USC-Exos in Corpus Spongiosum Reconstruction for Hypospadias

Shanghai Jiao Tong University

Status: Completed

Conditions: Hypospadias

Treatments: Procedure: Exsome; Procedure: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07495176

SHDC2020CR3013A

Details and patient eligibility

About

Hypospadias is one of the common congenital malformation disorders in male children, with a ratio of about 1 to 300 in newborn boys. Proximal hypospadias, due to the underdeveloped corpus spongiosum, has a high incidence of postoperative complications (e.g., urethral fistula, stricture, recurrence of penile curvature), exceeding 50%. Traditional surgeries focus on urethral tubularization but fail to restore the corpus spongiosum, leading to long-term micturition and sexual dysfunction.

Recent studies have shown that stem cell exosomes promote angiogenesis and tissue repair through paracrine mechanisms. Urine-derived stem cells (USC) have the advantages of non-invasive acquisition and high proliferative capacity, and the investigator's previous study found that the USCs secreted exosomes (USC-Exos) promoted the regeneration of cavernous sinusoids in an animal model. In this study, the investigators applied autologous USC-Exos for the first time to pediatric hypospadias surgery to evaluate its clinical value in corpus spongiosum reconstruction.

Enrollment: 82 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• 46, XY karyotype
• proximal hypospadias
• treated with Byar staged surgery
• informed consent from guardians.

Exclusion criteria

• patients with sexual development disorders
• those undergoing one-stage repair
• patients or guardians refusing participation
• those lost to follow-up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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82 participants in 2 patient groups, including a placebo group

exosome group

Experimental group

Description:

Children with proximal hypospadias admitted to the Department of Urology of Shanghai Children's Hospital Inclusion criteria: 46, XY karyotype; treated with Byar staged surgery; and informed consent from guardians. Exclusion criteria: patients with sexual development disorders; those undergoing one-stage repair; patients or guardians refusing participation; and those lost to follow-up.

Treatment:

Procedure: Exsome

Control group

Placebo Comparator group

Description:

Use the sodium hyaluronate

Treatment:

Procedure: Placebo