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Verdensomspennende årlig screening for hypospadier (WYSH)

28. september 2026 oppdatert av: University of Wisconsin, Madison

Pilottesting av den verdensomspennende årlige screeningen for hypospadier

The purpose of this study is to recruit approximately 20 male participants who have a history of repaired hypospadias to test the feasibility and acceptability of the Care Planning Tool within the Worldwide Yearly Screening for Hypospadias (WYSH) Web Application.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Several studies show that patients who undergo hypospadias repair report significant functional and psychosexual issues in adolescence or adulthood (in more than 50% of cases). The Care Planning tool within the Worldwide Yearly Screening for Hypospadias (WYSH) Web Application, developed using expert level consensus from a Delphi Measure including stakeholders (psychologists, urologists, endocrinologists, patients/families), is designed to support the functional and psychosexual health of male youth and adults treated for hypospadias, to support their physical and mental health after repair.

This is a pilot study of the WYSH intervention to access its feasibility and acceptability.

[Potential participants can enroll at their local clinic.]

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53792
        • Rekruttering
        • UW School of Medicine and Public Health

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

5 år til 65 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  • Males who have a documented history of repaired hypospadias.

  • Age groups targeted, based on recommended standards for user experience data from pilot studies:

    • 3-5 Males, age 0-4 (with parental consent)
    • 3-5 Males, age 5-10 (with parental consent and child assent)
    • 3-5 Males, age 11-15 (with parental consent and child assent)
    • 3-5 Males, age 16-20 (with parent consent, child assent until age 18)
    • 3-5 Males, age 21-65

Exclusion Criteria:

-

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Male Participants with Repaired Hypospadias
  • 3-5 Males, age 0-4 (with parental consent)
  • 3-5 Males, age 5-10 (with parental consent and child assent)
  • 3-5 Males, age 11-15 (with parental consent and child assent)
  • 3-5 Males, age 16-20 (with parent consent, child assent until age 18)
  • 3-5 Males, age 21-65

Worldwide Yearly Screening for Hypospadias (WYSH) Web Application

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility: Participant Count to Summarize answers of the Care Planning Tool
Tidsramme: Baseline, 3 weeks, 3 months

The Care Planning Tool within the Worldwide Yearly Screening for Hypospadias (WYSH) Application is a survey containing forty-eight questions regarding possible complications for participating patients (Subsections of penile function, voiding, sexual health, social functioning, psychological health, and doctor-patient communication). These questions will be completed by patients using a five point scale - "Never," "Rarely," "Sometimes," "Often," and "Always" - to populate a Care Plan highlighting areas of concern (with a threshold of two or more metrics above a "Sometimes" response).

Baseline, 3 weeks, 3 months
Acceptability: User Centered Metrics
Tidsramme: Baseline, 3 weeks, 3 months

Participating patients will complete a survey regarding the System Usability to determine ease of functionality throughout the application. This survey contains a scale for participants to graph their response from "Very Difficult" to "Very Easy" following the eleven questions of task completion. Additionally, there is a space provided for open-ended feedback.

Baseline, 3 weeks, 3 months
Acceptability: Cognitive Debriefing Measures
Tidsramme: Baseline, 3 weeks, 3 months

A team from the Wisconsin Surgical Outcomes Research Program (WiSOR) will complete a Cognitive Debriefing Interview with participating patients to assist in determining validation and comprehension. This interview consists of seven open-ended questions regarding participants' thought processes to provide an insight into areas of improvement for the application. Answers will be coded and themes summarized by participant count.

Baseline, 3 weeks, 3 months
Feasibility: System Usability Testing
Tidsramme: Baseline, 3 weeks, 3 months

The Center for User Experience will conduct masked System Usability Testing to provide user-based information on how to improve the online experience for young males and their caregivers and adult males. Usability will be assessed with a level of success rating from "Failure," "Success with a major issue," "Success with a minor issue," and "Complete Success," where minor or major issues and time taken are observed as the participating patient is completing the System Usability Scale.

Baseline, 3 weeks, 3 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Provider Acceptability: Usability Scale
Tidsramme: Data collected after participating patient completes questionnaire, up to approximately 3 months.

Participating UW Clinicians will rate the recommendations received in each care plan from patients in a separate usability scale (Provider Acceptability) to improve the ability for continuity of care. Providers will complete a survey of questions surrounding format, output, and utility from "Strongly Disagree" to "Strongly Agree." Additionally, there is a space provided for feedback.

Data collected after participating patient completes questionnaire, up to approximately 3 months.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Vinaya Bhatia, MD, UW School of Medicine and Public Health

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

23. juli 2025

Primær fullføring (Antatt)

1. november 2026

Studiet fullført (Antatt)

1. november 2026

Datoer for studieregistrering

Først innsendt

2. mai 2025

Først innsendt som oppfylte QC-kriteriene

2. mai 2025

Først lagt ut (Faktiske)

11. mai 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Individual participant data collected during pilot testing, after deidentification, will be accessible in the form of text, tables, publications, figures, etc. to disseminate efficacy of the Care Planning tool within the application.

IPD-delingstidsramme

Deidentified individual personal data and supporting information will be made available immediately after publication.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere