Two randomized controlled trials comparing the Hulka and Filshie Clips fortubal sterilization

To compare the effectiveness and safety of the Filshie Clip System(TM) and Hulka Clip System when applied via minilaparotomy and laparoscopy, we condu cted 2 multicenter randomized controlled trials of 2126 women (878 in the m inilaparotomy study and 1248 in the laparoscopy study) who received either the Filshie or Hulka Clip. A physician other than the operator evaluated pa tients postoperatively and again at 1, 6, and 12 months after surgery. We c ompared the cumulative incidence of pregnancy and the frequency of safety r elated events for the device groups. Twenty-four month follow-up was planne d for a subset of 599 women in the laparoscopy study. One woman who receive d 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 Cl ip group. The difference in the risk of pregnancy through 12 months between device groups neared statistical significance (p = 0.06). Among the extend ed follow-up subset, the 12- and 24-month cumulative pregnancy probabilitie s were 3.9 and 9.7 per 1000 women for the Filshie Clip group and 11.7 and 2 8.1 per 1000 women for the Hulka Clip group (p = 0.16 for comparison throug h 24 months). Both the Filshie and Hulka Clips are effective and safe for u se in tubal occlusion. (C) 2000 Elsevier Science Inc. All rights reserved.