A Randomized Controlled Multicenter US Food and Drug Administration Trial of the Safety and Efficacy of the Minerva Endometrial Ablation System: One-Year Follow-Up Results.

STUDY OBJECTIVE: To assess the safety and effectiveness of the Minerva Endometrial Ablation System for the treatment of heavy menstrual bleeding in premenopausal women. DESIGN: Multicenter, randomized, controlled, international study (Canadian Task Force classification I). SETTING: Thirteen academic and private medical centers. PATIENTS: Premenopausal women (n = 153) suffering from heavy menstrual bleeding (PALM-COEIN: E, O). INTERVENTION: Patients were treated using the Minerva Endometrial Ablation System or rollerball ablation. MEASUREMENTS AND MAIN RESULTS: At 1-year post-treatment, study success (alkaline hematin ≤80 mL) was observed in 93.1% of Minerva subjects and 80.4% of rollerball subjects with amenorrhea reported by 71.6% and 49% of subjects, respectively. The mean procedure times were 3.1 minutes for Minerva and 17.2 minutes for rollerball. There were no intraoperative adverse events and/or complications reported. CONCLUSION: The results of this multicenter randomized controlled trial demonstrate that at the 12-month follow-up, the Minerva procedure produces statistically significantly higher rates of success, amenorrhea, and patient satisfaction as well as a shorter procedure time when compared with the historic criterion standard of rollerball ablation. Safety results were excellent and similar for both procedures.

Ten-year literature review of global endometrial ablation with the NovaSure® device.

This review examines the peer-reviewed literature describing prospective studies that report amenorrhea rates, patient satisfaction, and surgical reintervention rates following the NovaSure® endometrial ablation procedure. A search of the English-language literature published from 2000 to 2011 was conducted using PubMed. Ten prospective studies, six single-arm NovaSure trials, and four randomized controlled trials comparing the NovaSure procedure with other global endometrial ablation modalities met the inclusion criteria and were reviewed. The follow-up periods ranged from 6 to 60 months. Amenorrhea rates for the NovaSure procedure ranged from 30.0% to 75.0%. Patients who reported being satisfied with the NovaSure procedure ranged from 85.0% to 94.0%. In randomized controlled trials with other global endometrial ablation modalities, amenorrhea rates at 12 months with the NovaSure procedure ranged from 43.0% to 56.0%, while other modalities ranged from 8% to 24%. In addition, this manuscript reviews the following: the NovaSure technology; use of the NovaSure procedure in the office setting; intraoperative and postoperative pain; effects on premenstrual syndrome (PMS); dysmenorrhea; special circumstances, including presence of uterine disease, history of cesarean delivery, coagulopathy, or use of anticoagulant medication; post-procedure uterine cavity assessment and cancer risk; contraception and pregnancy; and safety.

Direct injection of vasopressin during hysteroscopic myomectomy: a case report.

BACKGROUND: Hysteroscopic myomectomy is the ideal procedure for symptomatic women with submucosalfibroids who desire to preserve their fertility. Vascular myomas can limit visualization when a mechanical morcellator is used. Injection of a dilute vasopressin solution has been shown to decrease blood loss during laparoscopic myomectomy. To date, direct injection of a dilute vasopressin during hysteroscopic myomectomy has not been described. CASE: Our first patient's hysteroscopic myomectomy of a vascular submucosal myoma had to be terminated before complete resection due to impaired visualization and maximum fluid overload. During a subsequent patient's procedure, direct injection ofa dilute vasopressin through the operative port decreased intraoperaftve bleeding and enabled complete resection. CONCLUSION: Injecting a dilute vasopressin solution directly into a vascular submucosal myoma during hysteroscopic resection can assist with hemostasis and visualization, enabling complete resection.

Postmenopausal bleeding due to a Cu-7 intrauterine device retained for thirty years.

BACKGROUND: A retained intrauterine device is a rare, but easily correctable, cause of postmenopausal bleeding (PMB). CASE: A 64-year-old woman presented to her gynecologist with PMB. Sonographic evaluation of the endometrium revealed the presence of a Cu-7 IUD retained for at least 30 years. Hysteroscopically assisted retrieval of the IUD resulted in complete resolution of symptoms. CONCLUSION: A retained IUD should be considered in the differential diagnosis for PMB. In addition, the authors recommend pelvic sonography as the first-line diagnostic modality for PMB to aid the diagnosis of retained IUD as well as other pathology.

Unilateral placement of the Adiana device after failed bilateral placement of the Essure device for hysteroscopic sterilization.

This case report outlines the successful completion of hysteroscopic sterilization using the Adiana Permanent Contraception device (Hologic, Inc., Bedford, MA) after failure of multiple attempts to bilaterally place the Essure Permanent Birth Control system (Conceptus Inc., Mountain View, CA). The patient desired hysteroscopic sterilization using the Essure system. Although the first coil was easily placed in the right ostium, the second coil could not be passed beyond 2.4 cm into the left ostium. Inasmuch as the Adiana system needs to be passed only 1.4 cm into the ostium, this was found to be adequate for appropriate placement of the implant. Adiana may be an effective alternative to Essure, especially in patients in whom tubal stricture or spasm prevents Essure placement.

Summary of safety and effectiveness data from FDA: a valuable source of information on the performance of global endometrial ablation devices.

OBJECTIVE: To provide an overview of the approved second-generation endometrial ablation technologies. STUDY DESIGN: Data from the FDA Summary of Safety and Effectiveness Data were compared for Thermachoice, HydroThermablator, Her Option and Novasure devices. RESULTS: At 12 months' follow-up, Novasure and HydroThermablator had the highest amenorrhea rates. Thermochoice and Novasure had the highest success rates at 12 months. Novasure had the lowest adverse event rates in the first 24 hours, between 24 hours and 2 weeks and between 2 weeks and 1 year of follow-up. CONCLUSION: Summary of Safety and Effectiveness Data, obtainable on the FDA Web site, offers objective data for comparing second-generation endometrial ablation technologies.

A randomized, multicenter trial of safety and efficacy of the NovaSure system in the treatment of menorrhagia.

STUDY OBJECTIVE: To compare the safety and effectiveness of the NovaSure impedance-controlled endometrial ablation system with hysteroscopic wire loop resection plus rollerball ablation for treatment of excessive uterine bleeding in premenopausal women. DESIGN: Randomized, multicenter, double-arm study (Canadian Task Force classification I). SETTING: Nine academic medical centers and private offices. PATIENTS: Two hundred sixty-five premenopausal women with symptomatic menorrhagia. INTERVENTION: Ablation performed with the NovaSure system or wire loop resection and rollerball. MEASUREMENTS AND MAIN RESULTS: Success [pictorial blood loss-assessment chart (PBLAC) score < or =75] was achieved in 88.3% of NovaSure-treated and 81.7% of rollerball-treated patients. One year after treatment 90.9% and 87.8%, respectively, reported normal bleeding or less (PBLAC < or =100) and 41% and 35%, respectively, experienced amenorrhea (PBLAC = 0). Mean procedure time was 4.2 minutes (average 84 sec) in the NovaSure group and 24.2 minutes in the rollerball group. Local and/or intravenous sedation was administered in 73% of NovaSure patients and 18% of rollerball patients. Intraoperative adverse events occurred less frequently with NovaSure (0.6%) than with rollerball (6.7%). Postoperative adverse events occurred in 13% and 25.3% of patients, respectively. CONCLUSION: The NovaSure system was safe and effective in treatment of women with menorrhagia. The procedure is both quick and effective, and eliminates the expense and side effects of endometrial pretreatment.