A Prospective Registry of Patients With Congenital Penile Anomalies

Completed

• Conditions: Concealed Penis; Hypospadias; Phimosis; Chordee

• Registration Number: NCT04755803
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Study Timeline

• Study Start: 2020-07-10
• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-16
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dartos Fascia (Penile Tissue) sample collection	Procedure (At the time of penoplasty)	Collection of biological samples from pediatric patients who have been registered onto the prospective registry.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of