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

University of Sao Paulo General Hospital

Status and phase: Unknown; Phase 3

Conditions: Renal Calculi

Treatments: Drug: Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT01215708

278/06

Details and patient eligibility

About

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

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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136 participants in 3 patient groups, including a placebo group

Nifedipine

Active Comparator group

Description:

nifedipine retard 20mg daily

Treatment:

Drug: Tamsulosin

tamsulosin

Active Comparator group

Description:

tamsulosin 0,4mg

Treatment:

Drug: Tamsulosin

placebo

Placebo Comparator group

Description:

placebo capsule

Treatment:

Drug: Tamsulosin