A Prospective Registry of Patients With Congenital Penile Anomalies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-10

Study Completion Date

2023-03-30

Brief Summary

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Prospective registry and biobank in pediatric patients with congenital penile anomalies

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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.

Conditions

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Concealed Penis Hypospadias Phimosis Chordee

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type PROCEDURE

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).