A Comparative Study Of Silodosin vs Silodosin With Tadalafil For Relieving Lower Urinary Tract Symptoms Due To Benign Prostatic Hyperplasia

Lower Urinary Tract Symptoms(LUTS) are symptomatic complex of Benign Prostatic Hyperplasia(BPH). LUTS due to BPH includes obstructive symptoms (hesitancy poor stream sense of incomplete emptying straining) and irritative symptoms (frequency urgency nocturia)

LUTS severity doesn’t correlate with Prostate size.  LUTS are evaluated by international prostate symptoms score (IPSS). IPSS is most important tool to evaluate BPH patients before initiation of treatment and monitor treatment response

BPH patient is diagnosed on the basis of history, digital rectal examination, IPSS scores, USG KUB, prostate with PVR and uroflowmetry.

Ultra sonography is used to detect prostate size and amount of urine left in the urinary bladder after voiding (PVR). Prostate size below 20 ml, and PVR below 50 ml is considered as normal

Uroflowmetry is a method for observing urination. Maximum flow of urine (Qmax) is measured by uroflowmetry. Qmax more than 15 ml/sec is considered as normal

Treatment options for BPH include watchful waiting and medical treatment and surgery

Medical therapy for symptomatic BPH currently consist of alpha 1 blockers, 5 alpha reductase inhibitors and phosphodiesterase 5 inhibitors or combination therapy. For optimal management of symptomatic BPH patient medications should be chosen based on age, disease progression, need for long-term management and other clinical parameters Clinical guidelines for LUTS due to BPH proposed alpha 1 adrenoreceptor antagonists (a 1 blockers) as first-line drug therapy for LUTS due to BPH

Tadalafil is a Phosphodiesterase type 5 inhibitor (PDE 5 inhibitors) was approved for treating LUTS due to BPH in 2014, which is routinely used for erectile dysfunction. The inhibition of PDE5 isoenzymes relaxes smooth muscle in the prostate and bladder neck (via cGMP)  increases blood perfusion to the prostate and bladder and decreases bladder afferent nerve activity. resulting in relaxation and alleviation of the symptoms of LUTS due to BPH.

Osamu et al 2015(8) stated that clinical studies carried out in Asian and non-Asian countries have demonstrated that Tadalafil 5 mg once daily is an efficacious treatment for men with BPH-LUTS and has a safety profile consistent with the known safety profile of Tadalafil for ED.

Yoshida, M et al(7)., 2017 study showed that men with BPH have demonstrated improvements in IPSS with tadalafil .  Tadalafil can cause headache, dizzines

Lee J.Y et al(9)., 2012 stated that Silodosin is the most efficacious alpha 1 blocker with rapid onset of action. It significantly improves IPSS maximum flow rate and quality of life than other alpha 1 blocker  But a very few studies in the literature, compared the newer molecule silodosin (alpha 1 blocker) and silodosin with tadalafil (phosphodiesterase 5 inhibitor) in the treatment of BPH

So this study is designed to compare the safety and efficacy of silodosin monotherapy and silodosin with tadalafil add on therapy in patient with symptomatic BPH.