Comparing Patients After 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...
Brief Summary
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: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Tamsulosin
Outcome Measures for this Clinical Trial
Primary Measures
- stone status at 3 month .
- stone free
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Hadassah Medical Organization Other
Overall Clinical Trial Officials and Contacts
Mordechai Duvdevani, MD Principal Investigator Hadassah Medical Organization
Overall Contact: Mordechai Duvdevani, MD 0508946816 moti_duv@yahoo.com
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00478998
