Official Title: “Phase II Study Comparing Two Groups of Patients Undergoing ESWL Treated With Ureteral Stents Versus Expulsion Therapy With Tamsulosin”

The purpose of this study is to see whether patients undergoing ESWL, for upper tract urinary stones between 1.5-2.0cm, may be treated by expulsion therapy(Tamsulosin) instead of inserting ureteral stents .

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment

Intervention(s) in this Clinical Trial

• Drug: Tamsulosin

Primary Measures

• stone status at 3 month .
• stone free

Inclusion Criteria:

• Patients above 18 yrs of age.
• Single urolithiasis up to 2 cm.
• Kidney/ureters that haven't undergone previous ESWL or stent insertion.
• Normal renal function (creatinine below 100mmo1/1).
• Sterile urine culture.
• Normal CBC, blood electrolytes and coagulation studies.
• Radioopaque stones.

Exclusion Criteria:

• More than one stone per kidney unit.
• Patients receiving steroids, NSAIDS, calcium channel blockers or alpha blockers on a regular basis.
• Anatomical anomalies or uromechanical obstruction.
• Single kidney.
• Cystinuria.
• Soldiers or pregnant women.
• Patients under 18 year

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Lead Sponsor: Hadassah Medical Organization

Overall Clinical Trial Officials and Contacts

Mordechai Duvdevani, MD Principal Investigator Hadassah Medical Organization  

Overall Contact: Mordechai Duvdevani, MD 0508946816 moti_duv@yahoo.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00478998

Study ID Number: 890pal- HMO-CTIL

ClinicalTrials.gov Identifier: NCT00478998

Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration