Treatment of women with heavy menstrual bleeding:Results of a prospective cohort study alongside a randomised controlled trial

OBJECTIVE: The objective of this study was to compare the reintervention rate of women who opted for treatment with the levonorgestrel-releasing intrauterine system (LNG-IUS) to women who opted for endometrial ablation. Furthermore, the difference in reintervention rate between women in this observational cohort and women who were randomised was compared, with the hypothesis that women who actively decide on treatment have lower reintervention rates compared to women in a RCT. STUDY DESIGN: An observational cohort study alongside a multicentre randomised controlled trial (RCT) was conducted between April 2012 and January 2016, with a follow-up time of 24 months, in 26 hospitals and nearby general practices in the Netherlands. Women suffering from heavy menstrual bleeding, aged 34 years and older, without intracavitary pathology and without a future fertility desire, were eligible for this trial. Women who declined randomisation were asked to participate in the observational cohort. The outcome measure was reintervention rate at 24 months of follow-up. RESULTS: 276 women were followed in the observational cohort of which 87 women preferred an initial treatment with LNG-IUS and 189 women preferred an initial treatment with endometrial ablation. At 24 months of follow-up women in the LNG-IUS-group were more likely to receive a reintervention compared to the women in the ablation group, 28/81 (35 %) versus 25/178 (14 %) (aRR 2.42, CI 1.47-3.98, p-value 0.001). No differences in reintervention rates were found between women in the observational cohort and women in the RCT. CONCLUSIONS: Women who receive an LNG-IUS are more likely to undergo an additional intervention compared to women who receive endometrial ablation. Reintervention rates of women in the cohort and RCT population were comparable. The results of this study endorse the findings of the RCT and will contribute to shared decision making in women with heavy menstrual bleeding

Levonorgestrel-releasing intrauterine system versus endometrial ablation for heavy menstrual bleeding

Acknowledgments: We thank all the women who participated in this trial; the participating general practitioners, gynecologists, and hospitals; the research nurses; and the staff of the Dutch Consortium for Studies in Women’s Health and Reproduction.Peer reviewedPublisher PD

Tailoring treatment for women with heavy menstrual bleeding

Around 30% of women experience heavy menstrual bleeding during their reproductive years and it is a common reason for consulting a gynecologist. Heavy menstrual bleeding has a negative impact on quality of life as it negatively influences physical activity, psychosocial well-being and sexual life. Two frequently used treatments are the levonorgestrel-releasing intrauterine system (LNG-IUS, Mirena®) and endometrial ablation (Novasure®). This dissertation focuses on the effectiveness of the LNG-IUS compared to endometrial ablation, whereby cost-effectiveness is also investigated. Furthermore, it provides insight into patient's preferences and it investigates if certain women have a higher risk of treatment failure with either the LNG-IUS or endometrial ablation. The results of the studies in this dissertation contribute to a tailor-made treatment for women with heavy menstrual bleeding

Pregnancy in a Patient with an Intra-Abdominal Levonorgestrel-Releasing Intrauterine System

Background: The levonorgestrel-releasing-intrauterine system (LNG-IUS) is a frequently used method of contraception worldwide. A rare, but bothersome complication of the LNG-IUS is a perforation of the uterus after insertion. Knowledge about the preferred management option in case of an intra-abdominally situated LNG-IUS during pregnancy is lacking. Case: This case report concerns a 33-year-old patient who became pregnant despite having an intra-abdominally situated LNG-IUS. The patient was counseled about the management options. The advantages and disadvantages of expectant management versus laparoscopic removal of the LNG-IUS were discussed, and the patient preferred removal of the IUS. The procedure was performed laparoscopically at 15 weeks of pregnancy. Results: The IUS was removed without complications, and the patient's pregnancy proceeded uneventfully. Conclusions: Considering the degree of evidence, it is important to make a tailor-made decision in case of a pregnancy with a perforated LNG-IUS

Predictive factors for failure of the levonorgestrel releasing intrauterine system in women with heavy menstrual bleeding

Background: This study was conducted to identify factors that are associated with failure of treatment using the levonorgestrel releasing intrauterine system (LNG-IUS) in women with heavy menstrual bleeding. Methods: For this study, data of a cohort of women treated with an LNG-IUS was used. Women who suffered from heavy menstrual bleeding, aged 34 years and older, without intracavitary pathology and without a future child wish, were recruited in hospitals and general practices in the Netherlands. Eight potential prognostic baseline variables (age, body mass index, caesarean section, vaginal delivery, previous treatment, anticoagulant use, dysmenorrhea, and pictorial blood assessment score) were analyzed using univariable and multivariable regression models to estimate the risk of failure. The main outcome measure was discontinuation of the LNG-IUS within 24 months of follow up, defined as removal of the LNG-IUS or receiving an additional intervention. Results: A total of 209 women received the LNG-IUS, 201 women were included in the analyses. 93 women (46%) discontinued LNG-IUS treatment within 24 months. Multivariable analysis showed younger age (age below 45) (adjusted RR 1.51, 95% CI 1.10–2.09, p =.012) and severe dysmenorrhea (adjusted RR 1.36, 95% CI 1.01–1.82, p =.041) to be associated with a higher risk of discontinuation. Conclusions: High discontinuation rates are found in women who receive an LNG-IUS to treat heavy menstrual bleeding. A younger age and severe dysmenorrhea are found to be risk factors for discontinuation of LNG-IUS treatment. These results are relevant for counselling women with heavy menstrual bleeding

The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis

OBJECTIVE: To evaluate the costs and non-inferiority of a strategy starting with the LNG-IUS compared to endometrial ablation (EA) in the treatment of heavy menstrual bleeding (HMB). DESIGN: Cost-effectiveness analysis from a societal perspective alongside a multicentre randomised non-inferiority trial. SETTING: General practices and gynaecology departments in the Netherlands. POPULATION: 270 women with HMB, aged ≥34 years old, without intracavitary pathology or future child wish. METHODS: Randomisation to a strategy starting with the LNG-IUS (n=132) or EA (n=138). The incremental cost-effectiveness ratio (ICER) was estimated. MAIN OUTCOME MEASURES: Direct medical costs and (in)direct non-medical costs were calculated. The primary outcome was menstrual blood loss after 24 months, measured with the mean Pictorial Blood Assessment Chart (PBAC)-score (non-inferiority margin 25 points). A secondary outcome was successful blood loss reduction (PBAC-score ≤75 points). RESULTS: Total costs per patient were €2,285 in the LNG-IUS strategy and €3,465 in the EA strategy (difference: €1,180). At 24 months mean PBAC-scores were 64.8 in the LNG-IUS group (N=115) and 14.2 in the EA group (N=132); difference 50.5 points (95% CI: 4.3-96.7). In the LNG-IUS group, 87% of women had a PBAC-score ≤75 points versus 94% in the EA group (RR 0.93, 95% CI: 0.85-1.01). The ICER was €23 (95% CI: €5-€111) per PBAC-point. CONCLUSIONS: A strategy starting with the LNG-IUS was cheaper than starting with EA, but non-inferiority could not be demonstrated. The LNG-IUS is reversible and less invasive and can be a cost-effective treatment option, depending on the success rate women are willing to accept