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CompletedNCT01214525Updated Aug 21, 2018

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

An observational study in Urethral Meatal Stenosis, sponsored by Meir Medical Center. Completed at 1 site in Israel. Open to male participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2018-08-21.

Sponsored by Meir Medical Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
25
Ages
2 Years to 12 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Urethral Meatal Stenosis

Keywords

  • Meatal stenosis
  • Meatotomy
  • Uroflow
  • Postvoid residual
03

In context

Constriction, Pathologic

1,117 studies on the registry are indexed under Constriction, Pathologic; 231 are open to participants now.

This study's enrollment of 25 is below the median of 121 across 390 observational studies indexed under Constriction, Pathologic.

Browse Constriction, Pathologic studies →

Lead sponsor

Meir Medical Center is the lead sponsor of 389 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 12 Years
Sexes eligible
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.

Inclusion criteria

  • Toilet trained children
  • Before puberty
  • No other urologic disease that might affect the measurements
  • Primary (first) repair

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
25 participants (actual)

Groups and cohorts

  • Meatotomy

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

06

What researchers measure

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

07

Study locations

1 site
  • Meir Medical Center
    Kfar Saba, 44281, Israel
08

References and documents

Publications

  • 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. PubMed 18436251 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01214525
Lead sponsor
Meir Medical Center
Responsible party
Sponsor
First posted
Oct 5, 2010
Start date
Oct 2010
Primary completion
Aug 1, 2011
Completion
Aug 1, 2011
Last update
Aug 21, 2018

Study contacts

Itay A Sternberg, MD
principal investigator · Meir Medical Center
Amos Neheman, MD
principal investigator · Meir Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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