Two randomized controlled trials comparing the Hulka and Filshie Clips for tubal sterilization.

To compare the effectiveness and safety of the Filshie Clip System and Hulka Clip System when applied via minilaparotomy and laparoscopy, we conducted 2 multicenter randomized controlled trials of 2126 women (878 in the minilaparotomy study and 1248 in the laparoscopy study) who received either the Filshie or Hulka Clip. A physician other than the operator evaluated patients postoperatively and again at 1, 6, and 12 months after surgery. We compared the cumulative incidence of pregnancy and the frequency of safety related events for the device groups. Twenty-four month follow-up was planned for a subset of 599 women in the laparoscopy study. One woman who received the Filshie Clip and 6 women who received the Hulka Clip became pregnant within one year. The 12-month life-table pregnancy probability was 1.1 per 1000 women in the Filshie Clip group and 6.9 per 1000 women in the Hulka Clip group. The difference in the risk of pregnancy through 12 months between device groups neared statistical significance (p = 0.06). Among the extended follow-up subset, the 12- and 24-month cumulative pregnancy probabilities were 3.9 and 9.7 per 1000 women for the Filshie Clip group and 11.7 and 28.1 per 1000 women for the Hulka Clip group (p = 0.16 for comparison through 24 months). Both the Filshie and Hulka Clips are effective and safe for use in tubal occlusion.

A comparative study of the TCu200B with and without strings.

PIP: The role of the IUD string in the development of pelvic inflammatory disease (PID) was assessed in a multicenter trial. Subjects were 1st time IUD users with no clinical signs of uterine abnormalities or infection. TCu 200B IUDs with strings were inserted in 150 women; the remaining 150 women were fitted with devices without strings. Clinical follow up was scheduled at 1, 3, 6, and 12 months after insertion or at any time complications occurred. 5 cases of PID were reported during the follow up period: 3 involved women with parity 1 and 2 who received IUDs without strings, and 2 occurred in women of parity 3 or over who received IUDs with strings. These differences were not statistically significant. The 1-year PID rate in the current study was 2.2/100. About 75% of women in both study groups reported purulent discharge at least once during the 1-year follow up period. Urinary problems were reported by 5-10% of particpants. There were no significant differences between women with stringless IUDs and those receiving IUDs with strings in terms of dysmenorrhea, intermenstrual pain, spotting, or pain. Continuation rates at 1 year were 80% for women in both groups of parity 1-2 and 91% for those of parity 3 or more. These results fail to provide any evidence of an increased risk of PID in association with IUD strings.^ieng