Table 1.
Study | Sample Size | Diagnosis | Age (years) | Disease duration (months) | Treatment and dose (BoNT/A/placebo) | Injection sites | Outcome measures | Follow up (weeks) | Success % |
---|---|---|---|---|---|---|---|---|---|
Schurch et al. [2000] | 21 | SCI | 36.7 | 60.2 | 200/300 | 20/30 | UD, clinical parameters | 6, 16, 36 | 89 |
Schulte-Baukloh et al. [2003] | 20 | Menigo myelocele | 10.8 | lifelong | 12 U/kg, max. 300 | 30-50 | UD, clinical parameters | 2,4,12, 24 | 100 |
Schurch et al. [2005] | 59 | SCI 89.9%/ MS 6 | 41 | 63 | 200/300/Placebo | 30 | UD, UI- episodes | 2,6,12,18,24 | 82.2 |
Schurch et al. [2007] | 59 | SCI 53 | 41.6 | 63 | 200/300/Placebo | 30 | I-QOL | 2,6,12,18,24 | 86.4 |
MS 6 | 77.3 | ||||||||
Reitz et al. [2007] | 20 | SCI 18 | 41.1 | 132 | 300 | 30 | UD, clinical parameters | 4 | Improve |
MS 2 | |||||||||
Pannek et al. [2010] | 27 | SCI 27 | 34.5 | 62.9 | 300 | 30 | UD parameters | 4 after each injection | 74 |
Game et al. [2010] | 109 | SCI 4 | 48.2 | NA | 300 | 30 | IIQ-7, UDI-6, EQ-5D | 4 after each injection | Improve |
MS 87 | |||||||||
Spina bifida 5 | |||||||||
Others 13 | |||||||||
Abdel-Meguid [2010] | 38 | SCI 38 | 25 | NA | 300 Detrusor | 30 | UI, IPSS, UD, clinical parameters, AEs | 2,8,12,18 | 52.4 |
200 Detrusor/100 trigone | 80.9 | ||||||||
Herschorn et al. [2011] | 57 | SCI 38 | 42.8 | NA | 300 /Placebo | 30 | UI-episodes | 6, 12, 24, 36,48,60 | 100 |
MS 19 | ICIQ/I-QOL | ||||||||
Cruz et al. [2011] | 275 | SCI 121 | 46 | NA | 200/300/Placebo | 30 | UI-episodes | 2,6,12 | 100 |
MS 154 | UD | ||||||||
I-QOL | |||||||||
Ginsberg et al. [2012] | 416 | SCI 189 | 46 | 168 | 200/300/Placebo | 30 | UI-episodes | 6 | 79 |
MS 227 | UD | ||||||||
I-QOL | |||||||||
Kennelly et al. [2012] | 387 | SCI 157 | 46.4 | 96 | 200/300 | 30 | UI-episodes/week | 2, 6, 12 | 94 |
MS 228 | 55 |
NA not available; SCI, spinal cord injury; MS, multiple sclerosis; UD, urodynamics; UI, urinary incontinence; I-QOL, Incontinence Quality of Life questionnaire; IIQ-7, incontinence impact questionnaire-7; UDI-6, Urogenital Distress Inventory-6; EQ-5D, EuroQol-5D questionnaire; IPSS, International Prostate Syndrome Score; AE, adverse event, ICIQ, International Consultation on Incontinence Questionnaire.