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Steven R Goldstein

Publications and source records attributed to Steven R Goldstein.

16 recordsLinked to original sources
PubMed2006

Abnormal uterine bleeding: the role of ultrasound.

Abnormal uterine bleeding is an important clinical concern and accounts for much medical intervention. This article presents an ultrasound-based approach to help exclude endometrial carcinoma and identify the source of bleeding for better clinical management. Saline infusion sonohysterography can help to triage patients to (1) no anatomic pathology, (2) globally thickened anatomic pathology that may be evaluated with blind endometrial sampling, or (3) focal abnormalities that must be evaluated under direct vision.

Diagnosis, Differential↗
PubMed2005

Incidence of urinary incontinence in postmenopausal women treated with raloxifene or estrogen.

OBJECTIVE: Determine the effect of raloxifene or estrogen, as compared with placebo, on the reporting of urinary incontinence in postmenopausal women participating in an osteoporosis prevention trial. DESIGN: The current analysis is based on adverse event data that were collected as part of a double-blind, randomized, placebo-controlled trial designed to assess the efficacy and safety of raloxifene for osteoporosis prevention in postmenopausal women. Women were 40 to 60 years of age at study entry and had a prior hysterectomy. A total of 619 women were randomized to placebo, raloxifene 60 or 150 mg/d, or conjugated equine estrogen 0.625 mg/d and followed for up to 3 years. Urinary incontinence was self-reported and rated by participants as "mild," "moderate," or "severe." RESULTS: The prevalence of urinary incontinence as reported by patients at baseline was similar across treatment groups (3% to 6%, P = 0.46). During 3 years of follow-up, new or worsening urinary incontinence was reported with the following frequency: placebo (1.3%), raloxifene 60 mg/d (0.7%), raloxifene 150 mg/d (0.6%), and conjugated equine estrogen (7.0%). The percentage of estrogen subjects reporting urinary incontinence was significantly greater than that for placebo and both doses of raloxifene (P < or = 0.02). CONCLUSION: During 3 years of follow-up, conjugated equine estrogen was associated with an increased incidence of reports of urinary incontinence in women with a prior hysterectomy and this was significantly greater than both placebo and raloxifene.

Adult↗
PubMed2004

The endometrial echo revisited: have we created a monster?

Transvaginal ultrasound has been explored as an inexpensive, noninvasive, convenient way to indirectly visualize the endometrial cavity. For more than a decade numerous studies have indicated that a thin, distinct, well-visualized echo (<4-5 mm) in postmenopausal women with bleeding is as effective as any diagnostic modality in excluding endometrial cancer (99% negative predictive value). Unfortunately, this is not the same as saying that a thick endometrial echo is pathologic. In fact, the positive predictive value of an echo greater than 5 mm is less than 10% for any disease and only 4% for serious disease (cancer or hyperplasia). No studies validating the clinical significance of a nonthin endometrial echo observed in an incidental imaging study have ever been performed. Because 5 mm has been a "cutoff" for excluding endometrial cancers in women with bleeding, many clinicians have assumed that any findings greater than 5 mm need endometrial sampling to exclude disease. The number of postmenopausal women with quiescent fibroids, or polyps, or heterogeneous uterine echoes for technical reasons (previous scarring, axial uterus) is unknown but not insignificant. Furthermore, if transvaginal ultrasound is to be used, it must be performed appropriately, further recognizing that in a substantial number of patients it may not be possible to obtain technically adequate endometrial assessment. So, although transvaginal ultrasound can be a reliable method of excluding disease in many postmenopausal women with bleeding, the incidental finding of a non-thin endometrial echo has not been investigated and should not automatically trigger a need for formal tissue sampling.

Dilatation and Curettage↗
PubMed2004

Menorrhagia and abnormal bleeding before the menopause.

Abnormal uterine bleeding before the menopause accounts for 20% of visits to the gynaecology clinic and almost 25% of gynaecological operations. The patient who presents with such bleeding presents two distinct but important challenges for the clinician. The first is the exclusion of cancer or hyperplasia; the second is dealing with the annoyance as well as the fear that the bleeding engenders in the patient. Any attempt at appropriate therapy--whether surgical, hormonal or expectant--begins with an accurate diagnosis. Transvaginal ultrasound with saline infusion sonohysterography for selective patients has emerged as a safe, non-invasive and, inexpensive method of triaging patients with abnormal uterine bleeding in order to determine which patients require no further evaluation, blind endometrial sampling for a global endometrial process or visually directed endometrial sampling when pathology is thought to be focal.

Biopsy↗
PubMed2003

Transvaginal ultrasound-assisted gynecologic surgery: evaluation of a new device to improve safety of intrauterine surgery.

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.

Abortion, Induced↗
PubMed2003

ACOG technology assessment in obstetrics and gynecology. Number 3, September 2003. Saline infusion sonohysterography.

Saline infusion sonohysterography consists of ultrasonographic imaging of the uterus and uterocervical cavity, using real-time ultrasonography during injection of sterile saline into the uterus. When properly performed, saline infusion sonohysterography can provide information about the uterus and endometrium. The most common indication for sonohysterography is abnormal uterine bleeding. Sonohysterography should not be performed in a woman who is pregnant or who could be pregnant or in a woman with a pelvic infection or unexplained pelvic tenderness. Physicians who perform or supervise diagnostic saline infusion sonohysterography should have training, experience, and demonstrated competence in gynecologic ultrasonography and saline infusion sonohysterography. Portions of this document were developed jointly with the American College of Radiology and the American Institute of Ultrasound in Medicine.

Endosonography↗
PubMed2002

The effect of raloxifene on the incidence of ovarian cancer in postmenopausal women.

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: Raloxifene use was not associated with an increased risk for ovarian cancer.

Aged↗
PubMed2002

Evaluation of endometrial polyps.

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.

Adult↗
PubMed2002

Adverse events that are associated with the selective estrogen receptor modulator levormeloxifene in an aborted phase III osteoporosis treatment study.

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.

Abdominal Pain↗
PubMedDate not supplied

Controversy about uterine effects and safety of SERMs: the saga continues.

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).

Endometrial Neoplasms↗
PubMedDate not supplied

The case for less-than-monthly progestogen in women on HT: is transvaginal ultrasound the key?

Unopposed estrogen (previously called ERT, now referred to as ET) increases a patient's risk of endometrial cancer. The addition of a progestogen to estrogen (previously called HRT, now referred to as HT) will decrease that additional risk of endometrial cancer although it will not eliminate it. Initially this was always done in a sequential fashion. More recently, continuous-combined HT, utilizing daily progestogen, has been popularized. Increasingly, published data points to progestogen and estrogen together causing an increase in the risk of breast cancer two to three times above that of estrogen alone. In the past, less-than-monthly progestogen has been attempted. It results in less bleeding, as well as some simple hyperplasia. Transvaginal ultrasound has a very poor positive predictive value (4% for serious endometrial disease and 9% for any endometrial disease) but a very high negative predictive value (99%) when the echo is distinct, and thin (<5 mm). Thus, patients with an initial thin distinct endometrial echo can begin with unopposed estrogen. At 3 months, they get a progestogen withdrawal of 12 days and the endometrial echo is measured again. If thin and distinct (<5 mm), the interval between progestogen withdrawals can be further increased and in some women potentially eliminated. If the echo is not sufficiently thin, although this does not necessarily indicate anything more than proliferative endometrium, those patients may require either monthly progestogen or continuous-combined HT. The advantage for the successful patient is less progestogen exposure, as little as 24 days per year in most patients, and less bleeding (although because the majority will bleed, the patient has to be willing to accept a withdrawal bleed that she has planned and can control the timing of by when she chooses to take the progestogen). The patient should have an easily visible thin endometrial echo before initiation. Some women will not lend themselves to a reliable assessment of the endometrial echo (at least not without saline infusion enhancement). Examples of such patients are those with an axial uterus, coexisting fibroids, marked obesity, and previous endometrial ablation. Such an approach will allow a large number of patients whose initial endometrial echo is easily visualized to minimize their progestogen dose.

Breast Neoplasms↗