Preoperative diagnosis of ureteral medial deviations secondary to deep endometriosis using transvaginal ultrasound examinations: Can we predict the need for ureterolysis during laparoscopic surgery?

OBJECTIVE: To evaluate ureteral involvement using transvaginal sonography (TVS) regarding the distortion of the course of the ureters caused by deep endometriosis (DE), which can facilitate predicting the need for ureterolysis during surgery, even in the absence of ureteral stenosis or dilatation. METHODS: This is a single-center, observational, retrospective pilot study of 88 consecutive patients who later underwent surgery for DE that used ultrasound preoperative diagnosis of ureteral medial deviation of one or both ureters between January 2019 and January 2022. At TVS, the course of the ureter was considered medialized if, in longitudinal and transversal section, any distance was detectable between the ureter and the cervix at the point where the ureter crosses the uterine artery. The primary end point was to determine sensitivity, specificity, and positive and negative predictive values of "ureteral medial deviation" diagnosed using TVS, in order to predict the need for ureterolysis. RESULTS: Our series included 88 women with a median age of 39 (interquartile range 33-43) years. Ureteral medialization showed a relatively low false-positive rate (10.9%), with a specificity of 89.1% (95% confidence interval [CI] 81.4%-96.7%) and a sensitivity of 86.6% (95% CI 80.3%-92.9%), along with a high positive predictive value of 93.3% (95% CI 88.4%-98.1%), and a lower negative predictive value of 79.1% (95% CI 69.8%-88.5%), respectively. CONCLUSIONS: This study introduced a new ultrasound sign with a high degree of accuracy to predict ureterolysis and this may have positive implications in the management and surgical planning of patients with ureteral endometriosis.

Assessment of the safety of long-term bazedoxifene treatment on the reproductive tract in postmenopausal women with osteoporosis: results of a 7-year, randomized, placebo-controlled, phase 3 study.

OBJECTIVE: To evaluate the clinical safety of bazedoxifene (BZA) on the reproductive tract in postmenopausal women with osteoporosis over 7 years. STUDY DESIGN: This was a second, blinded, 2-year extension of a 3-year, randomized, double-blind, placebo (PBO)- and active-controlled phase 3 trial. In the core study, subjects were randomized to receive BZA 20 or 40mg, raloxifene 60mg, or PBO. During years 4-5, the raloxifene arm was discontinued and subjects receiving BZA 40mg were transitioned to BZA 20mg. Subjects continued to receive BZA 20mg or PBO during years 6-7. MAIN OUTCOME MEASURES: The primary endpoint was the incidence of new vertebral fractures at 7 years (reported separately). Reproductive tract safety findings at 7 years are reported here. Endometrial thickness was assessed by transvaginal ultrasonography for subjects in the endometrial safety substudy. Adverse events (AEs) were recorded throughout the study. RESULTS: At 7 years, the adjusted mean (±standard error) change in endometrial thickness was similar with BZA and PBO (-0.11 ± 0.21 and 0.07 ± 0.32 mm, respectively). The incidence of endometrial hyperplasia was low (0.1% for both groups). BZA showed significantly lower rates than PBO of endometrial carcinoma (0.1% vs. 0.4%; P=0.020) and vaginitis (6.1% vs. 7.6%; P=0.035). There were more cases of ovarian carcinoma with BZA (n=4 [0.1%]) than PBO (n=0); the difference was not statistically significant. Rates of breast-related and other gynecologic AEs were similar among groups. CONCLUSIONS: BZA was associated with a favorable reproductive safety profile in postmenopausal women with osteoporosis over 7 years.