Long-term outcome of childhood urinary symptoms
| ISRCTN | ISRCTN89818320 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89818320 |
| Secondary identifying numbers | PANAMA 108187 |
- Submission date
- 04/11/2020
- Registration date
- 04/11/2020
- Last edited
- 07/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Public
Geert Grooteplein zuid 10
Nijmegen
6500 HB
Netherlands
 ORCID ID |
0000-0002-1704-6772 |
|---|---|
| Phone | +31 (0)24 3613735 |
| liesbeth.dewall@radboudumc.nl |
Study information
| Study design | Single-center observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet written in Dutch |
| Scientific title | Long-term functional and psychosocial outcome at adolescence and young adulthood of patients treated for lower urinary tract dysfunction in childhood |
| Study acronym | LUCOS |
| Study objectives | A hypothesized 25% more lower urinary tract symptoms (LUTS) are expected in former patients versus healthy age-related controls. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2018 |
| Completion date | 01/06/2020 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 120 |
| Key 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 |
| Key exclusion criteria | Anatomical or neurological conditions resulting in lower urinary tract symptoms |
| Date of first enrolment | 01/04/2018 |
| Date of final enrolment | 01/06/2020 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Geert Grooteplein zuid 10
Nijmegen
6500 HB
Netherlands
Sponsor information
Hospital/treatment centre
Amalia Children's Hospital
Geert Grooteplein zuid 10
Nijmegen
6500 HB
Netherlands
| Phone | +31 (0)24 3613735 |
|---|---|
| liesbeth.dewall@radboudumc.nl | |
| Website | https://www.radboudumc.nl/EN/Pages/default.aspx |
"ROR" |
https://ror.org/05wg1m734 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Radboudumc, Radboud University Medical Center, Radboud University Nijmegen Medical Center, RUNMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 05/11/2020 | No | No | ||
| Results article | 03/09/2021 | 07/12/2021 | Yes | No |
Additional files
- ISRCTN89818320_PROTOCOL.pdf
- uploaded 05/11/2020
Editorial Notes
07/12/2021: Publication reference added.
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).
