Silent Ureteral Stone: Impact on Renal Function and Kidney Anatomy

Sponsor

University of Sao Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT01884870

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Calculi	Procedure: Surgical Treatment	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

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 :

Nov 1, 2012

Anticipated Primary Completion Date :

Jul 1, 2015

Anticipated Study Completion Date :

Aug 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Ipsilateral Renal Function [1 year]
Ipsilateral renal function determined by dimercaptosuccinic acid scintigraphy (DMSA) 12 months after surgery.

Secondary Outcome Measures

Serum Creatinine level [1 year]
Serum Creatinine level
Estimated Creatinine Clearance [1 year]
Estimated Creatinine Clearance
Renal Anatomy assessed by Ultrasound [1 year]
Renal Anatomy assessed by Ultrasound

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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