NCT07319780

Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias

A Multicenter Randomized Controlled Trial Comparing Fibrin-Enhanced Tubularized Incised Plate (F-TIP) and Grafted Tubularized Incised Plate (G-TIP) Urethroplasty in Distal Hypospadias With Unfavorable Urethral Plates

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National Children's Medical Center, Uzbekistan · Academic / Other
• Sex: Male
• Age: 6 Months – 84 Months
• Healthy volunteers: Not accepted

Summary

Hypospadias is a common congenital condition in boys in which the opening of the urethra is located on the underside of the penis. Distal hypospadias is the most common form and is usually treated surgically using tubularized incised plate (TIP) urethroplasty. In boys with an unfavorable urethral plate, graft-augmented techniques (G-TIP) are often used; however, postoperative complications such as urethrocutaneous fistula and narrowing of the urethral opening (meatal stenosis) may still occur. Platelet-rich fibrin (PRF) is a biological material obtained from the patient's own blood that contains natural growth factors and may help improve tissue healing. This study aims to evaluate whether the use of PRF during surgery can reduce postoperative complications and improve surgical outcomes in children undergoing hypospadias repair.

Detailed description

This is a prospective, multicenter, single-blinded randomized controlled trial designed to compare fibrin-enhanced tubularized incised plate (F-TIP) urethroplasty using autologous platelet-rich fibrin (PRF) with grafted tubularized incised plate (G-TIP) urethroplasty in children with distal hypospadias and an unfavorable urethral plate. Male children aged 6 months to 84 months with primary or redo distal hypospadias and mild penile curvature will be eligible for inclusion. Participants will be randomized in a 1:1 ratio to undergo either F-TIP urethroplasty with intraoperative application of autologous PRF or standard G-TIP urethroplasty without PRF. Autologous PRF will be prepared intraoperatively from the patient's peripheral blood using a standardized centrifugation protocol and applied to the incised urethral plate prior to tubularization. Participants will be followed postoperatively for the assessment of surgical complications, functional outcomes, and cosmetic results according to predefined outcome measures.

Conditions

• Distal Hypospadias
• Hypospadias

Interventions

Type	Name	Description
PROCEDURE	Fibrin-Enhanced TIP Urethroplasty	Tubularized incised plate urethroplasty augmented with autologous platelet-rich fibrin membrane applied to the incised urethral plate prior to tubularization.
PROCEDURE	Grafted TIP Urethroplasty	Graft-augmented tubularized incised plate urethroplasty performed using standard surgical techniques for unfavorable urethral plates.

Timeline

• Start date: 2026-01-05
• Primary completion: 2028-07-05
• Completion: 2028-12-25
• First posted: 2026-01-06
• Last updated: 2026-01-30

Locations

2 sites across 2 countries: Indonesia, Uzbekistan