This study is designed to assess post-procedural outcomes for women who chose to undergo either hysteroscopic sterilization (EssureĀ®) 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
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Up to 60 months
Patient reported outcomes for health status
Timeframe: Up to 60 months
Patient reported outcomes for pain intensity
Timeframe: Up to 60 months
Patient reported outcomes for pain interference
Timeframe: Up to 60 months
Patient reported outcomes for bleeding by AMSS
Timeframe: Up to 60 months
Patient reported outcomes for bleeding by intermenstrual bleeding questions
Timeframe: Up to 60 months
Patient reported outcomes for centralized pain
Timeframe: At baseline
Patient reported outcomes on adverse events from device reports
Timeframe: Up to 60 months
Patient reported outcomes on media sources for their medical decisioning
Timeframe: Up to 60 months
Rates of AEs in subjects undergoing Essure placement and laparoscopic tubal sterilization
Timeframe: Up to 60 months