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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
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...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9293194/ https://www.ncbi.nlm.nih.gov/pubmed/34464489 http://dx.doi.org/10.1111/1471-0528.16894 |
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author | Marschalek, M‐L Bodner, K Kimberger, O Zehetmayer, S Morgenbesser, R Dietrich, W Obruca, C Husslein, H Umek, W Koelbl, H Bodner‐Adler, B |
author_facet | Marschalek, M‐L Bodner, K Kimberger, O Zehetmayer, S Morgenbesser, R Dietrich, W Obruca, C Husslein, H Umek, W Koelbl, H Bodner‐Adler, B |
author_sort | Marschalek, M‐L |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9293194 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-92931942022-07-20 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 Zehetmayer, S Morgenbesser, R Dietrich, W Obruca, C Husslein, H Umek, W Koelbl, H Bodner‐Adler, B BJOG Randomised Controlled Trial 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. John Wiley and Sons Inc. 2021-09-21 2021-12 /pmc/articles/PMC9293194/ /pubmed/34464489 http://dx.doi.org/10.1111/1471-0528.16894 Text en © 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Randomised Controlled Trial Marschalek, M‐L Bodner, K Kimberger, O Zehetmayer, S Morgenbesser, R Dietrich, W Obruca, C Husslein, H Umek, W Koelbl, H Bodner‐Adler, B 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 |
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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Randomised Controlled Trial |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9293194/ https://www.ncbi.nlm.nih.gov/pubmed/34464489 http://dx.doi.org/10.1111/1471-0528.16894 |
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