Silent Ureteral Stone: Impact on Renal Function and Kidney Anatomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01884870
Recruitment Status : Unknown
Verified June 2015 by Giovanni Scala Marchini, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : June 24, 2013
Last Update Posted : June 4, 2015
Information provided by (Responsible Party):
Giovanni Scala Marchini, University of Sao Paulo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Urinary Calculi Procedure: Surgical Treatment Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Silent Ureteral Stone on Renal Function and Kidney Anatomy: a Prospective Analysis
Study Start Date : November 2012
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Surgical Treatment
Silent Ureteral Stone - Surgical Treatment
Procedure: Surgical Treatment
Surgical Treatment - open, endoscopic or laparoscopic
Other Name: Surgical Treatment - open, endoscopic or laparoscopic

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

Secondary Outcome Measures :
  1. Serum Creatinine level [ Time Frame: 1 year ]
    Serum Creatinine level

  2. Estimated Creatinine Clearance [ Time Frame: 1 year ]
    Estimated Creatinine Clearance

  3. Renal Anatomy assessed by Ultrasound [ Time Frame: 1 year ]
    Renal Anatomy assessed by Ultrasound

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01884870

Contact: Giovanni S Marchini, MD 55-11-98179-8186

Clinics Hospital - University of Sao Paulo Medical School Recruiting
Sao Paulo, SP, Brazil, 05403-000
Contact: Eduardo Mazzucchi, PhD    55-11-26618080   
Principal Investigator: Giovanni S Marchini, MD         
Sub-Investigator: Eduardo Mazzucchi, PhD         
Sponsors and Collaborators
University of Sao Paulo
Principal Investigator: Giovanni S Marchini, MD University of Sao Paulo

Responsible Party: Giovanni Scala Marchini, MD, University of Sao Paulo Identifier: NCT01884870     History of Changes
Other Study ID Numbers: CAAE: 01187012.2.0000.0068
Online Number: 9015 ( Registry Identifier: Online Number: 9015 )
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015

Keywords provided by Giovanni Scala Marchini, University of Sao Paulo:
renal function

Additional relevant MeSH terms:
Ureteral Calculi
Urinary Calculi
Pathological Conditions, Anatomical
Ureteral Diseases
Urologic Diseases