Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409227
Status:
UNKNOWN
Last Update Posted:
2008-06-18
First Post:
2006-12-07
Brief Title:
Does Treatment With Alfuzosin Increase Success Rates of SWL Shock Wave Lithotripsy
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
Prospective Randomized Placebo Controlled Blinded Study to Evaluate the Efficacy of Alfuzosin Alpha Blocker on the Success Rates Following SWL
Status:
UNKNOWN
Status Verified Date:
2008-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
EndpointsStone free rate time to stone free side effect
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
EndpointsStone free rate time to stone free side effect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None