Participant Characteristics in Endometrial Cancer Surgery Study with SUI Screening Data

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Robison K, Wohlrab K, Howe CJ, Richter HE, Sung V, Bevis KS, et al.Endometrial cancer surgery with or without concomitant stress urinary incontinence surgery. Obstet Gynecol 2023;141.

The authors provided this information as a supplement to their article.

Appendix 1. Participant Characteristics by Screening, Eligibility, and Enrollment

SUI screening result (n = 1322) Met all eligibility criteria if SUI positive (n = 702)

Enrolled if eligible (n = 642)

Variable Negative Positive P* Ineligible Eligible P† Did not

enroll

Enrolled P‡

Total, n (row %) 620 (46.9) 702 (53.1) 60 (8.5) 642 (91.5) 86 (13.4) 556 (86.6) Age (y)

62 (24 - 96)

63 (24 - 91)

0.47 61.5 (25 - 91)

63 (24 - 88)

0.51 67

(26 - 88) 62 (24 - 88)

0.002

Race and ethnicity (n =587) (n =690) (n =56) (n =634) (n =80) (n =554)

African American 87 (14.8) 78 (11.3) 13 (23.2) 65 (10.3) 9 (11.3) 56 (10.1)

Hispanic 39 (6.6) 23 (3.3) 0.002 1 (1.8) 22 (3.5) 0.03 1 (1.3) 21 (3.8) 0.14 White 436 (74.3) 570 (82.6) 40 (71.4) 530 (83.6) 65 (81.3) 465 (83.9)

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enroll

Enrolled P‡

None of the above or more than one

25 (4.3) 19 (2.8) 2 (3.6) 17 (2.7) 5 (6.3) 12 (2.2)

Histological Grade

Endometrial Grade 1 284 (45.8) 320 (45.6) 0.10 18 (30.0) 302 (47.0) <0.001 51 (59.3) 251 (45.1) 0.27 Endometrial Grade 2 96 (15.5) 106 (15.1) 5 (8.3) 101 (15.7) 9 (10.5) 92 (16.5)

Endometrial Grade 3 31 (5.0) 43 (6.1) 1 (1.7) 42 (6.5) 2 (2.3) 40 (7.2)

Papillary Serous 34 (5.5) 28 (4.0) 6 (10.0) 22 (3.4) 2 (2.3) 20 (3.6)

Clear Cell 7 (1.1) 3 (0.4) 0 (0.0) 3 (0.5) 0 (0.0) 3 (0.5)

Carcinosarcoma 20 (3.2) 10 (1.4) 0 (0.0) 10 (1.6) 1 (1.2) 9 (1.6)

EIN or CAH 129 (20.8) 159 (22.6) 26 (43.3) 133 (20.7) 18 (20.9) 115 (20.7)

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enroll

Enrolled P‡

Other 19 (3.1) 33 (4.7) 4 (6.7) 29 (4.5) 3 (3.5) 26 (4.7)

Clinical Stage

I 471 (76.0) 539 (76.8) <0.001 34 (56.7) 505 (78.7) <0.001 67 (77.9) 438 (78.8) 0.62

II 20 (3.2) 4 (0.6) 0 (0.0) 4 (0.6) 1 (1.2) 3 (0.5)

EIN or CAH 129 (20.8) 159 (22.6) 26 (43.3) 133 (20.7) 18 (20.9) 115 (20.7) SUI = Stress Urinary Incontinence; EIN or CAH = Endometrial Intraepithelial Hyperplasia/Complex Atypical Hyperplasia.

Data are median (range) or n (%). Comparisons were performed between treatment groups by Wilcoxon rank-sum or Fisher’s exact test.

* For variables with more than two categories, all categories were compared simultaneously between screen positive and negative groups.

† For variables with more than two categories, all categories were compared simultaneously between eligible and ineligible groups.

‡ For variables with more than two categories, all categories were compared simultaneously between enrolled and not enrolled groups.

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Appendix 2. Change in Functional Assessment of Cancer Therapy- Endometrial (FACT-En) Quality-of-Life Scores, the Primary Outcome, by Stress Urinary Incontinence Treatment Group Over Time, Without Multiple Imputation

Time point Change in FACT-En score (Postoperative - Preoperative) Concomitant SUI

surgery

Cancer surgery only Adjusted Median Difference (95% CI) Concomitant SUI surgery vs. Cancer

surgery only †

Averaged over time -- -- 1.2 (-1.5 to 3.8)

6 weeks (n = 83)

4.6 (-0.3 to 9.2)

(n = 297)

3.8 (-2.0 to 9.8) 0.4 (-2.7 to 3.5) ‡

6 months (n = 83)

5.5 (-0.5 to 13.7)

(n = 297)

3.6 (-1.1 to 10.5) 1.8 (-1.0 to 4.5) ‡

12 months (n = 83)

7.5 (0.6 to 14.1)

(n = 297)

4.8 (-1.2 to 11.9) 2.2 (-1.9 to 6.2) ‡

FACT-En = Functional Assessment of Cancer Therapy– Endometrial; SUI = Stress urinary incontinence; CI = 95% confidence interval.

Data are median (interquartile range). Positive change scores indicate increased quality of life postoperatively compared to the preoperative assessment.

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†Median differences in change score, averaged over postoperative time points, by multivariable median regression with clustered standard errors. Models were limited to 380 participants with complete preoperative covariate data and postoperative scores. Models included time (categorical) and the following preoperative covariates: age, race and ethnicity, education level, insurance, marital status, histology, clinical stage, body mass index (categorical), study site region, distance from home to clinic or hospital in miles (categorical), number of comorbidities (categorical), Life Orientation Test-Revised optimism score, and Urogenital Distress Inventory stress subscale score.

‡ Models included product terms between time and treatment group for estimation of time-specific median differences. None of the time- specific group differences were statistically significant at alpha = 0.05.

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Appendix 3. Change in Urinary Impact Questionnaire (UIQ-7) Quality-of-Life Scores, the Secondary Outcome, by Stress Urinary Incontinence Treatment Group Over Time, Without Multiple Imputation

Time point Change in UIQ-7 score (Postoperative - Preoperative) Concomitant SUI

surgery

Cancer surgery only Adjusted Median Difference (95% CI) Concomitant SUI surgery vs. Cancer

surgery only †

Averaged over time -- -- -2.7 (-6.3 to 1.0)

6 weeks (n = 83)

-4.8 (-23.8 to 0)

(n = 297)

0 (-9.5 to 4.8) -2.2 (-5.7 to 1.2) ‡

6 months (n = 83)

-9.5 (-28.6 to 0)

(n = 297)

0 (-9.5 to 4.8) -3.4 (-8.2 to 1.5) ‡

12 months (n = 83)

-9.5 (-28.6 to 0)

(n = 297)

0 (-9.5 to 0) -3.1 (-7.6 to 1.4) ‡

UIQ-7 = Urinary Impact Questionnaire-Short Form 7; SUI = Stress urinary incontinence; CI = 95% confidence interval.

Data are median (interquartile range). Negative change scores indicate increased quality of life (less impact of urinary incontinence) postoperatively compared to the preoperative assessment.

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†Median differences in change score, averaged over postoperative time points, by multivariable median regression with clustered standard errors. Models were limited to 380 participants with complete preoperative covariate data and postoperative scores. Models included time (categorical) and the following preoperative covariates: age, race and ethnicity, education level, insurance, marital status, histology, clinical stage, body mass index (categorical), study site region, distance from home to clinic or hospital in miles (categorical), number of comorbidities (categorical), Life Orientation Test-Revised optimism score, and Urogenital Distress Inventory stress subscale score.

‡ Models included product terms between time and treatment group for estimation of time-specific median differences. None of the time- specific group differences were statistically significant at alpha = 0.05.

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Appendix 4.

We searched PubMed from inception to July, 19 2022 for the following keywords: endometrial cancer, gynecologic cancer, endometrial intraepithelial neoplasia, urinary incontinence, prolapse, concomitant surgery, combined surgery, surgery, and incontinence.