NCT04755803

A Prospective Registry of Patients With Congenital Penile Anomalies

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Male
• Age: 0 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective registry and biobank in pediatric patients with congenital penile anomalies

Detailed description

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.

Conditions

• Concealed Penis
• Hypospadias
• Phimosis
• Chordee

Interventions

Type	Name	Description
PROCEDURE	Penoplasty	Modified penoplasty technique: 1. Degloved the penile skin and excise the inner prepuce. 2. Advanced penoscrotal skin to cover penile shaft 3. Fixed the penis base and reconstructed the penoscrotal angle

Timeline

• Start date: 2020-07-10
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2021-02-16
• Last updated: 2023-05-06

Locations

1 site across 1 country: South Korea