A Prospective Registry of Patients With Congenital Penile... | NCT04755803

Studies
A Prospective Registry of Patients With Congenital Penile Anomalies

NCT04755803

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

May 6, 2023Actual

Enrollment

32Actual

Phase

Not provided

Conditions

Concealed Penis
Hypospadias
Phimosis
Chordee

Interventions

Penoplasty

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2020Actual

Primary Completion Date

Mar 30, 2023Actual

Completion Date

Mar 30, 2023Actual

First Submitted Date

Feb 9, 2021

First Submission Date that Met QC Criteria

Feb 15, 2021

First Posted Date

Feb 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2023

Last Update Posted Date

May 6, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kwanjin Park, Principal Investigator, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

This registry is gender-specific and only males with congenital penile anomalies and receiving penoplasty at the institution are allowed to be enrolled.

Minimum Age

0 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Male patients between the ages of 0 to 18 years with congenital penile anomalies and receiving penoplasty at the institution.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007021	Hypospadias
D010688	Phimosis

Ancestor Terms

ID	Term
D014564	Urogenital Abnormalities
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Dartos Fascia is commonly known as subcutaneous tissue of the penis. It is located under the foreskin and superficially located on the outer external spermatic fascia of the scrotum and the axis of the penis. The primary role of dartos fascia is the mobility of the foreskin in the basal tissue and the blood supply from the external sinus vessels. Furthermore, it promotes heat loss and cools down the testicles.