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

Information source: University of Sao Paulo General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Calculi

Intervention: Tamsulosin (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: University of Sao Paulo General Hospital

Official(s) and/or principal investigator(s):
Miguel Srougi, MD, Study Chair, Affiliation: University of Sao Paulo

Summary

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

Clinical Details

Official title: Effect of Tamsulosin and Nifedipine on the Elimination of Fragments After Extracorporeal Shock Waves Lithotripsy in Patients With Kidney Stones - a Prospective, Double-blind and Randomized Study

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

Primary outcome: 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

Secondary outcome:

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

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

Detailed description: Extracorporeal shockwave lithotripsy is one of the modalities of treatment of renal stones. Itīs 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Clinics Hospital of University of Sao Paulo, Sao Paulo 05403900, Brazil
Additional Information

Starting date: August 2006
Last updated: October 5, 2010

Page last updated: August 23, 2015

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