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

NCT ID: NCT00478998

Last Updated: 2007-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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 .

Detailed Description

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Conditions

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Upper Tract Ureterolithiasis

Keywords

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expulsion therapy tamsulosin ureterolithiasis stents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tamsulosin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Principal Investigators

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Mordechai Duvdevani, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Mordechai Duvdevani, MD

Role: CONTACT

Phone: 0508946816

Email: [email protected]

Shilo Rosenberg, MD

Role: CONTACT

Phone: 0508946036

Email: [email protected]

Facility Contacts

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Mordechai Duvdevani, MD

Role: primary

Other Identifiers

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890pal- HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id