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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exosome group | Experimental | 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. |
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| Control group | Placebo Comparator | Use the sodium hyaluronate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exsome | Procedure | 200 ml of urine was collected by aseptic catheterization, after which it was centrifuged and expanded to the P6 generation using a gelatin-coated culture plate. Exosome extraction: USC-Exos was isolated via tangential flow filtration combined with ultrafiltration. Quality control was performed via nano-flow cytometry (particle size 72.27±21.90 nm), transmission electron microscopy (double-membrane structure), and Western blot (positive for CD9/CD63/TSG101). First stage, the dorsal penile foreskin flap was transferred to the ventral side to reconstruct the urethral plate (Byar Stage Ⅰ). In the exosome group, USC-Exos (1-3×10^10^/ml) were applied topically. Second-stage, urethral tubularization after 6-9 months, urethral plate tissues were taken for HE, CD31, α-SMA and VEGF immunohistochemical analysis during the surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 100% participants treated with the staged surgery | 82 participants were average divided into Exosome and Control group. All the participants were treated with the Byar's staged surgery(including I and II stage). | From enrollment to the 6 months after the second stage surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Children's Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| D007021 | Hypospadias |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Placebo | Procedure | First stage, the dorsal penile foreskin flap was transferred to the ventral side to reconstruct the urethral plate (Byar Stage Ⅰ). In the control group, sodium hyaluronate was used. Second-stage, urethral tubularization after 6-9 months, urethral plate tissues were taken for HE, CD31, α-SMA and VEGF immunohistochemical analysis during the surgery. |
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| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |