Comparison of the efficacy and safety of tamsulosin OCAS with tamsulosin MR and placebo in improving lower urinary tract symptoms

Phase 4

Recruiting

Conditions: ower Urinary Tract Symptoms (LUTS).
Enlarged prostate with lower urinary tract symptoms

Registration Number: IRCT20100817004582N8

Lead Sponsor: rology Research Centre, Guilan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 260

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The International Prostate Symptom Score (IPSS) Questionnaire. Timepoint: The beginning of the study (before the intervention) and 6 and 12 weeks after the start of the intervention. Method of measurement: The International Prostate Symptom Score (IPSS) Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Side effects. Timepoint: The beginning of the study (before the intervention) and 6 and 12 weeks after the start of the intervention. Method of measurement: Ask the patient.