RecruitingNot ApplicableNCT07319780

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


Sponsor

National Children's Medical Center, Uzbekistan

Enrollment

100 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 6 MonthsMax Age: 84 Months

Inclusion Criteria5

  • 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 Criteria6

  • 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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Interventions

PROCEDUREFibrin-Enhanced TIP Urethroplasty

Tubularized incised plate urethroplasty augmented with autologous platelet-rich fibrin membrane applied to the incised urethral plate prior to tubularization.

PROCEDUREGrafted TIP Urethroplasty

Graft-augmented tubularized incised plate urethroplasty performed using standard surgical techniques for unfavorable urethral plates.


Locations(2)

Dr. Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, Indonesia

National Children's Medical Center

Tashkent, Tashkent, Uzbekistan

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NCT07319780


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