Obstetrics and gynecology · 2008
A 12-month prospective evaluation of transcervical sterilization using implantable polymer matrices.
Клиническое исследование I фазыКлиническое исследование II фазыСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Vancaillie Thierry G, Anderson Ted L, Johns D Alan
Аннотация
OBJECTIVE: To evaluate placement efficacy and reliability of a an intratubal occlusion device for permanent contraception and to assess tolerability and overall satisfaction.
METHODS: Seven hundred seventy women with known parity were recruited to participate in a prospective, multicenter study. Bipolar, low-level radiofrequency energy delivery and porous silicon inserts were used. Inserts were placed bilaterally in the fallopian tube lumen. Subsequent bilateral occlusion was assessed with hysterosalpingography.
RESULTS: Overall, bilateral placement success was achieved in 611 of 645 women (95%). Bilateral occlusion was confirmed in 570 of 645 (88.4%). The 1-year pregnancy prevention rate as derived with life-table methods was 98.9%.
CONCLUSION: This transcervical sterilization system offers an effective contraceptive method, which was well tolerated and had a high satisfaction rate.
LEVEL OF EVIDENCE: III.
METHODS: Seven hundred seventy women with known parity were recruited to participate in a prospective, multicenter study. Bipolar, low-level radiofrequency energy delivery and porous silicon inserts were used. Inserts were placed bilaterally in the fallopian tube lumen. Subsequent bilateral occlusion was assessed with hysterosalpingography.
RESULTS: Overall, bilateral placement success was achieved in 611 of 645 women (95%). Bilateral occlusion was confirmed in 570 of 645 (88.4%). The 1-year pregnancy prevention rate as derived with life-table methods was 98.9%.
CONCLUSION: This transcervical sterilization system offers an effective contraceptive method, which was well tolerated and had a high satisfaction rate.
LEVEL OF EVIDENCE: III.