Number of individuals with each symptom and no symptoms at 3 and 6 months presented by randomisation group.
| Intervention | Standard care | ||||
|---|---|---|---|---|---|
| Total responders (n) | Individuals with symptom/event (n) | Total responders (n) | Individuals with symptom/event (n) | Difference (95% CI; P value) | |
| 3 months | |||||
| Leakage (several times per month) | 2483 | 1567 (63%) | 612 | 428 (70%) | −7% (−11 to −3; P = 0.002) |
| Frequency (≥ once hourly) | 2428 | 723 (30%) | 598 | 219 (37%) | −7% (−11 to −2; P = 0.001) |
| Urgency: very strong or overwhelming | 2503 | 819 (33%) | 618 | 248 (40% | −7% (−12 to −3; P = 0.001) |
| Nocturia (≥3 times per night) | 2502 | 497 (20%) | 617 | 164 (27%) | −7% (−11 to −3; P<0.001) |
| Improvement | 2378 | 1417 (60%) | 584 | 281 (48%) | 11% (7 to 16; P<0.001) |
| No symptoms (cure) | 2378 | 591 (25%) | 584 | 88 (15%) | 10% (6 to 13; P<0.001) |
| 6 months | |||||
| Leakage (several times per month) | 2235 | 1362 (61%) | 546 | 356 (65%) | −4% (−9 to 0; P = 0.066) |
| Frequency (≥once hourly) | 2231 | 539 (24%) | 545 | 182 (33%) | −9% (−14 to −5; P<0.001) |
| Urgency: very strong or overwhelming | 2236 | 682 (31%) | 546 | 228 (42%) | −11% (−16 to −7; P<0.001) |
| Nocturia (≥3 times per night) | 2236 | 420 (19%) | 547 | 133 (24%) | −6 % (−9 to −2; P = 0.004) |
| Improvement | 2201 | 1369 (62%) | 536 | 277 (52%) | 11% (6 to 15; P<0.001) |
| No symptoms (cure) | 2201 | 624 (28%) | 536 | 104 (19%) | 9% (5 to 13; P<0.001) |