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; Sandra E Zwolsman; Astrid Vollebregt; Ruben G Duijnhoven; Judith E Bosmans; Leonie Speksnijder; Eveline J Roos; Wilbert Spaans; Franca Gerards; Albert Adriaanse; Flora Vernooij; Alfredo L Milani; Marko Sikkema; Mirjam Weemhoff; Marieke Mous; Anne Damoiseaux; Heleen van Dongen; Marinus V/D Ploeg; Joggem Veen; Geerte van de Pol; Bart Broekman; Pieternel Steures; Fernando Tjin-Asjoe; Jolande van der Stege; Ronald Mouw; Carl H van der Vaart; Jan-Paul W R Roovers

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^*, Sandra E Zwolsman, Astrid Vollebregt, Ruben G Duijnhoven, Judith E Bosmans, Leonie Speksnijder, Eveline J Roos, Wilbert Spaans, Franca Gerards, Albert Adriaanse, Flora Vernooij, Alfredo L Milani, Marko Sikkema, Mirjam Weemhoff, Marieke Mous, Anne Damoiseaux, Heleen van Dongen, Marinus V/D Ploeg, Joggem Veen, Geerte van de PolBart Broekman, Pieternel Steures, Fernando Tjin-Asjoe, Jolande van der Stege, Ronald Mouw, Carl H van der Vaart, Jan-Paul W R Roovers

^*Corresponding author for this work

Research output: Contribution to Journal › Article › Academic › peer-review

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.

Original language	English
Article number	439
Pages (from-to)	1-10
Number of pages	10
Journal	BMC Women's Health
Volume	21
Issue number	1
DOIs	https://doi.org/10.1186/s12905-021-01587-9
Publication status	Published - 31 Dec 2021

Bibliographical note

Funding

This is an investigator initiated study, the Amsterdam University Medical Center – location AMC is the sponsor (contact information scientific queries: Prof. J.P.W.R. Roovers, department of Obstetrics and Gynecology, Meibergdreef 9, 1105 AZ Amsterdam, email: [email protected]). The study received an unrestricted grant from the ‘Leading the Change’ program from Stichting Zorgevaluatie Nederland (project number 80-85009-98-1009), a Dutch foundation that consist of the Dutch Medical Specialists Federation, the Dutch Health Insurers and the Dutch Patient Federation. Before receiving this grant, this study protocol was externally peer-reviewed by the Dutch organization for Health Research and Development (ZonMW), which is a governmental funding organization. Aspen Pharmacare provided the trial drug and placebo used for this trial. The design, management, analysis and reporting of the study are entirely independent of Stichting Zorgevaluatie Nederland and Aspen Pharmacare. We thank all staff members, and in particular T. van Hengel, from the Dutch Consortium for Healthcare Evaluation and Research in Obstetrics and Gynecology - NVOG Consortium 2.0.

Funders	Funder number
Dutch Consortium for Healthcare Evaluation and Research in Obstetrics and Gynecology
Dutch Health Insurers and the Dutch Patient Federation
Dutch foundation that consist of the Dutch Medical Specialists Federation
Dutch Organization for Health Research and Development
Stichting Zorgevaluatie Nederland	80-85009-98-1009
ZonMw

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Vodegel, E. V., Zwolsman, S. E., Vollebregt, A., Duijnhoven, R. G., Bosmans, J. E., Speksnijder, L., Roos, E. J., Spaans, W., Gerards, F., Adriaanse, A., Vernooij, F., Milani, A. L., Sikkema, M., Weemhoff, M., Mous, M., Damoiseaux, A., van Dongen, H., V/D Ploeg, M., Veen, J., ... Roovers, J.-P. W. R. (2021). 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. BMC Women's Health, 21(1), 1-10. Article 439. https://doi.org/10.1186/s12905-021-01587-9

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title = "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",

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.",

author = "Vodegel, {Eva V} and Zwolsman, {Sandra E} and Astrid Vollebregt and Duijnhoven, {Ruben G} and Bosmans, {Judith E} and Leonie Speksnijder and Roos, {Eveline J} and Wilbert Spaans and Franca Gerards and Albert Adriaanse and Flora Vernooij and Milani, {Alfredo L} and Marko Sikkema and Mirjam Weemhoff and Marieke Mous and Anne Damoiseaux and {van Dongen}, Heleen and {V/D Ploeg}, Marinus and Joggem Veen and {van de Pol}, Geerte and Bart Broekman and Pieternel Steures and Fernando Tjin-Asjoe and {van der Stege}, Jolande and Ronald Mouw and {van der Vaart}, {Carl H} and Roovers, {Jan-Paul W R}",

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doi = "10.1186/s12905-021-01587-9",

language = "English",

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journal = "BMC Women's Health",

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Vodegel, EV, Zwolsman, SE, Vollebregt, A, Duijnhoven, RG, Bosmans, JE, Speksnijder, L, Roos, EJ, Spaans, W, Gerards, F, Adriaanse, A, Vernooij, F, Milani, AL, Sikkema, M, Weemhoff, M, Mous, M, Damoiseaux, A, van Dongen, H, V/D Ploeg, M, Veen, J, van de Pol, G, Broekman, B, Steures, P, Tjin-Asjoe, F, van der Stege, J, Mouw, R, van der Vaart, CH & Roovers, J-PWR 2021, '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', BMC Women's Health, vol. 21, no. 1, 439, pp. 1-10. https://doi.org/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. / Vodegel, Eva V; Zwolsman, Sandra E; Vollebregt, Astrid et al.
In: BMC Women's Health, Vol. 21, No. 1, 439, 31.12.2021, p. 1-10.

Research output: Contribution to Journal › Article › Academic › peer-review

TY - JOUR

T1 - Cost-Effectiveness of perioperative Vaginally Administered estrogen in postmenopausal women undergoing prolapse surgery (EVA trial)

T2 - study protocol for a multicenter double-blind randomized placebo-controlled trial

AU - Vodegel, Eva V

AU - Zwolsman, Sandra E

AU - Vollebregt, Astrid

AU - Duijnhoven, Ruben G

AU - Bosmans, Judith E

AU - Speksnijder, Leonie

AU - Roos, Eveline J

AU - Spaans, Wilbert

AU - Gerards, Franca

AU - Adriaanse, Albert

AU - Vernooij, Flora

AU - Milani, Alfredo L

AU - Sikkema, Marko

AU - Weemhoff, Mirjam

AU - Mous, Marieke

AU - Damoiseaux, Anne

AU - van Dongen, Heleen

AU - V/D Ploeg, Marinus

AU - Veen, Joggem

AU - van de Pol, Geerte

AU - Broekman, Bart

AU - Steures, Pieternel

AU - Tjin-Asjoe, Fernando

AU - van der Stege, Jolande

AU - Mouw, Ronald

AU - van der Vaart, Carl H

AU - Roovers, Jan-Paul W R

PY - 2021/12/31

Y1 - 2021/12/31

N2 - 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.

AB - 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.

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DO - 10.1186/s12905-021-01587-9

M3 - Article

C2 - 34972504

SN - 1472-6874

VL - 21

SP - 1

EP - 10

JO - BMC Women's Health

JF - BMC Women's Health

IS - 1

M1 - 439

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Vodegel EV, Zwolsman SE, Vollebregt A, Duijnhoven RG, Bosmans JE, Speksnijder L et al. 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. BMC Women's Health. 2021 Dec 31;21(1):1-10. 439. doi: 10.1186/s12905-021-01587-9