PREDICT-H: Improving prediction of complications after hypospadias surgery
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
See if measurements of penis anatomy before surgery can predict which boys aged 1–12 will have complications after their first hypospadias repair.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1300 (estimated) |
| Ages | 1 Year to 12 Years |
| Sex | Male |
| Sponsor | Sidra Medicine Academic / other |
| Locations | 1 site (Doha, Baladiyat ad Dawhah) |
| Trial ID | NCT07017842 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort that will record standardized preoperative anatomical measurements (urethral plate width and length, glans size, chordee severity, meatal position, and related features) in boys undergoing primary hypospadias repair. Surgeons will use a common measurement protocol and postoperative complications will be tracked during follow-up. Statistical modeling will be used to derive and validate an objective nomogram linking preoperative anatomy to complication risk. The goal is to create a reproducible risk tool to support individualized surgical planning and family counseling.
Who should consider this trial
Good fit: Boys aged 1 to 12 years with primary distal, midpenile, or proximal hypospadias who are scheduled for initial surgical repair and whose parent or guardian provides consent.
Not a fit: Patients with prior hypospadias or penile surgery, major associated genital anomalies (e.g., ambiguous genitalia, severe DSD), or those unable to complete follow-up are excluded and unlikely to benefit from the prediction tool.
Why it matters
Potential benefit: If successful, the nomogram could help surgeons tailor surgical approaches and give families clearer, individualized information about risk of complications.
How similar studies have performed: Previous retrospective studies and meta-analyses have identified candidate anatomical risk factors, but large prospective multicenter validation of an objective prediction nomogram is limited.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Doha, Baladiyat ad Dawhah
- Sidra Medicine — Doha, Baladiyat ad Dawhah, Qatar (Recruiting)
Study contacts
- Study coordinator: Maraeh Angela Mancha
- Email: MMancha@sidra.org
- Phone: +974-40033333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.