762 860
Table 4 – Randomized controlled trials comparing drug therapy against tamsulosin for nocturia
Study description
Results
Outcome
Comparator
Tamsulosin
Author (yr)
Comparator
Main study
inclusion
criteria
Study
duration
Randomized
patients
Mean
age SD
(range)
Total no.
patients
(
N
)
Mean
difference
(before and after
intervention; SD)
Mean
age SD
(range)
Total no.
patients
(
N
)
Mean
difference
(before and after
intervention; SD)
Mean
difference IV,
fixed, 95% CI
Yee 2015,
[9]Weight reduction +
a-blocker vs
a-blocker
Men 50,
BPH/LUTS,
BMI 25–35 kg/m
2
12 mo
130
66.5 6.9 (NA)
60
–0.1, 0.3
63.3 7.8 (NA)
57
–0.1, 0.3
0.0
(–0.11, 0.11)
No difference
Simaioforidis
2011,
[24]
Tamsulosin vs
TUR-P
Nocturia for at
least 12 mo and
moderate to
severe LUTS
12 mo
66
69.8 7.9 (53–81)
33
–1, 0.2
67.5 7.1 (52–78)
33
–0.2, 0.2
–0.84
(–0.93, –0.75)
TUR-P appears
superior to
tamsulosin for
BPH related nocturia
Gorgel, 2013,
[46]
Tamsulosin 0.4 mg +
meloxicam 15 mg vs
tamsulosin 0.4 mg
Men 50,
BPH/LUTS,
IPSS:8–19,
Qmax 5–15 ml/s
3 mo
400
61.4 7.5 (NA)
200
–2.7, 0.6
63.3 6.6 (NA)
200
–1.4, 0.4
–1.3
(–1.4, –1.2)
Combination
improves sleep
quality
Oelke 2012,
[39]
Tadalafil 5 mg vs
tamsulosin 0.4 mg
Men 45,
BPH/LUTS, IPSS 13,
Qmax 4–15 ml/s
12 wk
339
63.5 NA (45–83)
171
–0.5, 0.1
63.5 NA (45–84)
167
–0.5, 0.1
0.0 (–0.02, 0.2) No difference
Chapple 2011,
[23]
Silodosin 8 mg vs
tamsulosin 0.4 mg
Men 50, BPH/LUTS,
IPSS 13,
Qmax 4–15 ml/s
12 wk
955
65.8 7.7 (50–87)
371
–0.9, NA
66 7.4 (50–81)
376
–0.8
Not estimable Silodosin is superior
to placebo only
Ukimura 2008,
[21]
Naftopidil 50 mg vs
tamsulosin 0.2 mg
Men 50 yr, BPH,
OAB, nocturia 2,
flow rate
<
15 ml/s
6–8 wk
59
69.6 6.8 (NA)
25
–3.8, 0.2
68.8 8.2 (NA)
23
–3.1, 0.1
–0.7
(–0.79, –0.61)
Early improvement
(2 wk) in naftopidil
arm but results are
comparable at 8 wk
Ichihara 2014
[26]
Mirabegron +
tamsulosin 0.2 mg vs
tamsulosin 0.2 mg
BPH, OAB
8 wk
96
75.9 7.5 (NA)
38
–0.47, 0.1 73.1 8.7 (NA)
38
–0.16, 0.1 –0.31
(–0.35, –0.27)
The combination is
not superior to
monotherapy
(IPSS Q7)
Ahmed 2015,
[25]
Desmopressin +
tamsulosin vs
tamsulosin 0.4 mg
Men 50 yr, BPH,
LUTS, nocturia 2
3 mo
248
70.1 9.3 (NA)
123
–1.96, 0.2 68.6 10.5 (NA)
125
–1.4, 0.1
–0.55
(–0.58, –0.52)
The combination
improves nocturnal
frequency and first
sleep period
Data modified for the purposes of the table.
BMI = body mass index; BPH = benign prostatic hyperplasia; CI = confidence interval; IPSS = International Prostate Symptom Score; IV = independent variable; LUTS = lower urinary tract symptoms; NA = not available;
NP = nocturnal polyuria; OAB = overactive bladder; SD = standard deviation; TUR-P = transurethral resection of the prostate.
E U R O P E A N U R O L O G Y 7 2 ( 2 0 1 7 ) 7 5 7 – 7 6 9
762