A systematic review of literature found that NovaSure® procedures resulted in high patient satisfaction, high rates of amenorrhea and low reintervention rates.
The study, “The NovaSure Endometrial Ablation Procedure: A 10-Year Review,” presented at AAGL by Richard Gimpelson, MD, examined 15 publications between 2001 and 2011. Studies that did not include outcomes or follow patients for a minimum of one year were excluded. Six of the studies were single-arm clinical trials and nine were double-arm trials that compared NovaSure with another ablation device.
Sample size ranged from 20 to 200 across the studies. Amenorrhea rates ranged from as low as 30% to 58% at twelve-months follow up, to as high as 97% at 7 years follow up. “You’re obviously going to get some women in menopause,” Gimpelson said, “they’re usually going to be amenorrheic.” He said that because endometrial ablation procedures intended result is amenorrhea with no cause for reintervention, menopausal women are considered a successful outcome.
Four of these studies covered 423 subjects with up to four years follow-up. Surgical reintervention ranged from 3% to 9% with 19 hysterectomies and three endometrial ablations.
These four studies found that amenorrhea rates with NovaSure ranged from 39% to 47%. Amenorrhea rates ranged from 8% to 32% using other methods. “You can see in all these studies that NovaSure was quite superior,” Gimpleson said.
NovaSure / ThermaChoice (Bongers, 2004)
|NovaSure / Hydrothermablator (Penninx, 2010)||NovaSure / Thermachoice (Clark, 2011)|
|Amenorrhea rate (%)||43/8||46.7/30.4||56/23|
Patients who reported being satisfied with the procedure range from 81.5% to 95.0%. More than 90% of patients were satisfied enough with the procedure that they said they would recommend it.