Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06966375

Worldwide Yearly Screening for Hypospadias

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

5 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UW School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location status: Recruiting

About this study

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.]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

-

Treatment and study plan

WYSH Web Application

Other

Worldwide Yearly Screening for Hypospadias (WYSH) Web Application

Primary outcomes

  1. Feasibility: Participant Count to Summarize answers of the Care Planning Tool

    Time frame: 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).

  2. Acceptability: User Centered Metrics

    Time frame: 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.

  3. Acceptability: Cognitive Debriefing Measures

    Time frame: 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.

  4. Feasibility: System Usability Testing

    Time frame: 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.

Secondary outcomes

  1. Provider Acceptability: Usability Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Pilot Testing of the Worldwide Yearly Screening for Hypospadias

Acronym: WYSH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 11, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.