Urethral Meatal StenosisNCT01214525
The Improvement in Uroflow and Postvoid Residual Urine After Urethral Meatotomy in Children With Meatal Stenosis
An observational study of Urethral Meatal Stenosis, run by Meir Medical Center at 1 site in Israel.
Trial 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 more about this study
- Who is it for?
- Ages 2 to 12 years, men only
- Conditions the study is for
- Urethral Meatal Stenosis
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2010to 1 Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- Men only
- No healthy volunteers
- Child
Study population: Toilet trained children, before puberty, scheduled for urethral meatotomy for the treatment of urethral meatal stenosis.
Who may be able to join
- Toilet trained children
- Before puberty
- No other urologic disease that might affect the measurements
- Primary (first) repair
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Urethral Meatal Stenosis
- Keywords
- Meatal stenosis, Meatotomy, Uroflow, Postvoid residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Meatotomy | Toilet trained children scheduled for urethral meatotomy for the treatment of urethral meatal stenosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved maximal urine flow
Measured: one month and one year
Secondary outcomes (1)
Improved (reduced) postvoid residual urine
Measured: One month and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startOct 2010
- Primary completion1 Aug 2011
- Study completion1 Aug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urethral Meatal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Itay A Sternberg, MD, Principal investigator, Meir Medical CenterAmos Neheman, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214525
- Sponsor's protocol ID
- MMC10144-2010CTIL
- Status last verified
- Aug 2018
- First submitted
- 3 Oct 2010
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Improvement in Uroflow and Postvoid Residual Urine After Urethral Meatotomy in Children With Meatal Stenosis
- ClinicalTrials.gov ID
- NCT01214525
- Acronym / sponsor ID
- MMC10144-2010CTIL
- Conditions
- Urethral Meatal Stenosis
- Keywords
- Meatal stenosis, Meatotomy, Uroflow, Postvoid residual
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- 1 Aug 2011 (actual)
- Study completion
- 1 Aug 2011 (actual)
- First posted
- 5 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meatotomy | – | –Toilet trained children scheduled for urethral meatotomy for the treatment of urethral meatal stenosis. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Toilet trained children, before puberty, scheduled for urethral meatotomy for the treatment of urethral meatal stenosis.
Key inclusion criteria (4 listed)
- Toilet trained children
- Before puberty
- No other urologic disease that might affect the measurements
- Primary (first) repair
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improved maximal urine flow
Time frame: one month and one year
1 secondary outcome
Improved (reduced) postvoid residual urine
Time frame: One month and one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Background: PubMed 18436251VanderBrink 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Itay A Sternberg, MD principal investigator
Meir Medical Center
Amos Neheman, MD principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urethral Meatal Stenosis, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved maximal urine flow (time frame: one month and one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01214525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018.