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

National Children's Medical Center, Uzbekistan

Status: Enrolling

Conditions: Distal Hypospadias; Hypospadias

Treatments: Procedure: Fibrin-Enhanced TIP Urethroplasty; Procedure: Grafted TIP Urethroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT07319780

102025-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 6 to 84 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

F-TIP Urethroplasty

Experimental group

Description:

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.

Treatment:

Procedure: Fibrin-Enhanced TIP Urethroplasty

G-TIP Urethroplasty

Active Comparator group

Description:

Participants will undergo grafted tubularized incised plate (G-TIP) urethroplasty using standard graft augmentation techniques for unfavorable urethral plates.

Treatment:

Procedure: Grafted TIP Urethroplasty