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Assessment of 12 months real-world experience with IUB Ballerine MIDI: a multinational cohort of 382 women

ABSTRACT

Assessment of 12 months real-world experience with IUBTM Ballerine® MIDI: a multinational cohort of 382 women
Ilan Baram (IL) Manuela Viviano (CH) Ketty Shkolnik (IL) Arnon Aharon (IL) Rinat Klein (IL) Michal Yaron (CH)

Context. The ongoing efforts to lower undesired pregnancy rates while improving long-acting reversible contraceptive acceptance and increasing user satisfaction, have spurred the development of new products. The IUBTM Ballerine® MIDI (Ocon Healthcare Ltd., Israel) is a uniquely designed spherical intrauterine copper device that better conforms to the uterine cavity, thereby minimizing endometrial irritation and ensuring maximal comfort. 

Objective. To determine the acceptability of IUBTM Ballerine® MIDI after 12 months of use. 

Methods. In two retrospective observational studies, conducted in Switzerland and Israel during 2017-2018, IUBTM Ballerine® MIDI users and their physicians were asked to fill out questionnaires relating to product insertion, user experience and outcome. Questions relating to current menstrual patterns, physical comfort and product satisfaction were only posed to women still carrying the device at the time of the study. Patients. Subjects undergoing an IUBTM Ballerine® MIDI insertion ≥12 months before completion of the study questionnaire Main Outcome Measures Expulsion and efficacy rates, physician experience, subject satisfaction and physical comfort. 

Results. In total, 382 women participated in the studies (IL: n=175, SW: n=207). The mean age at insertion was 31.8±7.1, with an average 16.0±4.7-month-lapse from time of insertion until the study. Most women were married (56.8%), multigra-vida (83.5%), and had experienced at least one abortion (42.7%). At the time of the study, 110 (28.7%) women were no longer carrying the device, with 5.2% of women (20/382) requesting removal due to wish to conceive. The expulsion rate was 4.5% (17/382) and pregnancy rate was 1.1% (4/382). Most of the 271 women still carrying the device (mean duration: 15.6±4.4 months) reported light to moderate menstruation (59.3%), and no to moderate pain/cramps (85.2%). The majority of women reported moderate to high (84.14%) satisfaction with the IUBTM Ballerine® MIDI, with 78.97% claiming they would recommend it to friends and relatives. All tested parameters showed similar patterns in both regions. Over 85% of physicians reported ease of use, with no difficulties during insertion. 

Conclusions. This first presentation of real-world, 12-month experience with IUBTM Ballerine® MIDI demonstrated the safety, efficacy and acceptability of the device. The overall satisfaction was high and similar in the two regions.

 

The study results have been submitted for publication.

IUB, SCu300A MINI, SCu300B MIDI, SCu300C MAXI, OCON and the OCON and IUB logos are trademarks of OCON Medical Ltd.
Ballerine and Sphera are registered trademarks of OCON Medical Ltd.
OCON products are not yet approved for sale in the United States. IUB Ballerine MAXI (previously SCu300C MAXI): CE mark pending. Copyright OCON Medical Ltd., d/b/a OCON Healthcare.