Worldwide Yearly Screening for Hypospadias

NCT ID: NCT06966375

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-23

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypospadias

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

WYSH Web Application

Intervention Type OTHER

Worldwide Yearly Screening for Hypospadias (WYSH) Web Application

Interventions

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WYSH Web Application

Worldwide Yearly Screening for Hypospadias (WYSH) Web Application

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

5 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vinaya Bhatia, MD

Role: PRINCIPAL_INVESTIGATOR

UW School of Medicine and Public Health

Locations

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UW School of Medicine and Public Health

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Haley Bryte

Role: CONTACT

Other Identifiers

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2K12DK100022-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A539800

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version

Identifier Type: OTHER

Identifier Source: secondary_id

2025-0402

Identifier Type: -

Identifier Source: org_study_id

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