Does Treatment With Alfuzosin Increase Success Rates of (SWL) Shock Wave Lithotripsy
Recruitment status was Recruiting
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.
Drug: Alpha blocker-alfuzosin
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Prospective Randomized Placebo Controlled Blinded Study to Evaluate the Efficacy of Alfuzosin (Alpha Blocker) on the Success Rates Following SWL.|
- use of pain control medication stone free rates [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- pain visual analogue scale [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
- side effects [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- stone free rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- time to stone free status [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- need for secondary procedures [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- auxiliary procedures [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2006|
|Estimated Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1
double blind placebo control
Drug: Alpha blocker-alfuzosin
P.O. alfuzosin 10 mg once a day
Placebo Comparator: 2
placebo control blinded arm
placebo once a day for 3 months or stone free
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409227
|Contact: yoram I siegel, MDfirstname.lastname@example.org|
|Endourology unit Urology department Assaf Harofeh MC||Recruiting|
|Zerifin, Israel, 40700|
|Contact: yoram i siegel, MD 972-577-345408 email@example.com|
|Principal Investigator: yoram i siegel, MD|
|Sub-Investigator: yaniv shilo, MD|
|Principal Investigator:||yoram I siegel, MD||Endourology unit Urology department Assaf harofeh MC.|