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Lower Urinary Tract Symptoms (LUTS)STREAMWAYNCT07339865

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

An observational study of Lower Urinary Tract Symptoms (LUTS) and Transition Care, run by University Hospital, Ghent at 1 site in Belgium.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 16 to 25 years
What is being tested?
Semi-structured in-depth interviews with standardized validated questionnaires and Completion of a urological time-line
How many people
20 participants
Where
1 siteBelgium
Study dates
28 Feb 2025to 31 Dec 2029
How long will I take part?
3 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: The Study of Transition in Real-life Experiences Affecting Micturition and Well-being in Adolescent Years (STREAMWAY) aims to map perceptions, attitudes and experiences of adolescents who have undergone the transfer from paediatric to adult urological care. Participants should have received follow-up care for childhood LUTS from a general practitioner, urologist, paediatric urologist, or paediatric nephrologist. At the initial study visit, before enrolment, AYA patients with LUTS undergo a complete diagnostic work-up as part of standard care to determine the presence of LUTS at the time of consultation.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Belgium1 site

  • Ghent University Hospital

    Ghent, East-Flanders, 9000

Other trials in Belgium

About this study

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

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.

Read the 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.

Being tested
Semi-structured in-depth interviews with standardized validated questionnaires, Completion of a urological time-line
Keywords
Transition Care, Adolescents, Lower urinary tract symptoms (LUTS), Mixed-method research, Pediatric urology, Functional Urology, Interviews, Urological Time-line, Questionnaires
Medical subject headings
Lower Urinary Tract Symptoms, Nocturnal Enuresis, Constipation, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semi-structured in-depth interviews with standardized validated questionnairesOther

    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.

  • Completion of a urological time-lineOther

    Participants complete a blank timeline representing their urological care pathway from birth to the moment of the in-depth interview.

Study groups in NCT07339865
Study groupRoleWhat they receive
Adolescents and young adults (AYA)Adolescents and young adults (AYA) with persisting childhood LUTS, none related to a congenital or neurological disorder.
Receives: Other: Semi-structured in-depth interviews with standardized validated questionnaires; Other: Completion of a urological time-line

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceptions, Attitudes, and Experiences Regarding Transition from Pediatric to Adult Urological Care

    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.

    Measured: Baseline (single assessment)

Secondary outcomes (7)

  1. Persisting LUTS in adolescence

    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.

    Measured: Baseline (single assessment)

  2. Constipation complaints

    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.

    Measured: Baseline (single assessment)

  3. Sleep quality

    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.

    Measured: Baseline (single assessment)

  4. Quality of Life reporting

    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.

    Measured: Baseline (single assessment)

  5. Quality of Life - LUTS related

    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.

    Measured: Baseline (single assessment)

  6. Adverse Childhood Experiences (ACE's)

    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.

    Measured: Baseline (single assessment)

  7. Genitourinary Pain

    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.

    Measured: Basline (Single assessment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2026
  2. Study start28 Feb 2025
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
20 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07339865
Sponsor's protocol ID
ONZ-2024-0541
Acronym
STREAMWAY
Status last verified
Dec 2025
First submitted
19 Dec 2025
Last updated
14 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Maintaning confidentiality and patient safety. Data is entered manually on an online firewall-protected data registry on the password-encrypted server of Ghent University. Subsequently, data is stored in a central IBM SPSS database also protected by the institutional firewall. Pseudonymized qualitative and quantitative data are registered in separated data sets, accessible to the PI, trial coordinator, and co-investigators. Only the trial coordinator has access to a key file with pseudonymization codes linked to patient data.

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.

    PubMed 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.

    PubMed 40829984

Questions about this trial

What is this clinical trial studying?

An observational study of Lower Urinary Tract Symptoms (LUTS) and Transition Care, run by University Hospital, Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceptions, Attitudes, and Experiences Regarding Transition from Pediatric to Adult Urological Care (time frame: Baseline (single assessment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07339865, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.

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