NL-OMON55535RecruitingPhase 3
Cost-effectiveness of perioperative vaginally administered oestrogen in postmenopausal women undergoing prolapse surgery. - EVA trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- Postmenopausal women (>1 year amenorrhoea) with a minimum age of 18 years old
- •- Pelvic organ prolapse; POP Quantification stage 2 or higher
- •- Women that will undergo primary POP surgery with native tissue repair;
- •including at least anterior OR posterior vaginal wall repair
Exclusion Criteria
- •- Previous POP surgery in concerning compartment
- •- Prolapse repair using mesh
- •- Current vaginal infection
- •- Use of oestrogens in the past 12 months
- •- Contraindication for use of topical oestrogen
- •- Known, past or suspected oestrogen-dependent malignant tumours (e.g. breast
- •cancer, endometrial cancer);
- •- Insufficient knowledge or understanding of the Dutch language
Investigators
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