MedTrace Logo

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

NCT04107896 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2019-09-27

No results posted yet for this study

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

Interventions

DRUG

Silodosin

Cap silodosin

DRUG

Tamsulosin

Cap tamsulosin

Sponsors & Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Principal Investigators

  • maidul islam, resident · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-31
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • Bangladesh

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04107896 on ClinicalTrials.gov