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

Sidra Medicine

Status: Enrolling

Conditions: Hypospadias

Study type: Observational

Funder types: Other

Identifiers

NCT07017842

SDR600058

Details and patient eligibility

About

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.

Enrollment: 1,300 estimated patients

Sex: Male

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,300 participants in 1 patient group

Hypospadias (Age 1-12 years old)

Description:

This study includes a single prospective observational cohort of male pediatric patients aged 1 to 12 years undergoing primary surgical repair for hypospadias at participating tertiary pediatric urology centers. No experimental interventions are assigned by the study; instead, patients receive standard-of-care surgical techniques as determined by their treating surgeons. Detailed preoperative anatomical assessments and surgical procedure documentation are collected to evaluate the impact of anatomical variables and surgical approaches on postoperative complication rates. Subgroup analyses will be performed based on hypospadias severity (distal, midpenile, proximal) and the surgical technique utilized.