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Fractional CO₂ Laser, Radiofrequency and Topical Estrogen for Treating Genitourinary Syndrome of Menopause: A Pilot Study Evaluating the Vulvar Vestibule.

ABSTRACT: Background and Objectives: Genitourinary syndrome of menopause (GSM) affects more than half of postmenopausal women. This study aimed to evaluate the clinical and histological aspects of microablative fractionated CO₂ laser (CO₂L), microablative fractionated radiofrequency (RF) and intravaginal estrogen (ET) therapy as GSM treatments for the vulvar vestibule. Materials and Methods: This study included postmenopausal women with at least one moderate-to-severe complaint of GSM. Women in the CO₂L and RF groups received three monthly sessions of outpatient vulvovaginal therapy. The procedures were performed 30 min after applying 4% lidocaine gel to the vulva and vaginal introitus. Vulvar vestibular pain was assessed after each application using a 10-point VAS. A follow-up evaluation was performed 120 days after beginning each treatment. Digital images of the vulva were obtained and a 5-point Likert scale (1 = much worse, 2 = worse, 3 = neutral, 4 = better, 5 = much better) was used to assess the global post-treatment women's impression of improvement regarding GSM. Results: A significant change in clinical aspects of the vulva was observed after all treatments with a reduction in the atrophic global vulvar aspect and an enhancement of the trophic aspect. High satisfaction was also reported after treatment according to the Likert scale evaluation: CO₂L (4.55 ± 0.97), RF (4.54 ± 0.95), CT (4 ± 1.41), p = 0.066. Histological evaluation revealed enhanced dermal papillae before pre-treatment, significantly reducing post-treatment in all groups (p = 0.002). No unintended effects were reported. Conclusions: CO₂L, RF, and ET significantly improved GSM concerning the vulvar vestibule at the 4 months follow-up.

SUBMITTER: Campos MLP

PROVIDER: S-EPMC10818998 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature

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Fractional CO2 Laser, Radiofrequency and Topical Estrogen for Treating Genitourinary Syndrome of Menopause: A Pilot Study Evaluating the Vulvar Vestibule.

Campos Madalena Leonor Pereira MLP Bianchi-Ferraro Ana Maria Homem Mello AMHM de Oliveira Carla Dias CD Nogueira Maria Cristina Caceres MCC Sartori Marair Gracio Ferreira MGF Fusco Irene I Lugollo Angela Flavia AF De Góis Speck Neila Maria NM

Medicina (Kaunas, Lithuania) 20231230 1

Background and Objectives: Genitourinary syndrome of menopause (GSM) affects more than half of postmenopausal women. This study aimed to evaluate the clinical and histological aspects of microablative fractionated CO2 laser (CO2L), microablative fractionated radiofrequency (RF) and intravaginal estrogen (ET) therapy as GSM treatments for the vulvar vestibule. Materials and Methods: This study included postmenopausal women with at least one moderate-to-severe c ...[more]

PMID: 38256341

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Project description:BackgroundGenitourinary syndrome of menopause (GSM) involves vaginal dryness (VD), pain during sexual activity (SAPain), vaginal itching (VI), burning, pain, and symptoms in the urinary organs. Non-ablative radiofrequency (RF) is a type of current with electromagnetic waves with a thermal effect that generates an acute inflammatory process with consequent neocolagenesis and neoelastogenesis. We aimed to describe the clinical response to VD, SAPain, vaginal laxity (VL), VI, burning sensation, pain in the vaginal opening, urinary incontinence, sexual dysfunction, cytological changes, and adverse effects of non-ablative RF in patients with GSM.MethodsThis single-arm pilot study included 11 women diagnosed with GSM with established menopause. Patients with hormone replacement initiation for six months, who used a pacemaker, or had metals in the pelvic region, were excluded. Subjective measures (numeric rating scale of symptoms, Vaginal Health Index-VHI) and objective measures (vaginal maturation index-VMI, vaginal pH, sexual function by the FSFI, and urinary function by the ICIQ-SF) were used. A Likert scale measures the degree of satisfaction with the treatment. Five sessions of monopolar non-ablative RF (41°C) were performed with an interval of one week between each application. The entire evaluation was performed before treatment (T0), one month (T1), and three months (T2) after treatment. Adverse effects were assessed during treatment and at T1 and T2.ResultsThe symptoms and/or signs were reduced after treatment in most patients (T1/T2, respectively): VD 90.9%/81.8%, SAPain 83.3%/66.7, VL 100%/100%, VI 100%/100%, burning 75%/87.5%, pain 75%/75%, and VHI 90.9%/81.9%. Most patients did not show changes in VMI (54.5%) and pH (63.6%) at T1, but there was an improvement in VMI in most patients (54.5%) at T2. Nine patients were satisfied, and two were very satisfied at T1. The treatment was well tolerated, and no adverse effects were observed. There was an improvement in sexual function (72.7%) and urinary function (66.7% in T1 and 83.3% in T2).ConclusionIntravaginal RF reduced the clinical symptoms of GSM in most patients, especially during T1, and women reported satisfaction with treatment. The technique showed no adverse effects, and there were positive effects on sexual and urinary function. Trial registration This research was registered at clinicaltrial.gov (NCT03506594) and complete registration date was posted on April 24, 2018.

Project description:ImportanceVaginal estrogen for genitourinary syndrome of menopause (GSM) should be used with caution in women with contraindications, highlighting the need for effective treatment alternatives.ObjectiveTo compare the severity of GSM after vaginal laser vs estrogen therapy.Data sourcesThe PubMed, Embase, and Cochrane Library databases were searched for articles published from database inception to April 8, 2022, with no language restrictions. Reference lists were also searched.Study selectionRandomized clinical trials (RCTs) that compared the use of lasers with vaginal estrogen in adults were selected.Data extraction and synthesisTwo investigators independently extracted data from included studies. The Cochrane risk of bias tool for RCTs was used to assess risk of bias of each study. A random-effects model was used to pool mean differences (MDs) with 95% CIs.Main outcomes and measuresPrimary outcomes were Vaginal Analog Scale (VAS; higher scores indicate severer symptoms), Vaginal Health Index (VHI; higher scores indicate better vaginal health), Vaginal Maturation Index (VMI; higher scores indicate higher estrogen effect on the vaginal epithelium), Female Sexual Function Index (FSFI; higher scores indicate better female sexual function), and Sexual Quotient-Female (SQ-F; higher scores indicate better female sexual function) questionnaire scores. Urinary symptoms were assessed as an additional outcome. Data analyses were performed from April 9 to 12, 2022.ResultsA total of 6 RCTs with 270 women with GSM were included (135 were randomized to laser therapy and 135 to estrogen therapy; mean age ranged from 54.6 to 61.0 years). No significant differences were found between carbon dioxide laser and vaginal estrogen from baseline to the end of follow-up in overall VAS scores (MD, -0.16; 95% CI, -0.67 to 0.36; I2, 33.31%), VHI (MD, 0.20; 95% CI, -0.56 to 0.97; I2, 83.25%), VMI (MD, -0.56; 95% CI, -1.14 to 0.02; I2, 35.07%), FSFI (MD, -0.04; 95% CI, -0.45 to 0.36; I2, 41.60%), and SQ-F (P = .37 based on 1 study). Other questionnaire-based outcome measures demonstrated no difference between groups from baseline to the end of follow-up for changes in urinary symptoms.Conclusions and relevanceThis systematic review and meta-analysis of RCTs found that vaginal laser treatment is associated with similar improvement in genitourinary symptoms as vaginal estrogen therapy. Further research is needed to test whether vaginal laser therapy could be a potential treatment option for women with contraindications to vaginal estrogen.

Project description:There is increasing attention about managing the adverse effects of adjuvant therapy (Chemotherapy and anti-estrogen treatment) for breast cancer survivors (BCSs). Vulvovaginal atrophy (VVA), caused by decreased levels of circulating estrogen to urogenital receptors, is commonly experienced by this patients. Women receiving antiestrogen therapy, specifically aromatase inhibitors, often suffer from vaginal dryness, itching, irritation, dyspareunia, and dysuria, collectively known as genitourinary syndrome of menopause (GSM), that it can in turn lead to pain, discomfort, impairment of sexual function and negatively impact on multiple domains of quality of life (QoL). The worsening of QoL in these patients due to GSM symptoms can lead to discontinuation of hormone adjuvant therapies and therefore must be addressed properly. The diagnosis of VVA is confirmed through patient-reported symptoms and gynecological examination of external structures, introitus, and vaginal mucosa. Systemic estrogen treatment is contraindicated in BCSs. In these patients, GSM may be prevented, reduced and managed in most cases but this requires early recognition and appropriate treatment, but it is normally undertreated by oncologists because of fear of cancer recurrence, specifically when considering treatment with vaginal estrogen therapy (VET) because of unknown levels of systemic absorption of estradiol. Lifestyle modifications and nonhormonal treatments (vaginal moisturizers, lubricants, and gels) are the first-line treatment for GSM both in healthy women as BCSs, but when these are not effective for symptom relief, other options can be considered, such as VET, ospemifene, local androgens, intravaginal dehydroepiandrosterone (prasterone), or laser therapy (erbium or CO2 Laser). The present data suggest that these therapies are effective for VVA in BCSs; however, safety remains controversial and a there is a major concern with all of these treatments. We review current evidence for various nonpharmacologic and pharmacologic therapeutic modalities for GSM in BCSs and highlight the substantial gaps in the evidence for safe and effective therapies and the need for future research. We include recommendations for an approach to the management of GSM in women at high risk for breast cancer, women with estrogen-receptor positive breast cancers, women with triple-negative breast cancers, and women with metastatic disease.

Dataset Information

Fractional CO₂ Laser, Radiofrequency and Topical Estrogen for Treating Genitourinary Syndrome of Menopause: A Pilot Study Evaluating the Vulvar Vestibule.

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Fractional CO<sub>2</sub> Laser, Radiofrequency and Topical Estrogen for Treating Genitourinary Syndrome of Menopause: A Pilot Study Evaluating the Vulvar Vestibule.

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