The Change of the Detrusor Thickness After Hypospadias Re... | NCT01762007

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

NCT01762007

Sponsor

Yonsei University

Status

Withdrawn

Last Update Posted

May 6, 2021Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Hypospadias

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to difficulty in purchasing reagents, study canceled without subject registration

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Jul 2013Estimated

Completion Date

Jul 2013Estimated

First Submitted Date

Dec 19, 2012

First Submission Date that Met QC Criteria

Jan 3, 2013

First Posted Date

Jan 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2021

Last Update Posted Date

May 6, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

5 Years

Standard Ages

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Sang Won		Seoul		120-752	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D007021	Hypospadias
D001748	Urinary Bladder Neck Obstruction

Ancestor Terms

ID	Term
D014564	Urogenital Abnormalities
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided