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CO2 laser and the genitourinary syndrome of menopause: a randomized sham-controlled trial.
Climacteric. 2021 04; 24(2):187-193.C

Abstract

PURPOSE

This study aimed to clarify the efficacy of intravaginal CO2-laser treatment in postmenopausal women with genitourinary syndrome of menopause (GSM).

MATERIALS AND METHODS

This double-blind, randomized, sham-controlled trial included postmenopausal women diagnosed with GSM and bothersome dryness and dyspareunia. Treatment consisted of three sessions. Active CO2-laser treatments (active group) were compared to sham treatments (sham group) with the primary endpoints being changes in dryness and dyspareunia intensity, as assessed by the 10-cm visual analog scale. Secondary endpoints were as follows: changes in Female Sexual Function Index (FSFI; total score and all domains), itching, burning, dysuria, and Urogenital Distress Inventory (UDI-6); incidence of symptoms; and presence of adverse events. All outcomes were evaluated at baseline and 4 months post baseline.

RESULTS

Fifty-eight women (28 in the active group and 30 in the sham group) were eligible for inclusion. In the active group, dryness, dyspareunia, FSFI (total score), itching, burning, dysuria, and UDI-6 were significantly improved (mean [standard deviation] -5.6 [2.8], -6 [2.6], 12.3 [8.9], -2.9 [2.8], -2.3 [2.8], -0.9 [2.1], and -8.0 [15.3], respectively). In the sham group, dryness, itching, and burning were significantly improved (-1.9 [2], -1.4 [1.9], and -1 [1.9], respectively). All changes were in favor of the active group. After completion of the protocol, the proportion of participants with dryness, dyspareunia, and sexual dysfunction was significantly lower in the active group compared to those in the sham group (all p < 0.005).

CONCLUSIONS

CO2 laser could be proposed as an effective alternative treatment for the management of GSM as it is superior to sham treatments.

Authors+Show Affiliations

Obstetrics and Gynecology Unit, IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy.Urogynaecology Unit, 1st Department of Obstetrics and Gynecology, 'Alexandra' Hospital, National and Kapodistrian University of Athens, Athens, Greece.Urogynaecology Unit, 1st Department of Obstetrics and Gynecology, 'Alexandra' Hospital, National and Kapodistrian University of Athens, Athens, Greece.Urogynaecology Unit, 1st Department of Obstetrics and Gynecology, 'Alexandra' Hospital, National and Kapodistrian University of Athens, Athens, Greece.UniSR-Social.Lab, Faculty of Psychology, Vita-Salute San Raffaele University, Milan, Italy.Obstetrics and Gynecology Unit, IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy.Urogynaecology Unit, 1st Department of Obstetrics and Gynecology, 'Alexandra' Hospital, National and Kapodistrian University of Athens, Athens, Greece.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

33089713

Citation

Salvatore, S, et al. "CO2 Laser and the Genitourinary Syndrome of Menopause: a Randomized Sham-controlled Trial." Climacteric : the Journal of the International Menopause Society, vol. 24, no. 2, 2021, pp. 187-193.
Salvatore S, Pitsouni E, Grigoriadis T, et al. CO2 laser and the genitourinary syndrome of menopause: a randomized sham-controlled trial. Climacteric. 2021;24(2):187-193.
Salvatore, S., Pitsouni, E., Grigoriadis, T., Zacharakis, D., Pantaleo, G., Candiani, M., & Athanasiou, S. (2021). CO2 laser and the genitourinary syndrome of menopause: a randomized sham-controlled trial. Climacteric : the Journal of the International Menopause Society, 24(2), 187-193. https://doi.org/10.1080/13697137.2020.1829584
Salvatore S, et al. CO2 Laser and the Genitourinary Syndrome of Menopause: a Randomized Sham-controlled Trial. Climacteric. 2021;24(2):187-193. PubMed PMID: 33089713.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - CO2 laser and the genitourinary syndrome of menopause: a randomized sham-controlled trial. AU - Salvatore,S, AU - Pitsouni,E, AU - Grigoriadis,T, AU - Zacharakis,D, AU - Pantaleo,G, AU - Candiani,M, AU - Athanasiou,S, Y1 - 2020/10/22/ PY - 2020/10/23/pubmed PY - 2021/10/30/medline PY - 2020/10/22/entrez KW - Vulvovaginal atrophy KW - atrophy KW - genitourinary syndrome of menopause KW - lower urinary tract symptoms KW - menopause KW - sexual function SP - 187 EP - 193 JF - Climacteric : the journal of the International Menopause Society JO - Climacteric VL - 24 IS - 2 N2 - PURPOSE: This study aimed to clarify the efficacy of intravaginal CO2-laser treatment in postmenopausal women with genitourinary syndrome of menopause (GSM). MATERIALS AND METHODS: This double-blind, randomized, sham-controlled trial included postmenopausal women diagnosed with GSM and bothersome dryness and dyspareunia. Treatment consisted of three sessions. Active CO2-laser treatments (active group) were compared to sham treatments (sham group) with the primary endpoints being changes in dryness and dyspareunia intensity, as assessed by the 10-cm visual analog scale. Secondary endpoints were as follows: changes in Female Sexual Function Index (FSFI; total score and all domains), itching, burning, dysuria, and Urogenital Distress Inventory (UDI-6); incidence of symptoms; and presence of adverse events. All outcomes were evaluated at baseline and 4 months post baseline. RESULTS: Fifty-eight women (28 in the active group and 30 in the sham group) were eligible for inclusion. In the active group, dryness, dyspareunia, FSFI (total score), itching, burning, dysuria, and UDI-6 were significantly improved (mean [standard deviation] -5.6 [2.8], -6 [2.6], 12.3 [8.9], -2.9 [2.8], -2.3 [2.8], -0.9 [2.1], and -8.0 [15.3], respectively). In the sham group, dryness, itching, and burning were significantly improved (-1.9 [2], -1.4 [1.9], and -1 [1.9], respectively). All changes were in favor of the active group. After completion of the protocol, the proportion of participants with dryness, dyspareunia, and sexual dysfunction was significantly lower in the active group compared to those in the sham group (all p < 0.005). CONCLUSIONS: CO2 laser could be proposed as an effective alternative treatment for the management of GSM as it is superior to sham treatments. SN - 1473-0804 UR - https://www.unboundmedicine.com/medline/citation/33089713/CO2_laser_and_the_genitourinary_syndrome_of_menopause:_a_randomized_sham_controlled_trial_ DB - PRIME DP - Unbound Medicine ER -