Platelet-rich fibrin versus grafted TIP repair for 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
This trial tests whether applying a boy's own platelet-rich fibrin during TIP repair leads to fewer complications than grafted TIP in boys aged 6 months to 7 years with distal hypospadias and an unfavorable urethral plate.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 6 Months to 84 Months |
| Sex | Male |
| Sponsor | National Children's Medical Center, Uzbekistan Academic / other |
| Locations | 2 sites (Jakarta, DKI Jakarta and 1 other locations) |
| Trial ID | NCT07319780 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Boys aged 6 months to 84 months with primary or redo distal hypospadias, an unfavorable urethral plate, penile curvature under 45 degrees after degloving, and who are candidates for TIP urethroplasty.
Not a fit: Children with severe penile curvature requiring urethral plate transection, previous graft-based urethroplasty, disorders of sex development, active infection, or known bleeding/platelet disorders are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, using autologous PRF could reduce rates of fistula and meatal stenosis and improve healing and cosmetic and functional outcomes after TIP repair.
How similar studies have performed: Grafted TIP is an established technique, and small observational studies of platelet-rich fibrin or other blood-derived products suggest improved wound healing, but randomized pediatric evidence for PRF in hypospadias repair is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jakarta, DKI Jakarta and 1 other locations
- Dr. Cipto Mangunkusumo Hospital — Jakarta, DKI Jakarta, Indonesia (Not_yet_recruiting)
- National Children's Medical Center — Tashkent, Tashkent, Uzbekistan (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.