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

May 3, 2021 updated by: Yonsei University
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 Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Detrusor thickness
Time Frame: immediate analysis of detrusor thickness at the enrollment time of this study
immediate analysis of detrusor thickness at the enrollment time of this study

Secondary Outcome Measures

Outcome Measure
Time Frame
urinary nerve growth factor level
Time Frame: immediate analysis of urinary nerve growth factor level at the enrollment time of this study
immediate analysis of urinary nerve growth factor level at the enrollment time of this study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

July 1, 2013

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

December 19, 2012

First Submitted That Met QC Criteria

January 3, 2013

First Posted (Estimate)

January 7, 2013

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2012-0372

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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