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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Sao Paulo General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01215708
First received: October 5, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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


Condition Intervention Phase
Renal Calculi
Drug: Tamsulosin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 136
Study Start Date: August 2006
Estimated Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nifedipine
nifedipine retard 20mg daily
Drug: Tamsulosin
tamsulosin 0,4mg every night for 30 consecutive days
Other Name: secotex
Active Comparator: tamsulosin
tamsulosin 0,4mg
Drug: Tamsulosin
tamsulosin 0,4mg every night for 30 consecutive days
Other Name: secotex
Placebo Comparator: placebo
placebo capsule
Drug: Tamsulosin
tamsulosin 0,4mg every night for 30 consecutive days
Other Name: secotex

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215708

Locations
Brazil
Clinics Hospital of University of Sao Paulo
Sao Paulo, Brazil, 05403900
Sponsors and Collaborators
University of Sao Paulo General Hospital
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Study Chair: Miguel Srougi, MD University of Sao Paulo
  More Information

No publications provided

Responsible Party: Fabio Carvalho Vicentini, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01215708     History of Changes
Other Study ID Numbers: 278/06
Study First Received: October 5, 2010
Last Updated: October 5, 2010
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
Kidney calculi
Lithotripsy
Calcium channel blockers
Adrenergic alpha-antagonists.

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Pathological Conditions, Anatomical
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Tamsulosin
Nifedipine
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Cardiovascular Agents
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on September 18, 2014