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

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.

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.

Inclusion Criteria:

• Male children aged 6 months to 84 months
• Primary or redo distal hypospadias
• Unfavorable urethral plate
• Penile curvature less than 45 degrees after degloving
• Eligibility for tubularized incised plate urethroplasty

Exclusion Criteria:

• Disorders of sex development or ambiguous genitalia
• Severe penile curvature requiring urethral plate transection
• Previous graft-based urethroplasty
• Active local or systemic infection at the time of surgery
• Known bleeding or platelet disorders
• Inability to comply with postoperative follow-up