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Sponsored by: |
Assaf-Harofeh Medical Center |
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Information provided by: | Assaf-Harofeh Medical Center |
ClinicalTrials.gov Identifier: | NCT00409227 |
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.
Condition | Intervention | Phase |
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Urolithiasis Nephrolithiasis Ureterolithiasis |
Drug: Alpha blocker-alfuzosin Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective Randomized Placebo Controlled Blinded Study to Evaluate the Efficacy of Alfuzosin (Alpha Blocker) on the Success Rates Following SWL. |
Estimated Enrollment: | 150 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
double blind placebo control
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Drug: Alpha blocker-alfuzosin
P.O. alfuzosin 10 mg once a day
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2: Placebo Comparator
placebo control blinded arm
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Drug: placebo
placebo once a day for 3 months or stone free
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: yoram I siegel, MD | 972-577-345408 | ysiegel@asaf.health.gov.il |
Israel | |
Endourology unit Urology department Assaf Harofeh MC | Recruiting |
Zerifin, Israel, 40700 | |
Contact: yoram i siegel, MD 972-577-345408 ysiegel@asaf.health.gov.il | |
Principal Investigator: yoram i siegel, MD | |
Sub-Investigator: yaniv shilo, MD |
Principal Investigator: | yoram I siegel, MD | Endourology unit Urology department Assaf harofeh MC. |
Responsible Party: | Assaf Harofeh MC ( Yoram I Siegel MD ) |
Study ID Numbers: | 165/05 |
Study First Received: | December 7, 2006 |
Last Updated: | June 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00409227 History of Changes |
Health Authority: | Israel: Ministry of Health |
swl lithotripsy stone disease urolithiasis nephrolithiasis |
Pathological Conditions, Anatomical Urinary Calculi Neurotransmitter Agents Adrenergic Agents Urolithiasis Ureteral Calculi Ureteral Diseases Cardiovascular Agents Adrenergic alpha-Antagonists |
Antihypertensive Agents Calculi Ureterolithiasis Alfuzosin Shock Urologic Diseases Adrenergic Antagonists Kidney Diseases Nephrolithiasis |
Pathological Conditions, Anatomical Urinary Calculi Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Urolithiasis Physiological Effects of Drugs Ureteral Calculi Ureteral Diseases Cardiovascular Agents Adrenergic alpha-Antagonists |
Antihypertensive Agents Calculi Pharmacologic Actions Ureterolithiasis Alfuzosin Urologic Diseases Therapeutic Uses Adrenergic Antagonists Kidney Diseases Nephrolithiasis |