Health Condition 1: N390- Urinary tract infection, site notspecified
Conditions
Interventions
Intervention1: SILODAL: Capsule Silodosin-8mg once daily
3 MONTHS
Control Intervention1: Capsule Tamsulosin: Tamsulosin-0.4mg once daily
3 MONTHS
Sponsors
Sun Pharma Industries Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male patients, aged 45 to 75 years. 2. Patients with a total AUASS score of 13 or higher. 3. Patients with a prostate volume measured by transabdominal ultrasonography, or TRUS of >= 20 ml. 4. Patients with a maximum urinary flow rate (Qmax) =125 ml). 5. Patients, who have been diagnosed with BPH through digital rectal exam. 6. PSA lesser than 4 ng/ml. 7. Patient or his legally accepted representative is willing to give informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with a residual urinary volume of >=250 ml. 2. Patients with a history of prostatectomy. 3. Patients with a history of intra pelvic radiation therapy. 4. Patients with prostate cancer or suspected prostate cancer. 5. Patients with complications considered likely to affect urinary passing such as bladder calculus and active urinary tract infection. 6. Patients conducting self-catheterization. 7. Patients who are active on catheterization. 8. Patients with renal impairment. Patients having out of normal ranges values for, BUN test-normal result is generally 6 to 20 mg/dL, Creatinine Blood -normal result is 0.7 to 1.3 mg/dL for men, Creatinine Urine-14 to 26 mg per kg of body mass per day for men, Creatinine Clearance-Male: 97 to 137 ml/min. 9. Patients with hepatic impairment-Severe hepatic impairment (Child-Pugh score >= 10). 10. Patients having point of median lobe protruding more than 1 cm 11. Patients with history of severe arrhythmia, cardiac failure, cardiac infarction, unstable angina, cerebral infarction within 6 months. 12. Patients with orthostatic hypotension at around screening visit (Orthostatic hypotension is defined as a decrease in systolic blood pressure of 20 mmHg or a decrease in diastolic blood pressure of 10 mmHg within three minutes of standing when compared with blood pressure from the sitting or supine position). 13 13. Patients with an experience of other investigational product treatments within 4 weeks from screening visit. 14. Patients who have taken unstable doses of antidepressants within the 3 months or who are expected to take unstable doses during the study. 15. Patients who have taken any other α-blockers within the 2 weeks from the start of the therapy. 16. Patients who have taken unstable doses of any other 5α-reductase inhibitors within the 3 months from the start of the therapy or who are expected to take unstable doses during the study. 17. Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with the assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, psychiatric, or hematological disease as determined by the clinical judgment of the investigator. 18. Any contra-indication to study drugs as mentioned in the prescribing information. 19. Intravesical obstruction from any cause other than BPH including vesicle neck contracture, Mullerian duct cysts, urethral stricture, valves, sclerosis, or other urethral tumor. 20. History of, or current neurogenic bladder and other conditions that might affect bladder function including detrusor-sphincter dyssynergia, prior CVA, spinal cord injury, brain or spinal cord tumors, multiple sclerosis, diabetic neuropathies, prior transient ischemic attacks, or dementia. 21. History of any type of procedure in the past that was considered intervention for BPH or bladder neck obstruction including prior TURP, bladder neck resection, thermotherapy, laser therapy, TUNA therapy, or any other minimally invasive surgical therapies specifically designed for relief of BPH. 22. History of inadequate clinical response to the use of alpha blockers specifically for the relief of BPH symptoms. 23. Hist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in AUASS measured over 12 weeksTimepoint: Assessed at Post-dose 4-6 hours and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in QmaxTimepoint: measured at Post-dose 4-6 hours, 1 week, 4 weeks, and 12 weeks;Change in AUASSTimepoint: measured at 1 week and 4 weeks;Change in Post-void bladder residual volume from baselineTimepoint: measured at Post-dose 4-6 hours, 1 week, 4 weeks and 12 weeks;Change in PSA Values from baselineTimepoint: measured at Post-dose 4-6 hours, 1 week, 4 weeks and 12 weeks;Change in QOL due to urinary symptoms from baselineTimepoint: measured at Post-dose 4-6 hours, 1 week, 4 weeks and 12 weeks;Change in sleep quality as measured by change from baseline in QOLTimepoint: measured at Post-dose 4-6 hours, 1 week, 4 weeks, and 12 weeks;Incidence and type of adverse eventsTimepoint: measured at all visits over the 12 weeks treatment period;Percentage change in AUASS voiding and storage sub scoresTimepoint: measured at Post-dose 4-6 hours, 1 week, 4 weeks and 12 weeks;Proportion of those treated achieving decrease in AUASS score from baselineTimepoint: measured at 4 weeks, and 12 weeks;Proportion of those treated achieving improvement in Qmax from baselineTimepoint: measured at 4 weeks, and 12 weeks | — |
Countries
India
Contacts
Public ContactDr Shirley Dsouza
Sun Pharma Industries Ltd.
Outcome results
None listed