Comparing Vaginal Estrogen - Twice Weekly with Vaginal Estrogen for pelvic organ prolapse (POP)

Inclusion

• +Age ≥18 years at the time of consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
• +Patients who are hypersensitive to the drug or to any ingredient in the formulation or component of the container.
• +Participants must meet all the following inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → to be eligible for enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → into the study:
• +Participant who, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, can and will comply with the requirements of the protocolProtocolThe detailed plan a study must follow.Read more →.
• +The participant has given written consent after the study has been explained according to local regulatory requirements and before any study specific procedures.
• +Undergoing an apical suspension (vaginal or abdominal, mesh or native tissue) for pelvic organ prolapse at one of the participating centers.
• +Willing to complete surveys related to demographics, pelvic health and function, and sexual health and function.
• +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
• +Any individual meeting any of the following criteria is not eligible for participation in this study:
• +Participant undergoing anterior and/or posterior repair only (no apical prolapse repair).
• +Participant undergoing obliterative procedures.
• +Participant with a contraindication to vaginal estrogen use, including but not limited to the following list, at the discretion of the study investigator:
• +Liver dysfunction or disease as long as liver function tests have failed to return to normal.
• +Known or suspected estrogen-dependent malignant neoplasia (e.g. endometrial cancer).
• +Endometrial hyperplasia.
• +Known, suspected, or past history of breast cancer.
• +Undiagnosed abnormal genital bleeding.
• +Active or past history of arterial thromboembolic disease (e.g. stroke, myocardial infarction, coronary heart disease).
• +Partial or complete loss of vision due to ophthalmic vascular disease.
• +Known thrombophilic disorders (e.g., protein C, protein S OR antithrombin deficiency); prothrombin mutation or anticardiolipin antibodies).
• +Any conditions that, in the Investigator's judgement, may interfere with participant's ability to comply with study procedures or receipt of care, such as behavioral or cognitive impairment or neuropsychiatric illness.
• +Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product.
• +Known or suspected pregnancy
• +Primary or recurrent prolapse surgery without a history of mesh surgery.
• +Plans to reside in the study area for at least 2 years after their surgery.
• +Participant with a history of mesh surgery for prolapse.
• +Participant undergoing uterine sparing surgery.