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

NCT ID: NCT01214525

Last Updated: 2018-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Urethral Meatal Stenosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Meatotomy

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Itay A Sternberg, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Amos Neheman, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 18436251 (View on PubMed)

Other Identifiers

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MMC10144-2010CTIL

Identifier Type: -

Identifier Source: org_study_id

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