NCT00478998

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 .

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2007

Completed
Last Updated

May 25, 2007

Status Verified

May 1, 2007

First QC Date

May 24, 2007

Last Update Submit

May 24, 2007

Conditions

Upper Tract Ureterolithiasis

Keywords

expulsion therapytamsulosinureterolithiasisstents

Outcome Measures

Primary Outcomes (2)

  • stone status at 3 month .

  • stone free

Interventions

TamsulosinDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Ureterolithiasis

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Ureteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Officials

  • Mordechai Duvdevani, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mordechai Duvdevani, MD

CONTACT

0508946816moti_duv@yahoo.com

Shilo Rosenberg, MD

CONTACT

0508946036shilo_inbar@bezeqint.net

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 24, 2007

First Posted

May 25, 2007

Last Updated

May 25, 2007

Record last verified: 2007-05

Locations

IL(1)