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NCT Number: NCT07319780

Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias

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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Key information

Conditions

Distal Hypospadias Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Hypospadias Male Urogenital Diseases Penile Diseases Urogenital Abnormalities Urogenital Diseases

Age range

6 month–84 month

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Cipto Mangunkusumo Hospital, Jakarta, DKI Jakarta, Indonesia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fibrin-Enhanced TIP Urethroplasty

Procedure

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

Grafted TIP Urethroplasty

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of urethral stricture

    Time frame: 6 months postoperatively

    Presence of urethral stricture confirmed clinically or by imaging during follow-up.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zafar Abdullaev, MD PhD

CONTACT

[email protected]

+998-90-909-9911

Sponsors and collaborators

Lead sponsor

National Children's Medical Center, Uzbekistan

Other

Collaborators

  • Dr Cipto Mangunkusumo General Hospital

Registry information

Official study title

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

Acronym: FTIP-RCT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 6, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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