Overview

This trial is active, not recruiting.

Condition renal calculi
Treatment tamsulosin
Phase phase 3
Sponsor University of Sao Paulo General Hospital
Collaborator Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Start date August 2006
End date June 2010
Trial size 136 participants
Trial identifier NCT01215708, 278/06

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
nifedipine retard 20mg daily
tamsulosin secotex
tamsulosin 0,4mg every night for 30 consecutive days
(Active Comparator)
tamsulosin 0,4mg
tamsulosin secotex
tamsulosin 0,4mg every night for 30 consecutive days
(Placebo Comparator)
placebo capsule
tamsulosin secotex
tamsulosin 0,4mg every night for 30 consecutive days

Primary Outcomes

Measure
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
time frame: 30 days

Secondary Outcomes

Measure
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
time frame: 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
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by University of Sao Paulo General Hospital.