Classic Bladder ExstrophyNCT02192801
Kidney Function in Patients With Bladder Exstrophy
An observational study of Classic Bladder Exstrophy and Renal Function, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Patients with classical bladder exstrophy undergo many surgical interventions with secondary urinary tract infections complicating their course. lately primary definitive surgical correction of this congenital anomaly has been implemented with satisfactory results. Read more about this study
- Who is it for?
- Ages 1 year to 30 years
- Conditions the study is for
- Classic Bladder Exstrophy, Renal Function, GFR
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2014to Apr 2016
- 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 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with calssic bladder exstrophy
Who may be able to join
- All patients with classic bladder exstrophy treated and followed in Pediatric urology clinic in Dana Children Hospital and Outpatient Clinic
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
Jacob Ben Chaim, MD contact
Israel1 site
Pediatric Outpatient Clinic Dana Children Hospital Tel Aviv Sourasky medical center
Tel Aviv
Jacob Ben Chaim, MD
About this study
Official title: Evaluation of Long-term Renal Function in Patients After Surgical Repair of Classical Bladder Exstrophy
Patients with classical bladder exstrophy undergo many surgical interventions with secondary urinary tract infections complicating their course. lately primary definitive surgical correction of this congenital anomaly has been implemented with satisfactory results. Although bladder exstrophy patients are born with normal kidneys, infectious and mechanical surgical complications can potentially damage their kidneys in the long-term. therefore we decided to evaluate renal function in the long-term in these patients.
- Conditions
- Classic Bladder Exstrophy, Renal Function, GFR, Proteinuria
- Keywords
- Classic Bladder Exstrophy, Renal function, GFR, Proteinuria
- Medical subject headings
- Proteinuria
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function
Creatinine and GFR estimation , proteinuria, albuminuria will be assessed as measures of renal function as well as renal mass estimation through renal size as by ultrasound and in certain cases through dimercaptosucicnic acid (DMSA)renal scan
Measured: 1 day (last visit )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classic Bladder ExstrophyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192801
- Sponsor's protocol ID
- TASMC-13-RC-0022-13-CTIL
- Status last verified
- Jan 2014
- First submitted
- 30 Jan 2014
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-term Renal Function in Patients After Surgical Repair of Classical Bladder Exstrophy
- ClinicalTrials.gov ID
- NCT02192801
- Acronym / sponsor ID
- TASMC-13-RC-0022-13-CTIL
- Conditions
- Classic Bladder Exstrophy, Renal Function, GFR, Proteinuria
- Keywords
- Classic Bladder Exstrophy, Renal function, GFR, Proteinuria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (estimated)
- First posted
- 17 Jul 2014 (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.
Patients with classical bladder exstrophy undergo many surgical interventions with secondary urinary tract infections complicating their course. lately primary definitive surgical correction of this congenital anomaly has been implemented with satisfactory results. Although bladder exstrophy patients are born with normal kidneys, infectious and mechanical surgical complications can potentially damage their kidneys in the long-term. therefore we decided to evaluate renal function in the long-term in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with calssic bladder exstrophy
Key inclusion criteria (1 listed)
- All patients with classic bladder exstrophy treated and followed in Pediatric urology clinic in Dana Children Hospital and Outpatient Clinic
Key exclusion criteria (1 listed)
- No
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
Renal function
Time frame: 1 day (last visit )
Creatinine and GFR estimation , proteinuria, albuminuria will be assessed as measures of renal function as well as renal mass estimation through renal size as by ultrasound and in certain cases through dimercaptosucicnic acid (DMSA)renal scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
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.
Jacob Ben Chaim, MD contact
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 Classic Bladder Exstrophy and Renal Function, run by Tel-Aviv Sourasky 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 1 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: status not confirmed, as of the sponsor's last update on 17 Jul 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roxana Cleper, MD (972-3-6972512, roxanac@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function (time frame: 1 day (last visit )). 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 17 Jul 2014; AzTrials last refreshed its copy on 27 Oct 2026.