Hysteroscopic sterilization using a micro-insert device: results of a multicentre Phase II study.
BACKGROUND
Unlike laparoscopic surgery for interval tubal sterilization, a hysteroscopic approach obviates surgical incision and requires only local anaesthesia or intravenous sedation. The safety, tolerability and efficacy of an hysteroscopically placed micro-insert device was evaluated.


METHODS
A cohort of 227 previously fertile women participated in this prospective international multicentre trial. Micro-inserts were placed bilaterally into the proximal Fallopian tube lumens under hysteroscopic visualization in outpatient procedures.


RESULTS
Successful bilateral micro-insert placement was achieved in 88% of women. The majority of women reported that intraprocedural pain was less than or equal to that expected, and 90% rated tolerance of the device placement procedure as good to excellent. Most women could be discharged in an ambulatory state within 1-2 h. Adverse events occurred in 7% of the women, but none was serious. Correct device placement was confirmed in 97% of cases at 3 months. Over 24 months follow-up, 98% of study participants rated their tolerance of the micro-insert as very good to excellent. After 6015 woman-months of exposure to intercourse, no pregnancies have been recorded.


CONCLUSIONS
Hysteroscopic sterilization resulted in rapid patient recovery without unacceptable post-procedure pain, as well as high long-term patient tolerability, satisfaction and effective permanent contraception.
Kerin
John F
JF
Reproductive Medicine Unit, University of Adelaide, Ashford Hospital, South Australia, Australia. kerinjf@senet.com.au
Cooper
Jay M
JM
Price
Thomas
T
Herendael
Bruno J Van
BJ
Cayuela-Font
Enrique
E
Cher
Daniel
D
Carignan
Charles S
CS
D000328:Adult; D005260:Female; D006801:Humans; D015907:Hysteroscopy; D010146:Pain; D017060:Patient Satisfaction; D011183:Postoperative Complications / Q000453:epidemiology; D019106:Postoperative Hemorrhage / Q000453:epidemiology; D013246:Sterilization, Tubal / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D016896:Treatment Outcome