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

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Unknown status
CT.gov ID
NCT00478998
Collaborator
(none)
1

Study Details

Study Description

Brief 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 .

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
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

Outcome Measures

Primary Outcome Measures

  1. stone status at 3 month . []

  2. stone free []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 Hadassah Medical Organization Jerusalem Israel 91120

Sponsors and Collaborators

  • Hadassah Medical Organization

Investigators

  • Principal Investigator: Mordechai Duvdevani, MD, Hadassah Medical Organization

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00478998
Other Study ID Numbers:
  • 890pal- HMO-CTIL
First Posted:
May 25, 2007
Last Update Posted:
May 25, 2007
Last Verified:
May 1, 2007
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2007