Effects of the Use of Adjuvant Drugs After Extracorporeal Shockwave Lithotripsy (ESWL) in Renal Calculus

Phase 3

• Conditions: Renal Calculi
• Interventions: Drug: Tamsulosin

• Registration Number: NCT01215708
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

The investigators objective is to study if some drugs can improve the success rate of extracorporeal shockwave lithotripsy for renal stones.

Detailed Description

Extracorporeal shockwave lithotripsy is one of the modalities of treatment of renal stones. It´s a machine that breaks the renal stones extracorporeally. Some drugs, like alpha blockers and calcium channel blockers, can improve the success rates of this procedure. Our objective is to study the real effects of two drugs, tamsulosin and nifedipine, compared to placebo, in the elimination of fragments after the extracorporeal shockwave lithotripsy treatment.

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2010-06
• Status Verified: 2010-09
• Study First Submitted: 2010-10-05
• Study First Submitted QC: 2010-10-05
• Last Update Submitted: 2010-10-05
• Study First Posted: 2010-10-06
• Last Update Posted: 2010-10-06
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• radiopaque renal stone, 5 to 20 mm, located at renal pelvis or superior or middle calix

Exclusion Criteria

• inferior calix, any contraindication for extracorporeal shockwave lithotripsy, pregnancy, coagulopathy, previous renal surgery, age under 18, abdominal aorta aneurism and urinary infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nifedipine	Tamsulosin	nifedipine retard 20mg daily
tamsulosin	Tamsulosin	tamsulosin 0,4mg
placebo	Tamsulosin	placebo capsule

Primary Outcome Measures

Name	Time	Method
To evaluate the effects of Tamsulosin and Nifedipine in the success rates after treatment of radiopaque renal stones between 5-20 mm with only one session of SWL	30 days

Secondary Outcome Measures

Name	Time	Method
To evaluate the effects of Tamsulosin and Nifedipine in the episodes of pain after treatment of radiopaque renal stones between 5-20 mm with only one session of SWL	30 days
To evaluate the effects of Tamsulosin and Nifedipine in the velocity of elimination of fragments after treatment of radiopaque renal stones between 5-20 mm with only one session of SWL	30 days

Trial Locations

Locations (1)

Clinics Hospital of University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil