A Multicenter Randomized Controlled Trial Comparing Platelet-Rich Fibrin and Ventral Dartos Flap as Intermediate Layers in Tabularized Incised Plate (TIP) Urethroplasty for Distal Hypospadias With Mild Penile Curvature

Launched by NATIONAL CHILDREN'S MEDICAL CENTER, UZBEKISTAN · Jun 30, 2025

Keywords

ClinConnect Summary

This international, randomized study is comparing two ways to reinforce the urethral repair done for distal hypospadias in young children with mild penile curvature. After consent, children are randomly assigned to Group A, where a patient’s own platelet-rich fibrin (PRF) membrane is placed over the repaired urethra, or Group B, where a tissue flap from the ventral dartos fascia is rotated over the repair. The main question is which method leads to fewer problems after surgery—especially the risk of a fistula (a leak where urine can escape)—evaluated at least 6 months after the operation. Researchers will also track other complications and how well the cosmetic appearance turns out, using a standardized scoring system based on photographs reviewed by blinded doctors.

Eligible participants are children aged 6 months to 5 years with primary distal hypospadias (Grade 1, Abbas classification) or redo distal hypospadias, and a penile curvature of less than 30 degrees after turning the skin back (degloving). Exclusions include previous hypospadias surgery, proximal (more complex) hypospadias, curvature 30 degrees or more, or certain health conditions. The trial is conducted at centers in Uzbekistan and Indonesia (National Children’s Medical Center, Tashkent, and a collaborating hospital in Jakarta) and uses TIP or GTIP repair techniques. After surgery, participants return for follow-ups at 1, 3, and 6 months to check for complications and to have cosmetic outcomes scored by blinded evaluators, with safety and data managed securely.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Primary and complex distal hypospadias (Grade 1, Abbas classification)
• • 2. Penile curvature \<30° after degloving (Methodology of curvature measurement: Abbas T. O. (2022).
• • 3. Children aged 6 months to 5 years
• Exclusion Criteria:
• • 1. Previous hypospadias surgery
• • 2. Proximal hypospadias
• • 3. Penile curvature ≥30°
• • 4. Syndromic anomalies or coagulopathy