Early research has explored a possible connection between lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) and has also suggested that LUTS associated with benign prostatic hyperplasia (BPH) may be improved with phosphodiesterase (PDE) inhibitors – drugs commonly prescribed for certain types of ED. The inhibition of PDE isoenzymes relaxes the smooth muscle in the prostate or bladderand can improve LUTS in BPH patients.

Three studies presented during the 102nd Annual Scientific Meeting of the American Urological Association (AUA) focus on the use of PDE-5 inhibitors in treating men with co-existent LUTS and ED. A special session for media moderated by Kevin T. McVary, M.D. was held on Tuesday, May 22, 2007 at 9:00 a.m.

EFFICACY OF TADALAFIL DOSED ONCE A DAY TO TREAT ERECTILE DYSFUNCTION IN MEN WITH COMORBID MODERATE OR SEVERE LOWER URINARY TRACT SYMPTOMS SECONDARY TO BENIGN PROSTATIC HYPERPLASIA (Abstract 956)

Data has shown a correlation between the severity of lower urinary tract symptoms (LUTS) and the severity of erectile dysfunction (ED). Researchers from the United States explored the question of whether LUTS severity can impact a patient’s response to ED treatment. Researchers used data from a randomized, double-blind, placebo-controlled study examining the safety and efficacy of tadalafil in men with moderate to severe benign prostatic hyperplasia (BPH) to perform this post-hoc analysis.

Of the 281 men enrolled in the study, 156 (68 percent) had a medical history of ED. Patients participated in a four-week, single-blind placebo run before being randomized to receive 5 mg tadalafil daily for six week with an increase to 20 mg daily for an additional six weeks. The control arm received placebo for the 12-week period. Patients were evaluated using the International Index of Erectile Function - Erectile Function (IIEF EF). Scores were significantly improved in patients receiving tadalafil as opposed to placebo, though no statistically significant difference was seen between patients with moderate BPH vs. severe BPH.

This study will be presented in Moderated Poster Session 28 on Monday, May 21, 2007 starting at 1:00 p.m.

VARDENAFIL IN THE TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (Abstract 1565)

The role of nitric oxide (NO) in the mechanism of erection is well known in the treatment of erectile dysfunction (ED). However, studies have also suggested a connection between the NO pathway in bladder and prostate smooth muscle regulation – which may benefit benign prostatic hyperplasia (BPH) patients. In a randomized, double-blind, placebo-controlled study, German researchers in Munich, Hamburg and Wuppertal tested the efficacy of vardenafil, a common PDE-5 inhibitor) in treating lower urinary tract symptoms (LUTS) in men with BPH.

The study was conducted in men with LUTS (defined as an International Prostate Symptom Score greater than or equal to 12) ranging from 45-64 years in age. Subjects in the active study group were given 10 mg vardenafil twice daily for eight weeks; the control arm received placebo for that period. Evaluation was performed using the IPSS and the UROLIFE QoL 9.

Investigators show that treatment with vardenafil resulted in an improved total IPSS score compared to placebo, as well as improvements in the sub-scores for obstruction and irritation. UROLIFE QoL scores were significantly increased in the vardenafil group, particularly in the perceived sexual life and interference with activities sub-scores.

This study will be presented in Moderated Poster Session 47 on Tuesday, May 22, 2007 starting at 3:30 p.m.

IMPROVEMENT WITH SILDENAFIL IN MEN WITH MODERATE AND SEVERE LOWER URINARY TRACT SYMPTOMS (Abstract 1547)

It is possible that erectile dysfunction (ED) shares a similar pathophysiology with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). In this 12-week, multi-center, double-blind, placebo controlled study, investigators from Chicago and New York investigated the efficacy of sildenafil in men with LUTS and BPH. 369 men aged 45 years or older with ED and LUTS were enrolled in the study.

Patients were given 50 mg sildenafil or matching placebo nightly, or one hour before sexual activity. Dose escalation to 100 mg occurred at two weeks. Patients were evaluated using the International Index of Erectile Function – Erectile Function (IIEF EF) and International Prostate Symptom scores as well as by measure peak flow rate (Qmax). Research showed that sildenafil improved urinary symptoms but not flow rate. 73 percent of the men in the study improved from severe LUTS to mild or moderate LUTS following treatment, suggesting that sildenafil treatment for LUTS may be comparable to alpha-blocker and 5-alpha-reductase inhibitor therapy for the condition.

This study will be presented in Moderated Poster Session 47 on Tuesday, May 22, 2007 starting at 3:30 p.m.

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About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is the pre-eminent professional organization for urologists, with more than 15,000 members throughout the world. An educational nonprofit organization, the AUA pursues its mission of fostering the highest standards of urologic care by carrying out a wide variety of programs for members and their patients, including UrologyHealth.org, an award-winning on-line patient education resource, and the American Urological Association Foundation, Inc., formerly AFUD.

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