Comparison of Silodosin Monotherapy vs FDC of Silodosin with Tadalafil in the Management of LUTS associated with BPH : An Open-Label Randomized Controlled Trial

Primary Objectives

To evaluate the severity of LUTS and monitor symptom improvement using International Prostate Symptom Score  scale.

To assess changes in urinary flow rate is measured by using uroflowmetry

Secondary Objectives

To assess improvement in quality of life using the international Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) scale.

To compare the onset and duration of symptom relief between the two groups.

To evaluate the safety, efficacy and tolerability of the FDC compared to silodosin alone.

To assess changes in post-void residual urine volume and prostate size is measured by Ultrasound.

Background & Justification for the conduct of the study

Benning Prostatic hyperplasia is a common condition cause predominantly on the elderly people over the age of 50. BPH mostly leads to LUTS . It significantly affects the quality of life of the men. Incomplete bladder emptying, nocturia, urgency, increased urine frequency, and weak urine stream are the most common symptoms. BPH leads to LUTS due the compression of the enlarged prostate compressing the bladder and the increased smooth muscle tone in the prostate and bladder neck. Medication remains the first-line treatment for patients with moderate to severe symptoms. Mostly Alpha-1 blockers are mostly used as it works by relaxing the prostate muscle thus alleviate symptoms. PDE-5 inhibitors are primarily used to treat erectile dysfunction but it shows beneficial action on LUTS in BPH patients by relaxing both prostate muscle and bladder neck. Several studies suggested that combination of this both may produce superior

relief to BPH patients. Still it needs well-designed clinical trials to confirm this findings to establish its efficacy and safety. Even with effective available treatment option but still get sonly the suboptimal relief of symptoms. Using the International Prostate Symptom Score IPSS, Uroflowmetry, Ultrasound the symptom improvement can be evaluated. Further this study may help in assessing the safety and tolerability of the combination therapy which may later can be applied in clinical practice.

Study Hypothesis

The combination of silodosin and Tadalafil may provide superior symptomatic relief in LUTS by measuring IPSS and Uroflowmetry parameters compared to silodosin alone by without any greater Adverse events.

Methodology:

Study design:

Open label, Randomized Controlled Trail.

Blinding:

Open label

Sample size

120 participants

60 participants with Silodosin 8mg Monotherapy group.

60 participants with FDC Silodosin 8mg with Tadalafil 5mg group.

Number of groups:

2 groups

Control group1: Silodosin 8mg monotherapy

Test group 2: Fixed-dose combination of Silodosin 8mg with Tadalafil 5mg.