Does preoperative locally applied estrogen treatment facilitate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse?: A randomised controlled double-masked, placebo-controlled, multicentre study

M-L Marschalek; K Bodner; O Kimberger; S Zehetmayer; R Morgenbesser; W Dietrich; C Obruca; H Husslein; W Umek; H Koelbl; B Bodner-Adler

doi:10.1111/1471-0528.16894

Does preoperative locally applied estrogen treatment facilitate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse? A randomised controlled double-masked, placebo-controlled, multicentre study

M-L Marschalek, K Bodner, O Kimberger, S Zehetmayer, R Morgenbesser, W Dietrich, C Obruca, H Husslein, W Umek, H Koelbl, B Bodner-Adler

Division of Gynaecology and Obstetrics (University Hospital Tulln)

Research output: Journal article (peer-reviewed) › Journal article

10 Citations (Scopus)

Abstract

OBJECTIVE: To evaluate whether locally applied vaginal estrogen affects prolapse-associated complaints compared with placebo treatment in postmenopausal women prior to surgical prolapse repair.

DESIGN: Randomised, double-masked, placebo-controlled, multicentre study.

SETTING: Urogynaecology unit at the Medical University of Vienna and University Hospital of Tulln.

POPULATION: Postmenopausal women with symptomatic pelvic organ prolapse and planned surgical prolapse repair.

METHODS: Women were randomly assigned local estrogen cream or placebo cream 6 weeks preoperatively.

MAIN OUTCOME MEASURES: The primary outcome was differences in subjective prolapse-associated complaints after 6 weeks of treatment prior to surgery, assessed with the comprehensive German pelvic floor questionnaire. Secondary outcomes included differences in other pelvic floor-associated complaints (bladder, bowel or sexual function).

RESULTS: Out of 120 women randomised, 103 (86%) remained for the final analysis. After 6 weeks of treatment the prolapse domain score did not differ between the estrogen and the placebo groups (4.4 ± 0.19 versus 4.6 ± 0.19; mean difference, -0.21; 95% CI -0.74 to 0.33; P = 0.445). Multivariate analysis, including only women receiving the intervention, showed that none of the confounding factors modified the response to estradiol.

CONCLUSIONS: These results demonstrate that preoperative locally applied estrogen does not ameliorate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse.

TWEETABLE ABSTRACT: Preoperative local estrogen does not ameliorate prolapse-associated symptoms in postmenopausal women with pelvic organ prolapse.

Original language	English
Pages (from-to)	2200-2208
Number of pages	9
Journal	BJOG: An International Journal of Obstetrics and Gynaecology
Volume	128
Issue number	13
DOIs	https://doi.org/10.1111/1471-0528.16894
Publication status	Published - Dec 2021

Keywords

Administration, Intravaginal
Aged
Double-Blind Method
Estradiol/blood
Estrogens/administration & dosage
Estrogens, Conjugated (USP)/administration & dosage
Female
Humans
Intraoperative Care/methods
Middle Aged
Pelvic Floor/physiopathology
Pelvic Organ Prolapse/drug therapy
Postmenopause
Prospective Studies
Treatment Outcome

Access to Document

10.1111/1471-0528.16894

Fingerprint

Dive into the research topics of 'Does preoperative locally applied estrogen treatment facilitate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse? A randomised controlled double-masked, placebo-controlled, multicentre study'. Together they form a unique fingerprint.

Cite this

Marschalek, M.-L., Bodner, K., Kimberger, O., Zehetmayer, S., Morgenbesser, R., Dietrich, W., Obruca, C., Husslein, H., Umek, W., Koelbl, H., & Bodner-Adler, B. (2021). Does preoperative locally applied estrogen treatment facilitate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse? A randomised controlled double-masked, placebo-controlled, multicentre study. BJOG: An International Journal of Obstetrics and Gynaecology, 128(13), 2200-2208. https://doi.org/10.1111/1471-0528.16894

Marschalek, M-L ; Bodner, K ; Kimberger, O et al. / Does preoperative locally applied estrogen treatment facilitate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse? A randomised controlled double-masked, placebo-controlled, multicentre study. In: BJOG: An International Journal of Obstetrics and Gynaecology. 2021 ; Vol. 128, No. 13. pp. 2200-2208.

@article{9176225d8db5475da9dc6eab357a0ed5,

title = "Does preoperative locally applied estrogen treatment facilitate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse?: A randomised controlled double-masked, placebo-controlled, multicentre study",

abstract = "OBJECTIVE: To evaluate whether locally applied vaginal estrogen affects prolapse-associated complaints compared with placebo treatment in postmenopausal women prior to surgical prolapse repair.DESIGN: Randomised, double-masked, placebo-controlled, multicentre study.SETTING: Urogynaecology unit at the Medical University of Vienna and University Hospital of Tulln.POPULATION: Postmenopausal women with symptomatic pelvic organ prolapse and planned surgical prolapse repair.METHODS: Women were randomly assigned local estrogen cream or placebo cream 6 weeks preoperatively.MAIN OUTCOME MEASURES: The primary outcome was differences in subjective prolapse-associated complaints after 6 weeks of treatment prior to surgery, assessed with the comprehensive German pelvic floor questionnaire. Secondary outcomes included differences in other pelvic floor-associated complaints (bladder, bowel or sexual function).RESULTS: Out of 120 women randomised, 103 (86%) remained for the final analysis. After 6 weeks of treatment the prolapse domain score did not differ between the estrogen and the placebo groups (4.4 ± 0.19 versus 4.6 ± 0.19; mean difference, -0.21; 95% CI -0.74 to 0.33; P = 0.445). Multivariate analysis, including only women receiving the intervention, showed that none of the confounding factors modified the response to estradiol.CONCLUSIONS: These results demonstrate that preoperative locally applied estrogen does not ameliorate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse.TWEETABLE ABSTRACT: Preoperative local estrogen does not ameliorate prolapse-associated symptoms in postmenopausal women with pelvic organ prolapse.",

keywords = "Administration, Intravaginal, Aged, Double-Blind Method, Estradiol/blood, Estrogens/administration & dosage, Estrogens, Conjugated (USP)/administration & dosage, Female, Humans, Intraoperative Care/methods, Middle Aged, Pelvic Floor/physiopathology, Pelvic Organ Prolapse/drug therapy, Postmenopause, Prospective Studies, Treatment Outcome",

author = "M-L Marschalek and K Bodner and O Kimberger and S Zehetmayer and R Morgenbesser and W Dietrich and C Obruca and H Husslein and W Umek and H Koelbl and B Bodner-Adler",

note = "Publisher Copyright: {\textcopyright} 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.",

year = "2021",

month = dec,

doi = "10.1111/1471-0528.16894",

language = "English",

volume = "128",

pages = "2200--2208",

journal = "BJOG: An International Journal of Obstetrics and Gynaecology",

issn = "1470-0328",

publisher = "Wiley-Blackwell Publishing Ltd",

number = "13",

}

Marschalek, M-L, Bodner, K, Kimberger, O, Zehetmayer, S, Morgenbesser, R, Dietrich, W , Obruca, C, Husslein, H, Umek, W, Koelbl, H & Bodner-Adler, B 2021, 'Does preoperative locally applied estrogen treatment facilitate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse? A randomised controlled double-masked, placebo-controlled, multicentre study', BJOG: An International Journal of Obstetrics and Gynaecology, vol. 128, no. 13, pp. 2200-2208. https://doi.org/10.1111/1471-0528.16894

Does preoperative locally applied estrogen treatment facilitate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse? A randomised controlled double-masked, placebo-controlled, multicentre study. / Marschalek, M-L; Bodner, K; Kimberger, O et al.
In: BJOG: An International Journal of Obstetrics and Gynaecology, Vol. 128, No. 13, 12.2021, p. 2200-2208.

Research output: Journal article (peer-reviewed) › Journal article

TY - JOUR

T1 - Does preoperative locally applied estrogen treatment facilitate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse?

T2 - A randomised controlled double-masked, placebo-controlled, multicentre study

AU - Marschalek, M-L

AU - Bodner, K

AU - Kimberger, O

AU - Zehetmayer, S

AU - Morgenbesser, R

AU - Dietrich, W

AU - Obruca, C

AU - Husslein, H

AU - Umek, W

AU - Koelbl, H

AU - Bodner-Adler, B

PY - 2021/12

Y1 - 2021/12

N2 - OBJECTIVE: To evaluate whether locally applied vaginal estrogen affects prolapse-associated complaints compared with placebo treatment in postmenopausal women prior to surgical prolapse repair.DESIGN: Randomised, double-masked, placebo-controlled, multicentre study.SETTING: Urogynaecology unit at the Medical University of Vienna and University Hospital of Tulln.POPULATION: Postmenopausal women with symptomatic pelvic organ prolapse and planned surgical prolapse repair.METHODS: Women were randomly assigned local estrogen cream or placebo cream 6 weeks preoperatively.MAIN OUTCOME MEASURES: The primary outcome was differences in subjective prolapse-associated complaints after 6 weeks of treatment prior to surgery, assessed with the comprehensive German pelvic floor questionnaire. Secondary outcomes included differences in other pelvic floor-associated complaints (bladder, bowel or sexual function).RESULTS: Out of 120 women randomised, 103 (86%) remained for the final analysis. After 6 weeks of treatment the prolapse domain score did not differ between the estrogen and the placebo groups (4.4 ± 0.19 versus 4.6 ± 0.19; mean difference, -0.21; 95% CI -0.74 to 0.33; P = 0.445). Multivariate analysis, including only women receiving the intervention, showed that none of the confounding factors modified the response to estradiol.CONCLUSIONS: These results demonstrate that preoperative locally applied estrogen does not ameliorate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse.TWEETABLE ABSTRACT: Preoperative local estrogen does not ameliorate prolapse-associated symptoms in postmenopausal women with pelvic organ prolapse.

AB - OBJECTIVE: To evaluate whether locally applied vaginal estrogen affects prolapse-associated complaints compared with placebo treatment in postmenopausal women prior to surgical prolapse repair.DESIGN: Randomised, double-masked, placebo-controlled, multicentre study.SETTING: Urogynaecology unit at the Medical University of Vienna and University Hospital of Tulln.POPULATION: Postmenopausal women with symptomatic pelvic organ prolapse and planned surgical prolapse repair.METHODS: Women were randomly assigned local estrogen cream or placebo cream 6 weeks preoperatively.MAIN OUTCOME MEASURES: The primary outcome was differences in subjective prolapse-associated complaints after 6 weeks of treatment prior to surgery, assessed with the comprehensive German pelvic floor questionnaire. Secondary outcomes included differences in other pelvic floor-associated complaints (bladder, bowel or sexual function).RESULTS: Out of 120 women randomised, 103 (86%) remained for the final analysis. After 6 weeks of treatment the prolapse domain score did not differ between the estrogen and the placebo groups (4.4 ± 0.19 versus 4.6 ± 0.19; mean difference, -0.21; 95% CI -0.74 to 0.33; P = 0.445). Multivariate analysis, including only women receiving the intervention, showed that none of the confounding factors modified the response to estradiol.CONCLUSIONS: These results demonstrate that preoperative locally applied estrogen does not ameliorate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse.TWEETABLE ABSTRACT: Preoperative local estrogen does not ameliorate prolapse-associated symptoms in postmenopausal women with pelvic organ prolapse.

KW - Administration, Intravaginal

KW - Aged

KW - Double-Blind Method

KW - Estradiol/blood

KW - Estrogens/administration & dosage

KW - Estrogens, Conjugated (USP)/administration & dosage

KW - Female

KW - Humans

KW - Intraoperative Care/methods

KW - Middle Aged

KW - Pelvic Floor/physiopathology

KW - Pelvic Organ Prolapse/drug therapy

KW - Postmenopause

KW - Prospective Studies

KW - Treatment Outcome

UR - http://www.scopus.com/inward/record.url?scp=85115155182&partnerID=8YFLogxK

U2 - 10.1111/1471-0528.16894

DO - 10.1111/1471-0528.16894

M3 - Journal article

C2 - 34464489

SN - 1470-0328

VL - 128

SP - 2200

EP - 2208

JO - BJOG: An International Journal of Obstetrics and Gynaecology

JF - BJOG: An International Journal of Obstetrics and Gynaecology

IS - 13

ER -

Marschalek ML, Bodner K, Kimberger O, Zehetmayer S, Morgenbesser R, Dietrich W et al. Does preoperative locally applied estrogen treatment facilitate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse? A randomised controlled double-masked, placebo-controlled, multicentre study. BJOG: An International Journal of Obstetrics and Gynaecology. 2021 Dec;128(13):2200-2208. doi: 10.1111/1471-0528.16894