Urolithiasis Clinical Trial
Official title:
Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy
Verified date | September 2013 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The majority of kidney stones are treated with shock wave lithotripsy (SWL). We are examining if the medication Flomax will result in improved stone passage rates following SWL.
Status | Terminated |
Enrollment | 24 |
Est. completion date | February 2009 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients 18 years old and above with urolithiasis scheduled for shock wave lithotripsy. Exclusion Criteria: - Contraindications to Flomax - Patients with renal impairment (serum creatinine above 2.0) - Patients with hepatic impairment (liver enzymes 2.5 times the upper limit of normal) - Use of other oral alpha blockers |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Passage of Stone Fragments | Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging. | 2 weeks and 3 months | No |
Secondary | Medical Evaluation | Evaluation of pain assessments, lower urinary tract symptoms, side effects of study medication and need for hospitalizations and additional endoscopic procedures. | 2 weeks and 3 months | Yes |
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