Urethral Plate Flap vs. Tunica Vaginalis Flap for Residual Severe Ventral Curvature in Hypospadias

NCT07404722 | Not Yet Recruiting

• 1 other identifier: 2025-IRB-0555-P-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The correction of ventral curvature in hypospadias follows a stepwise principle. Clinically, in some cases of hypospadias, residual severe ventral curvature (VC ≥ 30°) persists even after thorough skin degloving and transection of the urethral plate, due to the unbalanced development of the ventral and dorsal tunica albuginea of the corpus cavernosum. In such cases, ventral tunica albuginea incision and corporoplasty with a graft are mandatory. Although the currently commonly used pedicled Tunica Vaginalis Flap (TVF) corporoplasty can effectively correct the curvature, it requires additional dissection of the scrotum and tunica vaginalis sac. This prolongs the operative time and poses risks of donor-site complications, such as testicular retraction and scrotal hematoma. The novel Urethral Plate Flap (UPF) corporoplasty utilizes local pedicled urethral plate tissue for homologous repair. This study adopts a prospective, single-center, randomized, controlled, double-blind, non-inferiority trial design, enrolling 90 subjects. The aim is to verify that the therapeutic efficacy of the UPF technique in correcting such residual severe ventral curvature is non-inferior to that of TVF, while demonstrating significant advantages in surgical efficiency and donor-site safety. This study aims, through a single-center, double-blind, RCT design, and under the strict indication of "residual severe ventral curvature after urethral plate transection," to verify efficacy via a "non-inferiority" hypothesis, and to verify safety and efficiency via a "superiority" hypothesis. The goal is to provide Level I evidence for the update of hypospadias guidelines, while simultaneously exploring the establishment of postoperative imaging evaluation standards.

Conditions

Residual Severe Ventral Curvature; Transection of the Urethral Plate; Corporoplasty; Pedicled Tunica Vaginalis Flap (TVF); Novel Urethral Plate Flap (UPF); Hypospadias

Outcome Measures

Primary Outcomes (1)

• Recurrence Rate of Ventral Curvature at 12 Months Postoperatively

  Recurrence of ventral curvature is defined as residual ventral curvature ≥ 10° on lateral photographs during artificial erection.

  12 Months Postoperatively

Secondary Outcomes (4)

• Operative Time for Curvature Correction

  Intraoperative

• Incidence of Donor-Site Complications

  From enrollment to the end of treatment at 12 months

• Continuity of the tunica albuginea

  12 months postoperatively

• Echogenicity of the corpus cavernosum beneath the graft

  12 month postoperatively

Study Arms (2)

Urethral Plate Flap Corporoplasty

EXPERIMENTAL

1. After degloving and transecting the urethral plate, mobilize the urethral plate. 2. Transect the tunica albuginea at the point of maximal curvature to fully correct the ventral curvature. 3. Mobilize and open the tunica vaginalis sac, and harvest a pedicled Tunica Vaginalis Flap (TVF). 4. Transfer the TVF to the ventral side to repair the tunica albuginea defect, and suture with 6-0 absorbable sutures. 5. Mobilize the space between the scrotal skin and dartos fascia. Place 2 interrupted sutures between the external spermatic fascia near the testis and the dartos fascia at the scrotal base to fix the testis within the sub-dartos space.

Procedure: Urethral Plate Flap Corporoplasty

Tunica Vaginalis Flap Corporoplasty

ACTIVE COMPARATOR

1. After degloving and transecting the urethral plate, mobilize the urethral plate. 2. Transect the tunica albuginea at the point of maximal curvature to fully correct the ventral curvature. 3. Mobilize and open the tunica vaginalis sac, and harvest a pedicled Tunica Vaginalis Flap (TVF). 4. Transfer the TVF to the ventral side to repair the tunica albuginea defect, and suture with 6-0 absorbable sutures. 5. Mobilize the space between the scrotal skin and dartos fascia. Place 2 interrupted sutures between the external spermatic fascia near the testis and the dartos fascia at the scrotal base to fix the testis within the sub-dartos space.

Procedure: Tunica Vaginalis Flap Corporoplasty

Interventions

Urethral Plate Flap Corporoplasty PROCEDURE

1.After degloving and transecting the urethral plate, mobilize the urethral plate. 2.Transect the tunica albuginea at the point of maximal curvature to fully correct the ventral curvature. 3.Mobilize and open the tunica vaginalis sac, and harvest a pedicled Tunica Vaginalis Flap (TVF). 4.Transfer the TVF to the ventral side to repair the tunica albuginea defect, and suture with 6-0 absorbable sutures. 5.Mobilize the space between the scrotal skin and dartos fascia. Place 2 interrupted sutures between the external spermatic fascia near the testis and the dartos fascia at the scrotal base to fix the testis within the sub-dartos space.

Urethral Plate Flap Corporoplasty

Tunica Vaginalis Flap Corporoplasty PROCEDURE

1.After degloving and transecting the urethral plate, mobilize the urethral plate. 2.Transect the tunica albuginea at the point of maximal curvature to fully correct the ventral curvature. 3.Mobilize and open the tunica vaginalis sac, and harvest a pedicled Tunica Vaginalis Flap (TVF). 4.Transfer the TVF to the ventral side to repair the tunica albuginea defect, and suture with 6-0 absorbable sutures. 5.Mobilize the space between the scrotal skin and dartos fascia. Place 2 interrupted sutures between the external spermatic fascia near the testis and the dartos fascia at the scrotal base to fix the testis within the sub-dartos space.

Tunica Vaginalis Flap Corporoplasty

Eligibility Criteria

• Age: 6 Months - 14 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 6 months to 14 years.
• Diagnosis: Primary hypospadias (no history of prior hypospadias repair).
• Intraoperative Condition: Residual ventral curvature ≥ 30° confirmed by artificial erection test after transection of the urethral plate.
• Consent: Signed informed consent provided by the participant's legal guardian.

You may not qualify if:

• ① Glans diameter \< 1 cm; ② Combined with cryptorchidism; ③ Combined with severe bleeding disorders or coagulation dysfunction.

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

Children's hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

Location

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

Central Study Contacts

Wei Ru Associate Chief Physician, MD

CONTACT

+86 13588064041; ruwei@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: February 11, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): February 22, 2029
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

CN (1)