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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 because the information has not been verified recently.
Verified May 2007 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00478998
First received: May 24, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  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-Blind
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:

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 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

No publications provided

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

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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013