Efficacy of Silodosin in the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)

NCT ID: NCT04107896

Last Updated: 2019-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-31
• Study Completion Date: 2018-08-31

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 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 1,4 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 weight/volume 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 (BPH).Ambulatory 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 0.4 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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Silodosin

8 mg daily by mouth, 12 weeks

Group Type: EXPERIMENTAL

Silodosin

Intervention Type: DRUG

Cap silodosin

Tamsulosin

0.4 mg daily by mouth, 12 weeks

Group Type: ACTIVE_COMPARATOR

Tamsulosin

Intervention Type: DRUG

Cap tamsulosin

Interventions

Silodosin

Cap silodosin

Intervention Type: DRUG

Tamsulosin

Cap tamsulosin

Intervention Type: DRUG

Other Intervention Names

Rapasin; Uromax

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Maidul Islam

Resident,BSMMU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

maidul islam, resident

Role: PRINCIPAL_INVESTIGATOR

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Locations

Maidul islam

Dhaka, , Bangladesh

Countries

Bangladesh

Other Identifiers

No BSMMU/2017/9066

Identifier Type: -

Identifier Source: org_study_id