Objective To determine the feasibility and patient satisfaction of female sterilisation using the Essure™ system in an outpatient hysteroscopy clinic without conscious sedation or general anaesthesia.
Design Prospective cohort study.
Setting Outpatient hysteroscopy clinic in a large teaching hospital.
Population Women undergoing outpatient hysteroscopic sterilisation using the Essure™ system for permanent fertility control.
Methods Demographic and procedural data were prospectively collected from 112 consecutive women undergoing outpatient hysteroscopic sterilisation without sedation or general anaesthesia. A hysterosalpingogram (HSG) was performed routinely in all women 3 months after the procedure to confirm bilateral tubal occlusion. Postal questionnaires were sent at this time enquiring about patient satisfaction and experience with the outpatient procedure. Multivariable logistic regression was used to identify factors independently predictive of successful completion of the procedure.
Main outcome measures Technical feasibility, predictive factors for technical success (operator, body mass index, uterine size, axis, menstrual phase and cervical stenosis), complications, tubal occlusion on HSG, patient satisfaction and procedure-related experience.
Results Successful bilateral tubal placement of the Essure™ microinserts was achieved in 103/112 (92%, 95% CI 85–96%) women. Nonsecretory phase of the menstrual cycle (P = 0.04) and a clinically normal-sized uterus (P = 0.003) were independently predictive for successful completion of the outpatient procedure on multivariable modelling. There were no major procedure-related complications recorded, but transient vasovagal reactions occurred in 5/112 (5%) women. Of the original cohort of 112 women with successful procedures, 84 women were 3 months postprocedure and had undergone a HSG. Bilateral tubal occlusion was confirmed in 83/84 (99%, 95% CI 94–100%) women at 3 months and in 100% at 6 months. Seventy-six of 84 (91%) had returned the questionnaires, and 70/73 (96%, 95% CI 88–99%) were satisfied with their overall experience of the procedure including radiological follow up, with most reporting being ‘very satisfied’ (64/73, 88%, 95% CI 78–94%).
Conclusions Outpatient hysteroscopic sterilisation using the Essure™ system without sedation or general anaesthesia is a successful and safe procedure associated with high rates of patient satisfaction. If practical, women should be scheduled to have their procedures in the proliferative phase of the menstrual cycle to optimise successful placement of Essure™ devices, especially if the uterus is clinically enlarged.