Health Trials

Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias

ConditionsDistal HypospadiasHypospadias
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age6-84
SponsorNational Children's Medical Center, Uzbekistan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male children aged 6 months to 84 months

Primary or redo distal hypospadias

Unfavorable urethral plate

Penile curvature less than 45 degrees after degloving

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fibrin-Enhanced TIP Urethroplasty

    Procedure/Surgery

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

  • Grafted TIP Urethroplasty

    Procedure/Surgery

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: F-TIP UrethroplastyExperimental treatment 1 intervention
Group B: G-TIP UrethroplastyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of postoperative urethral complications

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.

Time frame
6 months postoperatively

Secondary outcomes

1

Incidence of urethral stricture

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

Time frame
6 months postoperatively
2

Cosmetic outcome assessed by HOSE score

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.

Time frame
6 months postoperatively
3

Maximum urinary flow rate (Qmax)

Maximum urinary flow rate (Qmax), measured in milliliters per second (mL/s), assessed by uroflowmetry. Higher values indicate better urinary flow.

Time frame
6 months postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Children's Medical Center, Uzbekistan

Lead sponsor

Dr Cipto Mangunkusumo General Hospital

Collaborator

Source ClinicalTrials.gov
Apply now