Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS
- Registration Number
- NCT01203371
- Lead Sponsor
- Apsen Farmaceutica S.A.
- Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of Naftopidil and Tamsulosin in the treatment of lower urinary tract symptoms through a comparative study of patients with benign prostatic hyperplasia.
- Detailed Description
Inclusion Criteria:
Men ≥ 50 years Signs and symptoms of BPH A total IPSS of ≥ 10 Prostate volume of ≥20 mL (estimated by ultrasonography) PVR \> 150mL
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
- Men ≥ 50 years
- Signs and symptoms of BPH
- IPSS of ≥ 10
- Prostate volume of ≥ 20 mL
- PVR > 150 mL
Exclusion Criteria
- History of allergy to a AR antagonists
- Treatment with antiandrogen drugs
- Drugs with anticholinergic activity
- Significant history of orthostatic hypotension
- Concomitant neurological diseases
- Known or suspected neurogenic bladder dysfunction
- Carcinoma of the prostate or bladder
- Previous surgery for BPH or bladder neck obstruction
- History of recurrent UTI
- Concomitant active UTI
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tamsusolin Tamsulosin 0,4 mg/day Naftopidil Naftopidil 0,25 mg (2 weeks) and 0,50 mg (10 weeks)
- Primary Outcome Measures
Name Time Method International Prostate Symptom Score 2, 4, 8 and 12 weeks
- Secondary Outcome Measures
Name Time Method Adverse Effect 2, 4, 8 and 12 weeks
Trial Locations
- Locations (1)
Hospital das Clínicas da Faculdade de Medicina da USP
🇧🇷São Paulo, Brazil