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

Distal hypospadias is the most common form of hypospadias. The Tubularized Incised Plate (TIP) repair is the standard surgical technique for this condition; however, complications such as fistula formation and meatal stenosis remain concerns. These complications are often influenced by the choice of intermediate tissue layer used to reinforce the neourethra. The traditional ventral dartos flap is effective but can be technically challenging and may result in a bulky tissue layer. Platelet-rich fibrin (PRF) is an autologous, growth factor-rich biological material that has shown promise in tissue regeneration and healing. It is easy to prepare intraoperatively and may serve as a biological reinforcement to reduce postoperative complications. This study aims to provide high-quality evidence comparing the effectiveness of PRF versus the ventral dartos flap in patients with distal hypospadias, specifically those with Grade 1 urethral defects and minimal penile curvature, using a stratified study population to ensure balanced groups.

NCT Number	NCT07045545
Lead Sponsor	National Children's Medical Center, Uzbekistan Collaborators: Dr Cipto Mangunkusumo General Hospital
Conditions	PRF, Hypospadias, Distal Hypospadias, Hypospadias Repair, Fistula Stenosis, Cosmetic Outcomes, Functional Outcomes, Tubularized Incised Plate
Enrollment	5 participants
Start Date	2025-06-05
Primary Completion	2026-06-05 (estimated)
Study Completion	2026-06-05 (estimated)
Updated on ClinicalTrials.gov	2025-07-01