Concealed PenisNCT04755803
A Prospective Registry of Patients With Congenital Penile Anomalies
An observational study of Concealed Penis and Hypospadias, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Prospective registry and biobank in pediatric patients with congenital penile anomalies Read more about this study
- Who is it for?
- Ages 0 months to 18 years, men only
- Conditions the study is for
- Concealed Penis, Hypospadias, Phimosis
- What is being tested?
- Penoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jul 2020to 30 Mar 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: Male patients between the ages of 0 to 18 years with congenital penile anomalies and receiving penoplasty at the institution.
Who may be able to join
- 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).
Who cannot join
- Those who are unwilling to participate and do not sign the informed consent.
- Unable to read or understand Korean.
Trial locations and contacts
1 site in 1 country.
About this study
Prospective registry and biobank in pediatric patients with congenital penile anomalies
Read the 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.
- Conditions
- Concealed Penis, Hypospadias, Phimosis, Chordee
- Being tested
- Penoplasty
- Medical subject headings
- Hypospadias, Phimosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PenoplastyProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Dartos Fascia (Penile Tissue) sample collection
Collection of biological samples from pediatric patients who have been registered onto the prospective registry.
Measured: Procedure (At the time of penoplasty)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start10 Jul 2020
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concealed PenisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwanjin Park, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755803
- Sponsor's protocol ID
- 2008-057-1147
- Status last verified
- May 2023
- First submitted
- 9 Feb 2021
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry of Patients With Congenital Penile Anomalies
- ClinicalTrials.gov ID
- NCT04755803
- Acronym / sponsor ID
- 2008-057-1147
- Conditions
- Concealed Penis, Hypospadias, Phimosis, Chordee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 0 months to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Male patients between the ages of 0 to 18 years with congenital penile anomalies and receiving penoplasty at the institution.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- Those who are unwilling to participate and do not sign the informed consent.
- Unable to read or understand Korean.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PenoplastyModified 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 | Procedure or surgery | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concealed Penis and Hypospadias, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dartos Fascia (Penile Tissue) sample collection (time frame: Procedure (At the time of penoplasty)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.