Back to resultsEffects of the Use of Adjuvant Drugs After Extracorporeal Shockwave Lithotripsy (ESWL) in Renal Calculus
Primary Purpose
Renal Calculi
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Tamsulosin
Sponsored by
About this trial
This is an interventional treatment trial for Renal Calculi focused on measuring Kidney calculi, Lithotripsy, Calcium channel blockers, Adrenergic alpha-antagonists.
Eligibility 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.
Sites / Locations
- Clinics Hospital of University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Nifedipine
tamsulosin
placebo
Arm Description
nifedipine retard 20mg daily
tamsulosin 0,4mg
placebo capsule
Outcomes
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
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
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
Full Information
NCT ID
NCT01215708
First Posted
October 5, 2010
Last Updated
October 5, 2010
Sponsor
University of Sao Paulo General Hospital
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
1. Study Identification
Unique Protocol Identification Number
NCT01215708
Brief Title
Effects of the Use of Adjuvant Drugs After Extracorporeal Shockwave Lithotripsy (ESWL) in Renal Calculus
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 Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Calculi
Keywords
Kidney calculi, Lithotripsy, Calcium channel blockers, Adrenergic alpha-antagonists.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nifedipine
Arm Type
Active Comparator
Arm Description
nifedipine retard 20mg daily
Arm Title
tamsulosin
Arm Type
Active Comparator
Arm Description
tamsulosin 0,4mg
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo capsule
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Other Intervention Name(s)
secotex
Intervention Description
tamsulosin 0,4mg every night for 30 consecutive days
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Srougi, MD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Clinics Hospital of University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403900
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Effects of the Use of Adjuvant Drugs After Extracorporeal Shockwave Lithotripsy (ESWL) in Renal Calculus
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