Comparing Patients After ESWL Treated With Ureteral Stents Versus Expulsion Therapy With Tamsulosin

This study is not yet open for participant recruitment.

Verified by Hadassah Medical Organization, May 2007

First Received: May 24, 2007 No Changes Posted

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00478998

Purpose

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 .

Condition	Intervention	Phase
Upper Tract Ureterolithiasis	Drug: Tamsulosin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:	Phase II Study Comparing Two Groups of Patients Undergoing ESWL Treated With Ureteral Stents Versus Expulsion Therapy With Tamsulosin

Resource links provided by NLM:

Drug Information available for: Tamsulosin Tamsulosin hydrochloride

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

stone status at 3 month .
stone free

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478998

Contacts

Contact: Mordechai Duvdevani, MD	0508946816	moti_duv@yahoo.com
Contact: Shilo Rosenberg, MD	0508946036	shilo_inbar@bezeqint.net

Locations

Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Mordechai Duvdevani, MD

Hadassah Medical Organization

More Information

No publications provided

Study ID Numbers:	890pal- HMO-CTIL
Study First Received:	May 24, 2007
Last Updated:	May 24, 2007
ClinicalTrials.gov Identifier:	NCT00478998 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

expulsion therapy
tamsulosin
ureterolithiasis
stents

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Urinary Calculi
Neurotransmitter Agents
Adrenergic Agents
Urolithiasis
Ureteral Calculi
Ureteral Diseases

Adrenergic alpha-Antagonists
Calculi
Ureterolithiasis
Urologic Diseases
Tamsulosin
Adrenergic Antagonists

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Urinary Calculi
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Antineoplastic Agents
Urolithiasis
Physiological Effects of Drugs
Ureteral Calculi

Ureteral Diseases
Adrenergic alpha-Antagonists
Calculi
Pharmacologic Actions
Ureterolithiasis
Urologic Diseases
Therapeutic Uses
Tamsulosin
Adrenergic Antagonists

ClinicalTrials.gov processed this record on July 06, 2009