A Randomized, Multicenter Trial of Safety and Efficacy of the NovaSure System in the Treatment of Menorrhagia

Cooper, Jay M.; Gimpelson, Richard J.; Laberge, Philippe Y.; Galen, Donald I.; Garza-Leal, J.; Scott, Josef Z.; Leyland, Nicholas; Martyn, Paul; Liu, James H.

doi:10.1016/s1074-3804(05)60513-0

Cited by 131 publications

(117 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…"Incomplete" treatment rates, as assessed by immediate post-operative hysteroscopy, may be reduced with experience. Despite this, the treatment outcomes in terms of amenorrhoea rates and patient satisfaction are comparable to other published inpatient NovaSure™ series, where post-operative hysteroscopy was not employed [8][9][10][11].…”

Section: Discussionsupporting

confidence: 68%

“…NovaSure™ endometrial ablation has been shown to be an effective treatment for women with excessive menstrual bleeding when performed as an inpatient procedure under general anaesthesia [8][9][10][11]. The current study is the first to show that NovaSure™ endometrial ablation is feasible, safe and effective for the treatment of HMB in the outpatient setting using local anaesthesia.…”

Section: Discussionmentioning

confidence: 62%

“…The current study is the first to show that NovaSure™ endometrial ablation is feasible, safe and effective for the treatment of HMB in the outpatient setting using local anaesthesia. Moreover, this study demonstrates that the effectiveness of outpatient treatment, in terms of amenorrhoea rates, reduction in menstrual bleeding, patient satisfaction and improvements in HRQL, are the same as procedures performed in the more traditional inpatient or day-case setting under general anaesthesia, both in the control group of this study and when compared to other published inpatient studies [8][9][10][11]. In contrast to other studies, we also chose to present clinically relevant combined "amenorrhoea and spotting rates."…”

Section: Discussionmentioning

confidence: 93%

“…It has been shown in randomised controlled trials [8][9][10] to be an effective treatment for the bleeding of endometrial origin under general anaesthesia. The short duration of the procedure (less than 2 min) suggests that the technique has the potential for use in the outpatient setting without the need for general anaesthesia.…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Outpatient versus day-case endometrial ablation using the NovaSure™ impedance-controlled ablative system

2008

View full text Add to dashboard Cite

The objective of this paper was to assess the feasibility and efficacy of the NovaSure™ endometrial ablation system in the outpatient setting using local anaesthesia and to compare this with the standard day-case procedure under general anaesthesia. A prospective cohortcontrolled study was undertaken at a university teaching hospital. The patient cohort was made up of 38 women with heavy menstrual bleeding refractory to medical therapy where endometrial ablation was indicated. Endometrial ablation using the NovaSure™ impedance-controlled ablative system was undertaken to compare outpatient treatment using local cervical anaesthetic (experimental group, n=18) with inpatient treatment under general anaesthesia (control group, n=20). The subjective self-assessment of uterine bleeding symptoms, patient satisfaction and health-related quality of life (HRQL; multi-attribute utility assessment) measures at six months following treatment were noted. Participants were also asked as to whether they would subsequently recommend the treatment, based on their experience. All procedures were successfully accomplished. Completed outcome questionnaires were returned by 17/18 (94%) women treated as outpatients and by 13/20 (65%) as inpatients. Overall, 27/30 (90%) women reported an improvement in menstrual bleeding symptoms, with an amenorrhoea rate of 37% (95% CI 20-56%) and a combined amenorrhoea/spotting rate of 53% (95% CI 34-72%). There was no significant difference between the outpatient and inpatient treatment groups in terms of improvement in menstrual blood loss (94% vs. 84%, P=0.6), amenorrhoea (29% vs. 46%, P=0.5), amenorrhoea/ spotting (47% vs. 62%, P=0.5), satisfaction (82% vs. 85%, P=1.0), improvement in HRQL (P=0.3) and treatment setting recommendation (88% vs. 77%, P=0.7). From our results, we conclude that NovaSure™ impedance-controlled endometrial ablation is an effective, safe and feasible treatment for heavy menstrual bleeding in both the outpatient and traditional inpatient settings. A choice of treatment settings should be offered to women suitable for this procedure.

show abstract

Section: Discussionsupporting

confidence: 68%

Section: Discussionmentioning

confidence: 62%

Section: Discussionmentioning

confidence: 93%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Outpatient versus day-case endometrial ablation using the NovaSure™ impedance-controlled ablative system

2008

View full text Add to dashboard Cite

show abstract

“…At 5 years following treatment, women report an impressive amenorrhea rate of 75%, while the study reveals an overall success of the method up to 98% [68]. There is one clinical trial comparing Novasure® with combined loop excision plus rollerball ablation, reporting an amenorrhea rate of 41% and a satisfaction rate of 93% in the Novasure® arm, compared with 35% and 94%, respectively in the rollerball arm [69]. Novasure® has been compared in prospective randomized controlled trials with other second-generation ablation techniques.…”

Section: Endometrial Laser Intrauterine Thermal Therapy (Elitt®)mentioning

confidence: 99%

Treatment options for dysfunctional uterine bleeding: evaluation of clinical results

et al. 2011

View full text Add to dashboard Cite

Abnormal uterine bleeding is one of the most common problems in women of reproductive age, and dysfunctional uterine bleeding (DUB) accounts for about half the cases. The aim of this review is to present all treatment options for women suffering from DUB and to evaluate their effectiveness. A detailed search strategy on electronic databases was carried out to identify trials and reviews on management of abnormal uterine bleeding. Tranexamic acid is the most effective medical treatment. A levonorgestrel-releasing intrauterine device is a low-cost, simple, and effective medical method, comparable to hysterectomy in terms of quality of life. In cases of DUB resistant to medical treatment, surgical treatment should be offered. First-generation ablation techniques are effective, but have a long learning curve. Second-generation ablation devices are highly effective and safe alternatives, thoroughly compared to first-generation techniques. Hysterectomy is the only method that guarantees treatment of dysfunctional uterine bleeding, but is a major operation associated with higher morbidity and mortality rates. Proper counseling of each woman with DUB regarding all treatment modalities can provide the best choice for each patient. More prospective randomized trials are needed to establish the effectiveness of these methods

show abstract

Endometrial destruction techniques for heavy menstrual bleeding

Lethaby¹,

Hickey

Garry³

2005

Cochrane Database of Systematic Reviews

View full text Add to dashboard Cite

A Randomized, Multicenter Trial of Safety and Efficacy of the NovaSure System in the Treatment of Menorrhagia

Cited by 131 publications

References 21 publications

Outpatient versus day-case endometrial ablation using the NovaSure™ impedance-controlled ablative system

Outpatient versus day-case endometrial ablation using the NovaSure™ impedance-controlled ablative system

Treatment options for dysfunctional uterine bleeding: evaluation of clinical results

Endometrial destruction techniques for heavy menstrual bleeding

Contact Info

Product

Resources

About