Table 2. Summary of placebo controlled studies in OAB.
| Study | Patients (n) | Treatment arms & BoNT-A dose | UI episodes (baseline) | Micturition (baseline) | MCC, mL (baseline) | Dry, % | QoL (baseline) | Duration of effect |
|---|---|---|---|---|---|---|---|---|
| Sahai et al. 2008 | 36 | Placebo: 18 | −0.7/day (3.91)† | −1 (14.3) | −29.5 (198.1) | 12.0 | IIQ-7 & UDI-6 significant improvement in BoNT-A arm | ≥24 weeks |
| onaBoNT 200 U: 18 | −3.1 (4.98)/day† | −7.51 (15.4) | +131.4 (181.8) | 50.0 | ||||
| Brubaker et al. 2008 | 43 | Placebo: 15 | −1 (19.0)/day | N/A | N/A | N/A | PGI-I significant improvement in BoNT-A arm | 26 weeks |
| onaBoNT 200 U: 28 | −18 (21.0)/day | |||||||
| Flynn et al. 2009 | 22 | Placebo: 7 | +0.7 (8.0)/day | −0.8 (11.1) | No statistical difference | N/A | IIQ-7 & UDI-6 significant improvement in BoNT-A arm | N/A |
| onaBoNT 200 U: 15 | −4.5 (7.9)/day | −1.3 (10.5) | ||||||
| Dmochowski et al. 2010 & Roverner et al. 2011 | 313 | Placebo: 44 | −17.4 (32.5)/week | −8.3 (73.3)/week | +49.5 (267.1) | 15.9 | +17.9 (35.9) | N/A |
| onaBoNT 50 U: 57 | −20.7 (30.3)/week | −15.3 (76.3)/week | +50 (262.9) | 29.8 | +29.8 (32.3) | 18 weeks | ||
| onaBoNT 100 U: 54 | −18.4 (27.8)/week | −21.7 (80.3)/week | +71 (255.0) | 37.0 | +32.9 (34.3) | 24 weeks | ||
| onaBoNT 150 U: 59 | −23.0 (28.3)/week | −18.8 (76.5)/week | +101.7 (258.4)† | 40.8 | +35.2 (30.5) | >36 weeks | ||
| onaBoNT 200 U: 53 | −19.6 (24.1)/week | −19.7 (76.7)/week | +91.5 (280.1) | 50.9 | +37.1 (32.0) | >36 weeks | ||
| onaBoNT 300 U: 56 | −19.4 (26.8)/week | −21.2 (75.6)/week | +130.8 (271.7)† | 57.1 | +39.7 (34.5) | >36 weeks | ||
| Deny et al. 2012 | 107 | Placebo: 31 | Improvement 30%>50% | −0.9 (11.2)/day | 24 (229.3) | 10.7 | I-QOL improvement in majority of patients on 100 & 150 U | 5–6 months |
| onaBoNT 50 U: 23 | 37%>50% | −1.6 (12.7)/day | 17 (212.2) | 15.8† | ||||
| onaBoNT 100 U: 23 | 68% with >50% | −3.8 (12.6)/day† | 20 (249.3) | 55.0† | ||||
| onaBoNT 150 U: 30 | 58% with >50% | −4.2 (12.8)/day† | 21 (220.5) | 50.0† | ||||
| Nitti et al. 2013 | 557 | Placebo: 277 | −0.87 (5.1)/day | −0.91 (11.2)/day | N/A | 6.5 | IIQ-7 & KHQ significant improvement in BoNT-A arm | N/A |
| onaBoNT 00 U: 280 | −2.65 (5.5)/day† | −2.15 (12.0)/day† | 22.9† | >24 weeks | ||||
| Chapple et al. 2013 | 548 | Placebo: 271 | −1.03 (5.7)/day | −0.8 (11.8)/day | N/A | N/A | IIQ-7 & KHQ significant improvement in BoNT-A arm | N/A |
| onaBoNT 100 U: 277 | −2.95 (5.5)/day† | −2.6 (12.0)/days† | >24 weeks |
OAB, overactive bladder; BoNT-A, botulinum toxin A; UI, urgency incontinence; MCC, maximum cytometric capacity; QoL, quality of life; Pdetmax, maximum detrusor pressure; †, P<0.05 vs. placebo; N/A, not available.