Silent Ureteral Stone: Impact on Renal Function and Kidney Anatomy

Urinary Calculi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01884870
• Other study ID #: CAAE: 01187012.2.0000.0068
• Secondary ID: Online Number: 9
• Status: Recruiting
• Phase: N/A
• First received: June 19, 2013
• Last updated: June 2, 2015
• Start date: November 2012
• Est. completion date: August 2015

Study information

• Verified date: June 2015
• Source: University of Sao Paulo
• Contact: Giovanni S Marchini, MD
• Phone: 55-11-98179-8186
• Email: giovanni_marchini[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calculi
• Ureteral Calculi
• Ureterolithiasis
• Urinary Calculi

Intervention

Procedure:
• Surgical Treatment
Surgical Treatment - open, endoscopic or laparoscopic

Locations

Country	Name	City	State
Brazil	Clinics Hospital - University of Sao Paulo Medical School	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ipsilateral Renal Function	Ipsilateral renal function determined by dimercaptosuccinic acid scintigraphy (DMSA) 12 months after surgery.	1 year	No
Secondary	Serum Creatinine level	Serum Creatinine level	1 year	No
Secondary	Estimated Creatinine Clearance	Estimated Creatinine Clearance	1 year	No
Secondary	Renal Anatomy assessed by Ultrasound	Renal Anatomy assessed by Ultrasound	1 year	No