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

NCT01215708 | Unknown Phase 3

• 1 other identifier: 278/06
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Calculi

Keywords

Kidney calculi; Lithotripsy; Calcium channel blockers; Adrenergic alpha-antagonists.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (3)

Nifedipine

ACTIVE COMPARATOR

nifedipine retard 20mg daily

Drug: Tamsulosin

tamsulosin

ACTIVE COMPARATOR

tamsulosin 0,4mg

Drug: Tamsulosin

placebo

PLACEBO COMPARATOR

placebo capsule

Drug: Tamsulosin

Interventions

Tamsulosin DRUG

tamsulosin 0,4mg every night for 30 consecutive days

Also known as: secotex

Nifedipine; placebo; tamsulosin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• radiopaque renal stone, 5 to 20 mm, located at renal pelvis or superior or middle calix

You may not qualify if:

• inferior calix, any contraindication for extracorporeal shockwave lithotripsy, pregnancy, coagulopathy, previous renal surgery, age under 18, abdominal aorta aneurism and urinary infection.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Clinics Hospital of University of Sao Paulo

São Paulo, São Paulo, 05403900, Brazil

Location

MeSH Terms

Conditions

Kidney Calculi

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Miguel Srougi, MD

  University of Sao Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: October 6, 2010
• Study Start: August 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 6, 2010

Record last verified: 2010-09

Locations

BR (1)