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

Phase 2

• Conditions: Urolithiasis; Nephrolithiasis; Ureterolithiasis
• Interventions: Drug: Alpha blocker-alfuzosin; Drug: placebo

• Registration Number: NCT00409227
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief 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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-07
• Study First Submitted QC: 2006-12-07
• Study First Posted: 2006-12-08
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-17
• Last Update Posted: 2008-06-18
• Primary Completion: 2009-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Alpha blocker-alfuzosin	double blind placebo control
2	placebo	placebo control blinded arm

Primary Outcome Measures

Name	Time	Method
side effects	3 months
stone free rate	3 months
time to stone free status	3 months
use of pain control medication stone free rates	3 months
pain visual analogue scale	3 month
need for secondary procedures	3 months
auxiliary procedures	3 months

Trial Locations

Locations (1)

Endourology unit Urology department Assaf Harofeh MC; 🇮🇱 Zerifin, Israel