Hysteroscopic Sterilization Device Follow-Up Rate: Hysterosalpingogram Versus Transvaginal Ultrasound.

STUDY OBJECTIVE: To assess if follow-up confirmation testing 3 months after hysteroscopic sterilization with the Essure device (Bayer HealthCare Pharmaceuticals, Inc., Whippany, NJ) improved with recommendation for transvaginal ultrasound (TVUS) versus hysterosalpingogram (HSG). DESIGN: Retrospective, observational case-controlled cohort study (Canadian Task Force classification II-2). SETTING: Two-physician private practice in Evansville, Indiana. PATIENTS: Compliance rates for a TVUS confirmation test on 100 women who underwent hysteroscopic sterilization compared with a previously published cohort of 1004 women who were scheduled to undergo an HSG confirmation test. INTERVENTION: Acquisition of 3-month confirmation testing after Essure hysteroscopic sterilization. MEASUREMENT AND MAIN RESULTS: All women who underwent Essure hysteroscopic sterilization with recommendation for TVUS confirmation testing between July 2015 and January 2017 were compared with a previously published cohort of 1004 patients with recommendation for HSG confirmation testing (HSG cohort). In addition, an HSG subgroup cohort (HSG subgroup) similar in size and closest chronology to the TVUS cohort was drawn from the original 1004 patients and analyzed for HSG follow-up. Records for all patients were reviewed for demographic, procedural, and confirmation testing and outcome data. One hundred patients were identified with successful Essure device placement and a recommendation for TVUS confirmation testing. Eighty-eight patients (88.0%) returned for TVUS at 3 months. In the HSG cohort 1004 successful Essure devices were placed, and 778 patients returned for the recommended HSG follow-up (77.5%). There was a significantly higher follow-up rate for TVUS compared with the HSG cohort (88.0% vs 77.5%, p = .008). In the HSG subgroup 184 patients were identified, and 133 patients presented for HSG follow-up (72.3%), indicating a significantly higher follow-up rate in the TVUS cohort (88.0% vs 72.3%, p = .001). No pregnancies after any confirmation testing were noted. CONCLUSION: Confirmation testing with TVUS rather than HSG 3 months after Essure device placement results in increased patient compliance that may lead to improved patient outcomes with reduction of unintended pregnancy.

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.

Cost effectiveness of endometrial ablation with the NovaSure(®) system versus other global ablation modalities and hysterectomy for treatment of abnormal uterine bleeding: US commercial and Medicaid payer perspectives.

OBJECTIVES: Abnormal uterine bleeding (AUB) interferes with physical, emotional, and social well-being, impacting the quality of life of more than 10 million women in the USA. Hysterectomy, the most common surgical treatment of AUB, has significant morbidity, low mortality, long recovery, and high associated health care costs. Global endometrial ablation (GEA) provides a surgical alternative with reduced morbidity, cost, and recovery time. The NovaSure(®) system utilizes unique radiofrequency impedance-based GEA technology. This study evaluated cost effectiveness of AUB treatment with NovaSure ablation versus other GEA modalities and versus hysterectomy from the US commercial and Medicaid payer perspectives. METHODS: A health state transition (semi-Markov) model was developed using epidemiologic, clinical, and economic data from commercial and Medicaid claims database analyses, supplemented by published literature. Three hypothetical cohorts of women receiving AUB interventions were simulated over 1-, 3-, and 5-year horizons to evaluate clinical and economic outcomes for NovaSure, other GEA modalities, and hysterectomy. RESULTS: Model analyses show lower costs for NovaSure-treated patients than for those treated with other GEA modalities or hysterectomy over all time frames under commercial payer and Medicaid perspectives. By Year 3, cost savings versus other GEA were $930 (commercial) and $3,000 (Medicaid); cost savings versus hysterectomy were $6,500 (commercial) and $8,900 (Medicaid). Coinciding with a 43%-71% reduction in need for re-ablation, there were 69%-88% fewer intervention/reintervention complications for NovaSure-treated patients versus other GEA modalities, and 82%-91% fewer versus hysterectomy. Furthermore, NovaSure-treated patients had fewer days of work absence and short-term disability. Cost-effectiveness metrics showed NovaSure treatment as economically dominant over other GEA modalities in all circumstances. With few exceptions, similar results were shown for NovaSure treatment versus hysterectomy. CONCLUSION: Model results demonstrate strong financial favorability for NovaSure ablation versus other GEA modalities and hysterectomy from commercial and Medicaid payer perspectives. Results will interest clinicians, health care payers, and self-insured employers striving for cost-effective AUB treatments.

Safety and Effectiveness of NovaSure® Endometrial Ablation After Placement of Essure® Micro-Inserts.

Objective: In-office NovaSure® after Essure® is a clinical paradigm for which physicians are seeking information. A PubMed search (July 2011) revealed no peer-reviewed articles describing this treatment sequence. To address the paucity of data on this topic, patients who had undergone Essure followed by NovaSure in a private practice office between July 1, 2008 and December 31, 2009 were evaluated. The objective was to evaluate safety and feasibility of in-office NovaSure after Essure, and to determine if the effectiveness of either procedure was altered by this treatment sequence. Design: This was a retrospective cohort study of 117 women (ages 24-52). Methods: Patients underwent Essure followed by NovaSure in two in-office sessions, separated by a median of 14 days. All patients had menorrhagia and desired permanent sterilization. A postprocedure patient questionnaire was administered to assess satisfaction and perceived effectiveness. Results: Among patients who underwent Essure followed by NovaSure, 83/117 (71%) returned for a 3-month hysterosalpingogram (HSG). Satisfactory placement and tubal occlusion were noted in 79/83 (95%) of these patients. Amenorrhea or spotting was observed in 72/97 (74%) of patients, 22/97 (23%) reported a satisfactory decrease in menstrual flow, and 3/97 (3%) reported ablation failure. Essure followed by NovaSure did not decrease the effectiveness of either procedure, and no adverse events were attributed to the combination of the two procedures. Patients reported high levels of satisfaction with both procedures. Conclusions: In women seeking permanent birth control and menorrhagia reduction, in-office Essure followed by NovaSure appeared to be safe, effective, and associated with high patient satisfaction. (J GYNECOL SURG 28:1).

A review of clinical data for currently approved hysteroscopic sterilization procedures.

TWO HYSTEROSCOPIC PERMANENT STERILIZATION PROCEDURES ARE APPROVED FOR USE IN THE UNITED STATES: Essure® Permanent Birth Control System (Conceptus Incorporated, Mountain View, CA) and Adiana® Permanent Contraception (Hologic, Inc., Bedford, MA). This review compares the clinical trial data for these procedures. A notable difference is the resultant clinical pregnancy risk. The clinical trials for the Essure procedure have reported no pregnancies in 643 relying women in the 9 years since initiation of the studies. The clinical trial for the Adiana procedure has reported 12 pregnancies in 570 relying women in nearly 5 years of collected data. Other clinical outcome parameters concerning Essure and Adiana are examined in this review.

Bladder-anal reflex.

AIMS: The purposes of this study were to evaluate the bladder-anal reflex (BAR) latency in asymptomatic women and determine the pathway of the reflex using selective anesthesia and neuromuscular block. METHODS: Urinary incontinence, voiding dysfunction, and pelvic organ prolapse are common problems in women. Evaluation of pelvic nerve function often augments the clinical assessment of these women. Urethral-anal and clitoral-anal reflex testing have been reported as methodologies to assess patients with neurogenic disorders. A bladder-anal reflex is also obtainable but has not been reported previously in the literature. Twenty-two subjects and two patients were recruited for evaluation of the BAR. RESULTS: This study has allowed us to estimate reference ranges for BAR latency and threshold. We defined the upper limit of these reference ranges as two standard deviations above their respective means. For the BAR latency, the upper limit of the reference range is 91 msec. Any latency value above this limit should be considered abnormal. The upper limit for the BAR threshold reference range is 37.7 mA. Lower thresholds are not thought to be clinically meaningful due to the presence of several low sensory thresholds in this asymptomatic normal population. CONCLUSIONS: The BAR was obtainable in asymptomatic women and compatible with known anatomy and innervation of the lower urinary tract.