PREDICT-H Study on Key Factors Affecting Surgical Outcomes in Male Children Aged 1 to 12 With Hypospadias A Multicenter Prospective Cohort Study to Improve Complication Prediction

What this Trial Is About

Hypospadias is a common birth condition affecting the anatomy of the penis, which can influence surgical results. Researchers are conducting a large, prospective multicenter study to systematically assess key anatomical features like urethral plate size, glans size, chordee severity, and meatal position. The goal is to create and validate a tool to predict the risk of complications after surgery, helping tailor surgical plans and improve counseling for patients and families. This observational study enrolls male children aged 1 to 12 years who are undergoing their first surgical repair for hypospadias at specialized pediatric urology centers. There are no experimental treatments patients receive the usual surgical care determined by their doctors. Detailed assessments of anatomy are done before surgery, and surgical details are recorded. The study will analyze outcomes based on the severity of hypospadias and the surgical methods used. Participants will be followed for at least six months after surgery to monitor complications, with additional optional assessments at one month, three months, 12 months, and at the last clinic visit. Researchers will evaluate complication rates, cosmetic and functional results, and how preoperative anatomy relates to specific postoperative issues. This will help improve prediction and management of surgical outcomes over the study period, which runs until early 2028.

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