NCT02192801

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Last Updated

July 17, 2014

Status Verified

January 1, 2014

Enrollment Period

2 years

First QC Date

January 30, 2014

Last Update Submit

July 16, 2014

Conditions

Classic Bladder ExstrophyRenal FunctionGFRProteinuria

Keywords

Classic Bladder ExstrophyRenal functionGFRProteinuria

Outcome Measures

Primary Outcomes (1)

  • 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 )

Eligibility Criteria

Age1 Year - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with calssic bladder exstrophy

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Outpatient Clinic Dana Children Hospital Tel Aviv Sourasky medical center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Proteinuria

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Roxana Cleper, MD

CONTACT

972-3-6972512roxanac@tlvmc.gov.il

Jacob Ben Chaim, MD

CONTACT

jacobbc@tlvmc.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2014

First Posted

July 17, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2016

Last Updated

July 17, 2014

Record last verified: 2014-01

Locations

IL(1)