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Randomized Controlled Trial
. 2021 Dec;128(13):2200-2208.
doi: 10.1111/1471-0528.16894. Epub 2021 Sep 21.

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  1 , K Bodner  1 , O Kimberger  2 , S Zehetmayer  3 , R Morgenbesser  1 , W Dietrich  4 , C Obruca  4 , H Husslein  1 , W Umek  1   5 , H Koelbl  1 , B Bodner-Adler  1   5
Affiliations
Randomized Controlled Trial

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 et al. BJOG. 2021 Dec.

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: Local estrogen therapy; pelvic organ prolapse; postmenopausal women.

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Figures

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Figure 1
Flow of participants through the trial.
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References

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