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

Area of Science:

• Reproductive Medicine
• Gynecologic Surgery
• Contraception

Background:

• Tubal occlusion is a common method of permanent contraception.
• Minilaparotomy and laparoscopy are established surgical approaches for tubal occlusion.
• The Filshie Clip System and Hulka Clip System are widely used devices for tubal occlusion.

Purpose of the Study:

• To compare the effectiveness and safety of the Filshie Clip System versus the Hulka Clip System.
• To evaluate these devices when applied via minilaparotomy and laparoscopy.
• To assess cumulative pregnancy rates and safety events over 12 and 24 months.

Main Methods:

• Two multicenter randomized controlled trials involving 2126 women.
• Participants received either the Filshie Clip or Hulka Clip via minilaparotomy or laparoscopy.
• Postoperative evaluations included follow-up at 1, 6, and 12 months; a subset had 24-month follow-up.

Main Results:

• The 12-month life-table pregnancy probability was 1.1/1000 for Filshie Clip and 6.9/1000 for Hulka Clip (p=0.06).
• In an extended follow-up subset, 24-month cumulative pregnancy probabilities were 9.7/1000 for Filshie Clip and 28.1/1000 for Hulka Clip (p=0.16).
• Both devices were found to be safe with no significant differences in safety-related events reported.

Conclusions:

• The Filshie Clip System showed a trend towards lower pregnancy rates compared to the Hulka Clip System.
• Both the Filshie Clip and Hulka Clip are effective and safe methods for achieving tubal occlusion.
• Surgical approach (minilaparotomy vs. laparoscopy) did not appear to significantly impact device effectiveness or safety in this study.