Worldwide Yearly Screening for Hypospadias

NCT06966375 | Recruiting

• 4 other identifiers: 2025-04022K12DK100022-06A539800Protocol Version 3/16/26
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypospadias

Keywords

Hypospadias Complications; Quality of Life; Patient-Reported Outcomes

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Provider Acceptability: Usability Scale

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

Study Arms (1)

Male Participants with Repaired Hypospadias

EXPERIMENTAL

* 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

Interventions

WYSH Web Application OTHER

Worldwide Yearly Screening for Hypospadias (WYSH) Web Application

Male Participants with Repaired Hypospadias

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males who have a documented history of repaired hypospadias.
• Age groups targeted, based on recommended standards for user experience data from pilot studies:
• Males, age 5-10 (with parental consent and child assent)
• Males, age 11-15 (with parental consent and child assent)
• Males, age 16-20 (with parent consent, child assent until age 18)
• Males, age 21-65

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UW School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Vinaya Bhatia, MD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haley Lange

CONTACT

wysh@urology.wisc.edu; wysh@urology.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 11, 2025
• Study Start: July 23, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Deidentified individual personal data and supporting information will be made available immediately after publication.

Locations

US (1)