NE-AUA 2006 Annual Meeting, September 28 - 30, 2006, The Westin Hotel & Rhode Island Convention Center Providence, Rhode Island
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Efficacy and Tolerability of Sildenafil in Men With Both Erectile Dysfunction and Lower Urinary Tract Symptoms
Jed C. Kaminetsky, MD1, Kevin T. McVary, MD2, Li-Jung Tseng, PhD3, Richard L. Siegel, MD3.
1University Urology Associates, New York, NY, USA, 2Feinberg School of Medicine, Northwestern University, Chicago, IL, USA, 3Pfizer Inc, New York, NY,

Background: Phosphodiesterase type 5 (PDE5) inhibitors are effective for the treatment of erectile dysfunction (ED), but few studies have specifically examined their efficacy and tolerability in men with both ED and comorbid lower urinary tract symptoms (LUTS). Studies suggest that PDE5 inhibition promotes relaxation of smooth muscle in the lower urinary tract and may improve LUTS.
Methods: This was a 12-week, double-blind, placebo-controlled study of sildenafil citrate (Viagra) in men ≥45 years old who scored ≤25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) and had an International Prostate Symptom Score (IPSS) ≥12. Men with prostate-specific antigen >10 ng/mL were excluded. Patients took sildenafil (50 mg) or placebo nightly at bedtime or 30-60 minutes before anticipated sexual activity. After 2 weeks, the dose was titrated to 100 mg with the option of returning to 50 mg if 100 mg was not tolerated. Endpoints were changes in EF domain score, total IPSS score, IPSS subscores for irritative and obstructive symptoms, a quality-of-life (QoL) question, the Benign Prostatic Hyperplasia Impact Index (BPHII), and maximum urinary flow rate (Qmax). Treatment satisfaction was assessed using the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS).
Results: Compared with men receiving placebo (n=179), men receiving sildenafil (n=189) demonstrated greater least squares mean improvement in EF domain (+9.2 vs +1.9, P<0.0001) and IPSS scores (-6.3 vs -1.9). Irritative (-2.3 vs -0.6) and obstructive (-4.1 vs -1.5) scores and the QoL question (-1.0 vs -0.3) were significantly improved in sildenafil- vs placebo-treated men (P<0.0001). Sildenafil (vs placebo) also significantly reduced the BPHII scores (-2.0 vs -0.9, P<0.0001). Qmax was not different for patients receiving sildenafil or placebo. Satisfaction with treatment was significantly (P<0.0001) higher for patients who received sildenafil compared with those who received placebo (EDITS Index Score 71.2 vs 41.7). The most frequent (≥5%) adverse events (all causality) in men receiving sildenafil (vs placebo) were headache (12% vs 6%), dyspepsia (9% vs 1%), and respiratory tract infection (7% vs 5%).
Conclusions: Sildenafil taken daily is well tolerated and improves erectile function and urinary symptoms in men with ED and LUTS. The improvements in IPSS are comparable to those achieved using α1-blockers and were accompanied by a significant improvement in QoL. The results of this study suggest that sildenafil may be beneficial in the treatment of LUTS.


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