Table 3.
Summary of results with different dosage at different observation points for NDO.
Outcomes | Number of RCTs | MD/RR | 95%CI | I2 (%) | P for I2 |
---|---|---|---|---|---|
Episodes of Urinary Incontinence (UI) per Week | |||||
2 weeks | |||||
BTX-A 200U VS. Placebo | 1 | -9.1 | -14.10, -4.10 | NA | NA |
BTX-A 300U VS. Placebo | 1 | -6.1 | -12.54, 0.34 | NA | NA |
BTX-A 300U VS. 200U | 1 | 3 | -3.30, 9.30 | NA | NA |
6 weeks | |||||
BTX-A 200U VS. Placebo | 3 | -10.72 | -13.40, -8.04 | 0 | 0.626 |
BTX-A 300U VS. Placebo | 3 | -11.42 | -13.91, -8.93 | 50 | 0.135 |
BTX-A 300U VS. 200U | 4 | -0.38 | -2.60, 1.84 | 0 | 0.765 |
12 weeks | |||||
BTX-A 200U VS. Placebo | 1 | -8.5 | -14.46, -2.54 | NA | NA |
BTX-A 300U VS. Placebo | 1 | -7.8 | -13.73, -1.87 | NA | NA |
BTX-A 300U VS. 200U | 1 | 0.7 | -4.73, 6.13 | NA | NA |
Maximum Detrusor Pressure (MDP) | |||||
6 weeks | |||||
BTX-A 200U VS. Placebo | 5 | -33.01 | -37.75, -28.27 | 0 | 0.998 |
BTX-A 300U VS. Placebo | 5 | -31.31 | -35.79, -26.84 | 0 | 0.679 |
BTX-A 300U VS. 200U | 6 | 1.16 | -3.29, 5.60 | 0 | 0.831 |
Detrusor compliance (DC) | |||||
6 weeks | |||||
BTX-A 200U VS. Placebo | 2 | 66.29 | 44.24, 88.34 | 0 | 0.837 |
BTX-A 300U VS. Placebo | 2 | 56.51 | 35.00, 78.03 | 0 | 0.910 |
BTX-A 300U VS. 200U | 2 | -9.79 | -35.00, 15.42 | 0 | 0.965 |
Post void residual (PVR) | |||||
2 weeks | |||||
BTX-A 200U VS. Placebo | 2 | 93.87 | 63.91, 123.84 | 0 | 0.887 |
BTX-A 300U VS. Placebo | 2 | 178.22 | 138.50, 217.95 | 0 | 0.751 |
BTX-A 300U VS. 200U | 2 | 84.13 | 35.74, 132.51 | 0 | 0.727 |
Adverse Events* | |||||
Urinary tract infections (UTI) | |||||
BTX-A 200U VS. Placebo | 5 | 1.44 | 1.27, 1.62 | 0 | 0.974 |
BTX-A 300U VS. Placebo | 6 | 1.51 | 1.35, 1.70 | 0 | 0.720 |
BTX-A 300U VS. 200U | 6 | 1.07 | 0.97, 1.18 | 0 | 0.909 |
Urinary retention | |||||
BTX-A 200U VS. Placebo | 4 | 5.85 | 3.84, 8.91 | 0 | 1.000 |
BTX-A 300U VS. Placebo | 4 | 6.78 | 4.46, 10.30 | 0 | 0.872 |
BTX-A 300U VS. 200U | 4 | 1.16 | 0.95, 1.43 | 0 | 0.438 |
Muscle weakness | |||||
BTX-A 200U VS. Placebo | 3 | 1.53 | 0.76, 3.06 | 69.9 | 0.036 |
BTX-A 300U VS. Placebo | 4 | 3.01 | 1.50, 6.02 | 0 | 0.910 |
BTX-A 300U VS. 200U | 3 | 1.75 | 1.03, 2.97 | 77.9 | 0.011 |
Hematuria | |||||
BTX-A 200U VS. Placebo | 5 | 1.59 | 0.97, 2.62 | 0 | 0.980 |
BTX-A 300U VS. Placebo | 6 | 1.97 | 1.24, 3.13 | 0 | 0.984 |
BTX-A 300U VS. 200U | 6 | 1.22 | 0.83, 1.80 | 0 | 0.902 |
NA, Not available.