Try a new search

Format these results:

Searched for:

in-biosketch:true

person:goldss01

Total Results:

198


Patient Satisfaction with the Use of Relizen to Treat Menopausal Symptoms [Meeting Abstract]

Goldstein, Steven R.; Veledar, Emir; Ojalvo, Sara Perez; Komorowski, James R.
ISI:000423298900119
ISSN: 1072-3714
CID: 2943652

Evaluation of postmenopausal bleeding: What is the standard of care? [Meeting Abstract]

Goldstein, S R
Cancer of the endometrium (EM) is the most common type of gynecologic cancer in the United States. In 2017, an estimated 60,050 cases of this cancer will occur with an estimated 10,470 deaths. Vaginal bleeding is the presenting sign in more than 90% of postmenopausal (PM) patients with EM carcinoma. The majority of patients with postmenopausal vaginal bleeding (PMB) experience bleeding secondary to atrophic changes of the vagina or endometrium. However, depending on age and risk factors 1-14% will have EM cancer. Thus the clinical approach to PMB requires prompt and efficient evaluation to exclude or diagnose carcinoma. SHORTCOMINGS OF BLIND ENDOMETRIAL SAMPLING In 1991, after a single study by Stovall et al in women with known carcinoma reported 97.5% accuracy, blind EM sampling became the standard approach to patients with PMB. This was widely publicized, marketed and promoted and was rapidly accepted as, "standard of care." In a similar study, however, Guido et al performed blind EM sampling in 65 patients with known carcinoma in the operating room just prior to their hysterectomy. They missed 11/65 cancers (sensitivity only 83%) but, upon opening all those uteri, they reported that when the cancers occupied 50% or more of the EMsurface the biopsy was 100% accurate. Similar studies in women with known carcinomas yielded false negative rates of 16% and 32%, respectively. As a result, in 2012, ACOG, in its Practice Bulletin, acknowledged the primary role of EM sampling in such patients is to determine if carcinoma or premalignant lesions are present. The bulletin goes on to state that, "EM biopsy has high overall accuracy in diagnosing EM cancer when an adequate specimen is obtained and when the EM process is global. If the cancer occupies less than 50% of the surface area of EM cavity the cancer can be missed by blind individual biopsy. Therefore, these tests are only an endpoint when they reveal cancer or a typical complex hyperplasia." This has tremendous ramifications for clinical practice. Certainly, healthcare providers, especially in low resource areas, can begin the evaluation with a blind biopsy but if the results do not indicate cancer or atypical hyperplasia the evaluation is not complete, especially if bleeding persists. Thus, the concept of distinguishing global from focal pathologies is becoming increasingly understood and important. Transvaginal ultrasonography (TV U/S) has been explored as an alternative technique to indirectly visualize the EM. The earliest reports comparing TV U/S measurement of EM thickness in women with PMB with EM sampling consistently found that an EM thickness of less than or equal to 4-5mm in these patients reliably excluded EM cancer. Since that time a number of confirmatory multicenter trials have been completed. Because TV U/S in patients with PMB has an extremely high negative predictive value, it is a reasonable first approach to such patients. It is not possible to complete a meaningful TV U/S examination with a reliable measurement of EM thickness in all patients. An axial uterus, obesity, coexisting myomas, adenomyosis, or previous uterine surgery can contribute to difficulty in obtaining reliable TV U/S assessment of EM thickness and texture. Failure to adequately identify a thin, distinct EM thickness in a PM woman with bleeding should trigger some alternative method of evaluation, like saline infusion sonohysterography (SIS) or hysteroscopy, preferably in an office setting. Since there has been widespread use of TV U/S to exclude pathology in PM women with bleeding, some clinicians have inappropriately extrapolated this information to assume that a thick echo discovered incidentally is abnormal and requires investigation. Data indicates that 13% of asymptomatic PM women will have an endometrial polyp. In a large multicenter trial in which 1152 polyps in non-bleeding PM women were removed only 1 contained a cancer, yet the serious complication rate from such removals is reported as 3.6%Thus, an EM measurement greater than 4mm incidentally discovered in a PM patient without bleeding need not routinely trigger evaluation, although, an individualized assessment based on patient characteristics and risk factors is appropriate
EMBASE:620232211
ISSN: 1530-0374
CID: 2930372

Effects of TX-001HR on uterine bleeding rates in menopausal women with vasomotor symptoms [Meeting Abstract]

Goldstein, S R; Constantine, G; Archer, D F; Pickar, J H; Graham, S; Bernick, B; Mirkin, S
Objective: Uterine bleeding can be associated with endometrial pathology. Case reports1-3 and a North American Menopause Society survey (n=1064)4 suggest a potential increase in uterine bleeding and endometrial cancer with compounded bio-identical hormone therapy (CBHT). TX- 001HR (TherapeuticsMD, Boca Raton, FL) is an investigational, single, oral softgel capsule of combined 17b-estradiol/progesterone (E2/ P4; sometimes referred to as bio-identical hormones) currently being developed to treat vasomotor symptoms (VMS), while protecting the endometrium, in menopausal women. The objective of this analysis was to evaluate uterine bleeding in the REPLENISH trial with TX-001HR vs placebo. Design: Menopausal women (40-65 years) with VMS and an intact uterus were enrolled in REPLENISH (NCT01942668), a phase 3, randomized, doubleblind, placebo-controlled, multicenter trial. Women with moderate-tosevere hot flushes (-7/day or -50/week) were in the VMS substudy and randomized 1:1:1:1:1 to daily E2/P4 of 1.0 mg/100 mg, 0.5 mg/100 mg, 0.5mg/50 mg, 0.25mg/50 mg or placebo; all other women were randomized 1:1:1:1 to E2/P4 only for assessing endometrial safety. All women completed daily bleeding (requiring sanitary protection) and spotting (not requiring sanitary protection) diaries up to month 12. Bleeding profiles, including cumulative amenorrhea (no bleeding or spotting) were assessed over thirteen 28-day cycles in women who took -1 treatment capsule. Results: Women (n=1835) were randomized to daily E2/P4 of 1.0 mg/ 100 mg (n=415), 0.5 mg/100 mg (n=424), 0.5mg/50 mg (n=421), 0.25mg/50mg (n=424) or placebo (n=151). Cumulative amenorrhea from cycle 1 to 13 was high with TX-001HR (56-73%), but lower than with placebo (81%; Fig 1A), and increased over time. Women with no bleeding was high (74-90%) with TX-001HR (Fig 1B). Few vaginal bleeding adverse events (1.0-4.6% TX-001HR vs 0.7% placebo) were reported and discontinuation due to bleeding was low (<1.5%). Conclusion: TX-001HR was associated with high amenorrhea rates and adequate endometrial protection in menopausal women with VMS and an intact uterus. Uterine bleeding and spotting improved over time; the potential for bleeding and abnormal pathology may be largely avoided with adequate doses of progesterone as studied with TX-001HR. TX-001HR, if approved, may provide the first oral combination of estradiol/progesterone for the treatment of VMS in menopausal womenwith an intact uterus, including themillions using unapproved and inadequately studied CBHT
EMBASE:620232469
ISSN: 1530-0374
CID: 2930352

Abnormal uterine bleeding in perimenopause

Goldstein, S R; Lumsden, M A
Abnormal uterine bleeding is one of the commonest presenting complaints encountered in a gynecologist's office or primary-care setting. The wider availability of diagnostic tools has allowed prompt diagnosis and treatment of an increasing number of menstrual disorders in an office setting. This White Paper reviews the advantages and disadvantages of transvaginal ultrasound, blind endometrial sampling and diagnostic hysteroscopy. Once a proper diagnosis has been established, appropriate therapy may be embarked upon. Fortunately, only a minority of such patients will have premalignant or malignant disease. When bleeding is sufficient to cause severe anemia or even hypovolemia, prompt intervention is called for. In most of the cases, however, the abnormal uterine bleeding will be disquieting to the patient and significantly affect her 'quality of life'. Sometimes, reassurance and expectant management will be sufficient in such patients. Overall, however, in cases of benign disease, some intervention will be required. The use of oral contraceptive pills especially those with a short hormone-free interval, the insertion of the levonorgestrel intrauterine system, the incorporation of newer medical therapies including antifibrinolytic drugs and selective progesterone receptor modulators and minimally invasive treatments have made outpatient therapy increasingly effective. For others, operative hysteroscopy and endometrial ablation are proven therapeutic tools to provide both long- and short-term relief of abnormal uterine bleeding, thus avoiding, or deferring, hysterectomy.
PMID: 28780893
ISSN: 1473-0804
CID: 2664002

Transcutaneous Nerve Stimulation for Pain Relief During Office Hysteroscopy: A Randomized Controlled Trial

Goldstein, Steven R
PMID: 28538485
ISSN: 1873-233x
CID: 2574842

First International Consensus Report on Adnexal Masses: Management Recommendations

Glanc, Phyllis; Benacerraf, Beryl; Bourne, Tom; Brown, Douglas; Coleman, Beverly G; Crum, Christopher; Dodge, Jason; Levine, Deborah; Pavlik, Edward; Timmerman, Dirk; Ueland, Frederick R; Wolfman, Wendy; Goldstein, Steven R
The First International Consensus Conference on Adnexal Masses was convened to thoroughly examine the state of the science and to formulate recommendations for clinical assessment and management. The panel included representatives of societies in the fields of gynecology, gynecologic oncology, radiology, and pathology and clinicians from Europe, Canada, and the United States. In the United States, there are approximately 9.1 surgeries per malignancy compared to the European International Ovarian Tumor Analysis center trials, with only 2.3 (oncology centers) and 5.9 (other centers) reported surgeries per malignancy, suggesting that there is room to improve our preoperative assessments. The American College of Obstetricians and Gynecologists Practice Bulletin on "Management of Adnexal Masses," reaffirmed in 2015 (Obstet Gynecol 2007; 110:201-214), still states, "With the exception of simple cysts on a transvaginal ultrasound finding, most pelvic masses in postmenopausal women will require surgical intervention." The panel concluded that patients would benefit not only from a more conservative approach to many benign adnexal masses but also from optimization of physician referral patterns to a gynecologic oncologist in cases of suspected ovarian malignancies. A number of next-step options were offered to aid in management of cases with sonographically indeterminate adnexal masses. This process would provide an opportunity to improve risk stratification for indeterminate masses via the provision of alternatives, including but not limited to evidence-based risk-assessment algorithms and referral to an "expert sonologist" or to a gynecologic oncologist. The panel believed that these efforts to improve clinical management and preoperative triage patterns would ultimately improve patient care.
PMID: 28266033
ISSN: 1550-9613
CID: 2477012

Transvaginal Ultrasound for the Diagnosis of Abnormal Uterine Bleeding

Wheeler, Karen C; Goldstein, Steven R
Transvaginal ultrasound is the first-line imaging test for the evaluation of abnormal uterine bleeding in both premenopausal and postmenopausal women. Transvaginal ultrasound can be used to diagnose structural causes of abnormal bleeding such as polyps, adenomyosis, leiomyomas, hyperplasia, and malignancy, and can also be beneficial in making the diagnosis of ovulatory dysfunction. Traditional 2-dimensional imaging is often enhanced by the addition of 3-dimension imaging with coronal reconstruction and saline infusion sonohysterography. In this article we discuss specific ultrasound findings and technical considerations useful in the diagnosis of abnormal uterine bleeding.
PMID: 28005589
ISSN: 1532-5520
CID: 2374422

Treatment of Symptomatic Uterine Fibroids with Ulipristal Acetate: Endometrial Safety [Meeting Abstract]

Catherino, William; Eisenhut, Carol; Blakesley, Rick; Chan, Anna; Sniukiene, Vilma; Goldstein, Steven
ISI:000393724401397
ISSN: 1530-0307
CID: 2506782

Treatment of Symptomatic Uterine Fibroids with Ulipristal Acetate: Endometrial Safety [Meeting Abstract]

Catherino, William; Eisenhut, Carol; Blakesley, Rick; Chan, Anna; Sniukiene, Vilma; Goldstein, Steven
ISI:000394467301397
ISSN: 1530-0285
CID: 2517602

Development and Validation of an Algorithm to Identify Endometrial Hyperplasia in US Administrative Claims Data [Meeting Abstract]

Esposito, Daina B; Yin, Ruihua; Russo, Leo J; Ridgeway, Gregory; Finkle, William J; Goldstein, Steven R; Mittal, Khushbakhat; Walsh, Brian W; Lanes, Stephan F
ISI:000385483501266
ISSN: 1099-1557
CID: 2386342