Randomized, double-blind, placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy in postmenopausal women

Cruz, Vera Lúcia; Steiner, Marcelo Luis; Pompei, Luciano de Melo; Strufaldi, Rodolfo; Fonseca, Fernando L. A.; Santiago, Lucila Heloísa Simardi; Wajsfeld, Tali; Fernandes, César Eduardo

doi:10.1097/gme.0000000000000955

Cited by 170 publications

(161 citation statements)

References 22 publications

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“…Likewise, Vera et al conducted a randomized, placebo‐controlled, double‐blind clinical trial in 2015 comparing the results of three controlled groups (45 patients divided into 3 groups of 15): Co2 fractionated laser, topical estrogen, and the combination of both for postmenopausal patients with symptoms of vulvovaginal atrophy. In contrast to the previous study, the laser‐only arm demonstrated an increase in pain in the Sexual Function Index, but an improvement in dyspareunia in the EVA . It is difficult to explain the incongruence of pain results in two studies where the same laser and parameters were used, but some differences are that in the latter study only two sessions of treatment were performed and that the first was not controlled by placebo.…”

Section: Discussionmentioning

confidence: 59%

Efficacy of fractional CO₂ laser in the treatment of genitourinary syndrome of menopause in Latin‐American Population: First Peruvian experience

et al. 2019

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Objective This PUBA study aimed to assess the efficacy of fractional CO2 laser in the treatment of genitourinary syndrome of menopause (GSM). Methods GSM symptoms were assessed before, 1 month after the first session and 1 month after the third session of laser (3 sessions with a 30 days interval between them) in 60 women (median, interquartile range: 55, 49–69). Subjective (visual analog scale) and objective (Vaginal Health Index, VHIS; Vaginal Maturity Index/Frost Index; Spanish Overactive Bladder Questionnaire‐Short Form, USMEX Spanish OAB‐qSF and Female Sexual Function Index, FSFI) measures were used during the study period to assess CO2 fractionated laser treatment outcomes compared to baseline. Results Fractional CO2 laser treatment was effective to improve GSM symptoms (vaginal dryness, vaginal itching, vaginal burning, dyspaurenia, dysuria, urinary urgency; P < 0.001) after three sessions, as well as VHIS (median, interquartile range: 13, 10–15 at baseline vs. 21, 20–23 at the fourth month follow up; P < 0.001), Frost Index (median, interquartile range: 28, 24–31 at baseline vs. 8, 6–10 at the fourth month follow up; P < 0.001), USMEX (median, interquartile range: 56, 46–68 at baseline vs 14, 13–16 at the fourth month follow up: P < 0,001) and FSFI (median, interquartile range: 5, 2–14 at baseline vs 30, 28–32). Conclusions In this sample, the data suggests that fractionated CO2 laser is an effective alternative for GSM treatment with positive outcomes that persists over time. Lasers Surg. Med. 51:509–515, 2019. © 2019 Wiley Periodicals, Inc.

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Section: Discussionmentioning

confidence: 59%

Efficacy of fractional CO₂ laser in the treatment of genitourinary syndrome of menopause in Latin‐American Population: First Peruvian experience

et al. 2019

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“…However, most stated three laser treatments led to a superior score and sustained results. Four studies used the VMV . Three of these studies reported a significant increase in maturation value, while the fourth reported no difference .…”

Section: Discussionmentioning

confidence: 99%

“…Sixteen studies used the VHIS . All reported a statistically significant improvement, regardless of whether it was one or up to three laser treatments.…”

Section: Discussionmentioning

confidence: 99%

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Review of non‐invasive vulvovaginal rejuvenation

Photiou

Lin

Dubin

et al. 2019

Acad Dermatol Venereol

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Vulvovaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM) may affect up to 90% of menopausal women. Features include vulvovaginal atrophy, vulvovaginal laxity, vulvovaginal dryness and irritation, dyspareunia, anorgasmia and urinary symptoms. The vulva, vagina and bladder are oestrogen‐responsive tissues, but oestrogen replacement therapy is not possible in women who have hormone‐responsive cancers or normal oestrogen levels. Therefore, there is a role for alternative treatments. To date, three non‐surgical energy‐based therapies have been proposed: fractional microablative CO2 laser, erbium:YAG laser and temperature‐controlled radiofrequency (RF). Our objective was to assess the available evidence for the safety and efficacy of erbium:YAG laser, microablative fractional CO2 laser and RF in the treatment of VVA/GSM. The authors reviewed the current published literature evaluating these therapies. All three therapies appear safe; however, all the studies were uncontrolled and used different protocols and outcome measurements. Therefore, comparison of treatments is difficult. It appears that there is more evidence in favour of the CO2 laser than the erbium:YAG laser. Both lasers have more evidence than RF. In conclusion, microablative CO2 laser, erbium:YAG laser and RF may be offered to patients suffering from VVA/GSM as an alternative or adjunct to conventional therapies. Further well‐conducted controlled studies are needed.

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“…However, the need for randomized, placebo-controlled trials with sham devices is highlighted by the first such trial published 9 . In a study of 45 women, the authors found that, although laser alone or in combination with vaginal estriol was as effective as estriol alone for VVA symptoms, there was an unexpected reported increase in sexual pain in the laser group.…”

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confidence: 99%

Turning the spotlight on lasers

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2017

Climacteric

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Randomized, double-blind, placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy in postmenopausal women

Abstract: CO2 vaginal laser alone or in combination with topical estriol is a good treatment option for VVA symptoms. Sexual-related pain with vaginal laser treatment might be of concern.

Cited by 170 publications

References 22 publications

Efficacy of fractional CO₂ laser in the treatment of genitourinary syndrome of menopause in Latin‐American Population: First Peruvian experience

Efficacy of fractional CO₂ laser in the treatment of genitourinary syndrome of menopause in Latin‐American Population: First Peruvian experience

Review of non‐invasive vulvovaginal rejuvenation

Turning the spotlight on lasers

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Randomized, double-blind, placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy in postmenopausal women

Abstract: CO2 vaginal laser alone or in combination with topical estriol is a good treatment option for VVA symptoms. Sexual-related pain with vaginal laser treatment might be of concern.

Cited by 170 publications

References 22 publications

Efficacy of fractional CO2 laser in the treatment of genitourinary syndrome of menopause in Latin‐American Population: First Peruvian experience

Efficacy of fractional CO2 laser in the treatment of genitourinary syndrome of menopause in Latin‐American Population: First Peruvian experience

Review of non‐invasive vulvovaginal rejuvenation

Turning the spotlight on lasers

Contact Info

Product

Resources

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Efficacy of fractional CO₂ laser in the treatment of genitourinary syndrome of menopause in Latin‐American Population: First Peruvian experience

Efficacy of fractional CO₂ laser in the treatment of genitourinary syndrome of menopause in Latin‐American Population: First Peruvian experience