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

Urolithiasis Clinical Trial

Official title:

Prospective Randomized Placebo Controlled Blinded Study to Evaluate the Efficacy of Alfuzosin (Alpha Blocker) on the Success Rates Following SWL.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00409227
• Other study ID #: 165/05
• Status: Recruiting
• Phase: Phase 2
• First received: December 7, 2006
• Last updated: June 17, 2008
• Start date: December 2006

Study information

• Verified date: June 2008
• Source: Assaf-Harofeh Medical Center
• Contact: yoram I siegel, MD
• Phone: 972-577-345408
• Email: ysiegel[@]asaf.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nephrolithiasis
• Ureteral Calculi
• Ureterolithiasis
• Urolithiasis

Intervention

Drug:
• Alpha blocker-alfuzosin
P.O. alfuzosin 10 mg once a day
• placebo
placebo once a day for 3 months or stone free

Locations

Country	Name	City	State
Israel	Endourology unit Urology department Assaf Harofeh MC	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	use of pain control medication stone free rates		3 months	Yes
Primary	pain visual analogue scale		3 month	Yes
Primary	side effects		3 months	Yes
Primary	stone free rate		3 months	Yes
Primary	time to stone free status		3 months	Yes
Primary	need for secondary procedures		3 months	Yes
Primary	auxiliary procedures		3 months	Yes