Alfuzosin for Medical Expulsion Therapy of Ureteral Stones

Unknown status
Trial end date:
Target enrollment:
Participant gender:
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 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Lead Sponsor:
United States Naval Medical Center, San Diego
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