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Silent Ureteral Stone: Impact on Renal Function and Kidney Anatomy

Primary Purpose

Urinary Calculi

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Surgical Treatment
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Calculi focused on measuring Asymptomatic, ureteral, calculi, renal function, treatment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinics Hospital - University of Sao Paulo Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Surgical Treatment

Arm Description

Silent Ureteral Stone - Surgical Treatment

Outcomes

Primary Outcome Measures

Ipsilateral Renal Function
Ipsilateral renal function determined by dimercaptosuccinic acid scintigraphy (DMSA) 12 months after surgery.

Secondary Outcome Measures

Serum Creatinine level
Serum Creatinine level
Estimated Creatinine Clearance
Estimated Creatinine Clearance
Renal Anatomy assessed by Ultrasound
Renal Anatomy assessed by Ultrasound

Full Information

First Posted
June 19, 2013
Last Updated
June 2, 2015
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01884870
Brief Title
Silent Ureteral Stone: Impact on Renal Function and Kidney Anatomy
Official Title
The Impact of Silent Ureteral Stone on Renal Function and Kidney Anatomy: a Prospective Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Calculi
Keywords
Asymptomatic, ureteral, calculi, renal function, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical Treatment
Arm Type
Other
Arm Description
Silent Ureteral Stone - Surgical Treatment
Intervention Type
Procedure
Intervention Name(s)
Surgical Treatment
Other Intervention Name(s)
Surgical Treatment - open, endoscopic or laparoscopic
Intervention Description
Surgical Treatment - open, endoscopic or laparoscopic
Primary Outcome Measure Information:
Title
Ipsilateral Renal Function
Description
Ipsilateral renal function determined by dimercaptosuccinic acid scintigraphy (DMSA) 12 months after surgery.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Serum Creatinine level
Description
Serum Creatinine level
Time Frame
1 year
Title
Estimated Creatinine Clearance
Description
Estimated Creatinine Clearance
Time Frame
1 year
Title
Renal Anatomy assessed by Ultrasound
Description
Renal Anatomy assessed by Ultrasound
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanni S Marchini, MD
Phone
55-11-98179-8186
Email
giovanni_marchini@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni S Marchini, MD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinics Hospital - University of Sao Paulo Medical School
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Mazzucchi, PhD
Phone
55-11-26618080
Email
mazuchi@terra.com.br
First Name & Middle Initial & Last Name & Degree
Giovanni S Marchini, MD
First Name & Middle Initial & Last Name & Degree
Eduardo Mazzucchi, PhD

12. IPD Sharing Statement

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Silent Ureteral Stone: Impact on Renal Function and Kidney Anatomy

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