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