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

August 19, 2018 updated by: Meir Medical Center
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar Saba, Israel, 44281
        • Meir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Toilet trained children, before puberty, scheduled for urethral meatotomy for the treatment of urethral meatal stenosis.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Meatotomy
Toilet trained children scheduled for urethral meatotomy for the treatment of urethral meatal stenosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improved maximal urine flow
Time Frame: one month and one year
one month and one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Improved (reduced) postvoid residual urine
Time Frame: One month and one year
One month and one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: Itay A Sternberg, MD, Meir Medical Center
  • Principal Investigator: Amos Neheman, MD, Meir Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

October 3, 2010

First Submitted That Met QC Criteria

October 3, 2010

First Posted (Estimate)

October 5, 2010

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 19, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC10144-2010CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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