Patients and study design

This was a longitudinal, prospective, observational, multicenter study to evaluate change in QoL in patients with moderate-to-severe LUTS/BPH managed in a urological setting. The study was performed in centers throughout Spain from September 2009 to June 2011. Quality of life and BPH symptoms were measured at baseline and at a 6-month follow-up visit. Patients were included if they were ≥40 years of age with a diagnosis of LUTS/BPH and an IPSS score of ≥8. Patients were excluded if they had received drug treatment for BPH in the 6 months prior to inclusion or if they had received any drug treatment with a known effect on BPH symptoms (such as diuretics, antihistamines, or tricyclic antidepressants) for any length of time in the 4 weeks prior to inclusion. Patients were also excluded if they had other urinary disorders (prostatitis, urinary incontinence, urethral strictures, or prostate cancer) or if they had previously undergone surgery of the lower urinary tract.