UW School of Medicine and Public Health
Madison, Wisconsin, 53792, United States
Location status: Recruiting
NCT Number: NCT06966375
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.
Interested in participating?
Request Info5 year–65 year
Male
Interventional
Not applicable
Madison, Wisconsin, 53792, United States
Location status: Recruiting
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.]
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
Worldwide Yearly Screening for Hypospadias (WYSH) Web Application
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).
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.
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.
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.
Time frame: Data collected after participating patient completes questionnaire, up to approximately 3 months.
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.
Contact information is provided by the study sponsor or research team.
University of Wisconsin, Madison
Other
Pilot Testing of the Worldwide Yearly Screening for Hypospadias
Acronym: WYSH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07426731
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06832280
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Indianapolis, Indiana, United States
View Trial DetailsNCT07675798
Caudal Block, Congenital Abnormalities
Diyarbakır, Eyalet/Yerleşke, Turkey (Türkiye)
View Trial DetailsNCT07619651
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Kayseri, Turkey (Türkiye)
View Trial Details