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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Meir Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01214525
First Posted: October 5, 2010
Last Update Posted: March 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meir Medical Center
  Purpose
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.

Condition
Urethral Meatal Stenosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Improvement in Uroflow and Postvoid Residual Urine After Urethral Meatotomy in Children With Meatal Stenosis

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Improved maximal urine flow [ Time Frame: one month and one year ]

Secondary Outcome Measures:
  • Improved (reduced) postvoid residual urine [ Time Frame: One month and one year ]

Estimated Enrollment: 30
Study Start Date: October 2010
Estimated Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Meatotomy
Toilet trained children scheduled for urethral meatotomy for the treatment of urethral meatal stenosis.

Detailed 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.
  Eligibility

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Toilet trained children, before puberty, scheduled for urethral meatotomy for the treatment of urethral meatal stenosis.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214525


Contacts
Contact: Itay A Sternberg, MD 09-7471557 sternberg.itay@clalit.org.il
Contact: Amos Neheman, MD 09-7471557

Locations
Israel
Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Contact: Itay A Sternberg, MD    09-7471557    sternberg.itay@clalit.org.il   
Contact: Amos Neheman, MD    09-7471557      
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Itay A Sternberg, MD Meir Medical Center
Principal Investigator: Amos Neheman, MD Meir Medical Center
  More Information

Publications:
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01214525     History of Changes
Other Study ID Numbers: MMC10144-2010CTIL
First Submitted: October 3, 2010
First Posted: October 5, 2010
Last Update Posted: March 19, 2012
Last Verified: March 2012

Keywords provided by Meir Medical Center:
Meatal stenosis
Meatotomy
Uroflow
Postvoid residual

Additional relevant MeSH terms:
Constriction, Pathologic
Urethral Stricture
Pathological Conditions, Anatomical
Urethral Obstruction
Urethral Diseases
Urologic Diseases