Condition category
Urological and Genital Diseases
Date applied
04/11/2020
Date assigned
04/11/2020
Last edited
05/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

https://www.radboudumc.nl/EN/Pages/default.aspx

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

Editorial Notes

05/11/2020: Uploaded protocol (not peer reviewed) version 2, March 2018. 04/11/2020: Trial's existence confirmed by the local ethics committee (CMO Arnhem-Nijmegen).