Clinical trial NCT00713739: Alfuzosin for Medical Expulsion Therapy of Ureteral Stones
Official title: Evaluation of Alfuzosin as Medical Expulsion Therapy for Ureteral Stones
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Kidney Stones
Keywords: kidney stones
ureteral stones
medical expulsion therapy
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2008-07-11
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: 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

Primary outcomes:
measure: 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).
timeFrame: Period of stone passage (30 days)
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
Study officials:
affiliation: NMCSD
name: Brian K. Auge, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NMCSD
name: Sean P. Stroup, M.D.
role: PRINCIPAL_INVESTIGATOR
References: