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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00478998
First Posted: May 25, 2007
Last Update Posted: May 25, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • stone status at 3 month .
  • stone free

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Not yet recruiting
Jerusalem, Israel, 91120
Contact: Mordechai Duvdevani, MD    0508946816    moti_duv@yahoo.com   
Principal Investigator: Mordechai Duvdevani, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Mordechai Duvdevani, MD Hadassah Medical Organization
  More Information

ClinicalTrials.gov Identifier: NCT00478998     History of Changes
Other Study ID Numbers: 890pal- HMO-CTIL
First Submitted: May 24, 2007
First Posted: May 25, 2007
Last Update Posted: May 25, 2007
Last Verified: May 2007

Keywords provided by Hadassah Medical Organization:
expulsion therapy
tamsulosin
ureterolithiasis
stents

Additional relevant MeSH terms:
Ureterolithiasis
Ureteral Calculi
Ureteral Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents