Does Treatment With Alfuzosin Increase Success Rates of (SWL) Shock Wave Lithotripsy
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|ClinicalTrials.gov Identifier: NCT00409227|
Recruitment Status : Unknown
Verified June 2008 by Assaf-Harofeh Medical Center.
Recruitment status was: Recruiting
First Posted : December 8, 2006
Last Update Posted : June 18, 2008
|Condition or disease||Intervention/treatment||Phase|
|Urolithiasis Nephrolithiasis Ureterolithiasis||Drug: Alpha blocker-alfuzosin Drug: placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Prospective Randomized Placebo Controlled Blinded Study to Evaluate the Efficacy of Alfuzosin (Alpha Blocker) on the Success Rates Following SWL.|
|Study Start Date :||December 2006|
|Estimated Primary Completion Date :||July 2009|
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
- use of pain control medication stone free rates [ Time Frame: 3 months ]
- pain visual analogue scale [ Time Frame: 3 month ]
- side effects [ Time Frame: 3 months ]
- stone free rate [ Time Frame: 3 months ]
- time to stone free status [ Time Frame: 3 months ]
- need for secondary procedures [ Time Frame: 3 months ]
- auxiliary procedures [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.|