EURURO Vol. 71 No. 4

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3.5. Oxybutynin plus ABs versus ABs alone
One 12-wk trial (n = 420) trial compared oxybutynin 10 mg
tablets plus tamsulosin 0.4 mg with tamsulosin 0.4 mg
alone . Individuals with a baseline postvoid residual of
>200 ml were excluded. RoB was moderate. SOE was
judged insufficient for all outcomes.
3.6. Solifenacin plus ABs versus ABs alone
Seven 12-wk trials randomized men with LUTS and
OAB symptoms (n = 3147) to solifenacin plus tamsulosin
versus tamsulosin monotherapy ). Five trials
examined solifenacin 5 mg and two examined
solifenacin 6 mg . The overall RoB was moderate.
Combination therapy was similar to AB monotherapy
in improving LUTS (moderate SOE; ). Improvement in
mean I-PSS score from baseline was similar with solifenacin
5 mg or 6 mg plus tamsulosin 0.2 mg or 0.4 mg versus
tamsulosin alone (WMD: –0.29, 95% CI: –0.88 to 0.30;
moderate SOE). Combination therapy lowered I-PSS QoL
score more than tamsulosin, but the difference between
groups was not clinically significant based on predetermined
thresholds (moderate SOE). Evidence from four trials using
solifenacin 3–9 mg reported no statistical
difference between treatment groups in rates of AUR, but
evidence was judged insufficient to draw conclusions due to
imprecision.
Withdrawal for any reason or due to AEs was similar
with both treatments (low SOE). More participants reported
Table 1 – Baseline characteristics of eligible comparative effectiveness trials
Study, [reference]/location Intervention
(daily dosage)
Control
(daily dosage)
No.
randomized
Duration
(wk)
Mean
Age (yr)
Mean
I-PSS
Alpha-blockers, silodosin versus tamsulosin
Takeshita (2016) /Japan Silodosin 4 mg Tamsulosin 0.2 mg 34 4 wk 70 16
Manjunatha (2016) /India Silodosin 8 mg Tamsulosin 0.4 mg 60 12 wks 64 19
Pande (2014) India Silodosin 8 mg Tamsulosin 0.4 mg 61 12 wk 62 18
Chapple (2011) /Europe Silodosin 8 mg Tamsulosin 0.4 mg 765 12 wk 66 19
Yokoyama (2012) /Japan Silodosin 8 mg Tamsulosin 0.2 mg 46 12 w 69 20
Watanabe (2011) /Japan Silodosin 8 mg Tamsulosin 0.2 mg 102 4 w 70 17
Yokoyama (2011) /Japan Silodosin 8 mg Tamsulosin 0.2 mg 90 12 wk 71 18
Yu (2011) /Taiwan Silodosin 8 mg Tamsulosin 0.2 mg 209 12 wk 66 20
Miyakita (2010) /Japan Silodosin 8 mg Tamsulosin 0.2 mg 65 4 w 69 17
Kawabe (2006) /Japan Silodosin 8 mg Tamsulosin 0.2 mg 367 12 wk 66 17
Totals and means 1799 67 18
Anticholinergics, fesoterodine plus alpha-blocker versus alpha-blocker monotherapy
Konstantinidis (2013) /Greece Fesoterodine 4 mg ER +/vs Tamsulosin 0.4 mg 47 4 wk 64 16
Kaplan (2011) /Multinational Fesoterodine 4 mg +/vs Various 943 12 wk 66 19
Totals and means 990 66 19
Anticholinergics, solifenacin plus alpha-blocker versus alpha-blocker tamsulosin monotherapy
Van Kerrebroeck (SATURN) (2013) Europe Solifenacin 3–9 mg +/vs Tamsulosin 0.4 mg OCAS 715 12 wk 65 18
Van Kerrebroeck (NEPTUNE) (2013)/Europe Solifenacin 6–9 mg +/vs Tamsulosin 0.4 mg OCAS 993 12 wk 65 19
Kaplan (2009) /USA Solifenacin 5 mg +/vs Tamsulosin 0.4 mg 398 12 wk 65 17
Ko (2014) /Korea Solifenacin 5 mg +/vs Tamsulosin 0.2 mg 187 12 wk 61 19
Lee (2014) /Korea Solifenacin 5 mg +/vs Tamsulosin 0.2 mg 156 12 wk 61 18
Seo (2011) Korea Solifenacin 5 mg +/vs Tamsulosin 0.2 mg 60 12 wk 58 18
Yamaguchi (2011) /Japan Solifenacin 2.5–5 mg +/vs Tamsulosin 0.2 mg 638 12 wk 70 14
Totals and means 3147 66 17
Anticholinergics, tolterodine plus alpha-blocker versus alpha-blocker monotherapy
Memon (2014) India Tolterodine 4 mg +/vs. Alfuzosin 10 mg 70 12 wk 62 24
Lee (2011) /Korea Tolterodine 4 mg ER +/vs Doxazosin 4 mg GITS 176 12 wk 61 21
Chapple (2009) Multinationa Tolterodine 4 mg ER +/vs Various 652 12 wk 65 19
Kaplan (2006) /USA Tolterodine 4 mg ER +/vs Tamsulosin 0.4 mg 440 12 wk 61 20
Totals and means 1338 63 20
Phosphodiesterase type 5 inhibitors, tadalafil versus alpha-blocker tamsulosin monotherapy
Oelke (2012) /Multinational Tadalafil 5 mg Tamsulosin 0.4 mg 339 12 wk 64 17
Yokoyama (2013) /Asia Tadalafil 2.5–5 mg Tamsulosin 0.2 mg 458 12 wk 63 17
Kim (2011) Korea Tadalafil 5 mg Tamsulosin 0.2 mg 100 12 wk 61 17
Singh (2014) /India Tadalafil 10 mg Tamsulosin 0.4 mg 89 12 wk 61 21
Totals and means 986 63 17
Phosphodiesterase type 5 inhibitors, tadalafil versus alpha-blocker monotherapy
Kumar (2014) India Tadalafil 10 mg Alfuzosin 10 mg 50 12 wk 62 18
Liguori (2009) /Italy Tadalafil 20 mg
(taken alternated d)
Alfuzosin 10 mg ER 43 12 wk 61 15
Totals and means 93 62 16
ER = extended release; GITS = gastrointestinal therapeutic system; I-PSS = International Prostate Symptom Score; OCAS = oral controlled absorption system;
vs = versus.
a Crossover study, first phase presented only.
b Includes several continents.
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