EURURO Vol. 71 No. 4

AB monotherapy group (77% vs 29%), but the SOE for the

comparisonwas judged as insufficient for this outcome due to

a high RoB and unknown consistency. Mean changes in I-PSS

scores were similar between treatment groups (WMD: –0.19,

95% CI: –1.08 to 0.68; moderate SOE). The mean change in

I-PSS QoL was also not different between treatment groups

(WMD: –0.34, 95% CI: –1.14 to 0.46; low SOE)

[35–37]

There were six incidences of AUR in the combination

group versus two in the monotherapy group, which was

judged as insufficient evidence

[35–37] .

Withdrawal for any

reason (low SOE), withdrawal due to adverse effects (low

SOE), and rates of 1 AEs (insufficient SOE) were not

different between groups

[35]

3.8.

Trospium plus ABs versus ABs alone

One 12-wk trial (

= 58) compared trospium 45 mg daily

doses with AB to AB monotherapy in men with LUTS and

OAB symptoms attributed to BPH

[39] .

Individuals with a

baseline postvoid residual of

100 ml were excluded. RoB

was moderate.

Evidence was insufficient to assess efficacy for any

outcome. One or more AE were reported in nine (35%)

trospium participants versus five (23%) placebo patients.

3.9.

Mirabegron plus AB versus AB alone

We found one 8-wk trial

[40]

(

= 94), which compared

50 mg of mirabegron combined with 0.2 mg tamsulosin

versus tamsulosin monotherapy in males with LUTS and

OAB symptoms attributed to BPH. Patients with postvoid

residual urine volume

100 ml were excluded. The study

was judged to be at high RoB. The SOE was judged

insufficient for all predetermined patient-important out-

comes. We found no comparative trials combining mirabe-

gron with other ABs for this indication.

3.10.

Tadalafil versus tamsulosin

Four 3-mo trials compared tadalafil 2.5 mg, 5 mg, or 10 mg

daily with tamsulosin 0.2 mg or 0.4 mg daily

( Table 1

)

[41–44]

. Most participants had a history of erectile

dysfunction (ED)

[41,43,44]

. The most frequently investi-

gated dose level of tadalafil was 5 mg; one trial included a

2.5-mg dose level

[42]

and one trial evaluated 10 mg

[41]

. Overall RoB ranged from low to high for the four trials.

Tadalafil 5 mg and tamsulosin were similar in improving

mean I-PSS scores (WMD: –0.07, 95% CI: –2.12 to 2.23;

moderate SOE) and I-PSS QoL (WMD: –0.01, 95% CI: –0.75 to

0.73; low SOE). Evidence was insufficient for the outcomes

of study withdrawal for any reason and the proportion of

participants reporting at least one AE, but withdrawal due

to AEs was higher with tadalafil (3% vs 1%; moderate SOE;

Table 6

3.11.

Tadalafil versus alfuzosin

Two 3-mo trials (

= 93) compared tadalafil with alfuzosin

10 mg daily

( Table 1

)

[45,46]

. Kumar et al

[45]

compared

tadalafil 10 mg daily with alfuzosin 10 mg daily. Liguori

et al

[46]

compared tadalafil 20 mg taken on alternate days

with alfuzosin 10 mg daily. All participants had a history of

ED. Both trials were open label with a high overall RoB.

Alfuzosin 10 mg improved mean I-PSS scores more than

tadalafil 10 mg or 20 mg (low SOE;

Table 7

). Mean

reductions in I-PSS scores were 4.1 and 7.2 points with

tadalafil and alfuzosin, respectively, favoring alfuzosin. I-

PSS QoL also improved more with alfuzosin than tadalafil

(low SOE). Study withdrawal for any reason and withdrawal

due to an AE were no different with tadalafil or alfuzosin

(insufficient SOE).

3.12.

Sildenafil versus ABs

Three trials (

= 181) compared sildenafil versus an AB

[47–49]

. One compared sildenafil 25 mg daily with alfuzosin

10 mg daily over 12 wk

[48]

and one compared sildenafil

25 mg taken 4 d/wk with tamsulosin 0.4 mg daily over 8 wk

[49]

. Abolyosr et al

[47]

compared sildenafil 50 mg to a low

dose of doxazosin 2 mg over 16 wk; frequency of adminis-

tration was not reported. All participants had a history of ED.

All trials were open label and the overall RoB was high.

Table 5 – Evidence overview of combined tolterodine 4 mg plus various alpha-blockers versus various alpha-blocker monotherapy

Outcome

No. of trials

(evaluated)

Intervention,

% (

) or mean

Control,

% (

) or mean

Results and magnitude

of effect (95% CI)

Strength of

evidence

Responders, defined as a 3-point

improvement in I-PSS score from baseline

1 (70)

77 (27/35)

29 (10/35)

RR 2.7 (1.55–4.70)

Insufficien

t a , c

I-PSS score, mean change from baseline

4 (1249)

–5.9 points

–5.6 points

Similar between groups:

WMD –0.19 (–1.08 to 0.69)

Moderat

e a

I-PSS QoL, mean change from baseline

3 (1182)

–1.3 points

–1.1 points

Similar between groups:

WMD –0.34 (–1.14 to 0.46)

w b , c

Overall withdrawals

3 (1268)

16 (101/639)

14 (88/629)

Similar between groups:

RR 1.11 (0.53–2.34)

w b

Withdrawals due to adverse effects

3 (1268)

6 (36/639)

3 (16/629)

RR 2.17 (0.93–5.06)

Insufficien

t b

Participants with 1 adverse effect

1 (652)

35 (114/329)

28 (89/323)

RR 1.26 (1.00–1.58)

Insufficien

t b , c

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:

Risk of bias (moderate or high).

Imprecision.

Unknown consistency or inconsistency.

E U R O P E A N U R O L O G Y 7 1 ( 2 0 1 7 ) 5 7 0 – 5 8 1

575