A Prospective Registry of Patients With Congenital Penile Anomalies

Study Overview
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Brief Summary
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Prospective registry and biobank in pediatric patients with congenital penile anomalies

Detailed Description
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According to the U.S. Center for Disease Control and Prevention, in the United States, one in 200 babies is born with congenital penile anomalies. In Korea, there is a rapid increase rate among other types of congenital anomalies from 1993 to 2010, from 0.7 to 10,000 to 9.9 per 10,000 cases. It leaves long term sequelae into adulthood even after the corrective operation has been performed. Some of the sequelae that patients experienced were difficulties in micturition, dissatisfaction with the appearance of the penis, and decreased sexual function, as well as psychosexual well-being. Despite its high prevalence, hypospadias and related penile anomalies have no specific known etiology and mechanisms. However, numerous studies have shown that both gene and environment play a significant role in making etiologies multifactorial. Furthermore, a molecular trial shows that both genetics and environmental factors disrupt the normal development course of the phallus, or penis. Penis formation, growth, or the formation of the male urogenital system, in general, have shown to be androgen dependent. Any defect in the androgen synthesis leading to androgen deficiency or receptors may play a role, specifically, in the development of penile anomalies. Pediatric patients between the ages of 0 to 18 years, with congenital penile anomalies and scheduled to undergo penoplasty will be enrolled. In this prospective observational study, our aims are to collect dartos fascia, which is a tissue in penile region, and examine histochemistry of the sample.

Official Title
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A Prospective Registry of Patients With Congenital Penile Anomalies

Conditions
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Concealed Penis, Hypospadias, Phimosis, Chordee

Intervention / Treatment
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* Procedure: Penoplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those with congenital penile anomalies (e.g. hypospadias, chordee, webbed penis) and receiving penoplasty at the institution. Those who understand the registry's content and are signed and dated by the patient (or the patient's legal guardian or representative). Exclusion Criteria: Those who are unwilling to participate and do not sign the informed consent. Unable to read or understand Korean.

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Penoplasty|Modified penoplasty technique: Degloved the penile skin and excise the inner prepuce. Advanced penoscrotal skin to cover penile shaft Fixed the penis base and reconstructed the penoscrotal angle|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dartos Fascia (Penile Tissue) sample collection | Collection of biological samples from pediatric patients who have been registered onto the prospective registry. | Procedure (At the time of penoplasty) |