Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias (FTIP-RCT)

January 28, 2026 updated by: Zafar Abdullaev, National Children's Medical Center, Uzbekistan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multicenter, single-blinded randomized controlled trial designed to compare fibrin-enhanced tubularized incised plate (F-TIP) urethroplasty using autologous platelet-rich fibrin (PRF) with grafted tubularized incised plate (G-TIP) urethroplasty in children with distal hypospadias and an unfavorable urethral plate.

Male children aged 6 months to 84 months with primary or redo distal hypospadias and mild penile curvature will be eligible for inclusion. Participants will be randomized in a 1:1 ratio to undergo either F-TIP urethroplasty with intraoperative application of autologous PRF or standard G-TIP urethroplasty without PRF.

Autologous PRF will be prepared intraoperatively from the patient's peripheral blood using a standardized centrifugation protocol and applied to the incised urethral plate prior to tubularization.

Participants will be followed postoperatively for the assessment of surgical complications, functional outcomes, and cosmetic results according to predefined outcome measures.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • Not yet recruiting
        • Dr. Cipto Mangunkusumo Hospital
        • Contact:
          • Dr. Cipto Mangunkusumo General Hospital Jakarta, Indonesia Pediatric Urology Department
          • Phone Number: +6285935071599
          • Email: anggariskyraharja@gmail.com
  • Uzbekistan
    • Tashkent
      • Tashkent, Tashkent, Uzbekistan, 100020
        • Recruiting
        • National Children's Medical Center
        • Contact:
          • National Children's Medical Center Pediatric Urology department
          • Phone Number: +998950047777 +998950047777
          • Email: abdullaev.med@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: F-TIP Urethroplasty
Participants will undergo fibrin-enhanced tubularized incised plate (F-TIP) urethroplasty. Autologous platelet-rich fibrin will be prepared intraoperatively and applied to the incised urethral plate and fixed with PDS 6/0-7/0 suture prior to tubularization.
Procedure: Fibrin-Enhanced TIP Urethroplasty
Tubularized incised plate urethroplasty augmented with autologous platelet-rich fibrin membrane applied to the incised urethral plate prior to tubularization.
Active Comparator: G-TIP Urethroplasty
Participants will undergo grafted tubularized incised plate (G-TIP) urethroplasty using standard graft augmentation techniques for unfavorable urethral plates.
Procedure: Grafted TIP Urethroplasty
Graft-augmented tubularized incised plate urethroplasty performed using standard surgical techniques for unfavorable urethral plates.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative urethral complications
Time Frame: 6 months postoperatively
Incidence of postoperative urethral complications, defined as the occurrence of meatal stenosis requiring dilation or surgical intervention and/or urethrocutaneous fistula identified on clinical examination.
6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of urethral stricture
Time Frame: 6 months postoperatively
Presence of urethral stricture confirmed clinically or by imaging during follow-up.
6 months postoperatively
Cosmetic outcome assessed by HOSE score
Time Frame: 6 months postoperatively
Standardized postoperative photographs were assessed by two blinded external pediatric urologists using the Hypospadias Objective Scoring Evaluation (HOSE) system. HOSE scores range from 5 to 16 points, with higher scores indicating better cosmetic outcomes.
6 months postoperatively
Maximum urinary flow rate (Qmax)
Time Frame: 6 months postoperatively
Maximum urinary flow rate (Qmax), measured in milliliters per second (mL/s), assessed by uroflowmetry. Higher values indicate better urinary flow.
6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Children's Medical Center, Uzbekistan

Collaborators

Dr Cipto Mangunkusumo General Hospital

Investigators

  • Principal Investigator: Zafar Abdullaev, MD, PhD, National Children's Medical Center, Tashkent, Uzbekistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2026

Primary Completion (Estimated)

July 5, 2028

Study Completion (Estimated)

December 25, 2028

Study Registration Dates

First Submitted

December 20, 2025

First Submitted That Met QC Criteria

December 20, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102025-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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