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OpenTrials
Completed

NCT Number: NCT01214525

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

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.

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Key information

Conditions

Urethral Meatal Stenosis

Age range

2 year–12 year

Sex eligibility

Male

Study type

Observational

Primary location

Meir Medical Center

Kfar Saba, 44281, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Improved maximal urine flow

    Time frame: one month and one year

Secondary outcomes

  1. Improved (reduced) postvoid residual urine

    Time frame: One month and one year

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 5, 2010
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.