Faculty Bibliography

OBJECTIVE: The purpose of this study was to evaluate a new device that couples any standard transvaginal ultrasound transducer to a special tenaculum by means of a specially designed adaptor that enables real-time ultrasound imaging and guidance of intrauterine surgical procedures. STUDY DESIGN: Forty-five patients who underwent intrauterine surgical interventions were evaluated. Forty of these patients had pregnancy terminations. Three patients had curettage for early pregnancy complications. One patient had a polyp removed, and one patient underwent hysteroscopic submucous myomectomy. Five attending physicians performed 26 procedures. Four residents in training performed 19 procedures. All operators were instructed in the assembly and use of the device before their first procedure. Evaluation of the device was done by means of a detailed questionnaire. RESULTS: The procedures were completed successfully and without complications. The time that was involved for the various components of the surgical procedures was recorded; 83% to 90% of the time the operators felt that the technique increased safety and accuracy for the parameters that were evaluated. They required fewer intrauterine instrument manipulations; in 85% of the cases, they could detect the exact end point of the procedure more accurately. In 12% of cases, the operators felt that the device interfered with the performance of the procedure. CONCLUSIONS: The transvaginal ultrasound-assisted gynecological surgery system provided high-resolution images of the cervical canal and the uterine cavity during all stages of the procedure and provided improved indication of the procedure's end point. The increased safety and accuracy that was reported by most users was encouraging. The transvaginal ultrasound-assisted gynecologic surgery system appears to provide an enhanced alternative to transabdominal ultrasound guidance for intrauterine surgical procedures

OBJECTIVE: In scanning the female pelvis the clear images of transvaginal sonography (TVS) result from placing the transducer close to the region of interest. The advantages of TVS over transabdominal sonography (TAS) and transperineal sonography are well documented. Transrectal scanning is proposed mostly for ultrasound guidance in draining a pelvic abscess. Our aim was to investigate the applicability of transrectal scanning (TRS) for cases in which TVS is impossible. METHODS: Forty-two patients with an absolute or a relative contraindication to TVS were scanned transabdominally and transrectally. The TRS was performed using a transvaginal probe, which was lubricated and slowly advanced into the rectum. The technique used was similar to that of TVS. Images were compared for resolution and quality. RESULTS: All scans were completed without significant patient discomfort or complaints. TRS was clearly superior to TAS in 31 cases. In nine cases TAS furnished some clinical information but TRS yielded better images. Only in one such case was TAS similar in quality to TRS. In four obese patients TAS did not reveal sufficient pelvic anatomy to generate a clinical diagnosis, whereas TRS revealed two sets of normal ovaries and two patients with ovarian cysts. In the two cases with vaginal agenesis TRS revealed the diagnosis of Rokitansky-Kuster syndrome. In three of the four patients with ruptured membranes the cervix could be measured precisely. CONCLUSION: Transrectal scanning should be used liberally after proper patient selection and counseling. The images obtained are superior to TAS and comparable to those obtained by TVS

OBJECTIVE:The aim of this study was to determine the incidence of ovarian cancer in postmenopausal women treated with raloxifene compared with placebo. METHODS:This analysis comprises integrated data from seven randomized, placebo-controlled trials of raloxifene (N = 9837). Ovarian cancer cases were identified from the safety database and reviewed by a gynecologic adjudication review board. RESULTS:Sixteen cases of ovarian cancer were reported: 8 women (79.4/100,000 patient-years) on placebo and 8 (37.4/100,000 patient-years) on pooled raloxifene doses. The relative risk of ovarian cancer associated with raloxifene therapy was 0.50 (95% confidence interval, 0.19-1.35). CONCLUSION/CONCLUSIONS:Raloxifene use was not associated with an increased risk for ovarian cancer.

From the perspective of endometrial safety, there has been great controversy about what special management, if any, tamoxifen-treated patients should undergo. Periodic blind endometrial sampling or transvaginal ultrasound has been advocated by some. Because of the problems associated with either of these techniques alone, we recommended an approach that used transvaginal ultrasound and then proceeded to sonohysterography when the endometrial echo on transvaginal ultrasound was not reliably thin and distinct. The American College of Obstetricians and Gynecologists (ACOG), in its committee opinion, stated that patients receiving tamoxifen therapy should only have an annual pelvic exam with pap smear if they remain asymptomatic. Newer data suggest, however, that there are high- and low-risk groups that can be identified by pretreatment screening. Before tamoxifen therapy, 17% of patients have polyps. These patients have 17 times the incidence of atypical hyperplasia than those whose uterus was negative before tamoxifen therapy. Such findings call into question the validity of the only study of raloxifene where uterine safety was the primary endpoint. In that study, any woman with baseline endometrial findings other than pristinely negative (i.e., low risk) was excluded. However, other raloxifene studies without pretreatment screening show relative risk (RR) = 0.8 (95% CI = 0.2, 2.7) for endometrial carcinoma. This compares with the women over 50 years of age in the Breast Cancer Prevention Trial (National Surgical Adjuvant Breast and Bowel Project P-1) with tamoxifen when the RR = 4.01 (95% CI= 1.70, 10.90). The existence of potentially high- and low-risk groups should be taken into account in any future clinical trials looking at the endometrial safety of selective estrogen receptor modulators (SERMs)

OBJECTIVE: Selective estrogen receptor modulators are novel compounds that bind to the estrogen receptor and have mixed agonistic and antagonistic activities. Recently, an increase in urinary incontinence has been reported with hormone replacement therapy use. A decrease in surgical procedures for pelvic floor relaxation has been recently reported with raloxifene, a selective estrogen receptor modulator that is not uterotropic. Levormeloxifene is a selective estrogen receptor modulator that was developed for the purpose of the treatment and prevention of postmenopausal osteoporosis. STUDY DESIGN: This was a multicentered prospective study of healthy women aged >or=65 years with osteoporosis who were randomized to blindly receive placebo or levormeloxifene 0.5 mg or 1.25 mg daily as part of a planned 3-year osteoporosis treatment study. Multiple medical and gynecologic evaluations were performed. Adverse events were reported to investigators and coded with the use of World Health Organization terminology. This study was halted after 10 months because of the large number of gynecologic and other adverse events. RESULTS: Among 2924 women who were studied, those women who were treated with levormeloxifene had a marked increase compared with placebo in leukorrhea (30% vs 3%), increased endometrial thickness on ultrasound scan (19% vs 1%), enlarged uterus (17% vs 3%), uterovaginal prolapse (7% vs 2%), urinary incontinence (17% vs 4%), increased micturition frequency (9% vs 4%), lower abdominal pain (17% vs 6%), hot flushes (10% vs 3%), and leg cramps (6% vs 0.8%). All of these differences were highly statistically significant with a probability value of.0001 for each. CONCLUSION: Levormeloxifene results in multiple adverse gynecologic and other events in postmenopausal women with osteoporosis

OBJECTIVE: Endometrial polyps are relatively common in all groups of women. More polyps are being diagnosed with the widespread use of transvaginal ultrasound scanning and sonohysterography. The reported incidence of malignancy is low. The potential benefit of a noninvasive technique to distinguish benign from malignant polyps is obvious. This study was undertaken to evaluate endometrial polyps by color flow Doppler ultrasound scanning and histopathologic examination. STUDY DESIGN: This was an observational study of patients with an endometrial polyp on sonohysterography who underwent interrogation of their polyp with color Doppler ultrasound scanning and subsequently polypectomy. Polyp volume, resistive index, pulsatility index, indication for scan (bleeding vs incidental), and patient age were correlated with histopathologic type of the polyp (nonfunctional, proliferative, secretory, hyperplastic, or malignant). RESULTS: Of 61 patients studied, 42 patients (68.9%) were scanned for abnormal bleeding, and 19 patients (31.1%) had their polyps discovered incidentally. There were no statistically significant differences between histologic categories and the resistive index, pulsatility index, or size of the polyp. The age of patients with nonfunctional polyps was significantly greater than any other group (P <.001). Ninety-four percent of the functional polyps were discovered because of abnormal bleeding; 38% of the nonfunctional polyps were discovered incidentally (P <.001). CONCLUSION: The data suggest that the objective assessment of blood flow impedance (resistive index, pulsatility index) in endometrial polyps and the size of these polyps cannot replace surgical removal and pathologic evaluation to predict histologic type. Patients with nonfunctional polyps were older and less likely to have vaginal bleeding