Residual Severe Ventral CurvatureNCT07404722
Urethral Plate Flap vs. Tunica Vaginalis Flap for Residual Severe Ventral Curvature in Hypospadias
A study testing Urethral Plate Flap Corporoplasty and Tunica Vaginalis Flap Corporoplasty in people with Residual Severe Ventral Curvature and Transection of the Urethral Plate, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 14 years, men only
- Conditions the study is for
- Residual Severe Ventral Curvature, Transection of the Urethral Plate, Corporoplasty
- What is being tested?
- Urethral Plate Flap Corporoplasty and Tunica Vaginalis Flap Corporoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2026to 22 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 months to 14 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- ① Glans diameter < 1 cm; ② Combined with cryptorchidism; ③ Combined with severe bleeding disorders or coagulation dysfunction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Children's hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052
About this study
Official title: Urethral Plate Flap Versus Tunica Vaginalis Flap Corporoplasty for the Correction of Residual Severe Ventral Curvature After Urethral Plate Transection in Hypospadias Repair: A Single-Center, Randomized, Controlled, Non-Inferiority Study
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.
Read more
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
- Being tested
- Urethral Plate Flap Corporoplasty, Tunica Vaginalis Flap Corporoplasty
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urethral Plate Flap CorporoplastyProcedure or surgery
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 CorporoplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Tunica Vaginalis Flap Corporoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months Postoperatively
Secondary outcomes (4)
Operative Time for Curvature Correction
Recorded as the time from the "incision of the tunica albuginea" to the "completion of tunica albuginea repair and confirmation of a straight penis" (in minutes). This metric specifically excludes the time taken for urethroplasty and penile skin reconstruction to minimize confounding factors.
Measured: Intraoperative
Incidence of Donor-Site Complications
Assessment of complications related to the graft harvest site, including:
Testicular events: Postoperative testicular retraction/ascent (defined as the testis position being higher than the middle of the scrotum).
Scrotal events: Scrotal hematoma, edema, and secondary infections caused by these conditions.
Measured: From enrollment to the end of treatment at 12 months
Continuity of the tunica albuginea
Evaluation is performed by a sonographer blinded to group allocation using High-Frequency Penile Ultrasound Evaluation
Evaluation Parameters:
Continuity of the tunica albuginea (Categorized as: Continuous / Interrupted).
Measured: 12 months postoperatively
Echogenicity of the corpus cavernosum beneath the graft
Evaluation is performed by a sonographer blinded to group allocation using High-Frequency Penile Ultrasound Evaluation Evaluation Parameters: Echogenicity of the corpus cavernosum beneath the graft (Assessed for consistency with the host cavernous tissue)
Measured: 12 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start23 Feb 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion22 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Residual Severe Ventral CurvatureStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Ru, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404722
- Sponsor's protocol ID
- 2025-IRB-0555-P-01
- Status last verified
- Feb 2026
- First submitted
- 9 Dec 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urethral Plate Flap Versus Tunica Vaginalis Flap Corporoplasty for the Correction of Residual Severe Ventral Curvature After Urethral Plate Transection in Hypospadias Repair: A Single-Center, Randomized, Controlled, Non-Inferiority Study
- ClinicalTrials.gov ID
- NCT07404722
- Acronym / sponsor ID
- 2025-IRB-0555-P-01
- Conditions
- Residual Severe Ventral Curvature, Transection of the Urethral Plate, Corporoplasty, Pedicled Tunica Vaginalis Flap (TVF), Novel Urethral Plate Flap (UPF), Hypospadias
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 23 Feb 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 22 Feb 2029 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urethral Plate Flap Corporoplasty | Experimental | Procedure: Urethral Plate Flap Corporoplasty1. 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 | Active comparator | Procedure: Tunica Vaginalis Flap Corporoplasty1. 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. |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- ① Glans diameter < 1 cm; ② Combined with cryptorchidism; ③ Combined with severe bleeding disorders or coagulation dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urethral Plate Flap Corporoplasty1.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 or surgery | Urethral Plate Flap Corporoplasty |
| Tunica Vaginalis Flap Corporoplasty1.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 or surgery | Tunica Vaginalis Flap Corporoplasty |
Primary outcome
Recurrence Rate of Ventral Curvature at 12 Months Postoperatively
Time frame: 12 Months Postoperatively
Recurrence of ventral curvature is defined as residual ventral curvature ≥ 10° on lateral photographs during artificial erection.
4 secondary outcomes
Operative Time for Curvature Correction
Time frame: Intraoperative
Incidence of Donor-Site Complications
Time frame: From enrollment to the end of treatment at 12 months
Continuity of the tunica albuginea
Time frame: 12 months postoperatively
Echogenicity of the corpus cavernosum beneath the graft
Time frame: 12 month postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urethral Plate Flap Corporoplasty and Tunica Vaginalis Flap Corporoplasty in people with Residual Severe Ventral Curvature and Transection of the Urethral Plate, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Ru Associate Chief Physician, MD (+86 13588064041, ruwei@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Rate of Ventral Curvature at 12 Months Postoperatively (time frame: 12 Months Postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.