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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
990
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.
Decision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol.
Decision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 60 months
Patient reported outcomes for health status
Medical Outcomes Study Short Form-36
Time frame: Up to 60 months
Patient reported outcomes for pain intensity
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New Horizons Women's Care
Chandler, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Huntington Beach, California, United States
Orange Coast Women's Medical Group - Laguna Hills Office
Laguna Hills, California, United States
Physicians Research Options, LLC
Lakewood, Colorado, United States
The Women's Health Group, P.C.
Thornton, Colorado, United States
M & O Clinical Research, LLC
Fort Lauderdale, Florida, United States
...and 47 more locations
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´.
Time frame: 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´.
Time frame: 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).
Time frame: Up to 60 months
Patient reported outcomes for bleeding by intermenstrual bleeding questions
Two questions used to characterize intermenstrual bleeding.
Time frame: Up to 60 months
Patient reported outcomes for centralized pain
Assessed with the Fibromyalgia Survey Questionnaire
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 60 months