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

Primary Purpose

Upper Tract Ureterolithiasis

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Tamsulosin
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Tract Ureterolithiasis focused on measuring expulsion therapy, tamsulosin, ureterolithiasis, stents

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Hadassah Medical Organization

Outcomes

Primary Outcome Measures

stone status at 3 month .
stone free

Secondary Outcome Measures

Full Information

First Posted
May 24, 2007
Last Updated
May 24, 2007
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00478998
Brief Title
Comparing Patients After ESWL Treated With Ureteral Stents Versus Expulsion Therapy With Tamsulosin
Official Title
Phase II Study Comparing Two Groups of Patients Undergoing ESWL Treated With Ureteral Stents Versus Expulsion Therapy With Tamsulosin
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Tract Ureterolithiasis
Keywords
expulsion therapy, tamsulosin, ureterolithiasis, stents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Primary Outcome Measure Information:
Title
stone status at 3 month .
Title
stone free

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mordechai Duvdevani, MD
Phone
0508946816
Email
moti_duv@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shilo Rosenberg, MD
Phone
0508946036
Email
shilo_inbar@bezeqint.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mordechai Duvdevani, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mordechai Duvdevani, MD
Phone
0508946816
Email
moti_duv@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mordechai Duvdevani, MD

12. IPD Sharing Statement

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

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