Abstract

ABSTRACT:
BACKGROUND:
We determined the efficacy and safety of combination therapy of α-blockers and anticholenergic drugs in patients with benign prostatic hyperplasia complain mainly of storage symptoms.
OBJECTIVE:
Study has been design to assess the efficacy and safety of combined treatment with oxybutynin plus tamsulosin in patients with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH).
PATIENTS AND METHODS:
Prospective randomized controlled study of patients with moderate to severe lower urinary tract symptoms. Eligible patients were men 40 years and older with a total IPSS of 12 or higher; An IPSS quality-of-life (QOL) item score of 3 or higher. Additional inclusion criteria were micturition frequency (≥8 micturitions per 24 hours) and urgency (micturitions with urgency rating>3 per 24 hours) for 3 or more months. Men with clinically significant bladder outlet obstruction, or serum prostate-specific antigen of more than 4 ng/mL with risk of prostate cancer were excluded.
RESULTS:
A total of 24(80%) patients receiving oxybutynin plus tamsulosin (Group3) reported treatment benefit by week 12 compared with 13(46.4%) patients receiving placebo (Group1) (P=0.02), 16 (53.4%) patients receiving tamsulosin(Group2) (P=0.45 vs. placebo), there is statistically significant difference between group 3 and group 2 with the p value 0.04. Patients receiving oxybutynin plus tamsulosin compared with placebo experienced significant reductions in urgency urinary incontinence, Urgency episodes, micturitions per 24 hours, and micturitions per night. Group3 Patients demonstrated significant improvements on the total International Prostate Symptom Score (−7.22 vs. −3.46 in G1, P=.003) and QOL item (−2.21 vs −1.17, In G1 P=.003). The incidence of acute urinary retention requiring catheterization was low in group3, the incidence was only 1 patient 3.3%; 3 patients(10.3%) in group1, while in tamsulosin group there was no patient complain of acute urinary retention 0% .
CONCLUSION:
These results suggest that treatment with oxybutynin plus tamsulosin provides benefit for men with moderate to severe LUTS and BPH.