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SAN FRANCISCO -- Adding the PDE5 inhibitor tadalafil (Cialis) to antibiotic therapy led to significantly greater symptomatic improvement in men with chronic pelvic pain syndrome/chronic prostatitis (CPPS/CP) versus antibiotics alone, a randomized trial showed.

Patients randomized to the combination had greater reductions in pain, urinary symptoms, and chronic prostatitis symptom score, as well as significant improvement in erectile function as compared with men who received antibiotics alone (P<0.05 to P<0.01). Quality of life remained similar between the treatment groups.

The only notable difference in adverse effects was flushing that occurred in fewer than 10% of men treated with tadalafil, Alaa Abdalla El Sayed, MD, of Al-Ansar Hospital in Madinah, Saudia Arabia, reported here at the American Urological Association meeting.

"Low-dose tadalafil added to antimicrobial treatment is well tolerated and significantly improved chronic prostatitis/chronic pelvic pain syndrome-related symptoms. The results are consistent with other reports on the role of tadalafil in the treatment of chronic prostatitis/chronic pelvic pain syndrome."

The rationale for evaluating a PDE5 inhibitor came from the recognition that the agents work by promoting relaxation of smooth muscle to increase blood flow to pelvic organs, which should promote increased circulation of antimicrobial agents and clearance of inflammatory products, he explained.

"Lower urinary tract symptoms [LUTS] are common in patients with chronic pelvic pain syndrome or prostatitis. Increased smooth muscle tension has an important role in the pathophysiology of LUTS, and the commonly used medications, such as alpha-adrenergic blockers and antimuscarinics, relax smooth muscle in either the prostate or the bladder. Many studies have suggested that PDE5 inhibitors improve LUTS."

Use of a PDE5 inhibitor in the treatment of prostatitis is reasonable given the drug's mechanism of action in the treatment of erectile dysfunction (ED) and LUTS, the latter being a prominent aspect of CPPS/CP, noted Jamin Brahmbhatt, MD, of the PUR Clinic in Clermont, Fla., who was not involved with the study. "There are studies suggesting that relaxation of smooth muscle is beneficial in prostatitis."

A reported 10 years ago at the AUA annual meeting showed significant symptomatic improvement in younger and middle-aged men who received tadalafil in addition to levofloxacin versus the antibiotic alone. A by the same group also yielded favorable results with tadalafil add-on therapy for younger men with CPPS/CP. The results showed improvement in erectile function, even though the patients did not have erectile dysfunction at baseline.

El-Sayed reported from a multicenter randomized trial involving 108 men with longstanding CPPS/CP. Patients received either levofloxacin 500 mg alone or in combination with tadalafil 5 mg daily for 4 weeks. Patients were evaluated by means of the National Institutes of Health Chronic Prostatitis Symptom Index (CPSI) and the International Index of Erectile Function (IIEF) at baseline and at the end of the study.

The study participants had a mean age of 40-41, and they did not differ at baseline with respect to mean values for CPSI pain (~15), urinary symptoms (~6), quality of life (~7), or total score (~28). Both groups had mean IIEF scores of 23-24 at baseline.

After 4 weeks of randomized treatment, the mean values for the tadalafil and levofloxacin-only groups were:

• Pain: 6.79 versus 8.42, P<0.05
• Urinary symptoms: 2.85 versus 3.57, P<0.05
• Quality of life: 3.34 versus 3.96 (not significant)
• CPSI total score: 12.7 versus 16.11, P<0.01
• IIEF: 24.04 versus 22.32, P=0.01

Analysis of relative differences from baseline yielded significant advantages for the tadalafil group for all endpoints: pain (-55.80% versus -44.52%, P<0.01); symptoms (-48.34% versus -36.75%, P<0.05); quality of life (-52.21% versus -40.73%, P<0.01); CPSI total (-54.86% versus -42.21%, P<0.001); and IIEF increase (9.95% versus 1.05%, P<0.001).

A similar-proportion of patients in each group had drug-related adverse events. The most commonly reported drug-related events in the tadalafil group were headache (11.15), flushing (7.4% versus 0 for control, P<0.05), dyspepsia (5.6%), and nasal congestion (5.6%). The most common drug-related events in the levofloxacin-only group were diarrhea (11.1%), nausea (7.4%), insomnia (7.4% versus 0%, P<0.05), and headache (5.6%).

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