Ten-year follow-up of a randomised controlled trial comparing bipolar endometrial ablation with balloon ablation for heavy menstrual bleeding
ABSTRACT Previously, we have reported that, at both 12 months and 5 years after treatment, bipolar endometrial ablation is superior to balloon ablation in the treatment of heavy menstrual bleeding. In this article, we evaluate the results at 10 years after these interventions.
Ten-year follow-up of a double-blind randomised controlled trial.
A teaching hospital in the Netherlands.
Premenopausal women suffering from heavy menstrual bleeding.
A follow-up questionnaire was sent to women 10 yearsafter randomisation for bipolar ablation and balloon ablation (2 : 1 ratio).
Amenorrhoea rates, re-intervention and patient satisfaction.
At 10 years of follow-up, the response rate was 69/83 (83%) in the bipolar group and 35/43 (81%) in the balloon group. Amenorrhoea rates were 50/69 (73%) in the bipolar group and 23/35 (66%) in the balloon group [relative risk, 1.1 (95% CI, 0.83-1.5)]. Further treatment following initial ablation was reported in 21 cases, 14 in the bipolar group and nine in the balloon group [relative risk, 0.9 (95% CI, 0.63-1.3)]. Eight of these women required further treatment after 5 years, including two hysterectomies. Patient satisfaction in the bipolar group was 81% (56/69) compared with 77% (27/35) in the balloon group [relative risk, 1.1 (95% CI, 0.82-1.2)].
Ten years after treatment, the superiority of bipolarablation over balloon ablation in the treatment of heavy menstrual bleeding was no longer evident.
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ABSTRACT: To compare long-term outcomes following microwave endometrial ablation (MEA™) and thermal balloon ablation (TBall). Follow up of a prospective, double-blind randomised controlled trial at 5 years. A teaching hospital in the UK. A total of 320 women eligible for and requesting endometrial ablation. Eligible women were randomised in a 1:1 ratio to undergo MEA or Tball. Postal questionnaires were sent to participants at a minimum of 5 years postoperatively to determine satisfaction with outcome, menstrual status, bleeding scores and quality of life measurement. Subsequent surgery was ascertained from the women and the hospital operative database. The primary outcome measure was overall satisfaction with treatment. Secondary outcomes included evaluation of menstrual loss, change in quality of life scores and subsequent surgery. Of the women originally randomised 217/314 (69.1%) returned questionnaires. Nonresponders were assumed to be treatment failures for data analysis. The primary outcome of satisfaction was similar in both groups (58% for MEA™ versus 53% for TBall, difference 5%; 95% CI -6 to 16%). Amenorrhoea rates were high following both techniques (51% versus 45%, difference 6%; 95% CI -5 to 17%). There was no significant difference in the hysterectomy rates between the two arms (9% versus 7%, difference 2%; 95% CI -5 to 9%). At 5 years post-treatment there were no significant clinical differences in patient satisfaction, menstrual status, quality of life scores or hysterectomy rates between MEA™ and Thermachoice 3, thermal balloon ablation.BJOG An International Journal of Obstetrics & Gynaecology 02/2014; 121(6). DOI:10.1111/1471-0528.12585 · 3.86 Impact Factor
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ABSTRACT: OBJECTIVE: To estimate the effectiveness of office-based bipolar radiofrequency ablation compared with thermal balloon ablation of the endometrium for the treatment of heavy menstrual bleeding at 5-year follow-up. METHODS: A single blind randomized controlled trial was conducted in an office hysteroscopy clinic in a university teaching hospital. A total of 81 women were randomly allocated to either bipolar radiofrequency ablation or thermal balloon ablation in an office setting avoiding use of general anesthesia or conscious sedation. The primary outcome for the trial was amenorrhea at 6 months follow-up. In this planned secondary analysis, the main outcome measures were amenorrhea rates, patient satisfaction, health-related quality of life, and incidence of further uterine surgery at 5-year follow-up. RESULTS: At 5-year follow-up, 59 (73%) women responded to postal questionnaires. Amenorrhea was reported in 60% of thermal balloon ablation and 62% of bipolar radiofrequency ablation (odds ratio [OR] 1.09 [0.38-3.11]) and satisfaction with treatment outcome in 96% of thermal balloon ablation and 96% of bipolar radiofrequency ablation (OR 0.92 [0.05-25.59]). Further surgical intervention was needed in three of 29 (10%) women treated with bipolar radiofrequency ablation compared with four of 30 (13%) of women treated with thermal balloon ablation (P=.7). There was no significant difference in either condition-specific or generic health-related quality-of-life measures. CONCLUSION: There was no difference in the effectiveness of bipolar radiofrequency ablation and thermal balloon ablation performed in an office setting at 5-year follow-up.Obstetrics and Gynecology 07/2014; 124(2). DOI:10.1097/AOG.0000000000000395 · 4.37 Impact Factor