Five-year follow up of a randomised controlled trial comparing NovaSure and ThermaChoice endometrial ablation
- PMID: 17617188
- DOI: 10.1111/j.1471-0528.2007.01427.x
Five-year follow up of a randomised controlled trial comparing NovaSure and ThermaChoice endometrial ablation
Abstract
Objective: We have previously reported that NovaSure was more effective than balloon ablation at 12 months follow up in the treatment of menorrhagia. In this paper, we report the 5-year outcome of this study. The objective was to evaluate amenorrhoea rates, hysterectomy rate, and quality of life associated with the bipolar impedance-controlled endometrial ablation technique (NovaSure) in comparison with balloon ablation technique (ThermaChoice) at 5 years after administration.
Design: Double-blind randomised controlled trial, 2:1 randomisation NovaSure versus ThermaChoice.
Setting: A teaching hospital with 500 beds in The Netherlands.
Population: A total of 126 premenopausal women suffering from menorrhagia with a pictorial blood loss assessment count > or = 150 without intracavitary abnormalities.
Methods: Women were randomly allocated to bipolar radio-frequency ablation and balloon ablation in a 2:1 ratio.
Main outcome measures: The main outcome measures were amenorrhoea rate, hysterectomies, and health-related quality of life (HRQol) as reported at 5 year follow up.
Results: At 5 years of follow up, the total response rate was 96% in the bipolar group and 90% in the balloon group. Amenorrhoea was reported in the bipolar group by 48% of women and in the balloon arm by 32% (relative risk 1.6 [.93-2.6]). There were eight women in the bipolar group (9.8%) and five in the balloon group (12.9%) who had undergone a hysterectomy. Furthermore, there was a significant equal improvement of HRQoL over time in both groups.
Conclusions: At 5 years follow up, bipolar thermal ablation was superior over balloon ablation in the treatment of menorrhagia.
Similar articles
-
Randomised controlled trial of bipolar radio-frequency endometrial ablation and balloon endometrial ablation.BJOG. 2004 Oct;111(10):1095-102. doi: 10.1111/j.1471-0528.2004.00253.x. BJOG. 2004. PMID: 15383112 Clinical Trial.
-
Ten-year follow-up of a randomised controlled trial comparing bipolar endometrial ablation with balloon ablation for heavy menstrual bleeding.BJOG. 2013 Jul;120(8):966-70. doi: 10.1111/1471-0528.12213. Epub 2013 Mar 21. BJOG. 2013. PMID: 23759085 Clinical Trial.
-
A randomised trial comparing the levonorgestrel intrauterine system and thermal balloon ablation for heavy menstrual bleeding.BJOG. 2006 Mar;113(3):257-63. doi: 10.1111/j.1471-0528.2006.00863.x. BJOG. 2006. PMID: 16487195 Clinical Trial.
-
Second-generation endometrial ablation treatment: Novasure.Best Pract Res Clin Obstet Gynaecol. 2007 Dec;21(6):989-94. doi: 10.1016/j.bpobgyn.2007.03.024. Epub 2007 May 8. Best Pract Res Clin Obstet Gynaecol. 2007. PMID: 17490913 Review.
-
Health technology assessment of surgical therapies for benign gynaecological disease.Best Pract Res Clin Obstet Gynaecol. 2006 Dec;20(6):841-79. doi: 10.1016/j.bpobgyn.2006.11.006. Best Pract Res Clin Obstet Gynaecol. 2006. PMID: 17145485 Review.
Cited by
-
Thermal balloon endometrial ablation in dysfunctional uterine bleeding.J Gynecol Endosc Surg. 2009 Jan;1(1):31-3. doi: 10.4103/0974-1216.51907. J Gynecol Endosc Surg. 2009. PMID: 22442508 Free PMC article.
-
Nationwide trends in the performance of inpatient hysterectomy in the United States.Obstet Gynecol. 2013 Aug;122(2 Pt 1):233-241. doi: 10.1097/AOG.0b013e318299a6cf. Obstet Gynecol. 2013. PMID: 23969789 Free PMC article.
-
Ambulatory management of heavy menstrual bleeding.Womens Health (Lond). 2016 Jan;12(1):35-43. doi: 10.2217/whe.15.80. Epub 2015 Dec 23. Womens Health (Lond). 2016. PMID: 26696502 Free PMC article. Review.
-
Prediction of treatment outcomes after global endometrial ablation.Obstet Gynecol. 2009 Jan;113(1):97-106. doi: 10.1097/AOG.0b013e31818f5a8d. Obstet Gynecol. 2009. PMID: 19104365 Free PMC article.
-
Endometrial resection and ablation techniques for heavy menstrual bleeding.Cochrane Database Syst Rev. 2019 Jan 22;1(1):CD001501. doi: 10.1002/14651858.CD001501.pub5. Cochrane Database Syst Rev. 2019. PMID: 30667064 Free PMC article.
Publication types
MeSH terms
LinkOut - more resources
Full Text Sources
Medical