Bipolar versus balloon endometrial ablation in the office: a randomized controlled trial.

OBJECTIVE: To compare the effectiveness of bipolar radiofrequency (Novasure®) ablation and balloon endometrial ablation (Thermablate®). STUDY DESIGN: We performed a multi-center double blind, randomized controlled trial in three hospitals in The Netherlands. Women with heavy menstrual bleeding were randomly allocated to bipolar or balloon endometrial ablation, performed in the office, using a paracervical block. The primary outcome was amenorrhea. Secondary outcome measures were pain, satisfaction, quality of life and reintervention. RESULTS: 104 women were randomized into the bipolar (52) and balloon (52) groups. After 12 months amenorrhea rates were 56% (29/52) in the bipolar group and 23% (12/52) in the balloon group (relative risk (RR) 0.6, 95% confidence interval (CI) 0.4-0.8). The mean visual analog pain score of the total procedure was 7.1 in the bipolar group and 7.4 in the balloon group (P<.577). 87% (45/52) of the patients in the bipolar group were satisfied with the result of the treatment versus 69% (36/52) in the balloon group (RR 0.44, 95% CI 0.2-0.97). The reintervention rates were 5/52 (10%) in the bipolar group and 6/52 (12%) in the balloon group (RR 1.02, 95% CI 0.9-1.2). Quality of life (Shaw score) improved over time (P<.001) and was significantly higher in the bipolar group at 12 months follow-up (P=.025). CONCLUSION: In the treatment of heavy menstrual bleeding, bipolar radiofrequency endometrial ablation is superior to balloon endometrial ablation as an office procedure in amenorrhea rate, patient satisfaction and quality of life.

Prognostic factors for the success of endometrial ablation in the treatment of menorrhagia with special reference to previous cesarean section.

OBJECTIVE: To assess whether, among other prognostic factors, a history of Cesarean section is associated with endometrial ablation failure in the treatment of menorrhagia. Study design We compared women who had failed ablation to women who had successful ablation for menorrhagia in a case-control study. Failed ablation was defined as the need for hysterectomy due to persistent heavy menstrual bleeding after ablation. Successful ablation was defined as an ablation for menorrhagia not needing hysterectomy and the woman being satisfied with the result. Both cases and controls were identified from the surgery registration in the Máxima Medical Center between January 1999 and January 2009. Cases were women that had an endometrial ablation and a hysterectomy, whereas controls only had an endometrial ablation. From the medical files we collected for each patient clinical history, including the presence of a previous Cesarean section, baseline characteristics at the moment of initial ablation, data of the ablation technique and follow-up status. We used univariable and multivariable logistic regression to estimate the risk of failure of endometrial ablation. RESULTS: We compared 76 cases to 76 controls. Among the cases, 12 women had had a previous Cesarean section versus 15 in the control group (15.8% versus 19.7%; odds ratio (OR) 0.76; 95% CI 0.3-1.8). Factors predictive for failure of ablation were dysmenorrhea (OR 3.0; 95% CI 1.5-6.1), having a submucous myoma (OR 3.2; 95% CI 1.5-6.8) and uterine depth (per cm OR 1.3; 95% CI 1.0-1.6). Presence of intermenstrual bleeding, sterilization and age were not associated with failure of ablation. CONCLUSION: A previous Cesarean delivery is not associated with an increased risk of failure of endometrial ablation, but dysmenorrhea, a submucous myoma and longer uterine depth are. This should be incorporated in the counseling of women considering endometrial ablation.

Five-year follow-up after comparing bipolar endometrial ablation with hydrothermablation for menorrhagia.

OBJECTIVE: To evaluate the results of a previous study comparing bipolar radiofrequency endometrial ablation with hydrothermablation for the treatment of menorrhagia at 5-year follow-up. METHOD: A double-blind, randomized, controlled trial was performed in a large teaching hospital in the Netherlands between March 2005 and August 2007. One-hundred sixty women with menorrhagia were randomly allocated to bipolar ablation or hydrothermablation. The results of follow-up at 12 months were previously reported. At 4-5 years of follow-up, a questionnaire was sent to all the participants to register amenorrhea rates, reinterventions, and patient satisfaction. RESULTS: At 5-year follow-up, response rates were 90% and 83% in the bipolar group and hydrotherm group, respectively. Amenorrhea rates were 55.4% and 35.3% in the bipolar group and the hydrotherm group, respectively (relative risk [RR] 1.5, 95% confidence interval [CI] 1.05-2.3). The number of surgical reinterventions was 11 compared with 23 (RR 0.43, 95% CI 0.23-0.80). Overall, more women were satisfied in the bipolar group compared with the hydrotherm group. CONCLUSION: After treatment, bipolar radiofrequency endometrial ablation system is more effective at 5 years than hydrothermablation in the treatment of menorrhagia. LEVEL OF EVIDENCE: II.

Bipolar radiofrequency endometrial ablation compared with hydrothermablation for dysfunctional uterine bleeding: a randomized controlled trial.

OBJECTIVE: To compare the effectiveness of two second-generation ablation techniques, bipolar radiofrequency impedance-controlled endometrial ablation and hydrothermablation, in the treatment of menorrhagia. METHODS: This study was a double-blind, randomized controlled trial, which took place in a large teaching hospital in The Netherlands with 500 beds. Women with menorrhagia were randomly allocated to bipolar radiofrequency ablation (bipolar group) and hydrothermablation (hydrotherm group). At follow-up, both women and observers remained unaware of the type of treatment that had been performed. The primary outcome was amenorrhea. Secondary outcome measures were patient satisfaction and reintervention. RESULTS: We included 160 women in the study, of which 82 were allocated to the bipolar group and 78 to the hydrotherm group. No complications occurred in either of the treatment groups. After 12 months, 87% (65 of 75) of the patients in the bipolar group were completely satisfied with the result of the treatment compared with 68% (48 of 71) in the hydrotherm group (relative risk 1.3, 95% confidence interval [CI] 1.03-1.6). The amenorrhea rates were 47% (35 of 75) in the bipolar group and 24% (17 of 71) in the hydrotherm group (relative risk 2.0, 95% CI 1.2-3.1). The relative risks for a reintervention in the bipolar group compared with the hydrotherm group was 0.29 (95% CI 0.12-0.67), whereas for hysterectomy, this was 0.49 (95% CI 0.15-1.5). CONCLUSION: In the treatment of menorrhagia, bipolar radiofrequency endometrial ablation system is superior to hydrothermablation. CLINICAL TRIAL REGISTRATION: ISRCTN Register, www.isrctn.org, ISRCTN23845359. LEVEL OF EVIDENCE: I.

Endometrial ablation with paracervical block.

OBJECTIVE: To evaluate the safety, feasibility and efficacy of endometrial ablation under local anesthesia. STUDY DESIGN: A prospective cohort study was performed at the gynecology department of a large teaching hospital. Women with dysfunctional uterine bleeding were included to undergo NovaSure endometrial ablation with paracervical block. We measured the acceptability, pain score (visual analog score scale), amenorrhea, and patients' satisfaction after the procedure. RESULTS: We treated 33 patients. No complications occurred during the procedure or postoperatively. Of the 33 women, 28 found treatment with NovaSure endometrial ablation under local anesthetics acceptable. After 24 hours, 23 of 33 women reported to be pain free, whereas 10 women still had mild pain. Twenty women developed amenorrhea (60.6%) and 13 women hypomenorrhea (39.4%). All women were satisfied with the treatment result and would recommend it to a friend. CONCLUSION: NovaSure endometrial ablation performed under local anesthesia is a safe, feasible and efficacious procedure.