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

Sponsor
Yonsei University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01762007
Collaborator
(none)
0
Enrollment
1
Location
8
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Study Start Date :
    Nov 1, 2012
    Anticipated Primary Completion Date :
    Jul 1, 2013
    Anticipated Study Completion Date :
    Jul 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Detrusor thickness [immediate analysis of detrusor thickness at the enrollment time of this study]

    Secondary Outcome Measures

    1. urinary nerve growth factor level [immediate analysis of urinary nerve growth factor level at the enrollment time of this study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 5 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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>

    2. patients with history of urethral operation other than hypospadias repair, febrile urinary tract infection, neurogenic abnormality

    3. patients with development urethra-cutaneous fistula

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sang Won Seoul Korea, Republic of 120-752

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT01762007
    Other Study ID Numbers:
    • 4-2012-0372
    First Posted:
    Jan 7, 2013
    Last Update Posted:
    May 6, 2021
    Last Verified:
    May 1, 2021
    Keywords provided by Yonsei University
    hypospadias, bladder outlet obstruction, ultrasonography
    Additional relevant MeSH terms:
    Hypospadias

    Study Results

    No Results Posted as of May 6, 2021