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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00169663
Other study ID # 03-049
Secondary ID
Status Completed
Phase N/A
First received September 9, 2005
Last updated April 23, 2012
Start date July 2003
Est. completion date November 2010

Study information

Verified date April 2012
Source Indiana Kidney Stone Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Brushite kidney stones are a unique form of calcium phosphate stones that have a tendency to recur quickly if patients are not aggressively treated with stone prevention measures. Little research has been undertaken to better understand the clinical history and potential urinary abnormalities that may predispose one to these troublesome kidney stones.


Description:

Multiple treatment options are available for the treatment of kidney or ureteral calculi. Treatment options include shock wave lithotripsy (SWL; shock waves are transmitted through the body wall and focused onto the stone to break the stone into gravel), percutaneous nephrolithotomy (PNL; a small flank incision is made and a telescope inserted into the kidney to allow stone fragmentation and removal from the patient), and ureteroscopic lithotripsy (URS; a small telescope is inserted into the ureter or kidney and a laser is used to break up the stone into gravel).

Brushite is a unique form of calcium phosphate kidney stone that often has sub-optimal stone fragmentation with shock wave lithotripsy (Heimbach et al, 1999). Due to its SWL resistance, brushite patients often undergo more invasive treatments such as URS or PNL to achieve a stone free status. Brushite patients often have multiple stones and have a high likelihood of developing recurrences (new stone formation or regrowth of existing stone fragments), often within the first year after surgery. These patients may also have a history of anatomical abnormalities of the urinary tract or a history of prior renal or ureteral surgery (Klee et al, 1991).

A thorough review of the clinical, radiological and metabolic data of brushite patients has the potential to clarify a number of important points. Many patients with brushite stones often have a history of non-brushite stones (e.g. calcium oxalate) predating the development of brushite stones and historical review is needed to define the factors contributing to this shift in stone composition. In addition, it has been shown that CT attenuation values can be used to predict stone composition (Joseph et al, 2002). As a result, it is crucial to review the radiologic appearance of known brushite stones to identify specific radiographic characteristics and possibly allow a radiographic diagnosis of brushite to be established. Finally, very little information has been reported on the urinary abnormalities in brushite patients. By carefully examining 24 hour urine data in a large population of brushite patients, information may be identified that can be used to provide improved management of specific abnormalities to prevent stone recurrences.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Male or female patients of Methodist Urology in Indianapolis, IN over the age of 18 with brushite stones.

Exclusion Criteria:

1. Patients unable to give informed consent

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Methodist Hospital Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana Kidney Stone Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To review the clinical and laboratory findings in a population of brushite patients who have been treated at Methodist Urology, LLC one year No
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