Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization

Study Overview
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Brief Summary
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This study is designed to assess post-procedural outcomes for women who chose to undergo either hysteroscopic sterilization (Essure®) or laparoscopic tubal sterilization, including: Pelvic and/or lower abdominal pain Abnormal uterine bleeding Surgical intervention (including insert removal and hysterectomy) Allergic, hypersensitivity, or autoimmune-like reactions

Official Title
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An Open-label, Non-randomized, Prospective Observational Cohort Study to Assess Post-procedural Outcomes in Two Cohorts of Women Who Chose to Undergo Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization

Conditions
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Contraception

Intervention / Treatment
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* Procedure: Blood draw
* Device: ESSURE (BAY1454032)
* Procedure: Laparoscopic tubal sterilization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are at least 21 years of age; Subjects of all weights will be included; Subjects who are scheduled to undergo an Essure insert placement procedure for permanent birth control or laparoscopic tubal sterilization. Decision for either treatment based upon clinical practice and physician/patient counseling. For the Essure group only: • Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU; For the laparoscopic tubal sterilization group only: Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care. Exclusion Criteria: Subjects who are post-menopausal; Subjects suspected of being or confirmed pregnant; Subjects post-partum or undergone pregnancy termination ≤6 weeks prior to scheduled procedure; Subjects uncertain about ending fertility; Subjects with an active upper or lower genital tract infection; Subjects with gynecologic malignancy (suspected or known); Subjects who have had an attempted prior sterilization procedure (either laparoscopic or hysteroscopic); Subjects scheduled to undergo concomitant intrauterine or laparoscopic procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure) or laparoscopic sterilization; Subjects with unexplained vaginal bleeding.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESSURE (BAY1454032)<br>Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU. Subject willing to use alternative contraception for at least 3 months post-Essure placement procedure, until a satisfactory Essure Confirmation Test is documented. | Procedure: Blood draw<br>* Decision for either treatment will be based upon clinical practice and physician/patient counseling. In addition of routine care practice, blood draws will be performed at baseline, 12 months and 60 months on subjects undergoing either an ESSURE procedure or a laparoscopic tubal sterilization.<br>Device: ESSURE (BAY1454032)<br>* Decision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol.<br>|
| Active Comparator: Laparoscopic tubal sterilization<br>Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care | Procedure: Blood draw<br>* Decision for either treatment will be based upon clinical practice and physician/patient counseling. In addition of routine care practice, blood draws will be performed at baseline, 12 months and 60 months on subjects undergoing either an ESSURE procedure or a laparoscopic tubal sterilization.<br>Procedure: Laparoscopic tubal sterilization<br>* Decision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain: The proportion of AEs of chronic lower abdominal and/or pelvic pain after insertion of Essure System compared to the proportion of AEs of chronic lower abdominal and/or pelvic pain after laparoscopic tubal sterilization | All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship. | Up to 60 months | 
| Bleeding: The proportion of AEs of abnormal uterine bleeding (AUB) after insertion of Essure System compared to the proportion of AEs of AUB after laparoscopic tubal sterilization | All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship. | Up to 60 months | 
| Hypersensitivity / allergy / autoimmune disorders: The proportion of subjects with new onset or worsening allergic/hypersensitivity reactions and newly diagnosed or worsening autoimmune disorders in Essure vs laparoscopic tubal sterilization arms | All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship. | Up to 60 months | 
| Proportion of subjects undergoing invasive gynecologic surgery after Essure placement (excluding second placement attempts), including Essure removal compared to subjects undergoing invasive gynecologic surgery after laparoscopic tubal sterilization | All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship. | Up to 60 months | 
| Patient reported outcomes for health status | Medical Outcomes Study Short Form-36 | Up to 60 months | 
| Patient reported outcomes for pain intensity | Patient-Reported Outcomes Measurement Information System (PROMIS) scale V1.0, form ´Pain Intensity 3a´. Pain intensity is assessed via questions and ranked across 5 levels from ´No pain´ to ´Very severe pain´. | Up to 60 months | 
| Patient reported outcomes for pain interference | Patient-Reported Outcomes Measurement Information System (PROMIS) scale V1.0, form ´Pain Interference 8a´. Pain interference is assessed via questions and ranked across 5 levels from ´Not at all´ to ´Very much´. | Up to 60 months | 
| Patient reported outcomes for bleeding by AMSS | Aberdeen Menorrhagia Severity Scale (AMSS) is used to characterize bleeding. AMSS is a questionaire consisting of 13 items giving a total score from 0 (least severe) to 42 points (most severe). | Up to 60 months | 
| Patient reported outcomes for bleeding by intermenstrual bleeding questions | Two questions used to characterize intermenstrual bleeding. | Up to 60 months | 
| Patient reported outcomes for centralized pain | Assessed with the Fibromyalgia Survey Questionnaire | At baseline | 
| Patient reported outcomes on adverse events from device reports | Assessed by questionnaires to actively solicit information on adverse events found in medical device reporting (MDR) reports with Essure and control potential bias in adverse event reporting. | Up to 60 months | 
| Patient reported outcomes on media sources for their medical decisioning | Assessed by Social Media questionnaire to elicit information about sources of influence on medical decisions. | Up to 60 months | 
| Rates of AEs in subjects undergoing Essure placement and laparoscopic tubal sterilization | All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship. | Up to 60 months |