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. 2015 Nov 20;27:1137–1147. doi: 10.1007/s00192-015-2890-7

Table 3.

Effect size of the average reduction on the VAS pain (12 weeks) and the response rates for controlled trials (CT)

Study Treatment Total patients Total instillations at week 12 VAS BT VAS AT VAS ↓ RR (%) VAS effect size RR effect size
Mean SD Mean SD d Minimum Maximum d Minimum Maximum
Shao et al. [34] Control 11 6 7.1 1 6.6 0.7 0.50 18.2 0.59 −0.27 1.44 0.88 0.01 1.76
Cystistat® 18 6 7.1 1.1 3.4 1 3.70 93.3 3.52 2.48 4.57 2.62 1.73 3.51
Lai et al. [41] Cystistat® 29 9 3.28 2.45 2.13 2.67 1.15 69.0 0.45 −0.07 0.97 1.77 1.16 2.38
Cystistat® 30 12 3.3 2.38 2.0 2.02 1.30 70.0 0.59 0.07 1.11 1.77 1.17 2.37
Nickel et al. [35] Placebo 30 6 6.2 1.31 4.1 1.98 2.10 23.3 1.28 0.72 1.83 1.01 0.47 1.54
Uracyst® 29 6 6.5 1.33 4.8 1.74 1.70 41.45 1.11 0.55 1.66 1.4 0.82 1.97
Nickel et al. [36] Placebo 40 8 6.38 1.83 4.66 2.84 1.72 31.3 0.74 0.28 1.19 1.95 1.42 2.49
Uracyst® 41 8 6.5 1.81 4.35 2.95 2.15 38 0.9 0.45 1.36 1.81 1.3 2.33
Bade et al. [37] Placebo 10 24 20.0 0.93 0.0 1.85
i-PPS 300 mgb 9 24 40.0 1.46 0.42 2.5
Davis et al. [38]a Placebo
+ daily
o-PPS 400 mg
20 36 4.7 1.3 3.2 2.2 1.50 90.0 0.86 0.21 1.50 2.5 1.67 3.33
i-PPS 200 mgc
+ daily o- 400 mg
20 36 4 0.7 2 1.9 2.00 85.7 1.54 0.83 2.24 2.37 1.58 3.15
Sairanen et al. [39] DMSO 37 6 6.4 2.1 30.0 1.08 0.59 1.56 1.16 0.67 1.65
BCG 31 6 6.8 2.1 11.0 0.68 0.21 1.14

VAS visual analogue pain score, BT before treatment, AT after treatment, RR response rate, d Cohen’s d, i-PPS intravesical PPS, o-PPS oral PPS, DMOS dimethyl sulfoxide, BCG intravesical Bacillus Calmette–Guérin

aResults at 24 weeks

bIntravesical instillation with 300 mg (three capsules) of Elmiron® + mixed with 50 ml of 0.9 % sodium chloride

c200 mg or two capsules mixed with 30 ml of sterile normal buffered saline