Status:
COMPLETED
Efficacy of Silodosin in the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
50-70 years
Phase:
PHASE4
Brief Summary
In this study the investigators had evaluated the effectiveness SILODOSIN (8 mg daily orally) in Benign prostatic Hyperplasia in comparison to Tamsulosin (0.4 mg daily orally) in a randomized controll...
Detailed Description
Benign prostatic hyperplasia (BPH) is the most common cause of lower urinary tract symptoms in elderly men. Selective α1-adrenergic antagonists are now first-line drugs in the medical management of BPH...
Eligibility Criteria
Inclusion
- Ambulatory male patients between 50 to 70 years and had diagnosis of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH)
- International prostate symptoms score (IPSS)≥ 8
- Peak urinary flow rate (Qmax)\<15ml/sec for a voided volume of 150 ml or more
- Post voidal residual urine volume ≥ 50 ml (by transabdominal ultrasonogram)
- Volume of prostate determine by transabdominal ultrasonogram ≥ 30 gm
Exclusion
- History of prostate cancer/raised PSA\>4 ng/ml
- Previous prostate surgery /Periurethral surgery.
- Patient undergone surgery to the bladder neck/Bladder neck contracture.
- Urethral stricture
- History of LUTS not due to benign prostatic hyperplasia (BPH).
- Postvoid residual urine volume of \>150ml
- Bladder stone
- Active urinary tract infection which might affect micturition
- Large intravesical protrusion \> 2 cm
- Known hypersensitivity or history of active substance abuse
Key Trial Info
Start Date :
August 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT04107896
Start Date
August 31 2017
End Date
August 31 2018
Last Update
September 27 2019
Active Locations (1)
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1
Maidul islam
Dhaka, Bangladesh