Does Treatment With Alfuzosin Increase Success Rates of (... | NCT00409227

Studies
Does Treatment With Alfuzosin Increase Success Rates of (SWL) Shock Wave Lithotripsy

NCT00409227

Sponsor

Assaf-Harofeh Medical Center

Status

Unknown status

Last Update Posted

Jun 18, 2008Estimated

Enrollment

150Estimated

Phase

Phase 2

Conditions

Urolithiasis
Nephrolithiasis
Ureterolithiasis

Interventions

Alpha blocker-alfuzosin
placebo

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 2008

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

Dec 2006

Primary Completion Date

Jul 2009Estimated

Completion Date

Not provided

First Submitted Date

Dec 7, 2006

First Submission Date that Met QC Criteria

Dec 7, 2006

First Posted Date

Dec 8, 2006Estimated

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 17, 2008

Last Update Posted Date

Jun 18, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Assaf-Harofeh Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

In latest literature more evidence is available about the positive effect of alpha blocker on stone expulsion from the ureter. Patients benefit from less pain and shortening time to stone expulsion. Our study is design to evaluate whether alfuzosin improves the stone free out come following SWL.

Detailed Description

All patients undergoing SWL are included in study. Exclusion criteria: Patient with radio-lucent stone, patients treated with calcium channel blockers, alpha blockers, steroids, patients with contraindication to alpha blocker treatment, postural hypotension patents with abnormal liver function tests.

Patient will be recruited to the study prospectively. Following signature on inform consent patients will be randomized into 2 groups. One group will be treated with alfuzosin 10mg a day and the control group with placebo. Treatment will be initiated following the lithotripsy treatment.

Parameters for investigation includes: demographic and personal data, stone size and location (obtained by CT or KUB), pain control medication and visual analogue scale assessment of pain, side effects, clinical squeals, stone free out come. Follow up evaluation will be at 1 week, 1 month, and 3 months post treatment. Success will be defined following CT evaluation at 3 months. Treatment ends at stone free achievement or at 3 months.

Endpoints:Stone free rate, time to stone free, side effect.

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	double blind placebo control	Drug: Alpha blocker-alfuzosin
2	Placebo Comparator	placebo control blinded arm	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alpha blocker-alfuzosin	Drug	P.O. alfuzosin 10 mg once a day	1
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
use of pain control medication stone free rates		3 months
pain visual analogue scale		3 month
side effects		3 months
stone free rate		3 months
time to stone free status		3 months
need for secondary procedures		3 months
auxiliary procedures		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing shock wave lithotripsy treatment for urolithiasis.

Exclusion Criteria:

patients with abnormal liver function, postural hypotension, alpha-blocker treatment, sensitivity to alpha-blockers, radio-lucent stone, calcium channel blocker treatment, steroids treatment.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
yoram I siegel, MD	Contact	972-577-345408		ysiegel@asaf.health.gov.il

Overall Officials

Name	Affiliation	Role
yoram I siegel, MD	Endourology unit Urology department Assaf harofeh MC.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Endourology unit Urology department Assaf Harofeh MC	Recruiting	Ẕerifin		40700	Israel

Condition Browse Module

MeSH Terms

ID	Term
D052878	Urolithiasis
D053040	Nephrolithiasis
D053039	Ureterolithiasis

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

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Browse Branches

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