Malou C. Herman

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

Ten‐year follow‐up of a randomised controlled trial comparing bipolar endometrial ablation with balloon ablation for heavy menstrual bleeding

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.

Factors attributing to the failure of endometrial sampling in women with postmenopausal bleeding

To determine which doctor‐ and patient‐related factors affect failure of outpatient endometrial sampling in women with postmenopausal bleeding, and to develop a multivariable prediction model to select women with a high probability of failed sampling.

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.

Choice of primary outcomes evaluating treatment for heavy menstrual bleeding

Heavy menstrual bleeding (HMB) is a common problem with a variety of treatment options and many studies have been performed evaluating treatment effects. Consistency in the choice and definition of primary and secondary outcomes is important for the interpretation of data and for the synthesis of data in systematic reviews or individual patient data meta‐analysis (IPDMA).

Diagnosis of heavy menstrual bleeding

Heavy menstrual bleeding (HMB) is an important health problem. This paper gives an overview of the diagnosis of HMB. For each woman, a thorough history should be taken as one should ascertain whether there are underlying factors that could cause complaints of HMB. Objectively knowing whether or not the blood loss is excessive could also be very beneficial. The pictorial blood assessment chart score can help with diagnosis. Physical examination starts with standard gynecological examination. Imaging tests are widely used in the work-up for women with HMB. The first step in imaging tests should be the transvaginal ultrasound. Other diagnostic tests should only be performed when indicated.

Women's preferences for the levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding

OBJECTIVES Womens preferences for treatment of heavy menstrual bleeding (HMB) are important in clinical decision-making. Our aim was to investigate whether women with HMB have a preference for treatment characteristics of the levonorgestrel intrauterine system (LNG-IUS) or endometrial ablation and to assess the relative importance of these characteristics. STUDY DESIGN A discrete choice experiment was performed in general practices and gynaecology outpatient clinics in the Netherlands. Women with HMB were asked to choose between hypothetical profiles containing characteristics of LNG-IUS or endometrial ablation. Characteristics included procedure performed by gynaecologist or general practitioner; reversibility of the procedure; probability of dysmenorrhea; probability of irregular bleeding; additional use of contraception; need to repeat the procedure after five years; and treatment containing hormones. Data were analysed using panel mixed logit models. The main outcome measures were the relative importance of the characteristics and willingness to make trade-offs. RESULTS 165 women completed the questionnaire; 36 (22%) patients were recruited from general practices and 129 (78%) patients were recruited from gynaecology outpatient clinics. The characteristic found most important was whether a treatment contains hormones. Women preferred a treatment without hormones, a treatment with the least side effects, and no need for a repeat procedure or additional contraception. Women completing the questionnaire at the gynaecology outpatient clinic differed from women in primary care in their preference for a definitive treatment to be performed by a gynaecologist. CONCLUSIONS Whether or not a treatment contains hormones was the most important characteristic influencing patient treatment choice for HMB. Participants preferred characteristics that were mostly related to endometrial ablation, but were willing to trade-off between characteristics.

Timing of insertion of levonorgestrel‐releasing intrauterine system: a randomised controlled trial

The objective was to assess whether patient‐perceived pain during the insertion of the levonorgestrel‐releasing intrauterine system (LNG‐IUS) depends on the timing during the menstrual cycle.

Is the Pictorial Blood Loss Assessment Chart (PBAC) score associated with treatment outcome after endometrial ablation for heavy menstrual bleeding? A cohort study

The Pictorial Blood Loss Assessment Chart (PBAC) is a validated tool that is used to diagnose heavy menstrual bleeding (HMB). Knowledge of the effect of its score and its relationship with outcome could have implications for using the PBAC as an outcome measurement in future HMB studies, and as a tool to evaluate the treatment effect in research and clinical practice. Our aim was to relate PBAC scores to other measures of success after endometrial ablation for HMB.

Authors' reply re: Choice of primary outcomes evaluating treatment for heavy menstrual bleeding

Sir, We absolutely agree with the sentiments described in this article. The CROWN initiative focuses on encouraging journals to promote core outcome sets for Women’s and Newborn Health. It is important that these outcomes are developed using a consensus from researchers to ensure that they are relevant. Already as part of the Core Outcomes Sets for Gynaecological Conditions Project outcomes are being developed for clinical trials involving heavy menstrual bleeding. This unified approach would allow individual participant data meta-analysis where raw data from individual patients in each study is amalgamated for the analysis. The International Consortium for Health Outcome Measurement is a non-profit organisation working towards transforming healthcare systems worldwide by measuring and reporting patient outcomes in a standardised way. It is the ideal that globally one standard is set and agreed worldwide otherwise countries may monitor different outcomes, rendering it impossible to make global comparisons. If outcome data are collected on all patients, such as the British Society for Urogynaecology database, real-life data can be analysed on a huge scale. This is made possible by computer power and the ability to transfer and share data in a quick, easy and secure manner. The methodology of this analysis must be developed with care to avoid erroneous conclusions. If the outcome measures gathered correlate to trial outcomes then meaningful comparisons can be made between trial data and real life data.