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Do baseline estrogen and testosterone affect lower urinary tract symptoms ( LUTS ) prior to or after pharmacologic treatment with tadalafil?
Author(s) -
Egan K. B.,
Miner M. M.,
Suh M.,
McVary K.,
Ni X.,
Roehrborn C. G.,
Wittert G.,
Wong D. G.,
Rosen R. C.
Publication year - 2015
Publication title -
andrology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.947
H-Index - 43
eISSN - 2047-2927
pISSN - 2047-2919
DOI - 10.1111/andr.12114
Subject(s) - tadalafil , lower urinary tract symptoms , medicine , international prostate symptom score , urology , placebo , testosterone (patch) , randomization , randomized controlled trial , erectile dysfunction , prostate , alternative medicine , pathology , cancer
Summary Little is known about how total testosterone and estradiol‐17β influence lower urinary tract symptoms ( LUTS ) in men with benign prostatic hypertrophy ( BPH ). We analyzed data from a subset of men aged ≥18 years randomized to tadalafil 5 mg once‐daily or placebo who had ≥6 month history of LUTS and an International Prostate Symptom Score ( IPSS )≥13 enrolled in one of three randomized, placebo‐controlled tadalafil clinical trials ( N = 958). Three specific aims were addressed, as follows: (i) To characterize enrolled men by treatment randomization and testosterone level; (ii) to assess cross‐sectional associations of estradiol‐17β, testosterone, and LUTS prior to treatment with tadalafil; and, (iii) to assess longitudinal associations between baseline estradiol‐17β and testosterone and improvements or worsening of LUTS during a 12‐week period of tadalafil or placebo administration. LUTS were assessed by total IPSS , IPSS voiding sub‐score ( IPSS ‐V) and IPSS storage sub‐score ( IPSS ‐S) for cross‐sectional analyses, and change in total IPSS (Δ IPSS ), Δ IPSS ‐V, and Δ IPSS ‐S between baseline and 12‐week visit for longitudinal analyses. Correlation analyses and linear regression examined associations. Baseline testosterone was not significantly associated with IPSS . In contrast, estradiol‐17β was inversely correlated with IPSS ( r = −0.08; p < 0.05) and IPSS ‐S ( r = −0.14; p < 0.05). Tadalafil treatment resulted in greater IPSS improvements in men with lower baseline estradiol‐17β versus those with higher baseline estradiol‐17β. Lower baseline estradiol‐17β was significantly associated with modestly improved Δ IPSS ‐V ( p = 0.04) and Δtotal IPSS ( p = 0.05) but not with Δ IPSS ‐S, following treatment which may substantiate the role of bladder dysfunction because of nerve and smooth muscle changes in the bladder in addition to benign prostatic enlargement in LUTS . Circulating baseline testosterone did not predict Δ IPSS . Men with lower baseline estradiol‐17β levels showed greater responsiveness to tadalafil 5 mg treatment than those with higher baseline estradiol‐17β levels when responsiveness was measured using total IPSS and IPSS ‐V.