HypospadiasWYSHNCT06966375
Worldwide Yearly Screening for Hypospadias
A study testing WYSH Web Application in people with Hypospadias, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 65 years, men only
- Conditions the study is for
- Hypospadias
- What is being tested?
- WYSH Web Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 65 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UW School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
Official title: 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.
Read the 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.]
- Conditions
- Hypospadias
- Being tested
- WYSH Web Application
- Keywords
- Hypospadias Complications, Quality of Life, Patient-Reported Outcomes
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WYSH Web ApplicationOther
Worldwide Yearly Screening for Hypospadias (WYSH) Web Application
| Study group | Role | What they receive |
|---|---|---|
| Male Participants with Repaired Hypospadias | Experimental | * 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 Receives: Other: WYSH Web Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 weeks, 3 months
Secondary outcomes (1)
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.
Measured: Data collected after participating patient completes questionnaire, up to approximately 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start23 Jul 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vinaya Bhatia, MD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966375
- Sponsor's protocol ID
- 2025-0402
- Other IDs
- 2K12DK100022-06, A539800, Protocol Version 9/25/26
- Acronym
- WYSH
- Status last verified
- Sep 2026
- First submitted
- 2 May 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing of the Worldwide Yearly Screening for Hypospadias
- ClinicalTrials.gov ID
- NCT06966375
- Acronym / sponsor ID
- WYSH / 2025-0402
- Conditions
- Hypospadias
- Keywords
- Hypospadias Complications, Quality of Life, Patient-Reported Outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Male Participants with Repaired Hypospadias | Experimental | Other: WYSH Web Application* 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 |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Males who have a documented history of repaired hypospadias.
- Age groups targeted, based on recommended standards for user experience data from pilot studies:
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WYSH Web ApplicationWorldwide Yearly Screening for Hypospadias (WYSH) Web Application | Other | Male Participants with Repaired Hypospadias |
Primary outcome
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).
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.
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.
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.
1 secondary outcome
Provider Acceptability: Usability Scale
Time frame: Data collected after participating patient completes questionnaire, up to approximately 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vinaya Bhatia, MD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WYSH Web Application in people with Hypospadias, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haley Lange (wysh@urology.wisc.edu, wysh@urology.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Participant Count to Summarize answers of the Care Planning Tool (time frame: Baseline, 3 weeks, 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.