Contraception
Conditions
Brief summary
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
Interventions
PROCEDUREBlood draw
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.
DEVICEESSURE (BAY1454032)
Decision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol.
PROCEDURELaparoscopic tubal sterilization
Decision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol.
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Reporting AEs of Chronic Lower Abdominal and/or Pelvic Pain After Insertion of Essure System or After Laparoscopic Tubal Sterilization | Up to 60 months | The proportion of subjects reporting AEs of chronic lower abdominal and / or pelvic pain after insertion of Essure System compared to the proportion of subjects reporting AEs of chronic lower abdominal and / or pelvic pain after laparoscopic tubal sterilization. Statistical analyses were exploratory and descriptive in nature and no confirmatory hypothesis testing was intended to be performed; p-values were to be interpreted as a metric for uncertainty (note: no analysis included in this final analysis provides p-values). Therefore, no adjustment for multiplicity was necessary. All endpoints and variables were analyzed by descriptive statistical methods. |
| Bleeding: The Proportion of Subjects Reporting AEs of Abnormal Uterine Bleeding (AUB) After Insertion of Essure System Compared to the Proportion of Subjects Reporting AEs of AUB After Laparoscopic Tubal Sterilization | Up to 60 months | Incidence of new onset or worsening abnormal bleeding events was based on AE reporting. If a potential bleeding AE was reported at a scheduled visit or if the subject spontaneously reports such an event to the site at some other time, the event was to be evaluated per standard AE assessment. If during the course of a scheduled PRO administration the subject indicated that she experienced abnormal bleeding that reached a preset threshold on the questionnaire, the investigator was alerted and instructed to investigate this finding in order to determine whether or not an AE occurred. |
| Proportion of Subjects With Reported Allergic/Hypersensitivity Reactions | Up to 60 months | For potential allergic/hypersensitivity reactions, investigators were instructed that an evaluation was to be performed in subjects who presented with symptoms that could have possibly been related to an inflammatory reaction. After the evaluation of the subject was complete, regardless of the investigator's assessment as to whether or not a hypersensitivity/allergic reaction had occurred, all information was to be forwarded to the Adjudication Committee in a blinded fashion. Final determination of whether or not a hypersensitivity/allergic event had occurred was based on the determination of this committee. |
| Proportion of Subjects With Newly Diagnosed or Worsening Autoimmune Disorders | Up to 60 months | Any subject presenting with symptoms indicating a potential autoimmune disorder was to be evaluated per standard medical practice. All effort was to be made to obtain records of any diagnostic workup conducted by outside physicians. NiLPT, chromium LPT, serum or plasma nickel level, and serum or plasma titanium level and serum inflammatory cytokines samples were also to be drawn by the study site. An appropriate human leukocyte antigen (HLA) panel was to be run on previously obtained baseline samples if sufficient sample existed. After the evaluation of the subject was complete, all information was to be forwarded to the adjudication committee in a blinded fashion, regardless of investigator's assessment as to whether or not an autoimmune disorder existed. Final determination of whether or not an autoimmune disorder had occurred was based on the determination of this committee. |
| 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 | Up to 60 months | — |
Countries
United States
Contacts
STUDY_DIRECTORBayer Study Director
Bayer
Participant flow
Recruitment details
The study was conducted at 60 study centers in United States between 03-May-2017 (first participant first visit) and 31-Dec-2024 (last participant last visit).
Pre-assignment details
990 subjects at 60 investigational sites in U.S. (285 in the Essure group and 705 in the LTS group) signed informed consent and attended the procedure visit. Of those, 280 and 705 had the procedure attempted. Allocation of procedure to a subject was driven by patient preference. Allocation bias must, therefore, be assumed as consequent potential for confounding. This study is not designed or powered to detect statistical differences.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 35.3 Years STANDARD_DEVIATION 5.47 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants |
| Race (NIH/OMB) More than one race | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 40 Participants |
| Race (NIH/OMB) White | 788 Participants |
| Sex: Female, Male Female | 280 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 285 | 0 / 705 |
| other Total, other adverse events | 165 / 285 | 369 / 705 |
| serious Total, serious adverse events | 18 / 285 | 36 / 705 |
Outcome results
None listed