is the score at the time of completing the survey
Intervention type
Other
Phase
Drug names
Primary outcome measure
Overall number of lower urinary tract symptoms measured using the validated Overactive Bladder Questionnaire (OAB-q) score at a single timepoint
Secondary outcome measures
Measured at a single timepoint:
1. Type of lower urinary tract symptoms measured using the validated Overactive Bladder Questionnaire (OAB-q)
2. General quality of life measured using Pediatric Quality of life Inventory (PedsQol) for subjects <18 years of age and Short Form-36 Health Survey (SF-36) for subjects ≥18 years of age
3. Disease-specific quality of life measured using the OAB-q
4. Mental health outcomes measured using the validated Hospital and Depression Scale (HADS)
5. Prognostic factors for lower urinary tract symptoms later in life related to treatment outcome in the past measured using a multivariable backward regression model at time of data analysis
Overall trial start date
01/01/2018
Overall trial end date
01/06/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Former patients treated for childhood lower urinary tract dysfunction (LUTD) in childhood in Radboud University Medical Center, currently between 16-26 years of age. LUTD includes any type of lower urinary tract symptom without an anatomical or neurological etiology
2. The control group is recruited by word of mouth and advertisement at the university faculty and high schools nearby
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
120
Total final enrolment
120
Participant exclusion criteria
Anatomical or neurological conditions resulting in lower urinary tract symptoms
Recruitment start date
01/04/2018
Recruitment end date
01/06/2020
Locations
Countries of recruitment
Netherlands
Trial participating centre
Radboud University Medical Center
Amalia Children's Hospital
Geert Grooteplein zuid 10
Nijmegen
6500 HB
Netherlands
Sponsor information
Organisation
Radboud University Nijmegen Medical Centre
Sponsor details
Amalia Children's Hospital
Geert Grooteplein zuid 10
Nijmegen
6500 HB
Netherlands
+31 (0)24 3613735
liesbeth.dewall@radboudumc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Radboud Universitair Medisch Centrum
Alternative name(s)
Radboudumc, Radboud University Medical Center, Radboud University Nijmegen Medical Center, RUNMC
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
Netherlands
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement
The researchers use CASTOR for data management, furthermore, studies are registered in PANAMA, this study is registered under number 108187. For analyses, data are loaded in SPSS as CASTOR is not able to do that. The data stored are the filled-in 4-part paper surveys and informed consents of all subjects. All data are anonymised and only the principal investigator has access to the actual identification of subjects.
Intention to publish date
01/06/2021
Participant level data
Stored in repository
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN89818320_PROTOCOL.pdf uploaded 05/11/2020