Alfuzosin for Medical Expulsion Therapy of Ureteral Stones - Full Text View

Sponsored by:	United States Naval Medical Center, San Diego
Information provided by:	United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:	NCT00713739

Purpose

The goal of this study is to conduct a prospective controlled trail of four currently approved 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. We will evaluate the effectiveness of MET as initial management for kidney stones using DOD-approved formulary medications.

Condition	Intervention
Kidney Stones	Drug: Alfuzosin Drug: nifedipine Drug: doxazosin Drug: prazosin

Drug Information available for: Nifedipine Doxazosin Doxazosin mesylate Alfuzosin Alfuzosin hydrochloride Prazosin Prazosin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Alfuzosin as Medical Expulsion Therapy for Ureteral Stones

Further study details as provided by United States Naval Medical Center, San Diego:

Primary Outcome Measures:

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 Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator 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.
3: Active Comparator 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.
4: Active Comparator 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

Criteria

Inclusion Criteria:

Age >/= 18 years
Single ureteral stone < 1 cm in greatest dimension

Exclusion Criteria:

Age < 18 years
Liver dysfunction (LFT's greater than 3 x normal)
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
Concomitant ipsilateral renal stone(s)
Current uncontrolled diabetes
Alpha-blocker therapy within 30 days for any reason
Current pregnancy or lactation
Patient desire for immediate stone removal
Significant lactose intolerance

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713739

Contacts

Contact: Brian K. Auge, M.D.	619-532-7200
Contact: Sean P. Stroup, M.D.	619-532-7200

Locations

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.

Sponsors and Collaborators

United States Naval Medical Center, San Diego

Investigators

Principal Investigator:	Brian K. Auge, M.D.	NMCSD
Principal Investigator:	Sean P. Stroup, M.D.	NMCSD

More Information

Responsible Party:	Dept of Urology, Naval Medical Center San Diego ( CDR Brian K. Auge )
Study ID Numbers:	NMCSD CID 06-050, Office of Naval Research FY08
Study First Received:	July 7, 2008
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00713739
Health Authority:	United States: Federal Government

Keywords provided by United States Naval Medical Center, San Diego:

kidney stones
ureteral stones
medical expulsion therapy

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Urinary Calculi
Urolithiasis
Ureteral Calculi
Ureteral Diseases
Calculi
Nifedipine
Doxazosin

Calcium, Dietary
Ureterolithiasis
Alfuzosin
Urologic Diseases
Prazosin
Kidney Diseases
Nephrolithiasis
Kidney Calculi

Additional relevant MeSH terms:

Neurotransmitter Agents
Vasodilator Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Calcium Channel Blockers
Reproductive Control Agents
Adrenergic alpha-Antagonists

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Membrane Transport Modulators
Tocolytic Agents
Therapeutic Uses
Adrenergic Antagonists

ClinicalTrials.gov processed this record on January 14, 2009