Does Treatment With Alfuzosin Increase Success Rates of (SWL) Shock Wave Lithotripsy
Primary Purpose
Urolithiasis, Nephrolithiasis, Ureterolithiasis
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Alpha blocker-alfuzosin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Urolithiasis focused on measuring swl, lithotripsy, stone disease, urolithiasis, nephrolithiasis
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.
Sites / Locations
- Endourology unit Urology department Assaf Harofeh MCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
double blind placebo control
placebo control blinded arm
Outcomes
Primary Outcome Measures
use of pain control medication stone free rates
pain visual analogue scale
side effects
stone free rate
time to stone free status
need for secondary procedures
auxiliary procedures
Secondary Outcome Measures
Full Information
NCT ID
NCT00409227
First Posted
December 7, 2006
Last Updated
June 17, 2008
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00409227
Brief Title
Does Treatment With Alfuzosin Increase Success Rates of (SWL) Shock Wave Lithotripsy
Official Title
Prospective Randomized Placebo Controlled Blinded Study to Evaluate the Efficacy of Alfuzosin (Alpha Blocker) on the Success Rates Following SWL.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
December 2006 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis, Nephrolithiasis, Ureterolithiasis
Keywords
swl, lithotripsy, stone disease, urolithiasis, nephrolithiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
double blind placebo control
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo control blinded arm
Intervention Type
Drug
Intervention Name(s)
Alpha blocker-alfuzosin
Intervention Description
P.O. alfuzosin 10 mg once a day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo once a day for 3 months or stone free
Primary Outcome Measure Information:
Title
use of pain control medication stone free rates
Time Frame
3 months
Title
pain visual analogue scale
Time Frame
3 month
Title
side effects
Time Frame
3 months
Title
stone free rate
Time Frame
3 months
Title
time to stone free status
Time Frame
3 months
Title
need for secondary procedures
Time Frame
3 months
Title
auxiliary procedures
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yoram I siegel, MD
Phone
972-577-345408
Email
ysiegel@asaf.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yoram I siegel, MD
Organizational Affiliation
Endourology unit Urology department Assaf harofeh MC.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endourology unit Urology department Assaf Harofeh MC
City
Zerifin
ZIP/Postal Code
40700
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yoram i siegel, MD
Phone
972-577-345408
Email
ysiegel@asaf.health.gov.il
First Name & Middle Initial & Last Name & Degree
yoram i siegel, MD
First Name & Middle Initial & Last Name & Degree
yaniv shilo, MD
12. IPD Sharing Statement
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Does Treatment With Alfuzosin Increase Success Rates of (SWL) Shock Wave Lithotripsy
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