Table 2.
Clinical outcome measures, Intention to treat (ITT) and per protocol analysis CTT versus 4D UGET.
| ITT CTT (n = 157) | ITT 4D UGET (n = 152) | ITT P-value | ITT odds ratio (95% confidence interval) | Per protocol CTT (n = 153) | Per protocol 4D UGET (n = 142) | Per protocol P-value | Per protocol odds ratio (95% confidence interval) | |
|---|---|---|---|---|---|---|---|---|
| CPR [n, %] | 56 (36) | 72 (47) | 0.04 | 1.62 (1.03–2.56) | 55 (36) | 71 (50) | 0.02 | 1.78 (1.12–2.84) |
| LBR [n, %] | 44 (28) | 59 (39) | 0.04 | 1.63 (1.01–2.63) | 43 (28) | 58 (41) | 0.02 | 1.77 (1.09–2.87) |
| BPR [n, %] | 71 (45) | 87 (57) | 0.04 | 1.62 (1.03–2.54) | 70 (46) | 84 (59) | 0.02 | 1.71 (1.08–2.72) |
| Miscarriage [n, %] | 12 (8) | 12 (8) | 0.40 | 0.69 (0.29–1.65) | 12 (8) | 12 (8) | 0.49 | 0.73 (0.30–1.79) |
| Ectopic pregnancy [n, %] | 1 (0.6) | 1 (0.7) | 0.98 | 1.03 (0.06–16.6) | 1 (0.6) | 1 (0.7) | 0.96 | 1.08 (0.07–17.3) |
| PUL [n, %] | 0 (0) | 2 (1.3) | 0.15 | 1.01 (0.99–1.03) | 0 (0) | 2 (1.4) | 0.14 | 1.01 (0.99–1.03) |
| TOP [n, %] | 0 (0) | 1 (0.7) | 0.31 | 1.01 (0.99–1.02) | 0 (0) | 1 (0.7) | 0.30 | 1.01 (0.99–1.02) |
| Duration of procedure (minutes) [mean ± SD] | 10.45 [2.42] | 16.19 [5.11] | < 0.01 | NA | 10.28 [2.18] | 15.77 [2.62] | < 0.01 | NA |