Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias
FTIP-RCT
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
1 other identifier
interventional
100
2 countries
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2025
CompletedStudy Start
First participant enrolled
January 5, 2026
CompletedFirst Posted
Study publicly available on registry
January 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 25, 2028
January 30, 2026
January 1, 2026
2.5 years
December 20, 2025
January 28, 2026
Conditions
Keywords
Outcome Measures
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.
6 months postoperatively
Secondary Outcomes (3)
Incidence of urethral stricture
6 months postoperatively
Cosmetic outcome assessed by HOSE score
6 months postoperatively
Maximum urinary flow rate (Qmax)
6 months postoperatively
Study Arms (2)
F-TIP Urethroplasty
EXPERIMENTALParticipants 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.
G-TIP Urethroplasty
ACTIVE COMPARATORParticipants will undergo grafted tubularized incised plate (G-TIP) urethroplasty using standard graft augmentation techniques for unfavorable urethral plates.
Interventions
Tubularized incised plate urethroplasty augmented with autologous platelet-rich fibrin membrane applied to the incised urethral plate prior to tubularization.
Graft-augmented tubularized incised plate urethroplasty performed using standard surgical techniques for unfavorable urethral plates.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dr. Cipto Mangunkusumo Hospital
Jakarta, DKI Jakarta, 10430, Indonesia
National Children's Medical Center
Tashkent, Tashkent, 100020, Uzbekistan
Related Publications (3)
Abbas TO, Khalil IA, Hatem M, Boyko A, Zorkin S. Plate Objective Scoring Tool (POST) in distal hypospadias: Correlation with post-repair complications. J Pediatr Urol. 2024 Apr;20(2):238.e1-238.e6. doi: 10.1016/j.jpurol.2023.11.022. Epub 2023 Nov 25.
PMID: 38071112RESULTAbbas TO. Evaluation of penile curvature in patients with hypospadias; gaps in the current practice and future perspectives. J Pediatr Urol. 2022 Apr;18(2):151-159. doi: 10.1016/j.jpurol.2021.12.015. Epub 2021 Dec 31.
PMID: 35031224RESULTAbbas TO. An objective hypospadias classification system. J Pediatr Urol. 2022 Aug;18(4):481.e1-481.e8. doi: 10.1016/j.jpurol.2022.05.001. Epub 2022 May 11.
PMID: 35644790RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zafar Abdullaev, MD, PhD
National Children's Medical Center, Tashkent, Uzbekistan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Pediatric Urology Department
Study Record Dates
First Submitted
December 20, 2025
First Posted
January 6, 2026
Study Start
January 5, 2026
Primary Completion (Estimated)
July 5, 2028
Study Completion (Estimated)
December 25, 2028
Last Updated
January 30, 2026
Record last verified: 2026-01