Alfuzosin for Medical Expulsion Therapy of Ureteral Stones
| Status: | Completed |
|---|---|
| Conditions: | Nephrology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | January 2008 |
| End Date: | December 2012 |
| Contact: | Brian K. Auge, M.D. |
| Phone: | 619-532-7200 |
Evaluation of Alfuzosin as Medical Expulsion Therapy for Ureteral Stones
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.
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.
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.
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.
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
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