Clinical Trial

Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias

Study acronym: FTIP-RCT
Recruiting
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-12-20; most recent amendment 2026-01-28.
Status change: Not Yet Recruiting → Recruiting 2026-01-28
Trial Details
NCT Number NCT07319780
Lead Sponsor National Children's Medical Center, Uzbekistan
Collaborators: Dr Cipto Mangunkusumo General Hospital
Conditions Distal Hypospadias, Hypospadias
Enrollment 100 participants
Start Date 2026-01-05
Primary Completion 2028-07-05 (estimated)
Study Completion 2028-12-25 (estimated)
Updated on ClinicalTrials.gov 2026-01-30