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

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: Silodosin; Drug: Tamsulosin

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.

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Phase 4

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • Maidul islam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Silodosin; 8 mg daily by mouth, 12 weeks	Drug: Silodosin; Cap silodosin; Other Names: Rapasin
Active Comparator: Tamsulosin; 0.4 mg daily by mouth, 12 weeks	Drug: Tamsulosin; Cap tamsulosin; Other Names: Uromax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in IPSS & Quality of life (QoL) score	Effectiveness of silodosin in benign prostatic hyperplasia assessed by symptom relief as assessed by IPSS. The total score was taken as the sum of the seven individual symptom scores. Each individual scored 0-5 (0 = Minimum; 5 = Maximum as worse as can be), yielding a total between 0 and 35. The Storage sub score was taken as the sum of the three individual symptom scores (Range 0-15) & the Voiding sub score was taken as the sum of the four individual symptom scores (Range 0-20). Quality of life (QoL) score assessment was done on a 7-point scale 0-6 (0= Delighted; 6= Terrible).	Screening visit, baseline visit, follow up visit at 1th, 4th and 12th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in peak urine flow rate & post voidal residual urine (PVR)	Changes in peak urine flow rate by uroflowmetry & post voidal residual urine (PVR) by USG.	Screening visit, baseline visit, follow up visit at 1th, 4th and 12th week

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Investigators: Principal Investigator: maidul islam, resident, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2017
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (Actual): September 27, 2019

Study Record Updates

• Last Update Posted (Actual): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 26, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin; Silodosin
• Other Study ID Numbers: No BSMMU/2017/9066

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No