Worldwide Yearly Screening for Hypospadias (WYSH)

Pilot Testing of the 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.

Study Overview

• Status: Recruiting
• Conditions: Hypospadias
• Intervention / Treatment: Other: WYSH Web Application

Detailed Description

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.]

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haley Lange; Phone Number: wysh@urology.wisc.edu; Email: wysh@urology.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • UW School of Medicine and Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Male Participants with Repaired Hypospadias; 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	Other: WYSH Web Application; Worldwide Yearly Screening for Hypospadias (WYSH) Web Application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Participant Count to Summarize answers of the Care Planning Tool	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	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	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider Acceptability: Usability Scale	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.

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Vinaya Bhatia, MD, UW School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: May 2, 2025
• First Submitted That Met QC Criteria: May 2, 2025
• First Posted (Actual): May 11, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Patient-Reported Outcomes; Hypospadias Complications
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Congenital Abnormalities; Urogenital Abnormalities; Penile Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypospadias
• Other Study ID Numbers: 2025-0402; A539800 (Other Identifier: UW Madison); 2K12DK100022-06 (U.S. NIH Grant/Contract); Protocol Version 3/16/26 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Sharing Time Frame: Deidentified individual personal data and supporting information will be made available immediately after publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No