Table 2.
Primary and secondary outcomes overall and by treatment allocation
| Follow-up time | Entire cohort (N = 59) |
Estrogen arm (B) (N = 31) |
Placebo arm (A) (N = 28) |
Mean difference* (Estrogen-placebo) (90% CI) |
||||
|---|---|---|---|---|---|---|---|---|
| N | Mean (SD) | N | Mean (SD) | N | Mean (SD) | |||
| Primary outcome | ||||||||
| VuAS (range = 0–3) | 12 weeks | 56 | 0.15 (0.24) | 28 | 0.10 (0.25) | 28 | 0.20 (0.22) | -0.10 (-0.20 to 0.01) |
| Secondary outcomes | ||||||||
| VuAS (range = 0–3) | 6 weeks | 56 | 0.76 (0.79) | 29 | 0.73 (0.80) | 27 | 0.79 (0.80) | -0.08 (-0.43 to 0.27) |
| 6 months | 53 | 0.14 (0.27) | 27 | 0.15 (0.27) | 26 | 0.14 (0.27) | 0.01 (-0.11 to 0.13) | |
| VAS (range = 0–3) | 6 weeks | 33 | 0.33 (0.40) | 18 | 0.28 (0.43) | 15 | 0.39 (0.36) | -0.13 (-0.34 to 0.09) |
| 12 weeks | 25 | 0.34 (0.39) | 13 | 0.33 (0.43) | 12 | 0.35 (0.36) | -0.03 (-0.30 to 0.23) | |
| EPDS (range = 0–30) | 6 weeks | 55 | 4.71 (4.02) | 28 | 4.68 (4.01) | 27 | 4.74 (4.10) | -0.04 (-1.89 to 1.81) |
| 12 weeks | 54 | 4.07 (3.34) | 27 | 4.07 (3.71) | 27 | 4.07 (2.99) | 0.01 (-1.54 to 1.56) | |
| 6 months | 50 | 3.52 (3.75) | 26 | 4.08 (3.86) | 24 | 2.92 (3.62) | 1.22 (-0.61 to 3.05) | |
| UDI-6 (range = 0–100) | 6 weeks | 55 | 12.2 (21.5) | 28 | 9.3 (11.3) | 27 | 15.2 (28.4) | -5.73 (-15.51 to 4.05) |
| 12 weeks | 54 | 8.0 (18.1) | 27 | 5.6 (10.2) | 27 | 10.5 (23.5) | -4.78 (-13.12 to 3.56) | |
| 6 months | 50 | 8.3 (15.4) | 26 | 6.8 (13.0) | 24 | 10.0 (17.8) | -2.58 (-10.11 to 4.95) | |
| FISI (range = 0–61) | 6 weeks | 55 | 17.5 (12.5) | 28 | 19.0 (11.9) | 27 | 16.9 (13.2) | 0.90 (-4.75 to 6.55) |
| 12 weeks | 54 | 15.9 (13.3) | 27 | 16.5 (14.3) | 27 | 15.4 (12.4) | 1.25 (-4.90 to 7.40) | |
| 6 months | 50 | 16.2 (14.1) | 26 | 18.2 (14.9) | 24 | 14.0 (13.1) | 5.01 (-1.76 to 11.78) | |
| FSFI (full scale range = 2–36) | 6 weeks | 51 | 12.5 (10.1) | 27 | 13.3 (11.1) | 24 | 11.7 (8.9) | 1.59 (-3.23 to 6.41) |
| 12 weeks | 53 | 22.9 (9.8) | 26 | 25.4 (8.1) | 27 | 20.5 (10.8) | 5.11 (0.70 to 9.51) | |
| 6 months | 48 | 23.6 (9.0) | 25 | 23.9 (8.8) | 23 | 23.3 (9.5) | 0.29 (-4.25 to 4.82) | |
*Mean difference is negative if adjusted estrogen arm scores are lower than placebo arm. Linear model is adjusted for laceration degree (2nd vs. 3rd/4th)
VuAS = Vulvar Assessment Scale; VAS = Vaginal Assessment Scale; EPDS = Edinburgh Postnatal Depression Scale; UDI-6 = Urinary Distress Inventory-6 ; FISI = Fecal Incontinence Severity Index; FSFI = Female Sexual Function Index