Alfuzosin for Medical Expulsion Therapy of Ureteral Stones (MET)

Naval Medical Center

Status and phase: Unknown; Phase 3

Conditions: Kidney Stones

Treatments: Drug: Alfuzosin; Drug: prazosin; Drug: doxazosin; Drug: nifedipine

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00713739

NMCSD CID 06-050

Office of Naval Research FY08

Details and patient eligibility

About

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.

Full description

Patients presenting to Naval Medical Center San Diego with symptomatic ureteral stones visible on CT and KUB, and who are medically stable will be offered enrollment. Upon consent, patients will be randomly assigned to one of four outpatient treatment arms, randomized 1:1:1:1 and include; Group 1 - Alfuzosin 10 mg daily, Group 2 - Nifedipine 30 mg daily, Group 3 - Doxazosin 4 mg daily, or Group 4 - Prazosin 1 mg twice daily. The primary endpoint is stone expulsion rate and secondary endpoints are time to expulsion, need for additional intervention, degree of pain control, amount of narcotic use, and evaluation of study drug side effects. The treatment regimens consist of daily medication until the stone passes or 21 days, whatever is shorter. Patients will also receive oral pain medication as needed.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 4 patient groups

1

Experimental group

Description:

Alfuzosin 10mg daily

Treatment:

Drug: Alfuzosin

2

Active Comparator group

Description:

Nifedipine XL 30mg daily

Treatment:

Drug: nifedipine

3

Active Comparator group

Description:

Doxazosin 4 mg daily

Treatment:

Drug: doxazosin

4

Active Comparator group

Description:

Prazosin 1 mg BID

Treatment:

Drug: prazosin