PREDICT-H: Improving prediction of complications after hypospadias surgery
Official title: 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
Run by Sidra Medicine · NCT07017842 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 1 Year to 12 Years |
| Sex | Men only |
| Enrollment | 1300 (estimated) |
| Sponsor | Sidra Medicine Academic / other |
| Locations | 1 site (Doha, Baladiyat ad Dawhah) |
| Status | Recruiting |
| Started | June 4, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | February 28, 2028 |
| Registry record updated | June 12, 2025 |
| Trial ID | NCT07017842 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous retrospective studies and meta-analyses have identified candidate anatomical risk factors, but large prospective multicenter validation of an objective prediction nomogram is limited.
Who can join: the full rules
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 it's running
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Sidra Medicine
Doha, Baladiyat ad Dawhah, Qatar Recruiting
Study contacts
- Study coordinator: Maraeh Angela Mancha
- Email: MMancha@sidra.org
- Phone: +974-40033333
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This trial will see if a sacral erector spinae plane block or a caudal epidural block gives better pain relief for boys aged 1–5 after hypospadias repair.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.