Energy‐based treatment for gynecologic conditions including genitourinary syndrome of menopause: Consensus, controversies, recommendations, and FDA clearance

Background and Objectives Fractional CO2 laser has been proposed as an effective treatment for the genitourinary syndrome of menopause (GSM). However, the effects of laser treatment on vulvar tissue have never been assessed. We aimed to assess histological changes related to fractional CO2 laser in vulvar tissue from GSM patients. Study Design/Materials and Methods A single‐center observational prospective cohort study was performed enrolling all GSM patients from July 2017 to October 2018. Patients underwent three outpatient vulvovaginal applications of fractional CO2 laser and vulvar biopsy before and after treatment. Rates of histological changes in vulvar tissue, the difference in means of Vulva Health Index (VuHI), Vaginal Health Index (VHI), Visual Analogue Scale scores for GSM symptoms, and procedure‐related pain, and rate of patient's overall satisfaction with treatment were assessed. Univariate comparisons between continuous variables were performed by using the paired t‐test (α error = 0.05). Results Of 20 enrolled patients, 18 underwent all laser applications, and 15 underwent both vulvar biopsies. 93.3% of patients showed remodeling of vulvar connective tissue; 80% showed improvement in vulvar epithelium trophism and 86.7% showed neovascularization. Differences in means between before and after treatment were significant for VuHI, VHI, and all GSM symptoms. Means ± standard deviation of the degree of pain at each laser application were 4.4 ± 0.9, 3.7 ± 1.6, and 2.9 ± 1.9. The rate of overall satisfaction with the treatment was 72.2%. Conclusions Fractional CO2 laser leads to a restoration of the normal architecture of vulvar tissue, with significant improvement in GSM‐related signs and symptoms, and overall satisfaction with the treatment in most GSM patients. Lasers Surg. Med. © 2020 Wiley Periodicals LLC

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“…On this account, it appears difficult to compare our results to those of local estrogens. Further studies are encouraged in this field [44,53].…”

Section: Discussionmentioning

confidence: 99%

Fractional Microablative CO₂ Laser‐Related Histological Changes on Vulvar Tissue in Patients With Genitourinary Syndrome of Menopause

et al. 2020

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Section: Introductionmentioning

confidence: 99%

“…At present, an accumulating body of evidence suggests safety and efficacy of laser and energy‐based devices for the treatment of women's genitourinary conditions [1–4]. More clinical studies are needed to assess the long‐term safety profile and clinical outcomes of the lasers and energy‐based devices to treat the symptoms associated with vulvovaginal atrophy (VVA) [2–4]. The European Vulvovaginal Epidemiological Survey (EVES) recently determined the prevalence of VVA confirmed by gynecological assessment among all postmenopausal women as 81.3% and the prevalence of at least one VVA symptom at 92.8% [5].…”

Section: Introductionmentioning

confidence: 99%

Fractional Co₂ Laser Treatment of the Vulva and Vagina and the Effect of Postmenopausal Duration on Efficacy

Alexiades

2020

Lasers Surg Med

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Background and Objectives More studies are needed to assess the long‐term safety profile and clinical outcomes of lasers and energy‐based devices to treat the symptoms associated with vulvovaginal atrophy. This study evaluated a series of three fractional CO2 laser treatments to the vulva and vagina with a 1‐year follow‐up in a postmenopausal population. Study Design/Materials and Methods In this prospective, self‐controlled, open‐label clinical study, 18 postmenopausal females with atrophic vaginitis received 3 monthly treatments to the vulva and vagina with a fractional CO2 laser system and 1‐, 3‐, 6‐, and 12‐month follow‐up. Investigators used the Vaginal Health Index (VHI) to assess changes in vaginal elasticity, fluid volume, vaginal pH, epithelial integrity, and moisture. Sexual function at each timepoint was subject‐reported, using the validated Female Sexual Function Index (FSFI). Results Treatment of the vulva and vagina in postmenopausal women with fractional CO2 laser resurfacing resulted in statistically significant improvements as compared with baseline at all post‐treatment and follow‐up intervals to 12 months in VHI and FSFI (P ≤ 0.003 and P ≤ 0.03, respectively). Mean total VHI score increased from a baseline of 11.8–22.8 (93.2% improved) at 6‐month follow‐up (P = 0.0002) slightly decreasing to 21.4 (81.4% improved) at 12‐month follow‐up post‐treatment (P = 0.0003). Mean FSFI Scores increased from a baseline of 17.9–26.3 (46.9% improvement) at 12‐month follow‐up post‐treatment (P ≤ 0.0048). Cohort analysis revealed restoration of normal or near‐normal (23–25) VHI following laser treatment in the recently menopausal (1–3 years) greatly exceeded that of the >3 years postmenopausal population and the difference was statistically significant (P ≤ 0.05). Normal/near‐normal VHI at 3‐, 6‐, and 12‐month post‐treatment was 88%, 88%, and 63% in the recently postmenopausal cohort, as compared with 30%, 40%, and 10% of the >3 years postmenopausal group (P ≤ 0.05). Patient satisfaction following treatment was rated as high at 94% at 12‐month follow‐up. Safety findings demonstrated no‐to‐slight discomfort in the majority of subjects and transient erythema and edema, with no adverse events associated with treatment. Conclusion Fractional CO2 laser treatment of the vulva and vagina resulted in statistically significant improvements in VHI and FSFI compared with baseline in postmenopausal population that were sustained to 12‐month follow‐up. Restoration of normal VHI was observed in a statistically significant greater percentage in the recently postmenopausal cohort (1–3 years) as compared with postmenopausal cohort of >3 years, suggesting that early intervention is correlated with improved outcomes. Lasers Surg. Med. © 2020 Wiley Periodicals, Inc.

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“…Other symptoms include burning, the pain increased susceptibility to physical and chemical irritation. All of these symptoms affect postmenopausal women's sexuality and relationships ( 37 , 38 ).…”

Section: Clinical Manifestationsmentioning

confidence: 99%

Genitourinary Syndrome of Menopause: Epidemiology, Physiopathology, Clinical Manifestation and Diagnostic

Sarmento

Costa

Vieira‐Baptista

et al. 2021

Front. Reprod. Health

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Genitourinary syndrome of menopause (GSM) is a term used to define a compilation of signs and symptoms arising from decreased estrogenic stimulation of the vulvovaginal and lower urinary tract. Among 27–84% of women in postmenopausal are affected for symptoms of GSM, and these can unquestionably impair health, sexual function, consequently the quality of life of these women. The main signs and symptoms of GSM include, among others, burning, irritation, vulvovaginal dryness, dyspareunia, urinary symptoms of urgency, dysuria, or recurrent urinary tract infection. The diagnosis can be made through anamnesis, questionnaires, physical exams, and, sometimes, complementary exams. Objective vaginal assessment is essential and can be complemented by using the Vaginal Health Index (VHI), Vaginal Maturation Index (VMI), or vaginal pH measurement. The acknowledgment of this condition by health professionals is crucial for its identification and proper management and exclusion of other conditions that make a differential diagnosis with it.

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Energy‐based treatment for gynecologic conditions including genitourinary syndrome of menopause: Consensus, controversies, recommendations, and FDA clearance

Cited by 13 publications

References 6 publications

Fractional Microablative CO₂ Laser‐Related Histological Changes on Vulvar Tissue in Patients With Genitourinary Syndrome of Menopause

Fractional Microablative CO₂ Laser‐Related Histological Changes on Vulvar Tissue in Patients With Genitourinary Syndrome of Menopause

Fractional Co₂ Laser Treatment of the Vulva and Vagina and the Effect of Postmenopausal Duration on Efficacy

Genitourinary Syndrome of Menopause: Epidemiology, Physiopathology, Clinical Manifestation and Diagnostic

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Energy‐based treatment for gynecologic conditions including genitourinary syndrome of menopause: Consensus, controversies, recommendations, and FDA clearance

Cited by 13 publications

References 6 publications

Fractional Microablative CO2 Laser‐Related Histological Changes on Vulvar Tissue in Patients With Genitourinary Syndrome of Menopause

Fractional Microablative CO2 Laser‐Related Histological Changes on Vulvar Tissue in Patients With Genitourinary Syndrome of Menopause

Fractional Co2 Laser Treatment of the Vulva and Vagina and the Effect of Postmenopausal Duration on Efficacy

Genitourinary Syndrome of Menopause: Epidemiology, Physiopathology, Clinical Manifestation and Diagnostic

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Product

Resources

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Fractional Microablative CO₂ Laser‐Related Histological Changes on Vulvar Tissue in Patients With Genitourinary Syndrome of Menopause

Fractional Microablative CO₂ Laser‐Related Histological Changes on Vulvar Tissue in Patients With Genitourinary Syndrome of Menopause

Fractional Co₂ Laser Treatment of the Vulva and Vagina and the Effect of Postmenopausal Duration on Efficacy