Controlled radiofrequency endotubal sterilization.

Abstract

Study objective: A safe, effective, inexpensive method of transcervical tubal sterilization could have a major impact on women's health. In this study, we evaluated the efficacy of a new radiofrequency catheter prototype designed for endotubal sterilization using animal models.

Setting: Animal research laboratory.

Design: Prospective observational study.

Method: The optimal energy delivery to create a complete circumferential transmural thermal lesion in the tube was determined in 114 in vitro acute studies using porcine and bovine fallopian tubes. A study was then initiated with eight mini-pigs. Thirty-four lesions were made in the fallopian tubes using computer-controlled power delivery. Three weeks later the animals were euthanized and evaluated.

Measurements and main results: A hydrosalpinx was evident in 8/11 of the tubes with separate proximal and distal cautery, implying occlusion at each of these sites. Complete occlusion of the tubes was seen at 12/22 sites evaluated by histology. Narrowing was seen in 9/22, and 1/22 was open.

Conclusion: The endotubal cautery prototype creates a reproducible lesion, but did not always cause complete closure of the tube in this preliminary study. However, based on our results, we hypothesize that a radiofrequency catheter can be developed for minimally invasive transcervical sterilization.