Proportion of Hysterectomy After Female Sterilization

Study Overview
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Brief Summary
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The objective of this study is to describe the proportion of hysterectomy in patients that had undergone sterilization through hysteroscopic device placement and the patients that had undergone sterilization through tubal ligation.

Official Title
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A Retrospective Analysis to Describe the Proportion of Hysterectomy After Female Sterilization With Hysteroscopic Device or Tubal Ligation Using Intermountain Healthcare Database in the US

Conditions
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Hysterectomy

Intervention / Treatment
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* Device: Hysteroscopic device placement including Essure (ESS305, BAY1454032)
* Procedure: Tubal ligation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 to 49 years at index date Gender: Female Diagnosis: Women who underwent hysteroscopic device sterilization procedure Diagnosis: Women who underwent tubal ligation sterilization procedure (includes laparoscopic tubal ligation), and salpingectomy Exclusion Criteria: Patients undergoing in-vitro fertilization (IVF) procedures Embryo transfer, intrauterine Follicle puncture for oocyte retrieval, any method

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1 / Hysteroscopic device placement<br>Patients that had undergone sterilization through hysteroscopic device placement | Device: Hysteroscopic device placement including Essure (ESS305, BAY1454032)<br>* Essure is a permanent, minimally invasive, non-hormonal implantable device used for contraception and Adiana sterilization method is a combination of controlled thermal damage to the lining of the fallopian tube followed by insertion of a non-absorbable biocompatible silicone elastomer matrix within the tubal lumen<br>|
| Cohort 2 / Tubal ligation<br>Patients that had undergone sterilization through tubal ligation | Procedure: Tubal ligation<br>* Tubal ligation or tubectomy is a surgical procedure for sterilization in which a woman's fallopian tubes are clamped and blocked, or severed and sealed, either method of which prevents eggs from reaching the uterus for implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients having hysterectomy procedure post-sterilization through hysteroscopic device placement | The study will also describe sub-outcomes related to post-sterilization hysterectomy procedure including: i. Average time (in days) from index date (sterilization) to hysterectomy ii. Percentage of patients having hysterectomy (abdominal) iii. Percentage of patients having hysterectomy (vaginal) iv. Percentage of patients having hysterectomy (laproscopically assisted vaginal hysterectomy - LAVH) v. Percentage of patients having hysterectomy (abdominal, vaginal and LAVH) | Retrospective analysis of 10 year period | 
| Percentage of patients having hysterectomy procedure post-sterilization through through tubal ligation | The study will also describe sub-outcomes related to post-sterilization hysterectomy procedure including: i. Average time (in days) from index date (sterilization) to hysterectomy ii. Percentage of patients having hysterectomy (abdominal) iii. Percentage of patients having hysterectomy (vaginal) iv. Percentage of patients having hysterectomy (laproscopically assisted vaginal hysterectomy - LAVH) v. Percentage of patients having hysterectomy (abdominal, vaginal and LAVH) | Retrospective analysis of 10 year period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sterilization, Hysteroscopic Device Placement, Tubal Ligation