The IUB, a newly invented IUD: a brief report

Abstract

Objective: To evaluate the initial safety and effectiveness of the intrauterine ball (IUB), a copper intrauterine device that, upon insertion in the uterus, takes a three-dimensional spherical form.

Study design: Fifteen women were followed for 1 year, with follow-up visits at 1, 3, 6, 9 and 12 months.

Results: The physician reported that all devices were very easy to insert. One subject discontinued before the 6-month visit (at 119 days after insertion) for a reason not related to the device. There were no perforations, expulsions, malpositions or complications, or pregnancies.

Conclusion: No safety or efficacy concerns were raised.

Implications: Due to its form and deployment process the IUB is expected to ease insertion and reduce perforation, malposition and expulsion rates and may also reduce dysmenorrhea and menorrhagia.

Trial registration: ClinicalTrials.gov NCT01590563.

Keywords: Discontinuation; Ease of insertion; Efficacy; Expulsion; Safety; Satisfaction.

Figure 1. The IUB™

Figure 2. The IUB™ in its free form (Left), and loaded into the insertion tube (right)