The ewe as an animal model of vaginal atrophy and vaginal Er:YAG laser application

Hympánová, Lucie; Rynkevic, Rita; Cunha, Marina Gabriela Monteiro Carvalho Mori da; Diedrich, Chantal M.; Blacher, Silvia; Landsheere, Laurent de; Mackova, Katerina; Krofta, Ladislav; Roovers, Jan‐Paul; Deprest, Jan

doi:10.1097/gme.0000000000001679

Cited by 7 publications

(12 citation statements)

References 38 publications

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“…Ovariectomised sheep display changes similar to menopausal women, including osteoporosis, 44 hot flushes, 45 atherosclerosis 22 and, for our purposes, also vaginal atrophy 33 . We earlier quantified the effects of laser on the vagina of menopausal sheep, demonstrating a significant increase of epithelial thickness 7 days after first laser application (93 ± 3.6 μm vs 71.4 ± 5.2 μm in sham; P < 0.05) 46 . However, by 30 days after the third laser application there were no demonstrable changes in epithelial thickness and nor were biomechanical properties visible.…”

Section: Discussionmentioning

confidence: 90%

“…33 We earlier quantified the effects of laser on the vagina of menopausal sheep, demonstrating a significant increase of epithelial thickness 7 days after first laser application (93 AE 3.6 lm vs 71.4 AE 5.2 lm in sham; P < 0.05). 46 However, by 30 days after the third laser application there were no demonstrable changes in epithelial thickness and nor were biomechanical properties visible. Because of the potential shortcomings of the design of the previous study, we modified the design in this study to include baseline measurements, a longer hypoestrogenic state, serial biopsies and physical examinations.…”

Section: Discussionmentioning

confidence: 93%

“…There are three clinical randomised controlled trials 45–47 that compared another type of laser (CO 2 ) to topical estrogens in women with GSM. None unfortunately included vaginal biopsies, which makes comparison difficult.…”

Section: Discussionmentioning

confidence: 99%

“…None unfortunately included vaginal biopsies, which makes comparison difficult. On the other hand, they all reported subjective improvement following laser, in one the improvement in vaginal dryness was comparable, 45 in one the vaginal health index increased more 46 and in a third there was a similar increase in vaginal health index, laser relieved dyspareunia, burning and dryness, whereas estrogens only improved dryness 47 . Only one study was double‐blind, and none used sham controls.…”

Section: Discussionmentioning

confidence: 99%

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Vaginal Er:YAG laser application in the menopausal ewe model: a randomised estrogen and sham‐controlled trial

Mackova

Mazzer

Cunha

et al. 2020

BJOG

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Objective To describe effects of non‐ablative erbium‐doped:yttrium‐aluminium‐garnet (Er:YAG) laser on vaginal atrophy induced by iatrogenic menopause in the ewe. Design Animal experimental, randomised, sham and estrogen‐treatment controlled study with blinding for primary outcome. Setting KU Leuven, Belgium. Sample Twenty‐four ewes. Methods Menopause was surgically induced, after which the ewes were randomised to three groups receiving vaginal Er:YAG laser application three times, with a 1‐month interval; three sham manipulations with a 1‐month interval; or estrogen replacement and sham manipulations. At given intervals, ewes were clinically examined and vaginal wall biopsies were taken. Vaginal compliance was determined by passive biomechanical testing from explants taken at autopsy. Main outcome measures Vaginal epithelial thickness (primary), composition of the lamina propria (collagen, elastin, glycogen and vessel content), vaginal compliance, clinical signs. Results Animals exposed to Er:YAG laser application and sham manipulation, but not to estrogens, displayed a significant and comparable increase in vaginal epithelial thickness between baseline and 7 days after the third application (69% and 67%, respectively, both P < 0.0008). In laser‐treated ewes, temporary vaginal discharge and limited thermal injury were observed. Estrogen‐substituted ewes displayed a more prominent increase in epithelial thickness (202%; P < 0.0001) and higher vaginal compliance (P < 0.05). None of the interventions induced changes in the lamina propria. Conclusions Vaginal Er:YAG laser has comparable effect to sham manipulation in menopausal ewes. Tweetable abstract Vaginal Er:YAG laser has comparable effect to sham manipulation in menopausal ewes #LASER #GSM #RCT.

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Section: Discussionmentioning

confidence: 90%

Section: Discussionmentioning

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Vaginal Er:YAG laser application in the menopausal ewe model: a randomised estrogen and sham‐controlled trial

Mackova

Mazzer

Cunha

et al. 2020

BJOG

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“…Thus far, the ovariectomised ewe has been used in a few studies as a large animal model for GSM. [12][13][14] However, the validity of these studies is questionable as there were a few flaws in the study design. These include a lack of premenopausal control groups, baseline measurements, long term follow-up, comparative analyses between the study groups at the same point in time and methods of statistical analyses.…”

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confidence: 99%

Vaginal changes after ovariectomy in ewes -- a large animal model for Genitourinary Syndrome of Menopause

Vodegel

Güler

Ras

et al. 2022

Preprint

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Objective: To evaluate the effect of iatrogenic menopause on the physiology of the vagina of the ewe, and to evaluate if vaginal changes in ewes can be translated to women with the genitourinary syndrome of menopause (GSM). Design: Animal study, randomised design for ovariectomy or control, blinded for allocation and outcome assessment. Setting: University of Cape Town, South Africa. Population or Sample: Twenty-five Dohne Merino ewes. Methods: Iatrogenic menopause was induced in 20 animals by bilateral ovariectomy. Five animals served as a control group (no intervention). Differences between groups were determined by linear regression analyses (adjusted for baseline scores) at 5 months after ovariectomy. Main Outcome Measures: Vaginal epithelial thickness, pH, vaginal maturation value, vaginal maturation index, epithelial glycogen accumulation, content of elastin fibres, collagen, and vascularity. Results: Ovariectomised ewes showed epithelial thinning of the vaginal wall from 146 µm to 47 µm (mean, p <0.001 ). In addition, epithelial glycogen accumulation (43%) and the vascularity (23%) of the vaginal wall significantly decreased as compared to the control group. No differences were found for vaginal pH, vaginal cytology outcomes, elastin fibres and collagen content. Conclusions: This study established the ewe as a suitable large animal model for GSM. Furthermore, the similar relevant outcomes in humans and ewes hold great value for future translational research for the evaluation and optimisation of different treatment modalities for GSM. Funding: None. Keywords: Atrophy, ewe, genitourinary syndrome of menopause, model, ovariectomy.

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Effect of Fractional Carbon Dioxide vs Sham Laser on Sexual Function in Survivors of Breast Cancer Receiving Aromatase Inhibitors for Genitourinary Syndrome of Menopause

et al. 2023

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ImportanceSurvivors of breast cancer present more severe symptoms of genitourinary syndrome of menopause (GSM) than patients without history of breast cancer. Recently, new treatments, such as vaginal laser therapy, have appeared, but evidence of their efficacy remains scarce.ObjectiveTo assess the safety and efficacy of carbon dioxide (CO2) vs sham vaginal laser therapy after 6 months of follow-up in survivors of breast cancer with GSM receiving aromatase inhibitors.Design, Setting, and ParticipantsThis prospective double-blind sham-controlled randomized clinical trial with two parallel study groups was performed during October 2020 to March 2022 in a tertiary referral hospital. Survivors of breast cancer using aromatase inhibitors were assessed for eligibility, and eligible patients were randomized into the 2 treatment groups. Follow-up was conducted at 6 months. Data were analyzed in July 2022.InterventionsAll patients from both groups were instructed to use the first-line treatment (FLT) based on nonhormonal moisturizers and vaginal vibrator stimulation. Patients for each group were allocated to 5 monthly sessions of fractional CO2 laser therapy (CLT) or sham laser therapy (SLT).Main Outcomes and MeasuresThe primary outcome was sexual function, evaluated through Female Sexual Function Index (FSFI) score. Other subjective measures of efficacy included a visual analog scale of dyspareunia, vaginal pH, a Vaginal Health Index, quality of life (assessed via Short-Form 12), and body image (assessed with the Spanish Body Image Scale). Objective measures of efficacy included vaginal maturation index, vaginal epithelial elasticity (measured in Pascals) and vaginal epithelial thickness (measured in millimeters). Measures were assessed before and after the intervention. Tolerance (measured on a Likert scale), adverse effects, and estradiol levels were recorded.ResultsAmong 211 survivors of breast cancer assessed, 84 women were deemed eligible and 72 women (mean [SD] age, 52.6 [8.3] years) were randomized to CLT (35 participants) or SLT (37 participants) and analyzed. There were no statistically significant differences between groups at baseline. At 6 months, both groups showed improvement in FSFI (mean [SD] score at baseline vs 6 months: CLT, 14.8 [8.8] points vs 20.0 [9.5] points; SLT, 15.6 [7.0] points vs 23.5 [6.5] points), but there was no significant difference between CLT and SLT groups in the improvement of sexual function evaluated through the FSFI test overall (mean [SD] difference, 5.2 [1.5] points vs 7.9 [1.2] points; P = .15) or after excluding women who were not sexually active (mean [SD] difference, 2.9 [1.4] points vs 5.5 [1.1] points; P = .15). There were also no differences between improvement of the 2 groups at 6 months of follow-up in the other assessed subjective outcomes, including dyspareunia (mean [SD] difference, −4.3 [3.4] vs −4.5 [2.3]; P = .73), Vaginal Health Index (mean [SD] difference, 3.3 [4.1] vs 5.0 [4.5]; P = .17), body image (mean [SD] difference, −3.7 [4.5] vs −2.7 [4.8]; P = .35), and quality of life (mean [SD] difference, −0.3 [3.6] vs −0.7 [3.2]; P = .39). Similarly, there were no differences in improvements in objective outcomes, including vaginal pH (mean [SD] difference, −0.6 [0.9] vs −0.8 [1.2]; P = .29), vaginal maturation index (mean [SD] difference, 10.2 [17.4] vs 14.4 [17.1]; P = .15), vaginal epithelial thickness (mean [SD] difference, 0.021 [0.014] mm vs 0.013 [0.012] mm; P = .30), vaginal epithelial elasticity (mean [SD] difference, −1373 [3197] Pascals vs −2103 [3771] Pascals; P = .64). There were significant improvements in the overall analysis regardless of group in many outcomes. The 2 interventions were well tolerated, but tolerance was significantly lower in the CLT group than the SLT group (mean [SD] Likert scale score, 3.3 [1.3] vs 4.1 [1.0]; P = .007). No differences were observed in complications or serum estradiol levels.Conclusions and RelevanceIn this randomized clinical trial, vaginal laser treatment was found to be safe after 6 months of follow-up, but no statistically significant differences in efficacy were observed between CLT and SLT.Trial RegistrationClinicalTrials.gov identifier: NCT04619485

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The ewe as an animal model of vaginal atrophy and vaginal Er:YAG laser application

Cited by 7 publications

References 38 publications

Vaginal Er:YAG laser application in the menopausal ewe model: a randomised estrogen and sham‐controlled trial

Vaginal Er:YAG laser application in the menopausal ewe model: a randomised estrogen and sham‐controlled trial

Vaginal changes after ovariectomy in ewes -- a large animal model for Genitourinary Syndrome of Menopause

Effect of Fractional Carbon Dioxide vs Sham Laser on Sexual Function in Survivors of Breast Cancer Receiving Aromatase Inhibitors for Genitourinary Syndrome of Menopause

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