Kidney Function in Patients With Bladder Exstrophy

Proteinuria Clinical Trial

Official title:

Evaluation of Long-term Renal Function in Patients After Surgical Repair of Classical Bladder Exstrophy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02192801
• Other study ID #: TASMC-13-RC-0022-13-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: January 30, 2014
• Last updated: July 16, 2014
• Start date: April 2014

Study information

• Verified date: January 2014
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Roxana Cleper, MD
• Phone: 972-3-6972512
• Email: roxanac[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 30 Years

Eligibility

Inclusion Criteria:

• All patients with classic bladder exstrophy treated and followed in Pediatric urology clinic in Dana Children Hospital and Outpatient Clinic

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bladder Exstrophy
• Classic Bladder Exstrophy
• GFR
• Proteinuria
• Renal Function

Locations

Country	Name	City	State
Israel	Pediatric Outpatient Clinic Dana Children Hospital Tel Aviv Sourasky medical center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 day (last visit )	No