Effect of Fractional Carbon Dioxide Laser vs Sham Treatment on Symptom Severity in Women With Postmenopausal Vaginal Symptoms: A Randomized Clinical Trial.

Importance: Postmenopausal vaginal symptoms are common and frequently detrimental to a woman's quality of life. Fractional carbon dioxide vaginal laser is increasingly offered as a treatment, but the efficacy remains unproven. Objective: To determine the efficacy of fractional carbon dioxide laser for treatment of vaginal symptoms associated with menopause. Design, Setting, and Participants: A double-blind, randomized, sham-controlled trial with 12-month follow-up was undertaken at a single tertiary referral hospital in Sydney, Australia. Enrollment commenced on September 19, 2016, with final follow-up on June 30, 2020. Participants were postmenopausal women with vaginal symptoms substantive enough to seek medical treatment. Of 232 participants approached, 85 were randomized. Interventions: Three treatments using a fractional microablative carbon dioxide laser system performed 4 to 8 weeks apart, with 43 women randomized to the laser group and 42 to the sham group. Main Outcomes and Measures: The co-primary outcomes were symptom severity assessed using a visual analog scale (VAS; range, 0-100; 0 indicates no symptoms and 100 indicates the most severe symptoms) and the Vulvovaginal Symptom Questionnaire (VSQ; range, 0-20; 0 indicates no symptoms and 20 indicates the most severe symptoms) at 12 months. The minimal clinically important difference was specified as a 50% decrease in both VAS and VSQ severity scores. There were 5 prespecified secondary outcomes, including quality of life (range, 0-100; higher scores indicate better quality of life), the Vaginal Health Index Score (range, 5-25; higher scores indicate better health), and vaginal histology (premenopausal or postmenopausal status). Results: Of 85 randomized participants (mean [SD] age, 57 [8] years), 78 (91.7%) completed the 12-month follow-up. From baseline to 12 months, there was no significant difference between the carbon dioxide laser group and the sham group in change in symptom severity (VAS score for overall vaginal symptoms: -17.2 vs -26.6; difference, 9.4 [95% CI, -28.6 to 47.5]; VAS score for the most severe symptom: -24.5 vs -20.4; difference -4.1 [95% CI, -32.5 to 24.3]; VSQ score: -3.1 vs -1.6; difference, -1.5 [95% CI, -5.9 to 3.0]). There were no significant differences between the laser and sham group in the mean quality of life score (6.3 vs 1.4; difference, 4.8 [95% CI, -3.9 to 13.5]) and Vaginal Health Index Score (0.9 vs 1.3; difference, -0.4 [95% CI, -4.3 to 3.6]) or in histological comparisons between laser and sham treatment groups. There were 16 adverse events in the laser group and 17 in the sham group, including vaginal pain/discomfort (44% vs 68%), spotting, discharge, and lower urinary tract symptoms. No severe adverse events were reported in either group. Conclusions and Relevance: Among women with postmenopausal vaginal symptoms, treatment with fractional carbon dioxide laser vs sham treatment did not significantly improve vaginal symptoms after 12 months. Trial Registration: Australian and New Zealand Clinical Trials Registry: ACTRN12616001403426.

Microablative Fractional CO2 Laser for Vulvovaginal Atrophy in Women With a History of Breast Cancer: A Pilot Study at 4-week Follow-up.

BACKGROUND: Breast cancer (BC) is the most common female cancer worldwide. Menopausal symptoms are a well-known side effect in women with BC and have a significant negative impact on quality of life (QoL) and sexuality. Nowadays, hormonal replacement therapy and local estrogens are the most common prescriptions to treat vulvovaginal (VVA) symptoms. However, in women with a history of BC, proper therapy for such conditions remains an often inadequately addressed clinical problem. A treatment with microablative fractional CO2 laser (MLT) can produce a remodeling of the vaginal connective tissue without causing damage to the surrounding tissue. The aim of this pilot study is to assess the efficacy and safety of MLT for treating VVA symptoms in women with a history of BC at 20-week follow-up since the first laser treatment. PATIENTS AND METHODS: Women with BC and VVA symptoms were enrolled in the study and treated with 5 laser applications (one every 4 weeks). The rate of satisfied patients at 20 weeks of follow-up was evaluated with a 5-point Likert scale. Changes of the Vaginal Health Index (VHI) after treatment was compared with baseline. Effects of the laser treatment on VVA symptoms was measured using a 10-cm visual analog scale (VAS). Changes in overall QoL were assessed with a generic QoL questionnaire: the Short Form 12 (SF-12) that we analyzed considering its physical (PCS12) and mental (MCS12) domains. Sexual function was evaluated by the Female Sexual Function Index (FSFI). RESULTS: In this prospective cohort study, we enrolled 40 women with a history of BC and who currently were or (Group 2) who had been (Group 1) on treatment with endocrine therapy for their condition. Six (15.0%) women were very satisfied, 25 (62.5%) were satisfied, 6 (15.0%) were uncertain, and 3 (7.5%) were dissatisfied with the MLT. VVA symptoms and VHI improved significantly at 20 weeks from baseline (P < .05) with no differences between the 2 groups (P > .05). In terms of QoL measured by the SF-12, the PCS12 and the MCS12 significantly improved at the 20-week follow-up. A significant improvement in total FSFI and in all domains was reported in both study groups (P < .05) with no differences between groups (P > .05). CONCLUSION: MLT was safe and effective in treating VVA symptoms in women with a history of BC, irrespective of being previously or currently on endocrine therapies.

Vaginal Er:YAG laser application in the menopausal ewe model: a randomised estrogen and sham-controlled trial.

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.

Treatment to External Labia and Vaginal Canal With CO2 Laser for Symptoms of Vulvovaginal Atrophy in Postmenopausal Women.

Background: Increasingly, women have sought alternatives to traditional options (lubricants, estrogen products, and hormone replacement therapy) for unwelcome vaginal changes of menopause. Objectives: This study evaluated whether a series of three monthly fractional CO2 laser treatments significantly improves and maintains vaginal health indices of elasticity, fluid volume, pH level, epithelial integrity, and moisture. Self-reported symptoms of vaginal atrophy were also measured. Biopsy samples after a series of three treatments were evaluated for histological changes to vaginal canal tissue. Methods: Forty postmenopausal women were treated extravaginally and internally with a fractional CO2 laser. Objective measurements of vaginal health index, as well as subjective measurements of symptoms of vulvovaginal atrophy (VVA), urinary incontinence, and sexual function were reported at baseline. Follow-up evaluations were at one, three, six, and 12 months after the third treatment. Results: Vaginal health index improved significantly after the first treatment and was maintained with mean improvement of 9.6 ± 3.3 (P < 0.001) and 9.5 ± 3.3 (P < 0.001) at the 6- and 12-month follow ups, respectively. Vaginal symptoms of dryness, itching, and dyspareunia improved significantly (P < 0.05) at all evaluations. Histological findings showed increased collagen and elastin staining, as well as a thicker epithelium with an increased number of cell layers and a better degree of surface maturation. Conclusions: Fractional CO2 laser treatments were well tolerated and were associated with improvement in vaginal health and amelioration of symptoms of VVA. Histological changes in the epithelium and lamina propria, caused by fractional CO2 laser treatments, correlated with clinical restoration of vaginal hydration and pH to premenopausal levels.

Fractional CO2 laser for genitourinary syndrome of menopause in breast cancer survivors: clinical, immunological, and microbiological aspects.

The composition of vaginal microbiome in menopause and cancer survivor women changes dramatically leading to genitourinary syndrome of menopause (GSM) in up to 70% of patients. Recent reports suggest that laser therapy may be valuable as a not hormonal therapeutic modality. The aim of the present study was to evaluate the effects of fractional CO2 laser treatment on the vaginal secretory pathway of a large panel of immune mediators, usually implicated in tissue remodeling and inflammation, and on microbiome composition in postmenopausal breast cancer survivors. The Ion Torrent PGM platform and the Luminex Bio-Plex platform were used for microbiome and immune factor analysis. The significant reduction of clinical symptoms and the non-significant changes in vaginal microbiome support the efficacy and safety of laser treatment. Moreover, the high remodeling status in vaginal epithelium is demonstrated by the significant changes in inflammatory and modulatory cytokine patterns. Laser therapy can be used for the treatment of GSM symptoms and does not show any adverse effects. However, further studies will be needed to clarify its long-term efficacy and other effects.

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.

OBJECTIVE: The aim of the study was to evaluate efficacy of fractional CO2 vaginal laser treatment (Laser, L) and compare it to local estrogen therapy (Estriol, E) and the combination of both treatments (Laser + Estriol, LE) in the treatment of vulvovaginal atrophy (VVA). METHODS: A total of 45 postmenopausal women meeting inclusion criteria were randomized in L, E, or LE groups. Assessments at baseline, 8 and 20 weeks, were conducted using Vaginal Health Index (VHI), Visual Analog Scale for VVA symptoms (dyspareunia, dryness, and burning), Female Sexual Function Index, and maturation value (MV) of Meisels. RESULTS: Forty-five women were included and 3 women were lost to follow-up. VHI average score was significantly higher at weeks 8 and 20 in all study arms. At week 20, the LE arm also showed incremental improvement of VHI score (P = 0.01). L and LE groups showed a significant improvement of dyspareunia, burning, and dryness, and the E arm only of dryness (P < 0.001). LE group presented significant improvement of total Female Sex Function Index (FSFI) score (P = 0.02) and individual domains of pain, desire, and lubrication. In contrast, the L group showed significant worsening of pain domain in FSFI (P = 0.04), but FSFI total scores were comparable in all treatment arms at week 20. CONCLUSIONS: 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.

Microablative fractional CO2 laser for the genitourinary syndrome of menopause: power of 30 or 40 W?

This retrospective case-control study aimed to compare 30 versus 40 W power of CO2 laser for the therapy of genitourinary syndrome of menopause (GSM). Postmenopausal women with severe intensity of dyspareunia and dryness were eligible to be included in this study. Primary outcomes were dyspareunia and dryness. Secondary outcomes were itching/burning, dysuria, frequency and urgency, Female Sexual Function Index (FSFI), vaginal maturation value (VMV), and Vaginal Health Index Score (VHIS). One laser therapy was applied every month for 3 months. Outcomes were evaluated at baseline and 1 month following the 3rd therapy. Fifty (25 per group) women were included in this study. In the 30-W group, mean improvement of dyspareunia, dryness, itching/burning, FSFI, VMV, and VHIS was 6.1 ± 1.7, 6.0 ± 1.9, 5.9 ± 2.0, 16.6 ± 6.7, 29.9 ± 13.0, and 11.0 ± 2.9, respectively (within group comparisons all p < 0.001). In the 40-W group, mean improvement of dyspareunia, dryness, itching/burning, FSFI, VMV, and VHIS was 6.1 ± 1.7, 6.5 ± 2.0, 5.2 ± 2.5, 14.8 ± 7.1, 25.0 ± 13.4, and 10.5 ± 4.1, respectively (within-group comparisons, all p ≤ 0.001). Comparison between 30 and 40 W revealed that mean improvement or presence of all GSM symptoms and clinical signs was not statistically significant different. CO2 laser therapy may improve GSM symptoms and clinical signs. This improvement did not seem to associate to power of 30 or 40 W.

Fractional CO2 Laser for Vulvovaginal Atrophy.

Objective: To evaluate the short term efficacy and safety of Fractional CO2 laser for the treatment of vulvovaginal atrophy. Material and Method: From March 2015 to October 2015, 112 menopausal women were recruited. All women with VVA were treated by using Fractional CO2 laser; power 30 watts, 1-3 stacks with 360° vaginal probe for 3 consecutive times, 4 weeks apart. Before laser treatment, the subjective measurement of VVA symptoms was evaluated by using a questionnaire and the objective measurements were evaluated by using pH paper and VMI. Visual analog pain-score was used to scaling their discomfort during and immediately after each treatment. At 3 months after the last procedure, the subjective and objective measurements were re-assessed. Any short-term and long-term adverse events were recorded. Statistical analysis was performed by using SPSS program with p-value <0.05. Results: The median of pre-screening VVA symptom score was 4 and the most bothersome symptom was the "feeling of dryness around vulvar". There was a significant reduction of the score after laser treatment. The average percentage of pretreatment VMI was 34.7±16.1% and at one and three months after complete laser course, it was significantly increased with the mean change of 25.0±12.2% and 34.8±15.5%, respectively. For the vaginal pH, the average pH before treatment was 7.5±1.0 and the average decrement after 3 months was 0.9±1.3 with statistical significance, p-value <0.01. There were no serious complications and all were satisfied with the treatment. Conclusion: Fractional CO2 laser could ameliorate the VVA symptoms with at least 3 months of long lasting improvement of vaginal health with safety.

A 12-week treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study.

OBJECTIVE: This pilot study aimed to assess the efficacy and feasibility of fractional CO2 laser in the treatment of vulvovaginal atrophy (VVA) in postmenopausal women. METHODS: VVA symptoms were assessed before and after three applications of laser over 12 weeks in 50 women (age 59.6 ± 5.8 years) dissatisfied with previous local estrogen therapies. Subjective (visual analog scale) and objective (Vaginal Health Index Score, VHIS) measures were used during the study period to assess VVA. Quality of life was measured by using the SF-12. A subjective scale to evaluate the degree of pain related to the laser application and the degree of difficulty to perform the laser procedure was used. RESULTS: Fractional CO2 laser treatment was effective to improve VVA symptoms (vaginal dryness, vaginal burning, vaginal itching, dyspareunia, dysuria; p < 0.001) at 12-week follow-up, as well as the VHIS (13.1 ± 2.5 at baseline vs. 23.1 ± 1.9; p < 0.001). Both physical and mental scores of quality of life were significantly improved in comparison with baseline (p < 0.001). Satisfaction with the laser procedure was reported by 42 women (84%) and a minimal discomfort was experienced at the first laser application, mainly because of the insertion and the movements of the probe. Finally, the technique was very easy to perform in all women starting from the second application at week 4 and no adverse events were recorded during the study period. CONCLUSIONS: A 12-week treatment with the fractional CO2 laser was feasible and induced a significant improvement of VVA symptoms by ameliorating vaginal health in postmenopausal women. Further controlled studies should be performed to confirm the present data and to assess the long-term effects of the laser procedure on vaginal tissues.

A case of persistent endometriosis after total hysterectomy with both salpingo-oophorectomy managed by radiation therapy.

Persistent endometriosis after total hysterectomy and both salpingo-oophorectomy (TH with BSO) is a rare condition and the etiology is uncertain. The exact incidence of persistent endometriosis after definitive surgery is not known. In addition, the treatment of persistent endometriosis after complete surgical excision is controversial. We report a case of persistent endometriosis with vaginal and sigmoid-colonic invasion after TH with BSO. The lesions were not responsive to hormonal therapy. The patient was managed successfully by therapeutic pelvic radiation.

[Condylomata acuminata. The correlation between affecting sexual partners and the risk of developing preneoplasia of the cervix uteri. The therapeutic potentials of the Nd-Yag laser]. / Condylomata acuminata. Korelatsiia mezhdu zasiagiane na seksualnite partn'ori i riska ot razvitie na preneoplazii na matochnata shiika. Terapevtichni vuzmozhnosti na Nd YAG laser.

The present study summarized results from 206 patients (120 females and 80 males) with diagnosis condylomata acuminata. The diagnostic and surveillance methods used in the present work were: clinical, colposcopic, histologies and microbiological examination. 114 from all patients--46.5% females, and 62.2% males were sexual partners. In 25 women (43.8%) from that group HPV-lesions were found. In 8 patients with cervical lesions CIN I-III was diagnosed. Our results confirmed the previously announced literary data about an enhanced risk for CIN development in women with HPV infection, whose sexual partners had clinical data of Condylomata acuminata. Our therapeutic protocol with Nd-YAG laser treatment in a determined scheme and number of applications according to the stage of the disease and pathological diagnosis was very successful, as compared to data from the literature.

[The radiotherapy of vaginal keloids by an intracavity high-dose-rate (HDR) afterloading procedure]. / Die Strahlentherapie vaginaler Keloide mittels des intrakavitären High-dose-rate-(HDR-)Afterloadingverfahrens.

One of the late complications in patients with vaginal agenesis who had the McIndoe procedure are keloids. Using HDR afterloading (three times 4 Gy in 5 mm tissue depth) and a shielded vaginal applicator we prevented recurrence of the keloids after surgical removal.

Adverse effects of pregnancy on multifocal eosinophilic granuloma.

An unusual case of a patient diagnosed as having the histiocytic proliferative disorder characterized by the lesion eosinophilic granuloma (histiocytosis X) is presented. Fifteen-year follow-up revealed a progression from a solitary eosinophilic granuloma of the bone to multifocal involvement of many body structures including the vulva, vagina, and cervix. This progression occurred after nine asymptomatic years and was temporally related to the patient's first pregnancy. After successful treatment and remission, rapid appearance and growth of observable genital lesions were noted during a second pregnancy. Pregnancy termination in the first trimester was advised due to signs of dissemination and local symptoms.