INTRODUCTION: The field of intrauterine devices (IUDs) has seen few innovations in the last few decades. The classical IUDs are T shaped or U frame and when positioned in the uterus, they take a two-dimensional shape. A recent innovation was the invention of the new IUB (Intrauterine Ball) by Dr. Baram. It is a copper-IUD, with a lifetime of 5 years, made by Nitinol and 17 copper pearls that, upon insertion in the uterus, takes a three-dimensional spherical form. Due to its form and deployment process, the IUB is expected to reduce perforation, malposition and expulsion rates and may also reduce dysmenorrhea and menorrhagia. In the literature there are no data available about its comparison with classical T shaped IUD, so we have decided to conduct a clinical randomized comparative trial about two types of IUDs (IUB vs. Nova T 380). The objective of the study is to evaluate if it is indeed possible to obtain improvements with the use of IUB compared to traditional IUDs.
MATERIAL AND METHODS: In this first report of the study we evaluated 60 patients, randomized to IUB (n=30) and Nova T 380 (n=30). The protocol provided a follow up to 60 months during which were performed 3 clinical visits in the first 12 months and 4 telephone contacts once a year for the following 48 months. The outcomes assessed were: pain during the insertion of the IUD and during the first month of use, difficulty in the insertion of the IUD for the operator, bleeding pattern (evaluated with menstrual diary), patient’s quality of life and of sexual life (evaluated with specific questionnaires SF-36 and FSFI), satisfaction with contraceptive method, adverse events (spontaneous expulsion, malpositioning, perforation, infections) and continuation rate at 24, 36, 48 and 60 months.
RESULTS: Women enrolled in the study had similar basal features apart from uterine volume (bigger in IUB group). We observed no difference between groups in questionnaires related to the pain felt by the patient during the procedure of placement, whereas we found that the pain that it seems to have given to the patient during the insertion by the physician was minor in group IUB (for IUB 1.5 ± 0.9 points vs. for Nova T 380 2.3 ± 1.0 points, p value= 0.0015). The satisfaction, after one month of use, was in general high and similar between groups with a mean of 8.5 ± 1.9 points in a range 0 – 10 points. In both groups, quality of life and sexual life did not change after insertion. During the first month of use, pelvic pain was similar between groups, instead we observed a significant difference in bleeding intensity that was higher in IUB group, especially in the total evaluation at 30 days (for IUB 26.3 ± 7.7 vs. for Nova T 380 20.6 ± 9.3; p value=0.03). A slight migration of the device from the uterine fundus occurred with both IUB and Nova T 380 after 1 month of use (from a mean of 1.8 ± 3.9 mm at the time of placement to a mean of 6.4 ± 11.3 mm after 1 month), directly related to uterine volume (p=0.04). However, this effect was greater in IUB group in which we performed the removal of a non-negligible percentage of devices (4/29, 13.8%) for istmo - cervical dislocation. At visit 4 (1 year) we evaluated 17 patients. The outcomes were positive and there were no significant difference between groups in term of continuation and satisfaction. At visit 4 we performed 3 IUD removal (17.6%) upon request of patients. To the present 47/57 (82.2%) patients are still using IUD that is well positioned with a follow up mean of 7.7 ± 4.9 months in a range 1 – 16. The satisfaction with treatment continues to be high with a mean of 8.7 ± 1.8 points in a range 0 – 10.
CONCLUSION: The use of IUB is associated with conflicting results compared to the classic T-shape IUD. The apparent reduction of pain during the insertion is associated with an increase in bleeding and a non-negligible risk of intracavitary migration in the first month of use after placement.