Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias

Recruiting now · Not applicable

Conditions studied: Distal Hypospadias, Hypospadias

In brief

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.

Key facts

Study ID

NCT07319780

Run by

National Children's Medical Center, Uzbekistan

People needed

100

Starts

2026-01-05

Expected to finish

2028-12-25

Last updated by the study team

2026-01-30

Who can join

Age: 1 and older, up to 7. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• National Children's Medical Center — Tashkent, Tashkent, Uzbekistan (enrolling)
• Dr. Cipto Mangunkusumo Hospital — Jakarta, DKI Jakarta, Indonesia

Full record on ClinicalTrials.gov

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