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

NCT04107896 | Completed Phase 4 DMC

• 1 other identifier: No BSMMU/2017/9066
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in peak urine flow rate & post voidal residual urine (PVR)

  Screening visit, baseline visit, follow up visit at 1th, 4th and 12th week

Study Arms (2)

Silodosin

EXPERIMENTAL

8 mg daily by mouth, 12 weeks

Drug: Silodosin

Tamsulosin

ACTIVE COMPARATOR

0.4 mg daily by mouth, 12 weeks

Drug: Tamsulosin

Interventions

Silodosin DRUG

Cap silodosin

Also known as: Rapasin

Silodosin

Tamsulosin DRUG

Cap tamsulosin

Also known as: Uromax

Tamsulosin

Eligibility Criteria

• Age: 50 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Maidul islam

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

silodosin; Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• maidul islam, resident

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident,BSMMU

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 27, 2019
• Study Start: August 31, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

BA (1)