Distal HypospadiasFTIP-RCTNCT07319780
Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias
A study testing Fibrin-Enhanced TIP Urethroplasty and Grafted TIP Urethroplasty in people with Distal Hypospadias and Hypospadias, run by National Children's Medical Center, Uzbekistan at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 84 months, men only
- Conditions the study is for
- Distal Hypospadias, Hypospadias
- What is being tested?
- Fibrin-Enhanced TIP Urethroplasty and Grafted TIP Urethroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 Jan 2026to 25 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 84 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Indonesia1 site, 1 recruiting
- Not yet recruiting
Dr. Cipto Mangunkusumo Hospital
Jakarta, DKI Jakarta, 10430
Dr. Cipto Mangunkusumo General Hospital Jakarta, Indonesia Pediatric Urology Department, +6285935071599, anggariskyraharja@gmail.com
Uzbekistan1 site, 1 recruiting
- Recruiting
National Children's Medical Center
Tashkent, Tashkent, 100020
National Children's Medical Center Pediatric Urology department, +998950047777 ext. +998950047777, abdullaev.med@gmail.com
About this study
Official 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
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.
Read the 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.
- Conditions
- Distal Hypospadias, Hypospadias
- Being tested
- Fibrin-Enhanced TIP Urethroplasty, Grafted TIP Urethroplasty
- Keywords
- Hypospadias repair, Tubularized incised plate, Platelet-rich fibrin, PRF, Grafted TIP, Pediatric urology
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin-Enhanced TIP UrethroplastyProcedure or surgery
Tubularized incised plate urethroplasty augmented with autologous platelet-rich fibrin membrane applied to the incised urethral plate prior to tubularization.
Grafted TIP UrethroplastyProcedure or surgery
Graft-augmented tubularized incised plate urethroplasty performed using standard surgical techniques for unfavorable urethral plates.
| Study group | Role | What they receive |
|---|---|---|
| F-TIP Urethroplasty | Experimental | 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. Receives: Procedure: Fibrin-Enhanced TIP Urethroplasty |
| G-TIP Urethroplasty | Active comparator | Participants will undergo grafted tubularized incised plate (G-TIP) urethroplasty using standard graft augmentation techniques for unfavorable urethral plates. Receives: Procedure: Grafted TIP Urethroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months postoperatively
Secondary outcomes (3)
Incidence of urethral stricture
Presence of urethral stricture confirmed clinically or by imaging during follow-up.
Measured: 6 months postoperatively
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.
Measured: 6 months postoperatively
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.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start5 Jan 2026
- Primary completion5 Jul 2028 (estimated)
- Study completion25 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Distal HypospadiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Children's Medical Center, Uzbekistan
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital
- Responsible party
- Principal investigator, Zafar Abdullaev, National Children's Medical Center, Uzbekistan
- Investigators
- Zafar Abdullaev, MD, PhD, Principal investigator, National Children's Medical Center, Tashkent, Uzbekistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319780
- Sponsor's protocol ID
- 102025-11
- Acronym
- FTIP-RCT
- Status last verified
- Jan 2026
- First submitted
- 20 Dec 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38071112Abbas 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.
PubMed 35031224Abbas 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.
PubMed 35644790