Alfuzosin for Medical Expulsion Therapy of Ureteral Stones (MET)
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Stones |
Drug: Alfuzosin Drug: nifedipine Drug: doxazosin Drug: prazosin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Alfuzosin as Medical Expulsion Therapy for Ureteral Stones |
- The primary measures are percent of stones passed and rates of occurrence of various side effects (categorical variables), and time to pass, pain scale, and amount of pain medication taken (continuous variables). [ Time Frame: Period of stone passage (30 days) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 240 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Alfuzosin 10mg daily
|
Drug: Alfuzosin
Patients who present to NMCSD with symptomatic ureteral stones visible on CT and KUB, and who are medically stable will be offered enrollment. The patients will be randomly assigned to one of 4 groups. Outpatient treatment groups will be 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 BID. 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.
|
|
Active Comparator: 2
Nifedipine XL 30mg daily
|
Drug: nifedipine
Patients who present to NMCSD with symptomatic ureteral stones visible on CT and KUB, and who are medically stable will be offered enrollment. The patients will be randomly assigned to one of 4 groups. Outpatient treatment groups will be 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 BID. 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.
|
|
Active Comparator: 3
Doxazosin 4 mg daily
|
Drug: doxazosin
Patients who present to NMCSD with symptomatic ureteral stones visible on CT and KUB, and who are medically stable will be offered enrollment. The patients will be randomly assigned to one of 4 groups. Outpatient treatment groups will be 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 BID. 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.
|
|
Active Comparator: 4
Prazosin 1 mg BID
|
Drug: prazosin
Patients who present to NMCSD with symptomatic ureteral stones visible on CT and KUB, and who are medically stable will be offered enrollment. The patients will be randomly assigned to one of 4 groups. Outpatient treatment groups will be 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 BID. 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.
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Brian K. Auge, M.D. | 619-532-7200 | |
| Contact: Sean P. Stroup, M.D. | 619-532-7200 |
| United States, California | |
| Naval Medical Center San Diego | Recruiting |
| San Diego, California, United States, 92134 | |
| Contact: Brian K Auge, M.D. 619-532-7200 | |
| Contact: Sean P. Stroup, M.D. 619-532-7200 | |
| Principal Investigator: Brian K. Auge, M.D. | |
| Principal Investigator: Sean P. Stroup, M.D. | |
| Principal Investigator: | Brian K. Auge, M.D. | NMCSD |
| Principal Investigator: | Sean P. Stroup, M.D. | NMCSD |
More Information
No publications provided
| Responsible Party: | Sean Stroup, Principle Investigator, United States Naval Medical Center, San Diego |
| ClinicalTrials.gov Identifier: | NCT00713739 History of Changes |
| Other Study ID Numbers: | NMCSD CID 06-050, Office of Naval Research FY08 |
| Study First Received: | July 7, 2008 |
| Last Updated: | April 25, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by United States Naval Medical Center, San Diego:
|
kidney stones ureteral stones medical expulsion therapy |
Additional relevant MeSH terms:
|
Calculi Kidney Calculi Nephrolithiasis Ureteral Calculi Ureterolithiasis Pathological Conditions, Anatomical Kidney Diseases Urologic Diseases Urolithiasis Urinary Calculi Ureteral Diseases Nifedipine Prazosin Alfuzosin Doxazosin |
Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Vasodilator Agents Antihypertensive Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents |
ClinicalTrials.gov processed this record on May 19, 2013