Objectives: Recent data suggest that there may be an association
between erectile dysfunction (ED) and lower urinary tract
symptoms (LUTS). Increasing evidence also indicates that the clinical use of phosphodiesterase type 5 (PDE5) inhibitors
provides relief from LUTS. The purpose of our study is to
investigate the safety and effects of Tadalafil 5 mg once daily in
men with ED and LUTS.
Design and Methods: This study included a total of 89 patients
who complained of ED and LUTS and who were given tadalafil
5 mg once daily for eight weeks between September 2009 and
February 2011. The International Prostate Symptom Score
(IPSS) and the International Index of Erectile Function (IIEF)-
5 questionnaire information were obtained prior to treatment
(V1), and again following treatment with Tadalafil 5 mg once
a day (weeks 4 (V2) and 12 (V3) after treatment began). We
also evaluated any adverse effects of Tadalafil 5 mg when it was
administered once daily during the follow-up period.
Results: A total, of 60 patients (67.4%) completed the eightweek
clinical study. The mean patient age was 57.0±9.2 years.
Regarding subjective symptoms, there were 48 patients (80.0%)
who experienced improvement of their ED and 43 patients
(71.7%) who experienced the improvement of their LUTS.
The IPSS values were 15.33±8.32 (V1), 11.78±7.69 (V2), and
9.91±7.77 (V3), with significant improvement (V1 vs. V2,
P=0.042, V1 vs. V3, P=0.006). The IIEF-5 values were 8.34±5.33
(V1), 15.74±8.99 (V2), and 18.72±19.58 (V3), with significant
improvement (V1 vs. V2, P=0.001, V1 vs. V3, P=0.001). A total
of three patients (5.0%) reported adverse effects, i.e. two patients
experienced facial flushing and one patient had mild chest
Conclusions: Treatment with Tadalafil 5 mg once daily was
beneficial for the treatment of both ED and LUTS. Adverse
effects on the cardiovascular system were minimal in our study.
Therefore, we believe that taking Tadalafil 5 mg once daily is safe
for patients with ED and LUTS.