Does Treatment With Alfuzosin Increase Success Rates of (SWL) Shock Wave Lithotripsy

Shamir Medical Center (Assaf-Harofeh)

Status and phase: Unknown; Phase 2

Conditions: Urolithiasis; Ureterolithiasis; Nephrolithiasis

Treatments: Drug: placebo; Drug: Alpha blocker-alfuzosin

Study type: Interventional

Funder types: Other

Identifiers

NCT00409227

165/05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

double blind placebo control

Treatment:

Drug: Alpha blocker-alfuzosin

2

Placebo Comparator group

Description:

placebo control blinded arm

Treatment:

Drug: placebo