A Multicenter Randomized Controlled Trial Comparing Platelet-Rich Fibrin and Ventral Dartos Flap as Intermediate Layers in Tabularized Incised Plate (TIP) Urethroplasty for Distal Hypospadias With Mild Penile Curvature

NCT07045545 | Enrolling By Invitation DMC

• 1 other identifier: 0620251
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Distal hypospadias is the most common form of hypospadias. The Tubularized Incised Plate (TIP) repair is the standard surgical technique for this condition; however, complications such as fistula formation and meatal stenosis remain concerns. These complications are often influenced by the choice of intermediate tissue layer used to reinforce the neourethra. The traditional ventral dartos flap is effective but can be technically challenging and may result in a bulky tissue layer. Platelet-rich fibrin (PRF) is an autologous, growth factor-rich biological material that has shown promise in tissue regeneration and healing. It is easy to prepare intraoperatively and may serve as a biological reinforcement to reduce postoperative complications. This study aims to provide high-quality evidence comparing the effectiveness of PRF versus the ventral dartos flap in patients with distal hypospadias, specifically those with Grade 1 urethral defects and minimal penile curvature, using a stratified study population to ensure balanced groups.

Conditions

PRF; Hypospadias; Distal Hypospadias; Hypospadias Repair; Fistula Stenosis; Cosmetic Outcomes; Functional Outcomes; Tubularized Incised Plate

Outcome Measures

Primary Outcomes (1)

• Hypospadias Cosmetic Score (HOSE)

  Assessment Method: Standardized digital photographs taken at 6 months postoperatively. Evaluators: Two independent pediatric urologists blinded to treatment allocation will evaluate the photographs. Measurement Tool: Cosmetic outcome scored using the Hypospadias Objective Scoring Evaluation (HOSE) system or a similar validated scale. Units: HOSE score (range 5-10). Higher scores: Indicate better cosmetic outcomes.

  Follow-up evaluations will occur at 1, 3, and 6 months postoperatively.

Secondary Outcomes (1)

• Clinical examination for postoperative complications (fistula, stenosis, )

  during follow-up visits at 1, 3, and 6 months post-surgery.

Other Outcomes (1)

• Body Mass Index (BMI)

  Patients will be followed at 1, 3, and 6 months postoperatively for

Study Arms (2)

Group A: PRF applied over neourethra;

EXPERIMENTAL

* In patients randomized to the PRF group (Group A), autologous platelet-rich fibrin will be prepared intraoperatively using the following standardized protocol: * Approximately 10 minutes before completion of urethroplasty, a 5-10 mL peripheral blood sample to be drawn from the cephalic vein under sterile conditions. The blood to be immediately transferred into a plain sterile glass tube without anticoagulants or additives. Centrifugation to be performed at 3000 rpm (approximately 400×g) for 10 minutes using a bench-top centrifuge. * Following centrifugation, three distinct layers were formed: 1. Acellular plasma (top) 2. Platelet-rich fibrin clot (middle) 3. Red blood cells (bottom) * The PRF clot to be carefully extracted using sterile forceps , and residual red blood cells were gently separated to ensure a clean PRF membrane. The PRF clot will then gently compressed between saline-soaked sterile gauze to form a pliable membrane suitable for surgical application.

Procedure: - Group A: Platelet-rich fibrin membrane prepared intraoperatively and applied over neourethra

Group B: Ventral dartos flap rotated over neourethra

ACTIVE COMPARATOR

Participants in this arm will undergo hypospadias repair with the application of a ventral dartos fascia flap. The procedure involves elevating a vascularized flap of ventral dartos fascia from the penile shaft, rotating it over the neourethra to provide additional tissue coverage and promote healing. This flap helps in reducing the risk of fistula formation and enhances vascular support to the neourethra. The surgical steps include dissecting the dartos fascia carefully, rotating it over the neourethral reconstruction, and securing it in place, followed by standard postoperative care and follow-up.

Procedure: Group B: Ventral dartos flap rotated over neourethra

Interventions

- Group A: Platelet-rich fibrin membrane prepared intraoperatively and applied over neourethra PROCEDURE

In this arm, a platelet-rich fibrin membrane will be prepared intraoperatively from the patient's blood using centrifugation. The prepared PRF membrane will then be applied directly over the neourethra following urethroplasty to promote healing and tissue regeneration.

Group A: PRF applied over neourethra;

Group B: Ventral dartos flap rotated over neourethra PROCEDURE

Participants in this arm will undergo hypospadias repair with the application of a ventral dartos fascia flap. The procedure involves elevating a vascularized flap of ventral dartos fascia from the penile shaft, rotating it over the neourethra to provide additional tissue coverage and promote healing. This flap helps in reducing the risk of fistula formation and enhances vascular support to the neourethra. The surgical steps include dissecting the dartos fascia carefully, rotating it over the neourethral reconstruction, and securing it in place, followed by standard postoperative care and follow-up.

Group B: Ventral dartos flap rotated over neourethra

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary and complex distal hypospadias (Grade 1, Abbas classification)
• Penile curvature \<30° after degloving (Methodology of curvature measurement: Abbas T. O. (2022).
• Children aged 6 months to 5 years

You may not qualify if:

• Previous hypospadias surgery
• Proximal hypospadias
• Penile curvature ≥30°
• Syndromic anomalies or coagulopathy

Sponsors & Collaborators

• National Children's Medical Center, Uzbekistan: lead
• Dr Cipto Mangunkusumo General Hospital: collaborator

Study Sites (1)

National Children's Medical Center

Tashkent, City, 100020, Uzbekistan

Location

Related Publications (7)

• Abbas 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: 35031224 BACKGROUND

• Abbas 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: 35644790 BACKGROUND

• Elnashar AM, Albishbishy M, Sheir H, Elayyouti M, Elsherbiny M, Elzohiri M, Ghazaly Waly ME, Elsaied A. Comparative Study Between Autologous Platelet-rich Fibrin Membrane and Local Flaps as Intervening Layer in Management of Distal Hypospadias. J Pediatr Surg. 2025 Jan;60(1):161994. doi: 10.1016/j.jpedsurg.2024.161994. Epub 2024 Oct 11.

  PMID: 39461004 BACKGROUND

• Guinot A, Arnaud A, Azzis O, Habonimana E, Jasienski S, Fremond B. Preliminary experience with the use of an autologous platelet-rich fibrin membrane for urethroplasty coverage in distal hypospadias surgery. J Pediatr Urol. 2014 Apr;10(2):300-5. doi: 10.1016/j.jpurol.2013.09.026. Epub 2013 Nov 13.

  PMID: 24325905 BACKGROUND

• Moraschini V, Miron RJ, Mourao CFAB, Louro RS, Sculean A, da Fonseca LAM, Calasans Maia MD, Shibli JA. Antimicrobial effect of platelet-rich fibrin: A systematic review of in vitro evidence-based studies. Periodontol 2000. 2024 Feb;94(1):131-142. doi: 10.1111/prd.12529. Epub 2023 Sep 22.

  PMID: 37740425 BACKGROUND

• Kajbafzadeh AM, Abolghasemi H, Eshghi P, Alizadeh F, Elmi A, Shafaattalab S, Dianat S, Amirizadeh N, Mohseni MJ. Single-donor fibrin sealant for repair of urethrocutaneous fistulae following multiple hypospadias and epispadias repairs. J Pediatr Urol. 2011 Aug;7(4):422-7. doi: 10.1016/j.jpurol.2010.06.004. Epub 2010 Jul 15.

  PMID: 20634140 BACKGROUND

• Soyer T, Cakmak M, Aslan MK, Senyucel MF, Kisa U. Use of autologous platelet rich fibrin in urethracutaneous fistula repair: preliminary report. Int Wound J. 2013 Jun;10(3):345-7. doi: 10.1111/j.1742-481X.2012.00983.x. Epub 2012 May 9.

  PMID: 22568526 BACKGROUND

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

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

Study Officials

• Tariq Abbas, MD, PhD

  Sidra Medicine

  STUDY CHAIR

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 Pediatric urology department at National Childrens' Medical Center, Tashkent, Uzbekistan

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: July 1, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): June 5, 2026
• Study Completion (Estimated): June 5, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

UZ (1)