EURURO Vol. 71 No. 4

574 692

one or more AEs with combination treatment than
monotherapy (moderate SOE).
3.7. Tolterodine plus ABs versus ABs alone
Four trials randomized men with LUTS and OAB symptoms
(n = 1338) to a combination of tolterodine 4 mg plus AB
versus AB monotherapy with tamsulosin, doxazosin, or
alfuzosin Overall RoB for three trials was
low and one trial had a high RoB
Responder analysis was provided in only the high RoB
trial with a response defined as a 3-point improvement
in I-PSS score from baseline ). The proportion of
responders was greater in the combination group than the
Table 4 – Evidence overview of combined solifenacin 5–6 mg plus tamsulosin 0.2–0.4 mg versus tamsulosin 0.2–0.4 mg monotherapy
Outcome No. of trials
(evaluated)
Intervention,
% (n/N) or mean
Control,
% (n/N) or mean
Results and magnitude
of effect (95% CI)
Strength of
evidence
Responders Not reported Insufficient
I-PSS score, mean change from baseline 6 (1948) –5.8 points –5.4 points Similar between groups:
WMD –0.29 (–0.88–0.30)
Moderat
I-PSS QoL, mean change from baseline 4 (1225) –1.2 points –0.9 points Similar between groups:
WMD –0.18 (–0.39 to –0.03)
Moderat
Overall withdrawals 7 (3147) 10 (203/2028) 11 (121/1119) Similar between groups:
RR 1.02 (0.74–1.41)
Lo
Withdrawals due to adverse effects 5 (2900) 4 (71/1904) 3 (30/996) Similar between groups:
RR 1.27 (0.81–2.0)
Lo
Participants with 1 adverse effect 5 (2918) 33 (623/1913) 29 (280/1005) Greater with combined therapy:
RR 1.21 (1.09–1.35)
Moderat
CI = confidence intervals; I-PSS = International Prostate Symptom Score; QoL = quality of life; RR = risk ratio; WMD = weighted mean difference.
Downgraded based on the following:
a Risk of bias (moderate).
b Imprecision.
Table 2 – Evidence overview of silodosin 8 mg versus tamsulosin 0.2–0.4 mg
Outcome No. of trials
(evaluated)
Intervention,
% (n /N) or mean
Control,
% (n/N) or mean
Results and magnitude
of effect (95% CI)
Strength of
evidence
Responders, based on 25% reduction in
total I-PSS score from baseline
3 (1283) 72 (456/632) 68 (440/651) Similar between groups:
RR 1.07 (0.91–1.26) Moderat
I-PSS score, mean change from baseline 8 (1598) –8.2 points –7.5 points Similar between groups:
WMD –0.52 (–1.58 to 0.54) Moderat
I-PSS QoL, mean change from baseline 6 (788) –1.7 points –1.4 points Similar between groups:
WMD –0.20 (–0.72 to 0.32) Moderat
Overall withdrawals 4 (1125) 9 (53/563) 9 (49/562) Similar between groups:
RR 1.05 (0.73–1.5) Lo
Withdrawals due to adverse effects 3 (1222) 5 (30/601) 3 (16/621) Greater with silodosin:
RR 1.96 (1.04–3.71) Moderat
Participants with 1 adverse effect 3 (1338) 52 (342/659) 46 (314/679) RR 1.11 (0.95–1.29) Insufficient
CI = confidence intervals; I-PSS = International Prostate Symptom Score; QoL = quality of life; RR = risk ratio; WMD = weighted mean difference.
Downgraded based on the following:
a Risk of bias (moderate).
b Imprecision.
Table 3 – Evidence overview of fesoterodine 4 mg plus various alpha-blockers versus various alpha-blockers monotherapy
Outcome No. of trials
(evaluated)
Intervention,
% (n/N) or mean
Control,
% (n/N) or mean
Results and magnitude
of effect (95% CI)
Strength of
evidence
Responders Not reported Insufficient
I-PSS score, mean change from baseline
2 (990)
Range
–2.4 to –4.4
Range
–0.7 to –4.4
Studies not pooled.
Both were similar to control Moderat
I-PSS QoL, mean change from baseline Not reported Insufficient
Overall withdrawals 1 (947) 15 (73/474) 10 (49/473) Greater with fesoterodine:
RR 1.49 (1.06–2.09)
Lo
Withdrawals due to adverse effects 1 (947) 10 (46/474) 4 (20/473) Greater with fesoterodine:
RR 2.30 (1.38–3.82)
Lo
Participants with 1 adverse effect 1 (947) 49 (230/474) 33 (157/473) Greater with fesoterodine:
RR 1.46 (1.25–1.71)
Lo
CI = confidence intervals; I-PSS = International Prostate Symptom Score; QoL = quality of life; RR = risk ratio; WMD = weighted mean difference.
Downgraded based on the following:
a Risk of bias (moderate).
b Unknown consistency or inconsistency.
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