HypospadiasNCT01762007
The Change of the Detrusor Thickness After Hypospadias Repair - Comparison With the Normal Control Group
An observational study of Hypospadias, run by Yonsei University at 1 site in South Korea.
Trial summary
Even successfully managed hypospadias without any complication, voiding problem could be developed due to the increased urethral resistance. The investigators are trying to analyze the effect of hypospadias operation on voiding function by checking the detrusor thickness and urinary nerve growth factor. Read more about this study
- Who is it for?
- Ages Up to 5 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypospadias
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to Jul 2013
- 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 Up to 5 years
- Men only
- Healthy volunteers accepted
- Child
Study population: Group 1: 13 patients with 6Mo-2Yr old penile hypospadias patients before operation Group 2: 13 patients with 6Mo-2Yr old male patients without hypospadias Group 3: 15 patients with penile hypospadias patients under the age of 5 Yr who got tubularized incised plate operation at out institution at the age between 6Mo and 2Yr old and more than 1 Yr have passed Group 4: 15 patients with 2Yr-5Yr old male patients without hypospadias
Who may be able to join
- <Group 1>
- 6Mo-2Yr old penile hypospadias patients before operation <Group 2>
- 6Mo-2Yr old male patients without hypospadias <Group 3>
- penile hypospadias patients under the age of 5 Yr who got tubularized incised plate operation at out institution at the age between 6Mo and 2Yr old and more than 1 Yr have passed <Group 4>
- 2Yr-5Yr old male patients without hypospadias1. 0-3 year old children without any abnormality of urinary tract
Who cannot join
- <Group 1, 2, 4>
- 1. patients with history of urethral operation, febrile urinary tract infection, neurogenic abnormality om operation <Group 3>
- patients with history of urethral operation other than hypospadias repair, febrile urinary tract infection, neurogenic abnormality
- patients with development urethra-cutaneous fistula
Trial locations and contacts
1 site in 1 country.
About this study
Even successfully managed hypospadias without any complication, voiding problem could be developed due to the increased urethral resistance. The investigators are trying to analyze the effect of hypospadias operation on voiding function by checking the detrusor thickness and urinary nerve growth factor.
- Conditions
- Hypospadias
- Keywords
- hypospadias, bladder outlet obstruction, ultrasonography
- Medical subject headings
- Hypospadias, Urinary Bladder Neck Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 6Mo-2Yr old penile hypospadias patients before operation | Not described | |
| 6Mo-2Yr old male patients without hypospadias | Not described | |
| penile hypospadias patients under the age of 5 Yr | penile hypospadias patients under the age of 5 Yr who got tubularized incised plate operation at out institution at the age between 6Mo and 2Yr old and more than 1 Yr have passed | |
| 2Yr-5Yr old male patients without hypospadias | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detrusor thickness
Measured: immediate analysis of detrusor thickness at the enrollment time of this study
Secondary outcomes (1)
urinary nerve growth factor level
Measured: immediate analysis of urinary nerve growth factor level at the enrollment time of this study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Why it stopped: Due to difficulty in purchasing reagents, study canceled without subject registration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762007
- Sponsor's protocol ID
- 4-2012-0372
- Status last verified
- May 2021
- First submitted
- 19 Dec 2012
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Change of the Detrusor Thickness After Hypospadias Repair - Comparison With the Normal Control Group
- ClinicalTrials.gov ID
- NCT01762007
- Acronym / sponsor ID
- 4-2012-0372
- Conditions
- Hypospadias
- Keywords
- hypospadias, bladder outlet obstruction, ultrasonography
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to difficulty in purchasing reagents, study canceled without subject registration
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 7 Jan 2013 (estimated)
- 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.
Even successfully managed hypospadias without any complication, voiding problem could be developed due to the increased urethral resistance. The investigators are trying to analyze the effect of hypospadias operation on voiding function by checking the detrusor thickness and urinary nerve growth factor.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 6Mo-2Yr old penile hypospadias patients before operation | – | – |
| 6Mo-2Yr old male patients without hypospadias | – | – |
| penile hypospadias patients under the age of 5 Yr | – | –penile hypospadias patients under the age of 5 Yr who got tubularized incised plate operation at out institution at the age between 6Mo and 2Yr old and more than 1 Yr have passed |
| 2Yr-5Yr old male patients without hypospadias | – | – |
Who may qualify
- Ages
- Up to 5 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Group 1: 13 patients with 6Mo-2Yr old penile hypospadias patients before operation Group 2: 13 patients with 6Mo-2Yr old male patients without hypospadias Group 3: 15 patients with penile hypospadias patients under the age of 5 Yr who got tubularized incised plate operation at out institution at the age between 6Mo and 2Yr old and more than 1 Yr have passed Group 4: 15 patients with 2Yr-5Yr old male patients without hypospadias
Key inclusion criteria (5 listed)
- <Group 1>
- 6Mo-2Yr old penile hypospadias patients before operation <Group 2>
- 6Mo-2Yr old male patients without hypospadias <Group 3>
- penile hypospadias patients under the age of 5 Yr who got tubularized incised plate operation at out institution at the age between 6Mo and 2Yr old and more than 1 Yr have passed <Group 4>
- 2Yr-5Yr old male patients without hypospadias1. 0-3 year old children without any abnormality of urinary tract
Key exclusion criteria (4 listed)
- <Group 1, 2, 4>
- 1. patients with history of urethral operation, febrile urinary tract infection, neurogenic abnormality om operation <Group 3>
- patients with history of urethral operation other than hypospadias repair, febrile urinary tract infection, neurogenic abnormality
- patients with development urethra-cutaneous fistula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detrusor thickness
Time frame: immediate analysis of detrusor thickness at the enrollment time of this study
1 secondary outcome
urinary nerve growth factor level
Time frame: immediate analysis of urinary nerve growth factor level at the enrollment time of this study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
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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 Hypospadias, run by Yonsei University 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 6 May 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Detrusor thickness (time frame: immediate analysis of detrusor thickness at the enrollment time of this study). 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 2021.