Silent Ureteral Stone: Impact on Renal Function and Kidney Anatomy

June 2, 2015 updated by: Giovanni Scala Marchini, University of Sao Paulo

The Impact of Silent Ureteral Stone on Renal Function and Kidney Anatomy: a Prospective Analysis

Ureteral stones may be silent in 5.3% of patients. The goal of this study was to prospectively evaluate the impact of a silent ureteral stone on renal function.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The prevalence of nephrolithiasis is increasing worldwide, reaching 5.2% in North America and 10.1% in Italy. The widespread use of computed tomography and ultrasonography have resulted in a greater detection rate of asymptomatic stones and, in part, might explain the trend. Clinically, kidney or ureteral stones range in severity from asymptomatic to presenting with complete renal failure. Therefore, it is not only the alarming incidence of urinary stone disease, but also the associated burden that makes this one of the most concerning conditions in public health.

The situation becomes even more distressing when managing asymptomatic stones. Studies of the natural history of stones have revealed that only 20% of patients yearly actually become symptomatic from a new stone, and one half of those require surgical intervention at some point. The guidelines are well established for the treatment of symptomatic urolithiasis, and many investigators have extensively studied the management of silent kidney stones. Conversely, the same is not true for silent ureterolithiasis. The purpose of the present study is to report the investigators experience managing silent ureteral stones and to prospectively analyze their true influence on renal function.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05403-000
        • Recruiting
        • Clinics Hospital - University of Sao Paulo Medical School
        • Contact:
        • Principal Investigator:
          • Giovanni S Marchini, MD
        • Sub-Investigator:
          • Eduardo Mazzucchi, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Silent ureteral stone: no subjective/objective symptoms related to the ureteral calculi.
  • Patient willing to participate in the study
  • Complete pre/post-operative work-up

Exclusion Criteria:

  • Treatment outside our institution
  • No will to be a part of the study
  • Incomplete pre/post-operative work-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Surgical Treatment
Silent Ureteral Stone - Surgical Treatment
Procedure: Surgical Treatment
Surgical Treatment - open, endoscopic or laparoscopic
Other Names:
  • Surgical Treatment - open, endoscopic or laparoscopic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ipsilateral Renal Function
Time Frame: 1 year
Ipsilateral renal function determined by dimercaptosuccinic acid scintigraphy (DMSA) 12 months after surgery.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Creatinine level
Time Frame: 1 year
Serum Creatinine level
1 year
Estimated Creatinine Clearance
Time Frame: 1 year
Estimated Creatinine Clearance
1 year
Renal Anatomy assessed by Ultrasound
Time Frame: 1 year
Renal Anatomy assessed by Ultrasound
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Giovanni S Marchini, MD, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ANTICIPATED)

July 1, 2015

Study Completion (ANTICIPATED)

August 1, 2015

Study Registration Dates

First Submitted

June 19, 2013

First Submitted That Met QC Criteria

June 21, 2013

First Posted (ESTIMATE)

June 24, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 4, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE: 01187012.2.0000.0068
  • Online Number: 9015 (REGISTRY: Online Number: 9015)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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