Nephrolithiasis, Ureterolithiasis, Urolithiasis
Conditions
Keywords
swl, lithotripsy, stone disease, urolithiasis, nephrolithiasis
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.
Interventions
DRUGAlpha blocker-alfuzosin
P.O. alfuzosin 10 mg once a day
DRUGplacebo
placebo once a day for 3 months or stone free
Sponsors
Assaf-Harofeh Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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 |
Countries
Israel
Contacts
Primary Contactyoram I siegel, MD
Outcome results
None listed