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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01214525
First received: October 3, 2010
Last updated: March 16, 2012
Last verified: March 2012
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improved (reduced) postvoid residual urine [ Time Frame: One month and one year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   2 Years to 12 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 3, 2010
Last Updated: March 16, 2012
Health Authority: Israel: Clalit Health Services

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

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 20, 2014