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| ID | Type | Description | Link |
|---|---|---|---|
| 2K12DK100022-06 | U.S. NIH Grant/Contract | View source | |
| A539800 | Other Identifier | UW Madison | |
| Protocol Version 3/16/26 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.]
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Male Participants with Repaired Hypospadias | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WYSH Web Application | Other | Worldwide Yearly Screening for Hypospadias (WYSH) Web Application |
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| 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. |
| 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. |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haley Lange | Contact | wysh@urology.wisc.edu | wysh@urology.wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vinaya Bhatia, MD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW School of Medicine and Public Health | Recruiting | Madison | Wisconsin | 53792 | United States |
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.
Deidentified individual personal data and supporting information will be made available immediately after publication.
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| ID | Term |
|---|---|
| D007021 | Hypospadias |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Baseline, 3 weeks, 3 months |
| Data collected after participating patient completes questionnaire, up to approximately 3 months. |
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |