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Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias

RecruitingNAAges 6 Months - 84 MonthsMaleNational Children's Medical Center, Uzbekistan
NCT07319780 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Fibrin-Enhanced TIP Urethroplasty
  • Grafted TIP Urethroplasty
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Where

2 sites
Dr. Cipto Mangunkusumo Hospital
Jakarta, Indonesia
National Children's Medical Center
Tashkent, Uzbekistan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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