Lower Urinary Tract Symptoms (LUTS). Enlarged prostate with lower urinary tract symptoms
Conditions
Interventions
Intervention 1: Intervention group 1: Tamsulosin capsule 0.4 mg (MR) with brand name Portral, manufacturing by Tasnim Pharmaceutical Co., daily for 12 weeks orally. Intervention 2: Intervention grou
Sponsors
Urology Research Centre, Guilan University of Medical Sciences
Tasnim Pharmaceutical Co.
Eligibility
Sex/Gender
Male
Age
40 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactKourosh Mojtabavi
Urology Research Center, Guilan University of Medical Sciences
Outcome results
None listed