Benign Prostatic Hyperplasia Clinical Trial
Official title:
Observational Study to Evaluate Effect of Thrupas® Capsule on Cardiovascular System in Patients With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia
To evaluate effect on cardiovascular system(blood pressure) when Thrupas® capsule is administered every day for 12 weeks in patients with Lower Urinary Tract Symptoms suggestive of Benign Prostatic Hyperplasia
BPH and hypertension are chronic senile diseases that increase in prevalence with age. It is
reported that 25% of men over 60 years old suffer from both BPH and hypertension. Though
these two diseases differ in nature, there is a hypothesis advanced from recent studies that
for both diseases, increase in sympathetic tone plays an important role in pathophysiology.
As a medical treatment of BPH, α-blockers are widely selected in clinical studies as a first
line treatment in patients with LUTS, for its non-invasiveness and superior clinical efficacy
[1, 5]. Such α-blockers increases urine flow and decreases residual urine by controlling
excitement of the sympathetic nervous system distributed around smooth muscle of prostate and
bladder neck. Through this, α-blockers improve conditions of clinical symptoms of patients
suffering from LUTS due to BPH, and decrease need for invasive surgery related to BPH, and
also have medical action to decrease morbidity rate of secondary complications of BPH such as
acute retention of urine, deterioration of renal function, bladder stone and urinary tract
infection.
However, in the case of patients who are on hypertension medication, when considering
concomitant administration with α-blockers, adverse events such as orthostatic hypotension
and dizziness due to drop in blood pressure is most concerned. In this regard, silodosin, as
an alpha 1A adrenoceptor antagonist, has been proven have low occurrence of adverse events
related to cardiovascular system and have little effect on blood pressure compared to other
α-blockers.
Thus, in this study, we aim to see the effect on cardiovascular system(blood pressure)
Thrupas® capsule is administered every day for 12 weeks in patients with LUTS suggestive of
BPH.
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