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Enrolling by invitation NCT07339865

Study of Transition in Real-life Experiences Affecting Micturition and Well-being in Adolescent Years

Observational Lower Urinary Tract Symptoms (LUTS) Transition Care Enuresis Nocturnal Adverse Childhood Experiences

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Semi-structured in-depth interviews with standardized validated questionnaires, Completion of a urological time-line.
Who it may be relevant to
Registry conditions: Lower Urinary Tract Symptoms (LUTS), Transition Care, Enuresis Nocturnal, Adverse Childhood Experiences. Basic parameters: 16 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Perceptions and Barriers of Transition in Care Among Patients on Pediatric and Adult Urology Services - STREAMWAY: Study of Transition in Real-life Experiences Affecting Micturition and Well-being in Adolescent Years

Overview

With this study, we would like to interview 16-25-year-olds who have experienced urinary problems since childhood and who are still experiencing symptoms in young adulthood. The transition from childhood, through puberty, to young adulthood is a time period marked by many psychological ans physiological changes, during which it can be difficult to properly monitor certain symptoms. With this study, we aim to gather opinions and experiences of adolescents and young adults in order to improve urological care for other patients in the future.

Detailed description

This study investigates the experiences of adolescents with urinary symptoms during the transition from pediatric to adult urological care. This transition is a complex, multidisciplinary process that impacts their well-being and treatment. Gaining insight into the perceptions of and barriers within this transition is crucial for improving care and guidance for future patients.

This mix-method study uses in-depth interviews and standardized questionnaires and focuses on adolescents (16-25 years) with a history of urinary symptoms who are currently being followed for these complaints. Data collection includes a timeline completion of the urological care pathway from birth untill the moment of the interview, semi-structured interviews, and questionnaires. Twenty participants will be included, with the possibility of expanding the sample or terminating recruitment early depending on interim results.

Participants will be recruited via healthcare providers at Ghent University Hospital (UZ Gent) from various departments: urology, pediatric urology, pediatric nephrology, and general practice, as well as through lecture evenings organized by UZ Gent for healthcare providers from peripheral settings (outside UZ Gent) involved in the care of adolescents with urinary symptoms. The informed consent form (ICF) will be provided first-signed by the participant in the case of adults, and, in the case of minors, through an informed assent form (IAF) completed by the participant and an informed consent form (ICF) signed by a parent or legal guardian. Subsequently, appointments for an introductory meeting and interview will be scheduled.

After the introductory meeting, participants will complete a timeline of their urological care pathway from birth to date and will independently collect their childhood growth curves, following instructions provided by the research team. The subsequent interview-if approved by the participant-will be audio-recorded, questionnaires will be completed, and all data will later be pseudonymized in accordance with GDPR guidelines. Interviews may take place at UZ Gent, at a preferred location, or via video consultation.

Interventions

  • Other Semi-structured in-depth interviews with standardized validated questionnaires
    Interviews utilize a semi-structured format, with one researcher conducting all interviews to ensure consistency. A piloted, multidisciplinary-approved interview guide is used to ask open-ended questions exploring adolescent transition experiences.
  • Other Completion of a urological time-line
    Participants complete a blank timeline representing their urological care pathway from birth to the moment of the in-depth interview.

Primary outcome measures

  • Perceptions, Attitudes, and Experiences Regarding Transition from Pediatric to Adult Urological Care [Time frame: Baseline (single assessment)]
Secondary outcome measures (7)
  • Persisting LUTS in adolescence [Time frame: Baseline (single assessment)]
  • Constipation complaints [Time frame: Baseline (single assessment)]
  • Sleep quality [Time frame: Baseline (single assessment)]
  • Quality of Life reporting [Time frame: Baseline (single assessment)]
  • Quality of Life - LUTS related [Time frame: Baseline (single assessment)]
  • Adverse Childhood Experiences (ACE's) [Time frame: Baseline (single assessment)]
  • Genitourinary Pain [Time frame: Basline (Single assessment)]

Eligibility criteria

Inclusion criteria

  • LUTS (according to ICCS definition) present during childhood
  • Participants receiving follow-up care for LUTS from a general practitioner, urologist, paediatric urologist, or paediatric nephrologist.
  • Individuals aged 16-25 years who have recently transitioned to adult care or are currently undergoing the transition process.

Exclusion criteria

  • Patients not comfortable conducting interviews and completing questionnaires in Dutch
  • Participants with neurological conditions or congenital anatomical anomalies that may cause LUTS, as these individuals are already followed in established transition pathways and cannot be compared to the target population
  • Individuals with cognitive impairments that impair their capacity to independently participate in interviews or complete questionnaires.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Belgium · 1 center
  • Ghent University Hospital — Ghent

Publications

  • Karamaria S, Mauel R, Van den Ende M, Oosterlinck A, Verheye A, De Bruyne E, Degrauewe E, Dhondt K, Dossche L, Raes A, Renson C, Samijn B, Spinoit AF, Everaert K, Walle JV. Transition in enuresis patients: Identifying the gaps and opportunities for the future. Neurourol Urodyn. 2024 Jun;43(5):1118-1126. doi: 10.1002/nau.25460. Epub 2024 Apr 8. PMID 38587243
  • Van den Ende M, Joinson C, Sinha S, Verbakel I, Ochoa DC, Lazar J, Baird A, Selai C, Van Huele A, Bou Kheir G, Spinoit AF, Abrams P, Everaert K, Herve F. Navigating the waters of LUTS from childhood to puberty - NOPIA meeting (ICI-RS 2024). J Pediatr Urol. 2025 Dec;21(6):1477-1485. doi: 10.1016/j.jpurol.2025.07.011. Epub 2025 Aug 18. PMID 40829984

Identifiers

NCT: NCT07339865 · ONZ-2024-0541

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗