Comparing Patients After ESWL Treated With Ureteral Stents Versus Expulsion Therapy With Tamsulosin
Information source: Hadassah Medical Organization
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Upper Tract Ureterolithiasis
Intervention: Tamsulosin (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Hadassah Medical Organization Official(s) and/or principal investigator(s):
Mordechai Duvdevani, MD, Principal Investigator, Affiliation: Hadassah Medical Organization
Overall contact:
Mordechai Duvdevani, MD, Phone: 0508946816, Email: moti_duv@yahoo.com
Summary
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 .
Clinical Details
Official title: Phase II Study Comparing Two Groups of Patients Undergoing ESWL Treated With Ureteral Stents Versus Expulsion Therapy With Tamsulosin
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Primary outcome: stone status at 3 month .stone free
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Mordechai Duvdevani, MD, Phone: 0508946816, Email: moti_duv@yahoo.com
Hadassah Medical Organization, Jerusalem 91120, Israel
Additional Information
Last updated: May 24, 2007
|
