IRCT20100817004582N8RecruitingPhase 4
Comparative study on the effectiveness and safety of tamsulosin Oral-Controlled Absorption System (OCAS®) with tamsulosin Modified Release (MR) and placebo in improving lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH)
rology Research Centre, Guilan University of Medical Sciences0 sites260 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 260
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 40 years to no limit (—)
- Sex
- Male
Inclusion Criteria
- •Patients who are at least 40 years of age.
- •Prostate-Specific Antigen (PSA) score should be at age-specific range.
- •International Prostate Symptom Score (IPSS) should be greater than or equal to 8.
- •The maximum urine flow (Qmax) should be in the range of greater than and/or equal to 4 ml/s and smaller and/or equal to 15 ml/s.
- •The urine residual should be below 120 ml.
Exclusion Criteria
- •History of prostatectomy
- •Severe liver dysfunction
- •Severe renal dysfunction
- •Severe cardiovascular dysfunction
- •History of syncope.
- •Other conditions that can be causing voiding dysfunction, such as neurogenic bladder, bladder or urinary stones, frequent urinary tract infection, bladder cancer, prostate cancer, urethral stenosis, and large diverticulum bladder.
- •History of allergy to tamsulosin
- •History of recent retention and nocturnal polyuria
- •Patients with benign prostatic hyperplasia (BPH) who are candidates for surgery on the basis of clinical and paraclinical symptoms.
- •History of use of 5a-reductase inhibitors in the last 3 months
- •History of taking diuretics and hypnotic tablets
- •Use of other therapies such as other alpha blockers or herbal extracts in the last month
- •Use of other drugs, such as alpha-agonists, cholinergic or anticholinergic drugs that may affect the effects of tamsulosin pharmacodynamics.
Investigators
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