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, Marie-Louise; Bodner‐Adler, Barbara; Kimberger, Oliver; Zehetmayer, Sonja; Morgenbesser, Raffaela; Dietrich, Wulf; Obruca, Christian; Husslein, H; Umek, Wolfgang; Koelbl, Heinz

doi:10.1111/1471-0528.16894

Cited by 11 publications

(5 citation statements)

References 34 publications

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“…In addition, such subjective improvement is not accompanied by other objective changes. Again, this is in line with previous trials including sham controls, both on laser therapy, as well as repeated vaginal estrogen applications 3,12,13,26–30 . Sham vaginal manipulations also induce measurable effects on vaginal biopsies in different animal models, including in a recent study in the ewe 31–34 .…”

Section: Discussionsupporting

confidence: 86%

“…Again, this is in line with previous trials including sham controls, both on laser therapy, as well as repeated vaginal estrogen applications. 3,12,13,[26][27][28][29][30] Sham vaginal manipulations also induce measurable effects on vaginal biopsies in different animal models, including in a recent study in the [31][32][33][34] Since the start of our trial, five other clinical RCTs have compared the effect of laser and sham manipulation, though four of them have notable limitations. [10][11][12][13][14] Ruanphoo and Bunyavejchevin 10 and Salvatore et al 11 reported improvement either in the VHIS or VAS after laser, but only in the short term (16 weeks from baseline).…”

Section: Discussionmentioning

confidence: 99%

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Laser versus sham for genitourinary syndrome of menopause: A randomised controlled trial

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Verbakel

Verhaeghe

et al. 2022

BJOG

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Objective To assess whether CO2 laser treatment is more effective than sham application in relieving the most bothersome symptom (MBS) in women with genitourinary syndrome of menopause (GSM). Design Single‐centre, sham‐controlled, double‐blind, randomised trial. Setting A tertiary centre in Belgium. Population Sixty women with moderate to severe GSM symptoms. Methods All participants eventually received three consecutive laser and three consecutive sham applications, either first laser followed by sham, or conversely. Main outcome measures The primary outcome was the participant‐reported change in severity of the MBS at 12 weeks. Secondary outcomes included subjective (patient satisfaction, sexual function, urinary function) and objective (pH, Vaginal Health Index Score, in vivo microscopy) measurements assessing the short‐term effect and the longevity of treatment effects at 18 months after start of the therapy. Adverse events were reported at every visit. Results The MBS severity score decreased from 2.86 ± 0.35 to 2.17 ± 0.93 (−23.60%; 95% CI −36.10% to −11.10%) in women treated with laser compared with 2.90 ± 0.31 to 2.52 ± 0.78 (−13.20%; 95% CI −22.70% to −3.73%) in those receiving sham applications (p = 0.13). There were no serious adverse events reported up to 18 months. Conclusions In women with GSM, the treatment response 12 weeks after laser application was comparable to that of sham applications. There were no obvious differences for secondary outcomes and no serious adverse events were reported.

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Section: Discussionsupporting

confidence: 86%

Section: Discussionmentioning

confidence: 99%

Laser versus sham for genitourinary syndrome of menopause: A randomised controlled trial

Page

Verbakel

Verhaeghe

et al. 2022

BJOG

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“…However, application of estrogen to facilitate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse remains controversial. Other reports showed that preoperative local estrogen cream does not ameliorate prolapse-associated symptoms in postmenopausal women with pelvic organ prolapse ( Marschalek et al, 2021 ). However, a 30-day oral estrogen therapy in postmenopausal women with or without prolapse found that hyaluronic acid, a predominant component of the ECM-sulfated glycosaminoglycan-in the parametrium and vaginal apex of women, was increased in the parametrium of women receiving estrogen compared to those treated with the placebo ( Nunes et al, 2011 ).…”

Section: Discussionmentioning

confidence: 99%

The protective effect of 17 β-estradiol on human uterosacral ligament fibroblasts from postmenopausal women with pelvic organ prolapse

Xie

Guo

et al. 2022

Front. Physiol.

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This study aims to explore the protective effects of 17 β-estradiol on the human uterosacral ligament fibroblasts (hUSLFs) under static or stretched conditions. The experiments were performed on hUSLFs derived from pelvic organ prolapse (POP) and non-POP patients. Fibroblasts were cultured after collagenase digestion and identified by morphological observation and immunocytochemical methods. 17 β-estradiol (10−10 M and 10−9 M) and mechanical stress induced by the FX-5000 T-cell stress loading system under a loading strain of 1/2 sin waveform uniaxial cyclic stress with a tensile strain of 20% and a frequency of 0.5 Hz were either or both applied on hUSLFs. Cell proliferation was measured by CCK8, and cell apoptosis and death were detected using Annexin V/7-AAD staining and flow cytometric analysis. We found that the fibroblasts growth rate of POP patients was significantly lower than controls. The cell apoptosis and death rate increased as the mechanical load intensifying. After 20% mechanical stretching for 24 h, the dead cell rate was higher in POP than control. Notably, 17 β-estradiol treatment reversed mechanical stress induced hUSLFs apoptosis and death in both POP and Control cells. The protein and mRNA levels of anti-apoptotic PARP1 (poly-ADP-ribose polymerase) and Bcl-2 were increased by estrogen treatment. Meanwhile, expression of estrogen receptor α, a target of Poly-ADP-Ribosylation of PARP1, was also enhanced by 17 β-estradiol under the mechanical load. In conclusion, estrogen application ameliorates the mechanical strain induced cell apoptosis and death in hUSLFs from POP patients. PARP1 might be involved in this protective process, providing novel insights into the mechanical biology of and possible therapies for POP.

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“…A study by M-L Marschalek et al revealed that 6 weeks of vaginal estrogen therapy before POP surgery yielded the same results as a placebo treatment. POP symptoms, bowel and bladder functions, as well as sexual function were assessed similarly in both groups [71]. Additionally, Zhixing Sun et al conducted a one-year follow-up after mesh implantation for POP in postmenopausal women.…”

Section: Discussionmentioning

confidence: 99%

New Possibilities for Hormonal Vaginal Treatment in Menopausal Women

Tomczyk

Chmaj-Wierzchowska

Wszołek

et al. 2023

JCM

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Hormonal vaginal therapy is an effective treatment option for women who experience vaginal symptoms related to hormonal changes. Estrogen and prasterone are widely used as vaginal treatments, particularly for urogenital atrophy. These symptoms may include vaginal dryness, itching, burning, and pain during sexual intercourse, all of which can significantly affect a woman’s quality of life. Previous studies have indicated that such treatment improves tissue elasticity, moisturizes the vagina, and can have a substantial impact on urine incontinence and vaginal microflora and decreases dyspareunia. Hormonal therapy is also useful and commonly used before vaginal surgical treatment. Prasterone is quite a new option for vaginal therapy in Poland and is mainly recommended for dyspareunia in menopausal women. The study related to prasterone therapy emphasizes its effectiveness and safety, making it advantageous to explore its beneficial impact. This paperwork aims to summarize the mechanism of action as well as the effects of both drugs and their beneficial action during vaginal treatment.

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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

Abstract: 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, multicenter study

Cited by 11 publications

References 34 publications

Laser versus sham for genitourinary syndrome of menopause: A randomised controlled trial

Laser versus sham for genitourinary syndrome of menopause: A randomised controlled trial

The protective effect of 17 β-estradiol on human uterosacral ligament fibroblasts from postmenopausal women with pelvic organ prolapse

New Possibilities for Hormonal Vaginal Treatment in Menopausal Women

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