NCT00409227

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Urolithiasis
• Nephrolithiasis
• Ureterolithiasis

Interventions

Type	Name	Description
DRUG	Alpha blocker-alfuzosin	P.O. alfuzosin 10 mg once a day
DRUG	placebo	placebo once a day for 3 months or stone free

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-07-01
• First posted: 2006-12-08
• Last updated: 2008-06-18

Locations

1 site across 1 country: Israel