Insertion experience of women and health care professionals in the Kyleena^® Satisfaction Study

Abstract

Purpose: The Kyleena V R Satisfaction Study (KYSS) is a prospective, observational study conducted to assess satisfaction with LNG-IUS 12 (Kyleena V R) in clinical practice and aims to provide adequate information for counselling women on what to expect regarding insertion and satisfaction. Materials and methods: Women deciding to use LNG-IUS 12 during routine counselling were informed of the study and provided informed consent. A baseline analysis was conducted to evaluate demographics, ease of insertion assessed by investigators, pain at insertion rated by women, additional interventions for insertion, and adverse events. Results: 1,110 women (536 parous, 574 nulliparous) had an insertion attempt and were included. Insertion was rated as easy in 494 (92.2%) parous and 516 (89.9%) nulliparous women. Pain was assessed as none or mild by 475 (88.6%) parous and 387 (67.4%) nulliparous women. Additional interventions were not required for most insertions (705; 63.6%). Overall 111 (10.0%) women reported adverse events at the time of baseline analysis. Conclusions: This analysis demonstrates that LNG-IUS 12 insertion is easy and associated with no or mild pain in most women. Additional interventions for insertion are not required in most cases. After 3 months, the number of adverse events is low. Implications: The present baseline analysis of the Kyleena V R Satisfaction Study (KYSS) demonstrates that most women rate insertion pain of LNG-IUS 12 as none or mild and clinicians consider insertion easy in the majority of cases.

Satisfaction and continuation with LNG-IUS 12: findings from the real-world kyleena® satisfaction study

“…In total, 100 women (8.9%) either had the device removed or expelled the device before 12 months of use. In the interim KYSS analysis, we reported that 24 women (2.2% of the 1101 participants included in the interim study population) had the device removed within 3 months of use [20]. Based on this and the discontinuation curves depicted in Figures 6 and 7, there does not appear to be any specific timepoint associated with greater discontinuation of LNG-IUS 12. .…”

“…Approval from the independent ethics committee/institutional review board (see details in Supplementary Table 1) was obtained for all participating centres. The methodology of this study has been described in detail in the previously published interim analysis, which was conducted after the last woman completed her initial visit at first attempt of LNG-IUS 12 insertion [20]. It should be noted that due to a delay in participant recruitment due to protocols for study acceptance, Mexico completed enrolment after the other countries and was thus not included in the interim analysis.…”

“…There is little evidence to support these concerns; LARCs are associated with favourable efficacy and safety profiles regardless of age or parity [12][13][14][15], and with high satisfaction and continuation rates in clinical trials [14,[16][17][18] and real-world surveys [19]. In addition, previously published data from the Kyleena V R Satisfaction Study (KYSS) interim analysis have shown that most women rate the insertion pain of the IUS as either none or mild and that clinicians consider placement to be easy in the majority of cases [20].…”

“…Levonorgestrel (LNG)-releasing IUS 12 (LNG-IUS 12, also known as Kyleena V R ) has demonstrated contraceptive efficacy for 5 years of use [21]. LNG-IUS 12 was developed with a smaller insertion tube which causes less insertion pain [20,21]. In addition, LNG-IUS 12 has other potential benefits such as lower levels of levonorgestrel and lower rates of amenorrhoea in women who desire this [17,18,21].…”

Digital Medical Device Companion (MyIUS) for New Users of Intrauterine Systems: App Development Study

“…Globally, over 922 million women of reproductive age rely on some form of contraception [6]. A woman's choice of contraceptive method can depend on a variety of factors, including ease and convenience of use, perceived efficacy, associated costs, and expectations of bleeding pattern [7,8]. Many contraceptive methods, such as oral contraceptive pills, implants, levonorgestrel-releasing intrauterine systems (LNG-IUSs), and copper intrauterine devices are associated with alterations in menstrual bleeding patterns [9][10][11], and some women cite the potential for unfavorable bleeding patterns (such as frequent or prolonged bleeding) or a fear of menstrual irregularity as key reasons for not choosing particular methods [12][13][14][15].…”