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.
RCT Entities:
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.
Authors: Magdalena Bofill Rodriguez; Sofia Dias; Vanessa Jordan; Anne Lethaby; Sarah F Lensen; Michelle R Wise; Jack Wilkinson; Julie Brown; Cindy Farquhar Journal: Cochrane Database Syst Rev Date: 2022-05-31
Authors: L J Middleton; R Champaneria; J P Daniels; S Bhattacharya; K G Cooper; N H Hilken; P O'Donovan; M Gannon; R Gray; K S Khan; J Abbott; J Barrington; S Bhattacharya; M Y Bongers; J-L Brun; R Busfield; M Sowter; T J Clark; J Cooper; K G Cooper; S L Corson; K Dickersin; N Dwyer; M Gannon; J Hawe; R Hurskainen; W R Meyer; H O'Connor; S Pinion; A M Sambrook; W H Tam; I A A van Zon-Rabelink; E Zupi Journal: BMJ Date: 2010-08-16
Authors: Bijan J Borah; Shannon K Laughlin-Tommaso; Evan R Myers; Xiaoxi Yao; Elizabeth A Stewart Journal: Obstet Gynecol Date: 2016-01 Impact factor: 7.661