Cost-Effectiveness of perioperative Vaginally Administered estrogen in postmenopausal women undergoing prolapse surgery (EVA trial): study protocol for a multicenter double-blind randomized placebo-controlled trial.
Eva V VodegelSandra E ZwolsmanAstrid VollebregtRuben G DuijnhovenJudith E BosmansLeonie SpeksnijderEveline J RoosWilbert SpaansFranca GerardsAlbert AdriaanseFlora VernooijAlfredo L MilaniMarko SikkemaMirjam WeemhoffMarieke MousAnne DamoiseauxHeleen van DongenMarinus V/D PloegJoggem VeenGeerte van de PolBart BroekmanPieternel SteuresFernando Tjin-AsjoeJolande van der StegeRonald MouwCarl H van der VaartJan-Paul W R RooversPublished in: BMC women's health (2021)
This study investigates whether perioperative vaginal estrogen will be cost-effective in the surgical treatment of POP in postmenopausal women. It is hypothesized that estrogen therapy will show a reduction in recurrent POP symptoms and a reduction in reoperations for POP, with subsequent improved quality of life among women and cost savings. Trial registrationNetherlands Trial Registry: NL6853; registered 19-02-2018, https://www.trialregister.nl/trial/6853 . EudraCT: 2017-003144-21; registered: 24-07-2017.
Keyphrases
- postmenopausal women
- phase iii
- double blind
- phase ii
- placebo controlled
- study protocol
- clinical trial
- bone mineral density
- open label
- randomized controlled trial
- cardiac surgery
- estrogen receptor
- patients undergoing
- minimally invasive
- acute kidney injury
- stem cells
- type diabetes
- cross sectional
- physical activity
- replacement therapy