Discontinuation rates and acceptability during one year of using the Intrauterine Ball (the SCu380A)

Abstract

OBJECTIVE: To characterize method-related discontinuation rates and acceptability over one year of SCu380A use STUDY DESIGN: Women enrolled into this prospective pilot study underwent SCu380A placement by a single clinician with follow-up at 6–8 weeks, 3, 6 9 and 12 months. Outcome measures included reasons for discontinuation and satisfaction. RESULTS: Fifty-one women had a 12 mm diameter intrauterine ball (IUB, SCu380A) inserted by a single clinician(EW). Post insertion ultrasonography showed all the devices to be correctly placed. By 8 weeks, there were 9 expulsions and two removals for symptoms. By 12 months there were 14 expulsions (27%), 8 removals for symptoms (16%), one pregnancy and 7 lost to follow-up. Of the remaining 21 women, 15 said they were satisfied. CONCLUSION: The high rate of expulsions and removals for symptoms in the first year indicate that this device, as presently designed, is unacceptable as an alternative to the currently available copper IUDs. IMPLICATIONS: More research is needed before we know if it is the spherical design, the size of the device or some other factor which led to the high expulsion rate. There are currently three different IUBs (12, 15 and 18 mm) approved and being investigated.