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Evaluation of Alfuzosin as Medical Expulsion Therapy for Ureteral Stones

This study is currently Recruiting

April 2009 By United States Naval Medical Center, San Diego

First Recieved on July 7, 2008

Last Updated on December 14, 2010

Sponsor: United States Naval Medical Center, San Diego
Collaborators:
Information provided by: United States Naval Medical Center, San Diego
Identifier: NCT00713739

Purpose

The goal of this study is to conduct a prospective controlled trail of four currently approved Department of Defense (DOD) - formulary medications for use as medical expulsion therapy (MET) for kidney stones. Between 8% and 15% of Americans will develop symptomatic urolithiasis in there life. Several medications, including steroids, calcium channel blockers, alpha-adrenergic antagonists and non-steroidal anti-inflammatory drugs, have been utilized to aid in the spontaneous passage of distal ureteral calculi. Recently, use of selective alpha-blockers has shown promise for medical expulsion therapy (MET) of distal ureteral calculi. None of these studies have been widely publicized outside the specialty of urology. Recent studies have shown a success rate of nearly 90% when the selective alpha-blocker tamsulosin (Flomax) was used for MET. MET has also been shown to result in a decreased narcotic requirement, shorter time to stone passage, and reduced requirement for further interventions. The investigators will evaluate the effectiveness of MET as initial management for kidney stones using DOD-approved formulary medications.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Accepts Healthy Volunteers
Criteria

Inclusion Criteria: - Age >/= 18 years - Single ureteral stone < 1 cm in greatest dimension Exclusion Criteria: - Age < 18 years - Active unstable angina - History of or active postural hypotension (>20 mmHg drop in orthostatic SBP) - Allergy to alpha-blockers - Acute or Chronic Renal Failure as demonstrated by a serum creatinine of > 1.4 mg/dl - Urinary tract infection - Multiple ureteral stones - Current uncontrolled diabetes - Alpha-blocker therapy within 30 days for any reason - Current pregnancy or lactation - Patient desire for immediate stone removal

Investigators

  • Investigator: Brian K. Auge, M.D. - Principal Investigator - NMCSD
  • Investigator: Sean P. Stroup, M.D. - Principal Investigator - NMCSD

Locations

  • Naval Medical Center San Diego

    San Diego, California 92134 United States

Conditions related to this trial:

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