Real-world experience with the IUB Ballerine MIDI copper IUD: an observational, single-centre study in Israel

Abstract

Objective: The aim of the study was to assess the acceptability of the intrauterine ball IUB Ballerine MIDI copper intrauterine device (IUD), using real-world data collected from users and physicians in Israel.

Methods: In this retrospective, observational study, conducted in a single clinic in Israel, healthy women (n = 175) who had had the device inserted ≥12 months prior to enrolment, and their physician, completed questionnaires relating to device insertion, user experience and performance.

Results: The mean age at insertion was 32.8 ± 6.7 years; most women were married (80.6%) and multigravid (89.1%). At the time of the study, 131 (74.9%) women were still using the device; in 13 cases (7.4%), premature removal was due to desire to conceive. The 12 month continuation rate, excluding the women seeking to conceive, was 90.1%. The expulsion rate was 3.4% (n = 6) and the pregnancy rate was 0.57% (n = 1). Most of the women still using the device reported no to moderate pain or cramps (90.0%) and moderate to high (72.6%) satisfaction with the device; 76.3% said they would recommend it to friends and relatives. Most of the insertion procedures (86.9%) were uneventful and none required cervical dilation.

Conclusion: The IUB Ballerine MIDI raised no major safety concerns and was both effective and highly accepted in a cohort of women, covering a broad age range, treated in a gynaecology clinic in Israel.

摘要

目的：本研究的目的是评估宫内球形IUB Ballerine MIDI 含铜宫内节育器（IUD）的接受性, 采用以色列IUD应用者和医生的真实数据。

方法：以色列单个临床中心回顾性、观察性研究, 175名健康观察对象在调查前已放置节育器12个月, 医生完成了她们放置与使用的体验的调查问卷。

结果：女性平均年龄为32.8±6.7年, 很多女性已婚（80.6%）, 多次妊娠过（89.1%）。在研究时, 131名（74.9%）女性仍在用IUD, 13名（7.4%）由于想要怀孕提早移出IUD。排除想要怀孕的女性, 12个月后续用率为90.1%。IUD脱落率3.4%（n=6）, 妊娠率0.57%（n=1）。大多数仍在用该IUD的女性报告称, 没有出现中度疼痛或痉挛（90.0%）, 对该IUD的满意度为中度至高度（72.6%）, 76.3%的女性称她们会推荐给朋友和亲人。大多数放置操作（86.9%）是安全的, 并且不需要宫颈扩张。

结论：IUB Ballerine MIDI没有引起大的安全性问题, 在以色列的妇科门诊队列研究对象中有很好的效果和高接受率, 适用年龄范围广。

Keywords:

• Contraceptive
• IUB
• IUB Ballerine MIDI
• IUD
• LARC

Acknowledgement

The authors thank Y. Posen for her editorial assistance in the preparation of this article.

Disclosure statement

IB is the founder of OCON Healthcare, inventor of the IUB and current chief medical officer at OCON Healthcare. KS serves as vice president of clinical affairs at OCON Healthcare. RK is a senior clinical project manager and AA a clinical consultant at OCON Healthcare.

Additional information

Funding

The study and article-processing costs were funded by OCON Medical Ltd (dba OCON Healthcare).