Ignite Creation Date:
2024-05-06 @ 1:44 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04107896
Status:
COMPLETED
Last Update Posted:
2019-09-27
First Post:
2019-09-04
Brief Title:
Efficacy of Silodosin in the Treatment of Symptomatic Benign Prostatic Hyperplasia BPH
Sponsor:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Organization:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Study Overview
Official Title:
Efficacy of Silodosin in the Treatment of Symptomatic Benign Prostatic Hyperplasia BPH
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study the investigators had evaluated the effectiveness SILODOSIN 8 mg daily orally in Benign prostatic Hyperplasia in comparison to Tamsulosin 04 mg daily orally in a randomized controlled trial design Study population would be patients attending Urology OPD of BSMMU Hospital Dhaka Target sample size will be 136 evaluable patients in each group assuming dropout rate 20 suffering from Benign prostatic Hyperplasia Subjects would be observed for 1 week without any drug At the end of 1 week they would be randomly allocated to Silodosin or Tamsulosin and treatment continued for 12 weeks Interim follow-up visits would be at 14 and 12 weeks USG confirmation of BPH would be required for recruitment Effectiveness of the drugs would be assessed by International Prostate Symptom score a quality of life QoL assessment done by a 7-point scale Prostate weightvolume determination by USG Change in post voidal residual urine PVR by USG and Changes in peak urine flow rate by uroflowmetry Safety would be assessed by following up vital signs treatment emergent adverse events and routine laboratory tests for drug safety
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 This Hospital based randomized controlled clinical study designed to evaluate the efficacy of the new α1-blocker silodosin in the treatment of symptomatic benign prostatic hyperplasia BPHAmbulatory patients of age between 50 to 70 years who were diagnosed as benign prostatic hyperplasia were divided into two groups after fulfilling selection criteria After informed consent random sampling by lottery silodosin 8 mg was given to group A study tamsulosin 04 mg was given to group B control Total 149 patients were enrolled in this study but 8 patients were lost during follow up Hence 141 patients completed the study during the period of June 2017 to August 2018
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None