PREDICT-H Study: Prospective Research on Essential Determinants Influencing Complication Trends in Hypospadias - a Landmark Prospective Multicenter Cohort Study Aimed at Improving Outcome Prediction in Hypospadias Surgery

Launched by SIDRA MEDICINE · Jun 4, 2025

Keywords

ClinConnect Summary

The PREDICT-H Study is a research trial aimed at improving the outcomes of surgery for a condition called hypospadias, which is when the opening of the urethra is not located at the tip of the penis. This study looks at important details about each patient's anatomy, like the size and shape of the urethra and other features, to help predict the chances of complications after surgery. By collecting information from many boys aged 1 to 12 who are undergoing their first surgery for hypospadias, the researchers hope to create a tool that will help doctors tailor surgical plans to each patient and provide better guidance to families about what to expect.

To be eligible for this study, boys must be between 1 and 12 years old and diagnosed with hypospadias, whether it's a mild or more severe case. They should be having their first surgery and have parental consent to participate. If a boy has had previous surgeries for hypospadias or has other major genital issues, he would not qualify for this trial. Participants can expect to be part of a larger group of boys undergoing similar surgeries and will contribute to a study that aims to improve future surgical care for this condition.

Gender

MALE

Eligibility criteria

• \* Inclusion Criteria:
• • Male patients aged 1 to 12 years
• • Diagnosed with hypospadias (distal, midpenile, proximal)
• • Undergoing primary surgical repair
• • Parent/legal guardian consent obtained
• \* Exclusion Criteria:
• • Prior hypospadias or penile surgery (revision cases)
• • Major associated genital anomalies (e.g., ambiguous genitalia, severe DSD)
• • Refusal of consent or inability to complete follow-up