Congenital Obstructive MegaureterPOMMENCT05639283
Primary Obstructive Megaureter Management in Eastern Interregional Area
An observational study of Congenital Obstructive Megaureter, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Congenital obstructive megaureter is a urinary malformation affecting the ureterovesical junction and causing obstruction to the flow of urine. It is the second most common cause of hydronephrosis. This malformation affects four times more boys than girls and is bilateral in 25% of cases. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Congenital Obstructive Megaureter
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2020to 31 Mar 2022
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Minor patient (from 1 to 17 years old) treated between January 2010 and December 2017 for an obstructive congenital mega-ureter
Who may be able to join
- Minor patient (from 1 to 17 years old)
- Patient treated between January 2010 and December 2017 in one of the participating centers for an obstructive congenital mega-ureter
- Subject (and/or his parental authority) not having expressed, after information, his opposition to the reuse of his data for the purposes of this research
Who cannot join
- Subject (and/or his parental authority) having expressed, after information, his opposition to the reuse of his data for the purposes of this research
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie pédiatrique - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Official title: Primary Obstructive Megaureter Management in Eastern Interregional Area : Current Status and Perspectives
Congenital obstructive megaureter is a urinary malformation affecting the ureterovesical junction and causing obstruction to the flow of urine. It is the second most common cause of hydronephrosis. This malformation affects four times more boys than girls and is bilateral in 25% of cases. It is also associated with contralateral renal dysplasia in 15% of cases. The obstruction is linked to aperistalsis and hypertrophy of the circular muscle bundles and increased collagen 1 level. This malformation is accessible to antenatal screening from the second trimester. It falls within the scope of CAKUT and requires regular monitoring. Indeed, this uropathy can cause repeated pyelonephritis, kidney scarring and affected kidney function.
- Conditions
- Congenital Obstructive Megaureter
- Keywords
- Congenital obstructive megaureter, Urinary malformation, Ureterovesical junction, Hydronephrosis, Renal dysplasia
- Medical subject headings
- Hydronephrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine over the past seven years, the operability factors of patients aged 0 to 5 years regardless of the surgical technique used
This study aims to make a retrospective inventory and perspective on the management of congenital obstructive mega ureter
Measured: Files analysed retrospectively from January 01, 2010 to December 31, 2017 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start2 Sep 2020
- Primary completion2 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Obstructive MegaureterStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639283
- Sponsor's protocol ID
- 7978
- Acronym
- POMME
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2022
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Obstructive Megaureter Management in Eastern Interregional Area : Current Status and Perspectives
- ClinicalTrials.gov ID
- NCT05639283
- Acronym / sponsor ID
- POMME / 7978
- Conditions
- Congenital Obstructive Megaureter
- Keywords
- Congenital obstructive megaureter, Urinary malformation, Ureterovesical junction, Hydronephrosis, Renal dysplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 6 Dec 2022 (actual)
- 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.
Congenital obstructive megaureter is a urinary malformation affecting the ureterovesical junction and causing obstruction to the flow of urine. It is the second most common cause of hydronephrosis. This malformation affects four times more boys than girls and is bilateral in 25% of cases. It is also associated with contralateral renal dysplasia in 15% of cases. The obstruction is linked to aperistalsis and hypertrophy of the circular muscle bundles and increased collagen 1 level. This malformation is accessible to antenatal screening from the second trimester. It falls within the scope of CAKUT and requires regular monitoring. Indeed, this uropathy can cause repeated pyelonephritis, kidney scarring and affected kidney function.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Minor patient (from 1 to 17 years old) treated between January 2010 and December 2017 for an obstructive congenital mega-ureter
Key inclusion criteria (3 listed)
- Minor patient (from 1 to 17 years old)
- Patient treated between January 2010 and December 2017 in one of the participating centers for an obstructive congenital mega-ureter
- Subject (and/or his parental authority) not having expressed, after information, his opposition to the reuse of his data for the purposes of this research
Key exclusion criteria (1 listed)
- Subject (and/or his parental authority) having expressed, after information, his opposition to the reuse of his data for the purposes of this research
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
Determine over the past seven years, the operability factors of patients aged 0 to 5 years regardless of the surgical technique used
Time frame: Files analysed retrospectively from January 01, 2010 to December 31, 2017 will be examined
This study aims to make a retrospective inventory and perspective on the management of congenital obstructive mega ureter
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 8 Dec 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Congenital Obstructive Megaureter, run by University Hospital, Strasbourg, France at 1 site in France.
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 3 inclusion and 1 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 8 Dec 2023. 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 France. 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?
Determine over the past seven years, the operability factors of patients aged 0 to 5 years regardless of the surgical technique used (time frame: Files analysed retrospectively from January 01, 2010 to December 31, 2017 will be examined). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2023.