Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin in the Management of Moderately and Severely Symptomatic Patients of Prostatic Hyperplasia
Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin in the Management of Moderately and Severely Symptomatic Patients of Prostatic Hyperplasia
To study Safety and efficacy of Tadalafil vs. Tadalafil with Sildosin in the management of
 moderately and severely symptomatic patients of prostatic hyperplasia
Introduction Benign prostatic hyperplasia (BPH) is a common cause of lower urinary tract
 symptoms (LUTS) in middle-aged and elderly men, and the incidence rate of LUTS associated
 with BPH (LUTS/BPH) increases with age.

 LUTS can be broadly grouped into: (i) storage symptoms, such as frequency, urgency, and
 nocturia (ii) voiding symptoms, such as intermittency, weak stream and straining, and (iii)
 post-micturition symptoms, such as a feeling of incomplete emptying and post micturition
 dribble.

 For optimal management of LUTS/BPH, medications should be chosen based on age, disease
 progression, need for long-term management, and other clinical parameters.

 Alpha 1 adreno-receptors antagonists (alpha 1 blockers) are proposed as first-line drug
 therapy for LUTS/BPH as these agents reduce the adrenergic tone of the smooth muscle within
 the prostate and bladder neck, thereby relieving the bladder outlet obstruction.

 Tadalafil (phosphodiesterase type 5 [PDE-5] inhibitor) was approved for treating LUTS/BPH.
 The inhibition of PDE-5leads to accumulation of cyclic guanosine monophosphate in the smooth
 muscles of the prostate and urethra which causes their relaxation resulting in alleviation of
 the symptoms of LUTS/BPH.
Inclusion Criteria:

 -  Patients to be included in the study will be either:

 1. diagnosis of BPH based on abdominal ultrasound or digital rectal examination.

 2. Moderate IPSS Score between 8 : 19.

 3. severe IPSS Score between 20 : 35.

 4. post void volume > 100 c.

 5. prostate size 50 to 80 gm.

 6. 2 or more weeks of freedom or washout from any medications known to influence
 LUTS before enrollment.

 7. mental and physical capacity to understand and fill out the study questionnaires.

 Exclusion Criteria:

 1. contraindications to Sildosin or Tadalafil.

 2. diagnosis of prostate cancer.

 3. possible presence of urinary infection, neurogenic bladder, stone bladder, refractory
 retention, hematuria of prostate origin or any cause for surgical intervention.

 4. clinically significant cardiovascular, hepatic, or renal disorders.

 5. cataract surgery planned during the study period.