Summary of characteristics of included trials
| Author/trial | Study and design | Population (1) Mean age (years) (2) Female (%) | OAB inadequately managed by anticholinergics | Interventions/comparators | Duration of treatment/ follow-up |
|---|---|---|---|---|---|
| BTX studies | |||||
| Al Taweel26 | RCT Single centre (Saudi Arabia) | (1) NR (2) NR | Yes | BTX: 2 doses (200/100 U) | 9 months |
| Brubaker27 | Double-blind RCT Multicentre (USA) | (1) 64.7–69.2 (2) 100.0 | Yes | BTX: 200 U Placebo | 12 months/≤1 month |
| Chapple23 | Double-blind RCT Multicentre (Europe, USA) | (1) 59.2–59.5 (2) 84.5–88.1 | Yes | BTX: 100 U Placebo | 12 weeks/12 weeks (non-placebo-controlled) |
| Cohen28 | RCT Single centre (USA) | (1) NR (2) NR | Yes | BTX: 2 doses (150/100 U) | 24 weeks |
| Denys29 | Double-blind RCT Multicentre (France) | (1) 61.6 (2) 87.9 | Yes | BTX: 3 doses (150/100/50 U) Placebo | 6 months |
| Dmochowski30 | Double-blind RCT Multicentre (Europe, USA, Canada) | (1) 58.8 (2) 92.0 | Yes | BTX: 5 doses (300/200/150/100/50 U) Placebo | 36 weeks |
| King31 | Double-blind RCT Single centre (Australia) | (1) 60.7–64.3 (2) 100.0 | Minimal response | BTX: 200 U Placebo | 6 weeks/unclear |
| Nitti24 | Double-blind RCT Multicentre (USA, Canada) | (1) 61.0–61.7 (2) 88.4–90.0 | Yes | BTX: 100 U Placebo | 12 weeks/12 weeks (non-placebo-controlled) |
| Sahai32 | Double-blind RCT Single centre (UK) | (1) 49.8–50.8 (2) 55.9 | Unclear | BTX: 200 U Placebo | 12 weeks/12-week open label extension (BTX arm only) |
| Tincello33 | Double-blind RCT Multicentre (UK) | (1) 58.2–60.7 (2) 100.0 | Yes | BTX: 200 U Placebo | 6 months/extension study |
| Visco34 | Double-blind RCT Multicentre (USA) | (1) 56.7–59.3 (2) 100.0 | Unclear | BTX: 100 U Anticholinergic protocol | 6 months/6 months (off treatment) |
| MBG studies | |||||
| ARIES35 | Double-blind RCT Multicentre (USA, Canada) | (1) 60.1 (2) 74.3 | NR | MBG: 2 doses (100/50 mg) Placebo | 12 weeks/30 days |
| Astellas 178-CL-04536 | Double-blind RCT Multicentre (Japan) | (1) 54.9–56.9 (2) 80.1–85.1 | NR | MBG: 3 doses (100/50/25 mg) Placebo | 12 weeks |
| BLOSSOM37 | Double-blind RCT Multicentre (international) | (1) NR (2) NR | NR | MBG: 2 doses (150/100 mg two times daily) Tolterodine ER 4 mg Placebo | 4 weeks/2-week placebo follow-up |
| CAPRICORN38 | Double-blind RCT Multicentre (Europe, North America) | (1) 59.0 (2) 68.7 | NR | MBG: 2 doses (50/25 mg) Placebo | 12 weeks/2 weeks |
| DRAGON39 | Double-blind RCT Multicentre (international: 14 countries) | (1) 57.2 (2) 89.3 | NR | MBG: 4 doses (200/100/50/25 mg) Placebo | 12 weeks |
| SCORPIO40 | Double-blind RCT Multicentre (Europe, Australia) | (1) 59.0–59.2 (2) 71.6–72.9 | NR | MBG: 2 doses (100/50 mg) Tolterodine ER 4 mg Placebo | 12 weeks/30 days |
| TAURUS41 | Double-blind RCT Multicentre (USA, Europe, Canada, South Africa, NZ, Australia) | (1) 59.2–60.1 (2) 73.9–74.1 | NR | MBG: 2 doses (100/50 mg) Tolterodine ER 4 mg | 12 months |
| Yamaguchi42 | Double-blind RCT Multicentre (Japan) | (1) NR (2) NR | NR | MBG: 50 mg Placebo | 12 weeks/2 weeks |
BTX, onabotulinumtoxinA; ER, extended release; MBG, mirabegron; NZ, New Zealand; NR, not reported; OAB, overactive bladder; RCT, randomised controlled trial.