Table 1.
Outcomes of placebo-controlled trials
| Study (time point of reporting) Dose (N) | Urgency incontinence episodes | Urgency | Symptom scores | Patient-reported measures |
|---|---|---|---|---|
| Chapple et al26 (week 12) | Change in IE/day | Change in urgency/day | Positive response on TBS | |
| 100 U (277) | −2.95 (P<0.001) | −2.95 (P<0.001) | 62.8% (P<0.001) | |
| Placebo (271) | −1.03 | −1.24 | 26.8% | |
| Nitti et al27 (week 12) | Change in IE/day | Change in urgency/day | Positive response on TBS | |
| 100 U (280) | −2.65 (P<0.001) | −2.93 (P<0.001) | 60.8% (P<0.001) | |
| Placebo (277) | −0.87 | −1.21 | 29.2% | |
| Denys et al24 (month 3) | >75% reduction in symptoms | |||
| 50 U (21) | 6% | |||
| 100 U (22) | 42% (P=0.03) | |||
| 150 U (27) | 42% (P=0.03) | |||
| Placebo (29) | 22% | |||
| Dmochowski et al23 (week 12) | Proportion IE free | |||
| 50 U (57) | 29.8% | |||
| 100 U (54) | 37.0% | |||
| 150 U (49) | 40.8% | |||
| 200 U (53) | 50.9% | |||
| 300 U (56) | 57.1% | |||
| Placebo (44) | 15.9% | |||
| Tincello et al25 (month 6) | IE/day | Urgency/day | Urgency severity score | IQOL |
| 200 U (122) | 1.67 (P=0.0001) | 3.83 (P<0.0001) | 1.50 (P=0.0006) | 55.11 (P<0.0001) |
| Placebo (118) | 6.0 | 6.33 | 1.9 | 27.27 |
| Brubaker et al22 (day 60 [clinical hold]) | 75% reduction | UDI-urge subscale | PGI-I score | |
| 200 U (28) | 72%* | 31 (P=0.003) | 2.7 (P=0.003) | |
| Placebo (15) | 0% | 52 | 4.0 | |
| Sahai et al20 (week 12) | Change in IE/day | Difference in UDI-6 | Difference in IIQ-7 | |
| 200 U (16) | −3.50 (P<0.0076) | −5.13 (P<0.0001) | −10.38 (P=0.0063) | |
| Placebo (18) | −0.71 | +0.5 | +0.61 | |
| Flynn19 (week 6) | Change in IE/day | Difference in UDI | Difference in IIQ | |
| 200 U or 300 U (15) | −4.5 (P<0.01) | −18.6 (P=0.04) | −39.5 (P=0.02) | |
| Placebo (7) | +0.7 | +3.1 | 0 |
Note:
*
P-value<0.0001.
Abbreviations: IE, incontinence episodes; IIQ, Incontinence Impact Questionnaire; IQOL, incontinence quality of life; PGI, Patient global impression of improvement; TBS, Treatment Benefit scale; UDI, Urinary Distress Inventory scale.