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. 2021 Dec 31;21(1):439.
doi: 10.1186/s12905-021-01587-9.

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 Vodegel  1 , Sandra E Zwolsman  2 , Astrid Vollebregt  3 , Ruben G Duijnhoven  4 , Judith E Bosmans  5 , Leonie Speksnijder  6 , Eveline J Roos  7 , Wilbert Spaans  8 , Franca Gerards  9 , Albert Adriaanse  10 , Flora Vernooij  11 , Alfredo L Milani  12 , Marko Sikkema  13 , Mirjam Weemhoff  14 , Marieke Mous  15 , Anne Damoiseaux  16 , Heleen van Dongen  17 , Marinus V/D Ploeg  18 , Joggem Veen  19 , Geerte van de Pol  20 , Bart Broekman  21 , Pieternel Steures  22 , Fernando Tjin-Asjoe  23 , Jolande van der Stege  24 , Ronald Mouw  25 , Carl H van der Vaart  26 , Jan-Paul W R Roovers  2   27
Affiliations

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 Vodegel et al. BMC Womens Health. .

Abstract

Background: Surgery for pelvic organ prolapse (POP) is associated with high recurrence rates. The costs associated with the treatment of recurrent POP are huge, and the burden from women who encounter recurrent POP, negatively impacts their quality of life. Estrogen therapy might improve surgical outcome for POP due to its potential beneficial effects. It is thought that vaginal estrogen therapy improves healing and long-term maintenance of connective tissue integrity. Hence, this study aims to evaluate the cost-effectiveness of perioperative vaginal estrogen therapy in postmenopausal women undergoing POP surgery.

Methods: The EVA trial is a multi-center double-blind randomized placebo-controlled trial conducted in the Netherlands comparing the effectiveness and costs-effectiveness of vaginal estrogen therapy. This will be studied in 300 postmenopausal women undergoing primary POP surgery, with a POP-Q stage of ≥ 2. After randomization, participants administer vaginal estrogen cream or placebo cream from 4 to 6 weeks preoperative until 12 months postoperative. The primary outcome is subjective improvement of POP symptoms at 1 year follow-up, measured with the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcomes are POP-Q anatomy in all compartments, re-interventions, surgery related complications, general and disease specific quality of life, sexual function, signs and complaints of vaginal atrophy, vaginal pH, adverse events, costs, and adherence to treatment. Follow up is scheduled at 6 weeks, 6 months and 12 months postoperative. Data will be collected using validated questionnaires and out-patient visits including gynecological examination performed by an independent gynecologist.

Discussion: 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.

Keywords: Cost-effectiveness; Pelvic organ prolapse; Pelvic reconstructive surgery; Postmenopausal; Recurrence; Vaginal estrogen therapy; Wound healing.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study design: schedule of enrolment, interventions and assessments. EQ-5D-5L emotional quotient, 5 dimensions, 5 levels, iMCQ Medical Consumption Questionnaire, iPCQ Productivity Cost Questionnaire, PFDI-20 Pelvic Floor Disability Index-20, PFIQ-7 Pelvic Floor Impact Questionnaire-7, PGI-I Patient Global Impression of Improvement, PISQ-IR Pelvic organ prolapse Incontinence Sexual Questionnaire-IR, POP Pelvic Organ Prolapse, POP-Q Pelvic Organ Prolapse Quantification
See this image and copyright information in PMC

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