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

NCT01762007 | Withdrawn

• 1 other identifier: 4-2012-0372
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypospadias

Keywords

hypospadias, bladder outlet obstruction, ultrasonography

Outcome Measures

Primary Outcomes (1)

• Detrusor thickness

  immediate analysis of detrusor thickness at the enrollment time of this study

Secondary Outcomes (1)

• urinary nerve growth factor level

  immediate analysis of urinary nerve growth factor level at the enrollment time of this study

Study Arms (4)

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 Criteria

• Age: Up to 5 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• \<Group 1, 2, 4\>
• \. 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Sang Won

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Hypospadias; Urinary Bladder Neck Obstruction

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urethral Obstruction; Urethral Diseases; Urologic Diseases; Urinary Bladder Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: January 7, 2013
• Study Start: November 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

KR (1)