A Prospective Registry of Patients With Congenital Penile Anomalies

Hypospadias Clinical Trial

Official title:

A Prospective Registry of Patients With Congenital Penile Anomalies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04755803
• Other study ID #: 2008-057-1147
• Status: Completed
• Start date: July 10, 2020
• Est. completion date: March 30, 2023

Study information

• Verified date: May 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Prospective registry and biobank in pediatric patients with congenital penile anomalies

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 0 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chordee
• Concealed Penis
• Hypospadias
• Phimosis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)