NCT07017842

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,300 (estimated)
• Sponsor: Sidra Medicine · Academic / Other
• Sex: Male
• Age: 1 Year – 12 Years
• Healthy volunteers: Not accepted

Summary

Hypospadias is a common congenital anomaly with complex anatomy that influences surgical outcomes. Despite numerous surgical techniques, a lack of standardized preoperative assessment protocols and consensus on anatomical risk factors limits prediction of complications. This study aims to systematically evaluate key anatomical features identified in previous meta-analyses-such as urethral plate width and length, glans size, chordee severity, meatal position, and others-in a large, prospective multicenter cohort. The ultimate goal is to develop and validate an objective nomogram predicting the risk of postoperative complications, enabling individualized surgical planning and improved patient counseling.

Conditions

• Hypospadias

Timeline

• Start date: 2025-06-04
• Primary completion: 2027-12-31
• Completion: 2028-02-28
• First posted: 2025-06-12
• Last updated: 2025-06-12

Locations

1 site across 1 country: Qatar