Using a very broad survey, the objective is to confirm the effectiveness of the Essure method, and to obtain more information on the conditions of use as well as on the methods used during the 3-month check-up, as well as the 12-month, 24-month and 5-year follow-up on patients.
The study is a prospective epidemiological survey to collect local real life data on patients under routine pratice
Study Type
OBSERVATIONAL
Enrollment
2,644
Bilateral insert placement
Unnamed facility
Le Chesnay, France
Number of patients being satisfied with successful Essure procedure having no complications at 5 years
Patient satisfaction will be assessed on a Likert scale. Complications are migration/expulsion of Essure, infection. Pregnancy will be measured at any time Point.
Time frame: At 5 years
Number of patients with moderate or important pain when placement is performed
Visual Analogue Scale (VAS) use to report the pain from 0 (no pain) to 10 (maximal pain). Moderate pain will range from 4 to 6 and important pain will range from 7 to 10 on the VAS.
Time frame: At initial visit
Number of unsatisfied patients
Time frame: Up to 5 years
Number of satisfied patients at 3, 12 and 24 months
Patients satisfaction assessed by Likert scale.
Time frame: At 3 ,12 and 24 months
Number of examinations by patients
Time frame: At 3 months
Number of good insert position by implant and patients with success in final result of the procedure
Time frame: At 3 months
Causes of unsatisfied patients
Possible causes of unsatisfaction : pregnancy, regret of the patient,migration/expulsion of Essure,or infection
Time frame: Up to 5 years
Type of examinations by patients
Ultrasound transvaginale, radiography, or hysterosalpingography (HSG)
Time frame: At 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of patients with regrets
Time frame: At 12 months, 24 months and 5 years