Table 1.
Surgical Pain Scales from Baseline to 3 Months After Surgery Modeling Outcome as Change from Baseline 1
| All Surgical Treatments (N=371) | ULS Surgical Treatment (N=185) | SSLF Surgical Treatment (N=186) | Surgical Treatment Difference | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Variable | Time Frame | Adjusted Mean (SE, N) | Adjusted P-value 2 | Adjusted Mean (SE, N) | Adjusted P-value 2 | Adjusted Mean (SE, N) | Adjusted P-value 2 | Adjusted Mean Difference (95% CI) 3 | Adjusted P-value 3 |
| Pain at Rest 4 | |||||||||
| Baseline | 2.24 (0.23, 369) | -- | 2.20 (0.25, 184) | -- | 2.28 (0.26, 185) | -- | −0.08 (−0.53, 0.36) | 0.711 | |
| 2 week change | 0.65 (0.23, 354) | 0.004 | 0.57 (0.26, 177) | 0.027 | 0.72 (0.26, 177) | 0.006 | −0.15 (−0.65, 0.35) | 0.551 | |
| 4–6 week change | −0.41 (0.23, 362) | 0.068 | −0.53 (0.26, 181) | 0.039 | −0.29 (0.26, 181) | 0.259 | −0.24 (−0.73, 0.26) | 0.347 | |
| 3 month change | −0.87 (0.23, 340) | <0.001 | −0.93 (0.26, 168) | <0.001 | −0.81 (0.26, 172) | 0.002 | −0.12 (−0.63, 0.39) | 0.644 | |
| Pain during Normal Activities 5 | |||||||||
| Baseline | 2.76 (0.25, 368) | -- | 2.66 (0.28, 183) | -- | 2.86 (0.28, 185) | -- | −0.20 (−0.69, 0.30) | 0.435 | |
| 2 week change | 0.74 (0.27, 353) | 0.007 | 0.63 (0.31, 176) | 0.042 | 0.85 (0.31, 177) | 0.006 | −0.23 (−0.81, 0.35) | 0.440 | |
| 4–6 week change | −0.46 (0.27, 362) | 0.087 | −0.60 (0.31, 180) | 0.052 | −0.33 (0.31, 182) | 0.287 | −0.27 (−0.84, 0.31) | 0.362 | |
| 3 month change | −1.14 (0.27, 338) | <0.001 | −1.20 (0.31, 167) | <0.001 | −1.08 (0.31, 171) | 0.001 | −0.12 (−0.71, 0.47) | 0.686 | |
| Pain during Exercise, Strenuous Activities | |||||||||
| Baseline | 3.71 (0.42, 211) | -- | 3.66 (0.47, 94) | -- | 3.76 (0.45, 117) | -- | −0.10 (−0.87, 0.67) | 0.794 | |
| 2 week change | −0.36 (0.57, 42) | 0.527 | −0.47 (0.74, 17) | 0.527 | −0.26 (0.65, 25) | 0.693 | −0.21 (−1.78, 1.36) | 0.793 | |
| 4–6 week change | −1.26 (0.51, 83) | 0.014 | −1.38 (0.62, 35) | 0.028 | −1.14 (0.56, 48) | 0.043 | −0.23 (−1.45, 0.98) | 0.703 | |
| 3 month change | −1.97 (0.48, 132) | <0.001 | −1.74 (0.55, 60) | 0.002 | −2.20 (0.54, 72) | <0.001 | 0.46 (−0.56, 1.48) | 0.376 | |
| Worst Pain 6 | |||||||||
| Baseline | 2.98 (0.29, 368) | -- | 2.91 (0.32, 183) | -- | 3.05 (0.32, 185) | -- | −0.14 (−0.70, 0.42) | 0.620 | |
| 2 week change | 0.42 (0.30, 350) | 0.168 | 0.23 (0.34, 175) | 0.506 | 0.61 (0.35, 175) | 0.082 | −0.38 (−1.04, 0.28) | 0.256 | |
| 4–6 week change | −0.95 (0.30, 361) | 0.002 | −1.08 (0.34, 179) | 0.002 | −0.83 (0.35, 182) | 0.017 | −0.25 (−0.90, 0.40) | 0.449 | |
| 3 month change | −1.50 (0.30, 338) | <0.001 | −1.66 (0.35, 166) | <0.001 | −1.35 (0.35, 172) | <0.001 | −0.32 (−0.98, 0.35) | 0.350 | |
The analyses for each outcome of interest were performed on the modified intent to treat population (mITT) which includes all participants that were eligible, gave consent, were randomized to both the PMT and surgical interventions, and for whom the outcome was assessed (i.e. non-missing). For analyses assessing each outcome’s change from baseline to a follow-up visit, all adjusted means, mean differences, standard errors, 95% confidence intervals, and p-values for outcomes were obtained from general linear models adjusting for randomized surgical intervention, randomized PMT intervention, visit, interaction between visit and randomized surgical intervention, interaction between visit and randomized PMT intervention, and three-way interaction between visit and randomized surgical intervention and randomized PMT intervention, concomitant hysterectomy, age at surgical randomization, race (white, black, other), ethnicity, public insurance, and private insurance while controlling for a random surgeon effect (if found statistically significant) and repeated subject visits. All tests were conducted at a significance level of 0.05.
This adjusted p-value corresponds to the test assessing if there was a statistically significant change from baseline.
This adjusted p-value corresponds to the test assessing if there was a statistically significant difference in the outcome between the two surgical treatments.
The effect of surgery varies across the PMT groups and across visits (p=0.006). See table 2 for the effect of randomized surgical intervention within the PMT and non-PMT groups.
The effect of surgery varies across the PMT groups and across visits (p=0.001). See table 2 for the effect of randomized surgical intervention within the PMT and non-PMT groups.
The effect of surgery varies across the PMT groups and across visits (p=0.001). See table 2 for the effect of randomized surgical intervention within the PMT and non-PMT groups.