Contraception
Conditions
Keywords
Permanent contraception method, Contraceptive device
Brief summary
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.
Detailed description
The study is a prospective epidemiological survey to collect local real life data on patients under routine pratice
Interventions
Bilateral insert placement
Sponsors
Hôpital André Mignot Centre Hospitalier de Versailles
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Woman ≥ 18 years old, * Scheduled for Essure procedure * Patient who has been given appropriate information about the study objectives and procedures and who has given her consent.
Exclusion criteria
* Patients with contraindications as listed in the current Instruction For Use (IFU) will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients being satisfied with successful Essure procedure having no complications at 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of unsatisfied patients | Up to 5 years | — |
| Number of satisfied patients at 3, 12 and 24 months | At 3 ,12 and 24 months | Patients satisfaction assessed by Likert scale. |
| Number of examinations by patients | At 3 months | — |
| Number of patients with moderate or important pain when placement is performed | At initial visit | 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. |
| Causes of unsatisfied patients | Up to 5 years | Possible causes of unsatisfaction : pregnancy, regret of the patient,migration/expulsion of Essure,or infection |
| Type of examinations by patients | At 3 months | Ultrasound transvaginale, radiography, or hysterosalpingography (HSG) |
| Number of patients with regrets | At 12 months, 24 months and 5 years | — |
| Number of good insert position by implant and patients with success in final result of the procedure | At 3 months | — |
Countries
France
Outcome results
None listed