Continuous transdermal nitroglycerin therapy for menopausal hot flashes: a single-arm, dose-escalation trial
Huang AJ, Cummings SR, Schembri M, Vittinghoff E, Ganz P, Grady D
Conclusions: Continuous nitroglycerin may substantially and reversibly decrease hot flash frequency and severity. If confirmed in a randomized blinded trial, it may offer a novel nonhormonal hot flash treatment.
PROMISe trial: a pilot, randomized, placebo-controlled trial of magnetic resonance guided focused ultrasound for uterine fibroids
Jacoby VL, Kohi MP, Poder L, Jacoby A, Lager J, Schembri M, Rieke V, Grady D, Vittinghoff E, Coakley FV
Conclusion: Women with fibroids were willing to enroll in a randomized, placebo-controlled trial of MRgFUS. A placebo effect may explain some of the improvement in fibroid-related symptoms observed in the first 12 weeks after MRgFUS.
Bridging the gap: determinants of undiagnosed or untreated urinary incontinence in women
Duralde ER, Walter LC, Van Den Eeden SK, Nakagawa S, Subak LL, Brown JS, Thom DH, Huang AJ
Conclusion: Even in an integrated health care system, lower income was associated with decreased rates of patient-provider discussion of incontinence among women with at least weekly incontinence. Despite being at increased risk of incontinence, diabetic women were also less likely to have discussed incontinence or received care. Findings provide support for systematic screening of women to overcome barriers to evaluation and treatment.
Predictors of impact of vaginal symptoms in postmenopausal women
Hunter MM, Nakagawa S, Van Den Eeden SK, Kuppermann M, Huang AJ
Conclusion: Findings suggest that special efforts should be made to identify and treat vaginal symptoms inpostmenopausal women known to have depression or urinary incontinence, as these women may experience greaterimpact of vaginal symptoms on multiple domains of functioning and quality of life.
Urinary Incontinence Before and After Bariatric Surgery
Subak LL, King WC, Belle SH, Chen JY, Courcoulas AP, Ebel FE, Flum DR, Khandelwal S, Pender JR, Pierson SK, Pories WJ, Steffen KJ, Strain GW, Wolfe BM, Huang AJ
CONCLUSION: Among women and men with severe obesity, bariatric surgerywas associated with substantially reduced urinary incontinence over 3 years. Improvement inurinary incontinence may be an important benefit of bariatric surgery.
Obstacles to Studying Emerging Technologies
LaWaetjen LE, Parvataneni R, Varon S, Saberi NS, Jacoby VL
paroscopic radiofrequency ablation of uterine leiomyomas with a new Federal Drug Administration (FDA)-approved device, a device that delivers radiofrequency energy, is a novel procedure that aims to meet patient and physician demand for effective, minimally invasive leiomyoma treatment. However, as a new procedure, the durability of symptom relief, the safety in widespread use, and ultimately the comparative effectiveness of radiofrequency ablation of leiomyomas need further study. In June 2013, the University of California Fibroid Network, a collaboration of the five University of California Departments of Obstetrics and Gynecology, launched the Uterine Leiomyoma Treatment with Radiofrequency Ablation Study, an investigator-initiated early postmarket approval clinical trial of radiofrequency ablation of leiomyomas. In this commentary, we provide a review of the FDA approval process for medical devices using the device that delivers radiofrequency energy as a case study and describe significant limitations of this process that may adversely affect clinical care. We show how the deficiencies in the FDA process have challenged our ability to conduct independent early postmarket research evaluating the safety and long-term effectiveness of this novel technology. Our experience validates the Institute of Medicine's recommendation that advancements in surgical technology introducing new treatments without long-term effectiveness data, comparative study, or both should emerge onto the market under research conditions. Until the FDA requires more rigorous study of novel devices, we suggest ways of working together as a community of gynecologic surgeons to evaluate promising new technologies in early postmarket studies, putting research before widespread adoption of surgical innovation.