Urolithiasis Clinical Trial
Official title:
Prospective Randomized Placebo Controlled Blinded Study to Evaluate the Efficacy of Alfuzosin (Alpha Blocker) on the Success Rates Following SWL.
In latest literature more evidence is available about the positive effect of alpha blocker on stone expulsion from the ureter. Patients benefit from less pain and shortening time to stone expulsion. Our study is design to evaluate whether alfuzosin improves the stone free out come following SWL.
All patients undergoing SWL are included in study. Exclusion criteria: Patient with
radio-lucent stone, patients treated with calcium channel blockers, alpha blockers,
steroids, patients with contraindication to alpha blocker treatment, postural hypotension
patents with abnormal liver function tests.
Patient will be recruited to the study prospectively. Following signature on inform consent
patients will be randomized into 2 groups. One group will be treated with alfuzosin 10mg a
day and the control group with placebo. Treatment will be initiated following the
lithotripsy treatment.
Parameters for investigation includes: demographic and personal data, stone size and
location (obtained by CT or KUB), pain control medication and visual analogue scale
assessment of pain, side effects, clinical squeals, stone free out come. Follow up
evaluation will be at 1 week, 1 month, and 3 months post treatment. Success will be defined
following CT evaluation at 3 months. Treatment ends at stone free achievement or at 3
months.
Endpoints:Stone free rate, time to stone free, side effect.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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