Does Treatment With Alfuzosin Increase Success Rates of (SWL) Shock Wave Lithotripsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Randomized Placebo Controlled Blinded Study to Evaluate the Efficacy of Alfuzosin (Alpha Blocker) on the Success Rates Following SWL.

Conditions
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Urolithiasis, Nephrolithiasis, Ureterolithiasis

Intervention / Treatment
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* Drug: Alpha blocker-alfuzosin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing shock wave lithotripsy treatment for urolithiasis. Exclusion Criteria: patients with abnormal liver function, postural hypotension, alpha-blocker treatment, sensitivity to alpha-blockers, radio-lucent stone, calcium channel blocker treatment, steroids treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>double blind placebo control | Drug: Alpha blocker-alfuzosin<br>* P.O. alfuzosin 10 mg once a day<br>|
| Placebo Comparator: 2<br>placebo control blinded arm | Drug: placebo<br>* placebo once a day for 3 months or stone free<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| use of pain control medication stone free rates |  | 3 months | 
| pain visual analogue scale |  | 3 month | 
| side effects |  | 3 months | 
| stone free rate |  | 3 months | 
| time to stone free status |  | 3 months | 
| need for secondary procedures |  | 3 months | 
| auxiliary procedures |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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swl, lithotripsy, stone disease, urolithiasis, nephrolithiasis