- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07339865
Study of Transition in Real-life Experiences Affecting Micturition and Well-being in Adolescent Years (STREAMWAY)
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
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East-Flanders
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Ghent, East-Flanders, Belgium, 9000
- Ghent University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adolescents and young adults (AYA)
Adolescents and young adults (AYA) with persisting childhood LUTS, none related to a congenital or neurological disorder.
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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.
Participants complete a blank timeline representing their urological care pathway from birth to the moment of the in-depth interview.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceptions, Attitudes, and Experiences Regarding Transition from Pediatric to Adult Urological Care
Time Frame: Baseline (single assessment)
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Assessment of adolescents' perceptions, attitudes, and experiences related to the transition from pediatric to adult urological care, as measured using a semi-structured in-depth interview after or during completion of the transition process, depending of the age of the included participant.
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Baseline (single assessment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Persisting LUTS in adolescence
Time Frame: Baseline (single assessment)
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Assessment of LUTS at the moment of the in-depth interview (cross-sectional) potentially being linked to the primary outcome.
The ICIQ-M+FLUTS symptom items are scored on a 0-4 Likert scale, and associated bother items are scored on a 0-10 numeric rating scale, with higher scores indicating greater symptom severity or impact.
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Baseline (single assessment)
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Constipation complaints
Time Frame: Baseline (single assessment)
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Assessment of constipation complaints at the moment of the in-depth interview (cross-sectional) potentially being linked to the primary outcome.
The Cleveland Clinic Constipation Score (CCCS) consists of 8 items scored on a 0-4 Likert scale, yielding a total score ranging from 0 to 30, with higher scores indicating more severe constipation symptoms.
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Baseline (single assessment)
|
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Sleep quality
Time Frame: Baseline (single assessment)
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Assessment of sleep quality at the moment of the interview (cross-sectional), potentially linked to the primary outcome.
The Pittsburgh Sleep Quality Index (PSQI) yields seven component scores (each scored 0-3) that are summed to produce a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
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Baseline (single assessment)
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Quality of Life reporting
Time Frame: Baseline (single assessment)
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Assessment of general quality of life at the moment of the interview (cross-sectional), potentially linked to the primary outcome.
The EQ-5D-5L assesses health-related quality of life across five dimensions, each scored on a 5-level categorical scale.
Responses are converted into a country-specific index score (typically ranging from <0 to 1.0) and a visual analogue scale (VAS) score ranging from 0 to 100, with higher scores indicating better health status.
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Baseline (single assessment)
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Quality of Life - LUTS related
Time Frame: Baseline (single assessment)
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Assessment of LUTS-related Quality of life at the moment of the interview (cross-sectional), potentially linked to the primary outcome.
The ICIQ-LUTSqol consists of 19 items scored on a 4-point Likert scale (1-4), yielding a total score ranging from 19 to 76, with higher scores indicating greater quality-of-life impairment related to lower urinary tract symptoms.
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Baseline (single assessment)
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Adverse Childhood Experiences (ACE's)
Time Frame: Baseline (single assessment)
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Assessment of adverse childhood experiences (ACE's) at the moment of the interview collected (cross-sectional), reporting from birth untill present, potentially linked to the primary outcome.
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Baseline (single assessment)
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Genitourinary Pain
Time Frame: Basline (Single assessment)
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Assessment of genitourinary pain at the moment of the in-depth interview (cross-sectional) potentially being linked to the primary outcome.
The Female/Male Genitourinary Pain Index (GUPI) consists of 15 items across pain, urinary symptoms, and quality-of-life domains, yielding a total score ranging from 0 to 45, with higher scores indicating greater symptom severity.
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Basline (Single assessment)
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Nervous System Diseases
- Mental Disorders
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Signs and Symptoms, Digestive
- Urination Disorders
- Urological Manifestations
- Behavioral Symptoms
- Elimination Disorders
- Sleep Wake Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Enuresis
- Sleep Initiation and Maintenance Disorders
- Constipation
- Lower Urinary Tract Symptoms
- Nocturnal Enuresis
Other Study ID Numbers
- ONZ-2024-0541
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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