Re-Essure study

BACKGROUND: Increasing number of symptomatic women request for Essure removal. RESEARCH QUESTIONS: 1) Are symptoms reversed after Essure removal? 2) Are symptoms comparable to other tubal occlusion methods? HYPOTHESIS: 1) Several symptoms will not improve after removal. 2) Symptoms are similar to other tubal occlusion methods. STUDY DESIGN: A prospective multicenter cohort study consisting of two parts STUDY POPULATION: 1) All women requesting for Essure removal. 2) Women who received any tubal occlusion method. FOLLOW-UP: 1) 2 times before, 3 and 12 months after removal. 2) A single questionnaire. OUTCOMES: 1) Primary: symptom reduction at 12 months after removal. Secondary: QOL (SF36) and satisfaction. SAMPLE SIZE/DATA-ANALYSIS: 1) Estimated 3000 women. 2) 600. 1) McNemar’s test will be used to test changes in occurrence of symptoms after removal and paired T-test for change in QOL. 2) Analysis of covariance and Chi square to compare QOL and symptoms after various occlusion methods.

1) Several symptoms will not improve after removal. 2) Symptoms are similar to other tubal occlusion methods

• Inclusion phase prospective trial: cohort study 1; 3000 patients (expected to be 2.5 years) and cohort study 2 will be executed in parallel during the first year: Gynecologists, research nurses and researchers.

• Follow-up phase (12 months)

• Analytic phase (6 months) Analysis and report: researchers

Participating women receive 4 questionnaires. The first will be send after their first visit followed by a second two months after the first visit to evaluate change in symptoms over time. The third and fourth form will be sent three and twelve months after the procedure. Ultrasound, X-ray and surgical findings will be registered before and during surgery. Women who decide to keep their Essure® will receive the questionnaires after their first visit, 3 and 12 months subsequently. The questionnaires contain a case report form (CRF) and QoL (using SF-36). The CRF will focus on complaints. Physicians will fill out 2 forms concerning pre- and perioperative data.