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083 Does Concomitant Testosterone Replacement Improve the Response of Tadalafil 5 mg Once Daily in Men with Lower Urinary Tract Symptoms?

H.J. Park, N.C. Park, K.H. Moon

The Journal of Sexual Medicine, 2018

46 participants

Abstract

Does concomitant testosterone replacement improve the response of tadalafil 5 mg once daily in men with lower urinary tract symptoms? Tadalafil was found to be effective for treating lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Testosterone (T) regulates nitric oxide synthase and is necessary to achieve an optimum response to PDE5 inhibitors. In the present study, we determined whether T replacement in men with low T levels receiving tadalafil to treat LUTS improved the response of tadalafil on LUTS. The present 12-week study was a randomized parallel study of clinical outcomes in men aged ≥ 40 years with symptomatic BPH (IPSS ≥ 12), prostate volumes ≥ 30 ml, and testosterone levels less than 300 ng/dl. Eligible patients received a combination of tadalafil 5 mg once daily and placement of a transdermal gel containing 10 g T (n=44), or tadalafil alone (n=46). The primary outcomes were post-treatment IPSS, peak urinary flow rate, and post-void residual urine volume (PVR). Secondary outcomes were changes in IIEF-EF domain scores, Global Assessment Questionnaire (GAQ) scores, and Life Satisfaction Checklist (LSC) scores.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 46 participants or records.

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