Reproducibility of dynamic MR imaging pelvic measurements: a multi-institutional study.

PURPOSE: To assess the reproducibility of bone and soft-tissue pelvimetry measurements obtained from dynamic magnetic resonance (MR) imaging studies in primiparous women across multiple centers. MATERIALS AND METHODS: All subjects prospectively gave consent for participation in this institutional review board-approved, HIPAA-compliant study. At six clinical sites, standardized dynamic pelvic 1.5-T multiplanar T2-weighted MR imaging was performed in three groups of primiparous women at 6-12 months after birth: Group 1, vaginal delivery with anal sphincter tear (n = 93); group 2, vaginal delivery without anal sphincter tear (n = 79); and group 3, cesarean delivery without labor (n = 26). After standardized central training, blinded readers at separate clinical sites and a blinded expert central reader measured nine bone and 10 soft-tissue pelvimetry parameters. Subsequently, three readers underwent additional standardized training, and reread 20 MR imaging studies. Measurement variability was assessed by using intraclass correlation for agreement between the clinical site and central readers. Acceptable agreement was defined as an intraclass correlation coefficient (ICC) of at least 0.7. RESULTS: There was acceptable agreement (ICC range, 0.71-0.93) for eight of 19 MR imaging parameters at initial readings of 198 subjects. The remaining parameters had an ICC range of 0.13-0.66. Additional training reduced measurement variability: Twelve of 19 parameters had acceptable agreement (ICC range, 0.70-0.92). Correlations were greater for bone (ICC, >or=0.70 in five [initial readings] and eight of nine [rereadings] variables) than for soft-tissue measurements (ICC, >or=0.70 in three [initial readings] of 10 and four [rereadings] of 10 readings, respectively). CONCLUSION: Despite standardized central training, there is high variability of pelvic MR imaging measurements among readers, particularly for soft-tissue structures. Although slightly improved with additional training, measurement variability adversely affects the utility of many MR imaging measurements for multicenter pelvic floor disorder research.

Randomized trial of medroxyprogesterone acetate for the prevention of endometrial pathology from adjuvant tamoxifen for breast cancer: SWOG S9630.

The proliferative effect of adjuvant tamoxifen on the endometrium can potentially result in endometrial abnormalities, including cancer in postmenopausal women. We conducted a randomized, controlled trial to assess endometrial pathological diagnoses in postmenopausal women with early stage, ER-positive breast cancer without endometrial pathology at baseline. They were assigned to tamoxifen alone versus tamoxifen plus cyclical medroxyprogesterone acetate (MPA 10 mg for 14 days every 3 months) for 5 years. Endovaginal sonograms (EVS) +/- endometrial biopsies (EMB) were required at baseline, 2 and 5 years. Of 313 patients registered, 296 were eligible and 169 (57%; 89, tamoxifen; 80, tamoxifen+MPA) were evaluable (completed year-2 EVS, with an EMB if stripe width was ⩾5 mm). Sixty (67%) of these in the tamoxifen arm had an endometrial stripe width ⩾5 mm (and underwent subsequent EMB) compared with 48 (60%) in the tamoxifen+MPA arm (P=0.40). There were four cases of proliferative endometrium and one simple hyperplasia on the tamoxifen arm (6% (95% confidence interval (CI): 2-13%) among evaluable patients and one proliferative endometrium on the tamoxifen+MPA arm (P=0.11). The overall fraction with benign endometrial abnormalities at year 2 was 3.6% (6/169; 95% CI: 1.3-7.6%), with only 1 (of 102) new benign proliferative event at year 5. The event rate in both arms was much lower than projected, making treatment arm comparisons less informative. A normal endometrium prior to tamoxifen may provide reassurance regarding future endometrial events. However, validation in a larger trial is needed before changing practice in asymptomatic, postmenopausal women.

Measurements from image-based three dimensional pelvic floor reconstruction: a study of inter- and intraobserver reliability.

PURPOSE: To describe inter- and intraobserver reliability of 3D measurements of female pelvic floor structures. MATERIALS AND METHODS: Twenty reconstructed MR datasets of primiparas at 6-12 months postpartum were analyzed. Pelvic organ measurements were independently made twice by three radiologists blinded to dataset order. A "within-reader" analysis, a "between-reader" analysis, and the intraclass correlation (ICC), and standard deviation ratio (SDR) were computed for each parameter. Fifteen continuous variables and one categorical variable were measured. RESULTS: Eight continuous parameters showed excellent agreement (ICC >0.85 / SDR <0.40), five parameters showed relatively good agreement (ICC >0.70 / SDR >or=0.40, <0.60). Two parameters showed poor agreement (ICC or=0.60). The categorical variable showed poor agreement. CONCLUSION: Agreement was best where landmark edges were well defined, acceptable where more "reader judgment" was needed, and poor where levator defects made landmarks difficult to identify. Automated measurement algorithms are under study and may improve agreement in the future.

Magnetic resonance assessment of pelvic anatomy and pelvic floor disorders after childbirth.

To compare pelvic anatomy, using magnetic resonance imaging, between postpartum women with or without pelvic floor disorders. We measured postpartum bony and soft tissue pelvic dimensions in 246 primiparas, 6-12-months postpartum. Anatomy was compared between women with and without urinary or fecal incontinence, or pelvic organ prolapse; P < 0.01 was considered statistically significant. A deeper sacral hollow was significantly associated with fecal incontinence (P = 0.005). Urinary incontinence was marginally associated with a wider intertuberous diameter (P = 0.017) and pelvic arch (P = 0.017). There were no significant differences in pelvimetry measures between women with and without prolapse (e.g., vaginal or cervical descent to or beyond the hymen). We did not detect meaningful differences in soft tissue dimensions for women with and without these pelvic floor disorders. Dimensions of the bony pelvis do not differ substantially between primiparous women with and without postpartum urinary incontinence, fecal incontinence and prolapse.