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Zvi Peled
Bnai Zion Medical Center, Haifa, Israel
Corresponding Author
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Objective: The aim of the study was to assess efficacy, safety and patient acceptability of the intrauterine ball (IUB) Ballerine MIDI copper intrauterine device (IUD), using real-world data collected from users and physicians.
Study design: Retrospective analysis of two cross-sectional survey studies conducted in seven private clinics in Israel or Switzerland, and in one Swiss hospital between January and October 2018. Participants were healthy women who had the non-hormonal IUB Ballerine MIDI inserted >12 months before enrolment. In total, 382 participants and their 19 physicians completed questionnaires relating to device insertion, user experience and performance.
Results: Mean age at insertion was 31.8±7.1 years, the survey was answered 16.0±4.7 months following IUB insertion. Most women were married (56.8%) and multigravid (83.5%). In 20 (5.2%) cases premature removal was due to desire to conceive. Excluding these women, the >12-month continuation rate was 71%. The expulsion rate was 17 (4.5%) and pregnancy rate was 4 (1.1%). The IUB was associated with high tolerability, 31% of current users reported no menstrual cramps/pain or light (34%) to moderate (20%) dysmenorrhea. The majority of women (69%) reported moderate to high satisfaction with the device, and 79% said they would recommend it to friends and relatives. Physicians reported in 87% of procedures the device was simple to deploy, with no difficulties encountered.
Conclusions: The IUB Ballerine MIDI was demonstrated to be safe, effective and highly accepted in a cohort of women in different clinical settings and among a socioeconomically and demographically diverse population of contraception seekers.
Keywords
Contraceptive, IUB, IUB Ballerine MIDI, IUD, LARC
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CURRENT STATUS: Under Review
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Posted 12 Nov, 2020
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On 02 Nov, 2020
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Subject Areas
Sexual & Reproductive Medicine
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
This preprint is under consideration at Contraception and Reproductive Medicine. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research
Zvi Peled
Bnai Zion Medical Center, Haifa, Israel
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 12 Nov, 2020
No community comments so far
Editor assigned
On 02 Nov, 2020
Reviewers invited
Invitations sent on 02 Nov, 2020
Submission checks complete
On 02 Nov, 2020
Editor invited
On 02 Nov, 2020
First submitted
On 28 Oct, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Sexual & Reproductive Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Objective: The aim of the study was to assess efficacy, safety and patient acceptability of the intrauterine ball (IUB) Ballerine MIDI copper intrauterine device (IUD), using real-world data collected from users and physicians.
Study design: Retrospective analysis of two cross-sectional survey studies conducted in seven private clinics in Israel or Switzerland, and in one Swiss hospital between January and October 2018. Participants were healthy women who had the non-hormonal IUB Ballerine MIDI inserted >12 months before enrolment. In total, 382 participants and their 19 physicians completed questionnaires relating to device insertion, user experience and performance.
Results: Mean age at insertion was 31.8±7.1 years, the survey was answered 16.0±4.7 months following IUB insertion. Most women were married (56.8%) and multigravid (83.5%). In 20 (5.2%) cases premature removal was due to desire to conceive. Excluding these women, the >12-month continuation rate was 71%. The expulsion rate was 17 (4.5%) and pregnancy rate was 4 (1.1%). The IUB was associated with high tolerability, 31% of current users reported no menstrual cramps/pain or light (34%) to moderate (20%) dysmenorrhea. The majority of women (69%) reported moderate to high satisfaction with the device, and 79% said they would recommend it to friends and relatives. Physicians reported in 87% of procedures the device was simple to deploy, with no difficulties encountered.
Conclusions: The IUB Ballerine MIDI was demonstrated to be safe, effective and highly accepted in a cohort of women in different clinical settings and among a socioeconomically and demographically diverse population of contraception seekers.
Figure 1
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