Platelet-rich fibrin versus grafted TIP repair for distal hypospadias

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, single-blinded randomized controlled comparison of fibrin-enhanced TIP (F-TIP) using autologous platelet-rich fibrin (PRF) versus grafted TIP (G-TIP) in children with distal hypospadias and an unfavorable urethral plate. Boys aged 6 to 84 months with primary or redo distal hypospadias and penile curvature under 45 degrees are randomized 1:1 to receive intraoperative PRF applied to the incised urethral plate or standard graft augmentation without PRF. PRF is prepared from the patient’s peripheral blood using a standardized centrifugation protocol and applied before tubularization. Participants are followed postoperatively to record surgical complications (such as urethrocutaneous fistula and meatal stenosis), functional outcomes, and cosmetic results using predefined outcome measures.

Why it matters

Who can join: the full rules

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

Where it's running

• National Children's Medical Center
  Tashkent, Tashkent, Uzbekistan Recruiting
• Dr. Cipto Mangunkusumo Hospital
  Jakarta, DKI Jakarta, Indonesia Not yet recruiting

Study contacts

• Principal investigator: Zafar Abdullaev, MD, PhD — National Children's Medical Center, Tashkent, Uzbekistan
• Study coordinator: Zafar Abdullaev, MD PhD
• Email: Abdullaev.med@gmail.com
• Phone: +998-90-909-9911

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.