TY - JOUR
T1 - Vaginal Er:YAG laser application in the menopausal ewe model: a randomised estrogen and sham-controlled trial
AU - Mackova, K.
AU - Mazzer, A. M.
AU - Mori da Cunha, M. G. M. C.
AU - Hajkova Hympanova, L.
AU - Urbankova, I.
AU - Kastelein, A. W.
AU - Vodegel, E.
AU - Vander Linden, K.
AU - Fehervary, H.
AU - Guler, Z.
AU - Roovers, J. P.
AU - Krofta, L.
AU - Verhaeghe, J.
AU - Deprest, J.
N1 - Funding Information: Fotona laser (Ljubljana, Slovenia) supported this experiment. The contract is handled by Leuven Research and Development. Fotona did not interfere with the design, analysis and eventual reporting of this experiment. Neither does it own the results. LHH and LK were supported by a grant Progress Q34, Charles University, Prague, Czechia. We thank Rosita Kinnart (Centre for Surgical Technologies, KU Leuven), Catherine Luyten, Petra Stevens (Department of Development and Regeneration, G-PURE laboratory, KU Leuven), Stijn Massart and Wouter Merckx (Department of Biosystems, KU Leuven) for their technical support. We thank Zdenko Vizintin (Fotona, Ljubljana, Slovenia) for kindly providing the laser FotonaSmooth? XS. Publisher Copyright: © 2020 John Wiley & Sons Ltd
PY - 2021/5
Y1 - 2021/5
N2 - 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.
AB - 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.
KW - Atrophy
KW - epithelium
KW - estrogen
KW - laser
KW - planar biaxial testing
KW - sheep
KW - vagina
UR - http://www.scopus.com/inward/record.url?scp=85096809122&partnerID=8YFLogxK
U2 - https://doi.org/10.1111/1471-0528.16558
DO - https://doi.org/10.1111/1471-0528.16558
M3 - Article
C2 - 33017509
SN - 1470-0328
VL - 128
SP - 1087
EP - 1096
JO - BJOG: An International Journal of Obstetrics and Gynaecology
JF - BJOG: An International Journal of Obstetrics and Gynaecology
IS - 6
ER -