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

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01215708

Collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. (Other)

136

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Renal Calculi	Drug: Tamsulosin	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

136 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Jun 1, 2010

Anticipated Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Nifedipine nifedipine retard 20mg daily	Drug: Tamsulosin tamsulosin 0,4mg every night for 30 consecutive days Other Names: secotex
Active Comparator: tamsulosin tamsulosin 0,4mg	Drug: Tamsulosin tamsulosin 0,4mg every night for 30 consecutive days Other Names: secotex
Placebo Comparator: placebo placebo capsule	Drug: Tamsulosin tamsulosin 0,4mg every night for 30 consecutive days Other Names: secotex

Arm

Intervention/Treatment

Active Comparator: Nifedipine

nifedipine retard 20mg daily

Drug: Tamsulosin

tamsulosin 0,4mg every night for 30 consecutive days

Other Names:

secotex

Active Comparator: tamsulosin

tamsulosin 0,4mg

Drug: Tamsulosin

tamsulosin 0,4mg every night for 30 consecutive days

Other Names:

secotex

Placebo Comparator: placebo

placebo capsule

Drug: Tamsulosin

tamsulosin 0,4mg every night for 30 consecutive days

Other Names:

secotex

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.