Alfuzosin for Medical Expulsion Therapy of Ureteral Stones

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: United States Naval Medical Center, San Diego
• Treatments: Alfuzosin; Doxazosin; Nifedipine; Prazosin

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