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The Change of the Detrusor Thickness After Hypospadias Repair - Comparison With the Normal Control Group

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Yonsei University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01762007
First Posted: January 7, 2013
Last Update Posted: January 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  Purpose
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.

Condition
Hypospadias

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Detrusor thickness [ Time Frame: immediate analysis of detrusor thickness at the enrollment time of this study ]

Secondary Outcome Measures:
  • urinary nerve growth factor level [ Time Frame: immediate analysis of urinary nerve growth factor level at the enrollment time of this study ]

Estimated Enrollment: 56
Study Start Date: November 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

<Group 1>

  1. 6Mo-2Yr old penile hypospadias patients before operation <Group 2>
  2. 6Mo-2Yr old male patients without hypospadias <Group 3>
  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>
  4. 2Yr-5Yr old male patients without hypospadias1. 0-3 year old children without any abnormality of urinary tract

Exclusion Criteria:

<Group 1, 2, 4>

1. patients with history of urethral operation, febrile urinary tract infection, neurogenic abnormality om operation <Group 3>

  1. patients with history of urethral operation other than hypospadias repair, febrile urinary tract infection, neurogenic abnormality
  2. patients with development urethra-cutaneous fistula
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762007


Contacts
Contact: Sang Won Han, MD 82-2-2228-2316 swhan@yuhs.ac

Locations
Korea, Republic of
Sang Won Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Sang Won Han, MD    +82-2-2228-2316    swhan@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01762007     History of Changes
Other Study ID Numbers: 4-2012-0372
First Submitted: December 19, 2012
First Posted: January 7, 2013
Last Update Posted: January 7, 2013
Last Verified: January 2013

Keywords provided by Yonsei University:
hypospadias, bladder outlet obstruction, ultrasonography

Additional relevant MeSH terms:
Hypospadias
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities