Clinical trial NCT00409227: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Urolithiasis
Nephrolithiasis
Ureterolithiasis
Keywords: swl
lithotripsy
stone disease
urolithiasis
nephrolithiasis
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-12-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: use of pain control medication stone free rates
timeFrame: 3 months
measure: pain visual analogue scale
timeFrame: 3 month
measure: side effects
timeFrame: 3 months
measure: stone free rate
timeFrame: 3 months
measure: time to stone free status
timeFrame: 3 months
measure: need for secondary procedures
timeFrame: 3 months
measure: auxiliary procedures
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Endourology unit Urology department Assaf Harofeh MC
Study officials:
affiliation: Endourology unit Urology department Assaf harofeh MC.
name: yoram I siegel, MD
role: PRINCIPAL_INVESTIGATOR
References: