A Prospective Registry of Patients With… | Clinical Trial

Key information

Conditions

Concealed Penis Chordee Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Hypospadias Male Urogenital Diseases Penile Diseases Phimosis Urogenital Abnormalities Urogenital Diseases

Age range

0 month–18 year

Sex eligibility

Male

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Penoplasty

Procedure

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

Primary outcomes

Dartos Fascia (Penile Tissue) sample collection

Time frame: Procedure (At the time of penoplasty)

Collection of biological samples from pediatric patients who have been registered onto the prospective registry.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Feb 16, 2021
Registry last updated: May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed