A Multicenter Randomized Controlled Trial Comparing Fibrin-Enhanced TIP and Grafted TIP Urethroplasty in Distal Hypospadias With Unfavorable Urethral Plates

What this Trial Is About

This research evaluates surgical methods for treating distal hypospadias, a common condition in boys where the urethral opening is on the underside of the penis. The study compares the standard graft-augmented tubularized incised plate (G-TIP) urethroplasty with a newer approach using fibrin-enhanced TIP (F-TIP) that applies the patient's own platelet-rich fibrin (PRF) during surgery. The goal is to see if PRF reduces complications like urethrocutaneous fistula and narrowing of the urethral opening after surgery. Participants are male children aged 6 months to 7 years with primary or redo distal hypospadias and an unfavorable urethral plate. They will be randomly assigned to receive either F-TIP urethroplasty with PRF applied to the incised urethral plate or standard G-TIP urethroplasty without PRF. The PRF is prepared during surgery from the child's own blood using a specific centrifugation process and fixed in place before tubularization. After surgery, children will be monitored for complications, urinary function, and cosmetic outcomes over six months. Researchers will assess the occurrence of urethral complications, urethral narrowing, urinary flow rates, and cosmetic appearance using standardized scoring. The study is conducted at multiple centers and aims to provide clearer information on which surgical approach may improve healing and results in boys with this condition.

Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias