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

Beelen, Pleun; Brink, Marian van den; Herman, Malou C.; Geomini, Peggy M.A.J.; Duijnhoven, Ruben G.; Bongers, Marlies Y.

doi:10.1186/s12905-021-01210-x

Cited by 4 publications

(3 citation statements)

References 20 publications

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“…41 This is a little higher than the 47% of women allocated to receive the LNG-IUS in the ECLIPSE trial who still had the LNG-IUS in situ at 5 years. 29 Younger age (< 45 years) and severe dysmenorrhoea have been identified as factors associated with discontinuation of the LNG-IUS within 2 years, although the overall rate of discontinuation in this cohort study was 46%, 42 higher than the 36% observed in the ECLIPSE trial at 2 years. An investigation of subsequent procedures following endometrial ablation and hysterectomy using data linkage in the entire Scottish health record system 23 achieved a median follow-up of 6.2 and 11.6 years, respectively.…”

Section: Introductioncontrasting

confidence: 56%

“…The MMAS has a high degree of reliability and internal consistency, 45 has good content and construct validity, 47,48 is responsive 38,49 and is acceptable to respondents. 42,46,49,50 The MMAS seeks responses in relation to current HMB, so was anticipated to be not relevant to the vast majority of women at this 10-year follow-up and was presented as an optional section of the questionnaire to complete.…”

Section: Outcome Measuresmentioning

confidence: 99%

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Rates of medical or surgical treatment for women with heavy menstrual bleeding: the ECLIPSE trial 10-year observational follow-up study

Kai,

Dutton,

Vinogradova

et al. 2023

Health Technol Assess

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Background Heavy menstrual bleeding is a common problem that can significantly affect women’s lives until menopause. There is a lack of evidence on longer-term outcomes after seeking health care and treatment for heavy menstrual bleeding. Objectives To assess the continuation rates of medical treatments and the rates of ablative and surgical interventions among women who had participated in the ECLIPSE trial (ISRCTN86566246) 10 years after initial management for heavy menstrual bleeding in primary care. To explore experiences of heavy menstrual bleeding and influences on treatment for women. Design This was a prospective observational cohort study, with a parallel qualitative study. Setting Primary care. Participants A total of 206 women with heavy menstrual bleeding who had participated in the ECLIPSE trial consented to providing outcome data via a questionnaire approximately 10 years after original randomisation. Their mean age at follow-up was 54 years (standard deviation 5 years). A purposeful sample of 36 women also participated in semistructured qualitative interviews. Interventions The ECLIPSE trial randomised participants to either the levonorgestrel-releasing intrauterine system (52 mg) or the usual medical treatment (oral tranexamic acid, mefenamic acid, combined oestrogen–progestogen or progesterone alone, chosen as clinically appropriate by general practitioners and women). Women could subsequently swap or cease their allocated treatment. Main outcome measures The main outcome measures were rates of ablative and surgical treatments; the rate of continuation of medical treatments; and quality of life using the Short Form questionnaire-36 items and EuroQol-5 Dimensions; women’s experiences of heavy menstrual bleeding; and the influences on their decisions around treatment. Results Over the 10-year follow-up period, 60 out of 206 (29%) women had received a surgical intervention [hysterectomy, n = 34 (17%); endometrial ablation, n = 26 (13%)]. Between 5 and 10 years post trial intervention, 89 women (43%) had ceased all medical treatments and 88 (43%) were using the levonorgestrel-releasing intrauterine system alone or in combination with other oral treatments. More women in the usual medical treatment group had also used the levonorgestrel-releasing intrauterine system than women in the levonorgestrel-releasing intrauterine system group. Fifty-six women (28%) used the levonorgestrel-releasing intrauterine system at 10 years. There was no statistically significant difference in generic quality-of-life scores between the two original trial groups, although small improvements in the majority of domains were seen in both groups across time. Women reported wide-ranging impacts on their quality of life and normalisation of their heavy menstrual bleeding experience as a result of the taboo around menstruation. Women’s treatment decisions and experiences were influenced by the perceived quality of health-care interactions with clinicians and their climacteric status. Limitations Fewer than half of the original 571 participants participated; however, the cohort was clinically and demographically representative of the original trial population. Conclusions Medical treatments for women with heavy menstrual bleeding can be initiated in primary care, with low rates of surgical intervention and improvement in quality of life observed 10 years later. Clinicians should be aware of the considerable challenges that women with heavy menstrual bleeding experience at presentation and subsequently over time, and the importance and value to women of patient-centred communication in this context. Future work Any further evaluation of treatments for heavy menstrual bleeding should include long-term evaluation of outcomes and adherence. Trial registration The original ECLIPSE trial was registered as ISRCTN86566246. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 17. See the NIHR Journals Library website for further project information.

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Section: Introductioncontrasting

confidence: 56%

Section: Outcome Measuresmentioning

confidence: 99%

Rates of medical or surgical treatment for women with heavy menstrual bleeding: the ECLIPSE trial 10-year observational follow-up study

Kai,

Dutton,

Vinogradova

et al. 2023

Health Technol Assess

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show abstract

“…A recent investigation enrolled a cohort of 1714 subjects and followed them for 5 years, with 495 participants finishing the entire period. As shown in Figure 4 , the rate of amenorrhea among these women increased with time, and at the end of the five years, it almost reached 42% [ 129 ].…”

Section: Use In Abnormal Uterine Bleedingmentioning

confidence: 99%

Utility of the Levonorgestrel-Releasing Intrauterine System in the Treatment of Abnormal Uterine Bleeding and Dysmenorrhea: A Narrative Review

Bianchi

Guo

Habiba

et al. 2022

JCM

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Introduction: We undertook a literature review of the use of levonorgestrel-releasing intrauterine devices when utilized for heavy menstrual bleeding and/or dysmenorrhea. Methods: A narrative review of articles in the Scopus and Medline databases was conducted. Results: A number of options exist for the management of both abnormal uterine bleeding (AUB) and dysmenorrhea, and evidence is accumulating that the insertion of a levonorgestrel-releasing intrauterine system (LNG-IUS) represents a useful option for their long-term treatment. The idea of using a progestogen released in utero was initially conceived to achieve long-term contraception, but it was quickly found that these systems could be utilized for a number of therapeutic applications. The first device to be made commercially available, Progestasert, was withdrawn from the market because, in the event of contraceptive failure, it caused a disproportionate percentage of extrauterine pregnancies. On the other hand, the LNG-IUS continues to be successfully utilized in its various variants, releasing 20, 13, or 8 μg/day. These devices have a respective duration of action of 7 (possibly 8), 5, and 3 years, and there exist versions of frameless systems affixed to the myometrium of the uterine fundus. In the present review, following a brief description of the major causes of AUB and dysmenorrhea, the molecular bases for the use of the LNG-IUS are summarized. This is followed by a compendium of its use in AUB and dysmenorrhea, concluding that the insertion of the system improves the quality of life, reduces menstrual blood loss better than other medical therapies, and decreases the extent of dysmenorrhea and pelvic pain. In addition, there is no evidence of a significant difference in these outcomes when the use of the LNG-IUS was compared with improvements offered by endometrial ablation or hysterectomy. Possibly, the most important mechanism of action of the system consists of its ability to induce amenorrhea, which effectively eliminates heavy bleeding and dysmenorrhea. However, no method is ideal for every woman, and, in the case of the LNG-IUS, younger age and severe dysmenorrhea seem to be associated with a higher risk of discontinuation. Conclusion: The higher-dose LNG-IUS is a useful tool for HMB and dysmenorrhea in women of all ages. The low cost and ease of use make the LNG-IUS an attractive option, especially when contraception is also desired.

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Contraceptive efficacy and safety of the 52-mg levonorgestrel intrauterine system for up to 8 years: findings from the Mirena Extension Trial

Jensen

Lukkari-Lax

Schulze

et al. 2022

American Journal of Obstetrics and Gynecology

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

Cited by 4 publications

References 20 publications

Rates of medical or surgical treatment for women with heavy menstrual bleeding: the ECLIPSE trial 10-year observational follow-up study

Rates of medical or surgical treatment for women with heavy menstrual bleeding: the ECLIPSE trial 10-year observational follow-up study

Utility of the Levonorgestrel-Releasing Intrauterine System in the Treatment of Abnormal Uterine Bleeding and Dysmenorrhea: A Narrative Review

Contraceptive efficacy and safety of the 52-mg levonorgestrel intrauterine system for up to 8 years: findings from the Mirena Extension Trial

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