ABSTRACT
PURPOSE: Tadalafil is a phosphodiesterase type 5 inhibitor that is used for the treatment of erectile dysfunction (ED). Previous clinical trials have assessed its efficacy and safety in Western populations, but this drug has not been investigated in a large clinical trial involving Korean men with ED. Thus, the aim of this study was to assess the efficacy and safety of 20 mg tadalafil in comparison to placebo when it is taken on demand by Korean men suffering with ED over a study period of 12 weeks. MATERIALS AND METHODS: Men more than 18 years of age with mild to severe ED of various etiologies were randomized to receive placebo or tadalafil 20 mg that was taken as needed (maximum once daily). Efficacy assessments included the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary and Global Assessment Questions (GAQ). RESULTS: Tadalafil significantly improved erectile function, as measured by the erectile function domain of the IIEF, compared to placebo (p<0.001). At the endpoint, the patients receiving tadalafil 20mg reported a greater mean per-patient percentage of successful intercourse attempts (SEP3: 71% compared to 31% for placebo) and a greater proportion of improved erections (GAQ: 80% compared to 44%). The most common treatment emergent adverse events were headache (16.3%), flushing (5%) and eye pain (5%), and most of the adverse events were mild or moderate in severity. CONCLUSIONS: Tadalafil was an effective, well-tolerated therapy for Korean men suffering with ED of broad-spectrum severity and etiology.
Subject(s)
Humans , Male , Erectile Dysfunction , Eye Pain , Flushing , Headache , Korea , TadalafilABSTRACT
PURPOSE: Benign prostatic hyperplasia (BPH) frequently combines other geriatric diseases, which affect voiding in complicated manner. However, differential diagnosis of BPH attributable to voiding dysfunction in such complicated cases has been difficult. Videourodynamic study, allowing the better correlation of structure and function, have had an important position in the diagnosis of various kind of voiding dysfunction. We compared diagnostic values between traditional pressure-flow study and videourodynamic study in the evaluation of the BPH. MATERIAL AND METHODS: Forty-seven men were subjected to this study, who showed lower urinary tract symptoms (LUTS) secondary to BPH combined with other underlying diseases (cerebrovascular disease, spinal cord injury, diabetes mellitus, Parkinson's disease) which could affect the voiding pattern. Included was patients older than 50 years, with a total International Prostate Symptom Score (IPSS) of 8 points or more. All patients were evaluated with detailed history, physical examination including digital rectal examination, prostate specific antigen (PSA), transrectal ultrasonography (TRUS), and videourodynamic study. Pressure-flow study was additionally performed in 27 patients who had been diagnosed as equivocal or obstructed or unobstructed on videourodynamic findings. RESULTS: The sensitivity of videourodynamic study and pressure-flow procedures was 87% and 55%, respectively, as complete pressure-flow data are not available in 12 patients due to difficult urination by catheterization. The specificity of videourodynamic study and pressure-flow study was 76% and 100%, respectively. Videourodynamic study additionally showed uninhibited bladder contraction and/or detrusor sphincter dyssynergia (internal or external) in 65.1% of the patients, which are not available from pressure-flow study. CONCLUSIONS: To diagnose voiding dysfunction from BPH in complicated case, videourodynamic study showed advantages over pressure-flow study in terms of diagnostic sensitivity, both functional and anatomical informations on lower urinary tract. It is likely that the videourodynamic study is the method of choice for the assessment of voiding dysfunction in BPH combined with other diseases.