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Brushite Kidney Stones: A Registry and Database of Clinical and Laboratory Findings

This study has been completed.
Sponsor:
Information provided by:
Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier:
NCT00169663
First received: September 9, 2005
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

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.


Condition
Nephrolithiasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Brushite Stones: A Registry and Database of Clinical and Laboratory Findings

Resource links provided by NLM:


Further study details as provided by Indiana Kidney Stone Institute:

Primary Outcome Measures:
  • To review the clinical and laboratory findings in a population of brushite patients who have been treated at Methodist Urology, LLC [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: July 2003
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients of Methodist Urology in Indianapolis, IN who have a stone analysis of 100% brushite stone

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169663

Locations
United States, Indiana
Methodist Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana Kidney Stone Institute
Investigators
Principal Investigator: James E Lingeman, MD IU Health Physicians Urology
  More Information

Additional Information:
No publications provided

Responsible Party: James Lingeman, MD, IU Health Physicians Urology
ClinicalTrials.gov Identifier: NCT00169663     History of Changes
Other Study ID Numbers: 03-049
Study First Received: September 9, 2005
Last Updated: April 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana Kidney Stone Institute:
Brushite Kidney Stones
Nephrolithiasis

Additional relevant MeSH terms:
Nephrolithiasis
Kidney Diseases
Urolithiasis
Urologic Diseases

ClinicalTrials.gov processed this record on November 27, 2014