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Combination therapy of tadalafil and tamsulosin for men with moderate to severe benign prostatic hyperplasia

Login to Access Video or Poster Abstract: MP09-03
Sources of Funding: none

Introduction

Benign prostatic hyperplasia (BPH) is commonly treated with alpha-blockers and 5-alpha-reductase inhibitors (5ARIs). However, tamsulosin has sexual side-effects, including ejaculatory dysfunction. Recently, tadalafil 5 mg daily has been shown to be helpful in treating lower urinary tract symptoms (LUTS). Thus, we compared tadalafil and tamsulosin with tamsulosin alone in terms of symptom improvement in males with moderate to severe BPH.

Methods

This 12-week study was a randomized, parallel group evaluation of clinical outcomes in males aged ≥ 50 years with symptomatic (IPSS≥12) BPH and a prostate volume ≥ 30 mL. Eligible patients received a combination of tadalafil 5 mg daily with tamsulosin 0.4 mg daily (n=30), or tamsulosin 0.4 mg daily only (n=30). The primary outcomes included the post-treatment IPSS, peak urinary flow rate, and post-void residual urine volume. The secondary outcomes were changes in scores on the IIEF, the Global Assessment Questionnaire (GAQ), and the Life Satisfaction Checklist (LSC).

Results

The IPSS improved similarly from baseline to 12 weeks in both groups (tadalafil+tamsulosin; -2.2 vs. tamsulosin only; -2.3; p=0.528). However, the IPSS storage subscale improved to a significantly greater extent in the tadalafil+tamsulosin group. Changes in the Q(Max) and PVR did not differ significantly between the groups. The tadalafil+tamsulosin group showed significantly greater changes in the erectile and orgasmic function domain scores of the IIEF compared to the tamsulosin-only group. In terms of the GAQ and LSC scores, the tadalafil+tamsulosin group exhibited significantly greater improvements. The adverse events profiles were consistent with those of previous reports.

Conclusions

Combination therapy with tadalafil and tamsulosin afforded improvements in LUTS/BPH scores similar to those seen when tamsulosin only was given. However, the combination also had obvious benefits in terms of sexual function. Tadalafil can compensate for the decreased sexual performance that is a side-effect of tamsulosin, and improve the LUTS.

Funding

none

Authors
Hyun Jun Park
Tae Nam Kim
Jong Kil Nam
Du Geon Moon
Nam Cheol Park
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