The Improvement in Uroflow and Postvoid Residual Urine After Urethral Meatotomy in Children With Meatal Stenosis

Urethral Meatal Stenosis Clinical Trial

Official title:

The Improvement in Uroflow and Postvoid Residual Urine After Urethral Meatotomy in Children With Meatal Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214525
• Other study ID #: MMC10144-2010CTIL
• Status: Completed
• Start date: October 2010
• Est. completion date: August 1, 2011

Study information

• Verified date: August 2018
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The improvement in uroflow and postvoid residual urine in children after urethral meatotomy for meatal stenosis. The hypothesis is that there is an improvement in both parameters, thus justifying the procedure.

Description:

Urethral meatal stenosis is a known complication of circumcision occuring in up to 3% of newborns undergoing circumcision. It is customary to perform a meatotomy in order to prevent bladder outlet obstruction, although bladder outlet obstruction has never been proven and improvement has only been proved in a single, small, retrospective study. Our intention is to evaluate the improvement in objective parameters (uroflow and postvoid residual urine) after urethral meatotomy by measuring these parameter before the procedure, one month after the procedure and one year after the procedure. Symptoms assessment will also be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 1, 2011
• Est. primary completion date: August 1, 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 2 Years to 12 Years

Eligibility

Inclusion Criteria:

• Toilet trained children

• Before puberty

• No other urologic disease that might affect the measurements

• Primary (first) repair

Exclusion Criteria:

• Children unable to urinate on command

• Children that have started their sexual puberty

• Children with other urologic disease that might affect the study measurements

• Recurrent stenosis after previous repair

Related Conditions & MeSH terms

• Constriction, Pathologic
• Urethral Meatal Stenosis
• Urethral Stricture

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

VanderBrink BA, Gitlin J, Palmer LS. Uroflowmetry parameters before and after meatoplasty for primary symptomatic meatal stenosis in children. J Urol. 2008 Jun;179(6):2403-6; discussion 2406. doi: 10.1016/j.juro.2008.01.169. Epub 2008 Apr 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved maximal urine flow		one month and one year
Secondary	Improved (reduced) postvoid residual urine		One month and one year