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Daily Low dose Tadalafil in treatment of Chronic prostatitis/Chronic pelvic pain syndrome: randomized controlled study of efficacy and safety

Abdalla El Sayed hassan, A1; Dosuky, H2; Marouf, A2; Nady, M3; Ragab, G4; Habose, M5

1: elaj medical center ,zagzzig university, Sao Tome and Principe; 2: Zagazig University; 3: Al azhar university; 4: Al ansar hospital; 5: Elaj medical center

Background: Chronic prostatitis is a common urological problem without clearly defined pathogensis or definitive treatment. Phosphodiesterase 5 (PDE5) Inhibitor mediated relaxation of prostatic duct smooth muscle increases washout of prostatic secretions and reduces prostate inflammation. Additionally (PDE5I) increases blood supply to the pelvic organs carrying more antimicrobials and washing more inflammatory products.

Objectives: To assess the efficacy and safety of daily low dose tadalafil (5mg) added to antimicrobial treatment of Chronic prostatitis/Chronic pelvic pain syndrome.

Methods: A total of 108 patients who attend urology outpatient clinic with national Institutes of Health (NIH) diagnosis of category III CP/CPPS, but without erectile dysfunction, were randomized into two treatment groups: group I (54 patients) received levefloxacin 500 mg OD, and group II (54 patients) where Tadalafil 5 mg was added to levofloxacin. Treatment lasted for 4 weeks in single-blinded manner. Patients were evaluated using NIH chronic prostatitis symptom index (NIH-CPSI) and International index of erectile function (IIEF-5) filled at baseline and after the end of treatment.

Results: The mean patient’s ages were 41.3±4.2 and 39.8±5.1 years, for group I and II respectively. There were no significant difference between both groups in baseline assessment characteristics. In both groups a statistically significant improvement was reported after treatment in all the three domains and the total NIH-CPSI. When comparing both groups, a statistically significant difference in favor of tadalafil group was reported in the pain domain (p <0.05) , urinary symptom domain (p <0.05) , total NIH-CPSI score(p <0.01) and IIEF-5 score (p <0.01) but not in quality of life domain(p >0.05) . In tadalafil group the mean % reduction from baseline to 4 weeks was significant in all the three domains and the total NIH-CPSI scores (-54.86%- p <0.001). However there was a mean increase in IIEF-5 score (9.95 % - p <0.001).  The only significant treatment-related adverse effect in tadalafil group was flushing (7.4%). Other adverse effects were infrequent and no patients discontinued treatment due to adverse events.

Conclusion: Low dose Tadalafil (5 mg) added to antimicrobial treatment is well tolerated and significantly improved Chronic prostatitis/Chronic pelvic pain syndrome related symptoms.


Work supported by industry: no.

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