Is There is a Role of Prophylactic Therapy With Tamsulosi... | NCT00489723

Studies
Is There is a Role of Prophylactic Therapy With Tamsulosin Before Extracorporeal Shock Wave Lithotripsy to Avoid Development of Steinstrasse ?

NCT00489723

Sponsor

HaEmek Medical Center, Israel

Status

Unknown status

Last Update Posted

Jun 21, 2007Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Kidney Stones

Interventions

tamsulosin 0.4mg

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 19, 2007

First Submission Date that Met QC Criteria

Jun 20, 2007

First Posted Date

Jun 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2007

Last Update Posted Date

Jun 21, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine if there is a role of prophylactic therapy with tamsulosin prior extracorporeal shock wave lithotripsy to avoid development of steinstrasse. 150 persons that will go to Extracorporeal shock wave lithotripsy will randomize to 2 groups.

Group 1 -of 75 persons will recieve tamsulosin 0.4 mg x 1/d 2 days before the lithotripsy .

Group 2 - of 75 persons will not recieve tamsulosin. 48 hour after the ESWL all 2 group will take abdominal radiograph to evaluate the presence of steinstrasse.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
tamsulosin 0.4mg	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

size of stone 1-2 cm

Exclusion Criteria:

ureteral stricture Presence of internal stent prior use of alfa bloker prior ESWL

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
DORON PEREZ, M.D.	Contact	+972-4-6495115		perez_do@clalit.org.il

Overall Officials

Name	Affiliation	Role
doron perez	Urology department: Haemek Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haemek medical center	Recruiting	Afula		18100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi

Ancestor Terms

ID	Term
D053040	Nephrolithiasis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077409	Tamsulosin

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided