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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Alpha blocker-alfuzosin
  • P.O. alfuzosin 10 mg once a day
• Drug: placebo
  • placebo once a day for 3 months or stone free

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • double blind placebo control
• Placebo Comparator: 2
  • placebo control blinded arm

Primary Measures

• use of pain control medication stone free rates
  • Time Frame: 3 months
    Safety Issue?: Yes
• pain visual analogue scale
  • Time Frame: 3 month
    Safety Issue?: Yes
• side effects
  • Time Frame: 3 months
    Safety Issue?: Yes
• stone free rate
  • Time Frame: 3 months
    Safety Issue?: Yes
• time to stone free status
  • Time Frame: 3 months
    Safety Issue?: Yes
• need for secondary procedures
  • Time Frame: 3 months
    Safety Issue?: Yes
• auxiliary procedures
  • Time Frame: 3 months
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Assaf-Harofeh Medical Center

Overall Clinical Trial Officials and Contacts

yoram I siegel, MD Principal Investigator Endourology unit Urology department Assaf harofeh MC.  

Overall Contact: yoram I siegel, MD 972-577-345408 ysiegel@asaf.health.gov.il

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00409227

Study ID Number: 165/05

ClinicalTrials.gov Identifier: NCT00409227

Health Authority: Israel: Ministry of Health