The efficacy and feasibility of fractional CO2 laser therapy for the treatment of urinary incontinence: a multicentric case-control study.

BACKGROUND: Female urinary incontinence is a significant public health problem. Conservative treatments require high patient compliance, while surgery often leads to more complications and recovery time. Our aim is to evaluate the efficacy of microablative fractional CO2 laser (CO2-laser) therapy in women with urinary incontinence (UI). METHODS: This is a retrospective analysis of prospectively collected data on women with stress urinary incontinence (SUI) and mixed urinary incontinence (MUI) with predominant SUI subjected to four sessions of CO2-laser therapy performed once a month, between February 2017 and October 2017, with a 12-month follow-up. The subjective Visual Analogue Scale (VAS) 0-10 was used to score and variables were evaluated at baseline and at one, six and 12 months after initiation of therapy. Finally, results were compared to a control group. RESULTS: The cohort consisted of 42 women. The proportion of patients with vaginal atrophy among those younger than 55 years was substantially lower (3/23; 13%) than among those older than 55 years (15/19; 78.9%). CO2 laser treatment was associated with a significant improvement in VAS scores recorded one-month, six-months, and one-year, after conclusion of therapy (P<0.001). VAS scores improved significantly in patients with either SUI (26/42; 61.9%) or mixed UI (16/42; 38.1%). No major post treatment complications were registered. Women with vaginal atrophy demonstrated significantly better results (P<0.001). CONCLUSIONS: Results confirm the efficacy and a good safety profile, for CO2 laser treatment in SUI, mostly in women with postmenopausal vaginal atrophy and should be considered as a treatment option for female patients with concomitant SUI and vaginal atrophy.

Monitoring the activities of Italian colposcopy clinics before and during the COVID-19 pandemic.

OBJECTIVE: To evaluate the impact of healthcare reorganization during the severe acute respiratory syndrome coronavirus 2 pandemic on Italian colposcopy clinic activities, focusing on cervical excision procedures, follow-ups for conservative management of low-grade lesions, and follow-ups post cervical excision. METHODS: Retrospective study conducted in 14 Italian colposcopy clinics. The number and clinical characteristics of cervical excisions, follow-ups for conservative management of low-grade lesions, and follow-ups after cervical excision were compared between the period March 1, 2019 to February 29, 2020 (pre-pandemic) and March 1, 2020 to February 28, 2021 (pandemic) with a Poisson regression analysis. RESULTS: In the pandemic period, the number of cervical excisions was reduced by 8.8% (95% confidence interval [CI]=-15.6% to -2%; p=0.011). Excisions were less frequently performed in the operating room (-35.1%; 95% CI=-47.6% to -22.6%; p<0.001), the number of patients from spontaneous screening was reduced by -14.0% (95% CI=-23.4% to -4.6%; p=0.003), and the CO2-laser technique was used less frequently (-30%; 95% CI=-45.1% to -15.0%; p<0.001). As compared to the pre-pandemic period, the number of follow-ups for conservative management of low-grade lesions was reduced by -26.7% (95% CI=-39.0% to -14.4%; p<0.001), and the follow-up appointments after cervical excision were reduced by -51.0% (95% CI=-58.1% to -43.9%; p<0.001). CONCLUSION: The most significant impact of the healthcare reorganization during the coronavirus disease 2019 pandemic was on follow-ups after cervical excision. The resumption of disrupted activities should follow a risk-based prioritization, starting from women in follow-up after cervical excision. It is advisable that the trend of performing cervical excision as an outpatient procedure is maintained in the post-pandemic period.

High-risk HPV positivity is a long-term risk factor for recurrence after cervical excision procedure in women living with HIV.

OBJECTIVE: To evaluate the risk factors for recurrence of high-grade disease after cervical excision in women living with HIV (WLWH), with a specific interest in the role of high-risk (HR-) HPV positivity. METHODS: Multicentric retrospective study conducted on WLWH who underwent cervical excision between January 1987 and June 2017 in six Italian institutions. The rate of high-grade recurrence was determined. Risk factors for recurrence and HR-HPV positivity were determined with the Log-rank test and Cox proportional hazards regression models. RESULTS: A total of 271 WLWH were included in the final analysis. A high-grade recurrence was found in 58 (21.4%) patients. Age 41 years or more at inclusion and HR-HPV positivity during follow up were independently associated with a higher risk of disease recurrence with relative risks of 4.15 (95% confidence interval [CI] 2.01-8.58, P < 0.001) and 5.18 (95% CI 2.12-12.67, P < 0.01), respectively. Age 41 years or more (relative risk 1.75, 95% CI 1.01-3.04, P = 0.047) resulted as a risk factor for HR-HPV positivity during follow up. CONCLUSION: HR-HPV positivity is a risk factor for recurrence after cervical excision in WLWH. Women older than 41 years may benefit from a long-term yearly follow up. Future studies regarding HPV vaccination after treatment in WLWH may be useful, considering the protective role of the higher probability of HPV negativity in vaccinated women.

The beneficial effects of fractional CO2 laser treatment on perineal changes during puerperium and breastfeeding period: a multicentric study.

Childbirth is a great change in woman life because of hormonal, physical and psychological alterations that are associated with this process. Dyspareunia and perineal pain are commonly reported symptoms in the postpartum period, mainly due to perineal trauma, lacerations, episiotomy, and forceps or vacuum use at delivery. Among non-pharmacological treatment, a new trend is gaining popularity, which is the energy-based therapy, including fractional micro-ablative CO2 laser. We conducted a multicentric retrospective study to assess the efficacy and the possible side effects of CO2 laser treatment on transient vulvovaginal atrophy and perineal postpartum pain related to puerperium and breastfeeding period. All patients were submitted to 3 or 4 sessions of CO2 laser treatment. As per protocol, an initial, intermediate (after 2 sessions) and final (3 months after the last cycle) evaluation of the symptoms were made, using a VAS (Visual Analogue Scale 0-10). We also compared this group of patients with a control group with no treatment. At the final evaluation, patients showed a significant improvement for dyspareunia (VAS from 7.95 to 3.14, p < 0.0001). A significant improvement was also registered in pain at the vaginal orifice (VAS from 6.94 to 2.05, p = 0.0001), dryness (VAS from 6.6 to 2.9, p = 0.0022), itching (VAS from 4.5 to 1.16, p = 0.0053), heat (VAS from 3 to 0, p = 0.0119) and burning (VAS from 5.5 to 1.6, p = 0.0013) if compared with the control group. Quality of life for the women during the breastfeeding and puerperium is important and training is mandatory to avoid side effects in order to improve the CO2 laser performance.

Clinical Characteristics and Long-Term Follow-up of Patients Treated for High-Grade Vaginal Intraepithelial Neoplasia: Results From a 20-Year Survey in Italy.

OBJECTIVES: The aim of this survey was to evaluate the different surgical approaches for women with high-grade vaginal intraepithelial neoplasia (HG-VaIN) used in 8 hospitals in central and northern Italy in the last 20 years. In particular, the baseline characteristics of the patients and factors potentially leading to excisional treatment rather than ablation were considered. Moreover, the clinical outcome of patients treated for HG-VaIN (disease persistence or recurrence and progression toward invasive vaginal cancer) was analyzed. MATERIALS AND METHODS: The medical records of all women initially diagnosed with HG-VaIN and subsequently treated in 8 Italian hospitals from January 1996 to December 2016 were analyzed in a multicenter retrospective case series. RESULTS: Among the 226 women included, 116 (51.3%) underwent ablative procedures and 110 underwent excisional surgery (48.7%). An ablative procedure was preferred in cases where multiple lesions were found on colposcopic examinations. Physicians decided more frequently to perform excisional procedures in women with menopausal status, high-grade referral cervical cytology, previous hysterectomy for human papillomavirus-related disease, or VaIN 3 on colposcopic-guided biopsy. CONCLUSIONS: The surgical treatment of HG-VaIN should be tailored according to the clinical characteristics of each woman and each lesion. However, in potentially high-risk cases (VaIN 3, previous hysterectomy for human papillomavirus-related disease, and menopausal women) or in those cases in which an occult invasive disease cannot be ruled out, an excisional approach should be preferred.In any case, long-term follow-up is advisable in women treated for HG-VaIN.

Effectiveness of CO2 laser on urogenital syndrome in women with a previous gynecological neoplasia: a multicentric study.

BACKGROUND: Many women diagnosed with gynecological cancers undergo adjuvant therapy, which may lead to transient or permanent menopause that ultimately leads to urogenital syndrome and vulvovaginal atrophy. Studies advise against the use of estrogen in women with a history of hormone-dependent cancer. One alternative is vaginal microablative fractional CO2 laser, which promotes tissue regeneration through the production of collagen and elastic fibers. OBJECTIVE: To evaluate the effectiveness of CO2 laser in the treatment of urogenital syndrome-in particular, symptomatic vulvovaginal atrophy in women who have survived gynecological cancers. METHODS: A retrospective study was carried out, including all patients with a history of gynecological cancers and vulvovaginal atrophy who underwent CO2 laser treatment between November 2012 and February 2018 in four Italian centers. The study was approved by the local ethics committee of each participating institution. The inclusion criteria were women aged between 18 and 75; Eastern Cooperative Oncology Group performance status <2; and history of breast, ovarian, cervical, or uterus cancer. Patients had to have vulvovaginal atrophy and at least one of the following symptoms of urogenital syndrome: vaginal dryness, dyspareunia, vaginal introitus pain, burning, or itching. Three applications were administered at baseline, 30 days, and 60 days. All patients were evaluated before the first laser session, at each session, and 4 weeks after the last session. In particular, patients were asked to indicate the intensity of symptoms before the first session and 4 weeks after the last session, using Visual Analog Scale (VAS) scoring from 0 ('no discomfort') to 10 ('maximum discomfort'). RESULTS: A total of 1213 patients underwent CO2 laser treatment and of these, 1048 were excluded because they did not meet the inclusion criteria in the analysis. Finally, a total of 165 patients were included in the study. The mean age at the time of treatment was 53 years (range 31-73). Dryness improved by 66%, dyspareunia improved by 59%, burning improved by 66%, pain at introitus improved by 54%, and itching improved by 54%. The side effects were evaluated as pain greater than VAS score 6 during and after the treatment period. No side effects were seen in any sessions. CONCLUSIONS: Fractional microablative CO2 laser therapy offers an effective strategy in the management of the symptoms of genitourinary syndrome in post-menopausal women and in survivors of gynecological cancer.

HPV genotype distribution and age correlation in a selected Italian population undergoing conization.

BACKGROUND: Detection and genotyping of human papillomavirus (HPV) has gained increasing importance in cervical cancer prevention and treatment of cervical intraepithelial neoplasia (CIN). This study aims to determine the HPV type distribution in cervical specimens obtained from women diagnosed with CIN. We evaluated in a selected Italian population the distribution of HPV genotypes. METHODS: Cervical samples were collected from women undergoing laser CO2 conization for high grade at Colposcopic Laser Surgery Unit of the Careggi University Hospital and at the Colposcopy Service of Local Health Unit Toscana Centro in Florence, Italy, between September 2014 and February 2017. HPV genotyping was performed using the LINEAR ARRAY® HPV Genotyping Test. RESULTS: Three hundred and six patients were enrolled. HPV infection was detected on 244 samples (79.7%). A different rate of mono- and poly-infections was observed, with higher poly-infection rates in younger women. Moreover, depending on different age groups (clustered in 5-years interval from 22 to 69 years old) significant different distribution of HPV was fund as genotype, phylogenetic type and cancer-related risk. CONCLUSIONS: Our results suggest that some physiological conditions (i.e. menopause), could influence selection and clearance of specific HPV genotypes. The results of this study represent the basis for supporting the HPV genotyping as clinical tool providing benefits in the management of women with high CIN grade.

Efficacy of fractional CO2 laser treatment in postmenopausal women with genitourinary syndrome: a multicenter study.

OBJECTIVE: Genitourinary syndrome of menopause (GSM), especially vulvovaginal atrophy (VVA), is one of the most common conditions among women in either natural (4%-47%) or medically induced (23.4%-61.5%) menopause. The aims of this study are to assess the efficacy and effectiveness of CO2 laser in postmenopausal women with clinical signs and symptoms of GSM, in particular VVA, and to evaluate both possible early and late side effects related to this kind of treatment. METHODS: This retrospective, multicenter study was conducted after collecting data from a pre-existing database. We performed three to four CO2 laser treatments on all the women enrolled in this protocol. We used a fractional CO2 laser system (SmartXide VLR, Deka m.e.l.a., Florence, Italy) with a VulvoVaginal Laser Reshaping (VLR) scanning system and appropriate handpieces for the vaginal area. All women before and after the treatment were assessed. The pre- and post-treatment averages of the symptoms, the standard deviation, and the P values were calculated. RESULTS: Six hundred forty-five women who met the inclusion criteria were considered. In all the parameters examined (dyspareunia, vaginal orifice pain, dryness/atrophy, itching, burning, pH) statistically significant data were found between the pretreatment and the post-treatment (dryness: before = 8.30, after = 2.97 [P < 0.0001], dyspareunia: before = 8.70, after = 3.51 [P < 0.0001]; burning: before = 6.12, after = 1.78 [P < 0.0001]; vaginal orifice pain: before = 8.07, after = 2.94 [P < 0.0001]; itching: before = 6.09, after = 1.32 [P < 0.0001]). CONCLUSIONS: Our results show the effectiveness and a good degree of tolerance of treatment with the CO2 laser system in postmenopausal women with GSM.

Data on post-partum evaluation of women with abnormal cervical cytology in pregnancy.

During pregnancy, the only diagnosis that may alter management is invasive cancer. Thus, the primary aim of the cytological screening and subsequent colposcopy performed during pregnancy should be the exclusion of invasive cancer, "Practice Bulletin No. 140: management of abnormal cervical cancer screening test results and cervical cancer precursors," (American College of Obstetricians and Gynecologists, 2013) [1]. However, the impact of the delivery on the regression of the cervical lesions is still debated. This data article concerns the post-partum evaluation of colposcopic patterns, cytological and histopathology findings in women diagnosed with abnormal cervical cytology in pregnancy, included in the paper entitled "Reliability of colposcopy during pregnancy" (Ciavattini et al., 2018). Data about the rates of persistence, progression and regression of CIN after delivery are reported.

Indication of prophylactic vaccines as a tool for secondary prevention in HPV-linked disease.

PURPOSE: To determine whether quadrivalent HPV vaccination is effective in reducing recurrent disease in women with a previous history of HPV disease. METHODS: All women under 45 years of age treated for HPV-linked disease and with negative HPV test, cytology and colposcopy 3 months after treatment were enrolled. Women were randomly assigned into two groups: a group that received HPV vaccine post treatment and a group that was only submitted to follow-up. Follow-up was performed every 6 months for a duration of at least 3 years. Kaplan-Meier curve was used to estimate the overall disease-free survival during the follow-up period. Statistical analysis was performed by Fisher's exact test. RESULTS: From November 2013 to October 2014, we enrolled a total of 178 women at Careggi University Hospital in Florence and at Azienda USL in Massa Carrara. 12 out of 89 patients in the non-vaccination group recurred (13.5%), while 3 out of 89 patients in the vaccination group recurred (3.4%). The Kaplan-Meier curves showed a statistically difference in the log rank test (p = 0.0147) for the overall disease-free survival in the study groups during follow-up. The rate of recurrence was significantly higher in the non-vaccination group, with a p = 0.0279 by Fisher exact test. CONCLUSION: The introduction of anti-HPV vaccination during the follow-up post treatment for HPV-linked disease is recommended to reduce the risk of recurrence. The clinical implication of this could be very important to influence post-treatment management of HPV disease.

Reliability of colposcopy during pregnancy.

OBJECTIVE: To investigate the reliability of colposcopy during pregnancy and to evaluate the concordance between colposcopic patterns and histopathological findings in these women. STUDY DESIGN: Multicenter observational study of women diagnosed with an abnormal cervical cytology, who subsequently underwent a colposcopic evaluation with cervical biopsy during pregnancy. The "colpo-histopathological concordance‿ was evaluated. The "colposcopic overestimation and underestimation‿ were evaluated as well. RESULTS: 69 women, fulfilling the study inclusion/exclusion criteria, constituted the study cohort. Among them, on colposcopic examination, 14 women (20.3%) showed "grade I abnormal colposcopic findings‿, 52 (75.4%) showed "grade II abnormal colposcopic findings‿ and the remaining 3 women (4.3%) had a "suspicious for invasion‿ colposcopy. The histopathological diagnosis showed 2 negative biopsies, 12 (17.4%) cases of CIN1, 50 (72.5%) cases of CIN2 and 5 (7.2%) cases of invasive cervical cancer. We found a colposcopic overestimation in 10 cases (14.5%), underestimation in 12 cases (17.4%), and a concordance in 47 cases (68.1%). A better reliability of colposcopy in women in the firsts two trimesters and in particular in women ≤20 weeks pregnant was found (Cohen's weighted kappa: 0.65). CONCLUSIONS: When performed by gynecologists with expertise, colposcopy is a reliable diagnostic tool, even during pregnancy. Whenever possible, a colposcopic evaluation during the first half of pregnancy is preferable.

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.

Colposcopic patterns of vaginal intraepithelial neoplasia: a study from the Italian Society of Colposcopy and Cervico-Vaginal Pathology.

The aim of this study was to evaluate the colposcopic patterns observed in women with a histopathological diagnosis of vaginal intraepithelial neoplasia (VaIN). The medical charts and the colposcopy records of women diagnosed with VaIN from January 1995 to December 2013 were analysed in a multicentre retrospective case series. The abnormal colposcopic patterns observed in women with VaIN1, VaIN2 and VaIN3 were compared. The vascular patterns and micropapillary pattern were considered separately. A grade II abnormal colposcopic pattern was more commonly observed in women with a biopsy diagnosis of VaIN3 rather than with VaIN1 or VaIN2 (P<0.001). Vascular patterns were also more common in women with VaIN3 rather than with VaIN1 or VaIN2 (P<0.001). Moreover, in women with grade I colposcopy, the rate of VaIN3 was significantly higher when a vascular pattern was observed (62.5 vs. 37.5%; P=0.04). The micropapillary pattern was more common in women with grade I colposcopy and it was more frequently observed in women with VaIN1 rather than in those with VaIN2 or VaIN3 (P<0.001). Grade II abnormal colposcopic pattern was more commonly observed in women with VaIN3. Moreover, the detection of vascular patterns appeared to be associated with more severe disease (VaIN3) even in women with grade I colposcopy, whereas the micropapillary pattern should be considered an expression of a less severe disease (VaIN1 and VaIN2).

Erratum to: Long-term reliability of fractioned CO2 laser as a treatment for vulvovaginal atrophy (VVA) symptoms.

In original publication, the Fig. 1 was incorrect. The correct figure has been given below.

Long-term reliability of fractioned CO2 laser as a treatment for vulvovaginal atrophy (VVA) symptoms.

PURPOSE: The aim of this study was to evaluate long-term effects of the fractional CO2 laser for the treatment of vulvovaginal atrophy (VVA) symptoms. METHODS: Women presenting with VVA symptoms and meeting inclusion criterion were enrolled to fractioned CO2 laser therapy. Patient's satisfaction was measured on five-point Likert scale at 4 weeks and 6, 12, 18, 24 months after treatment by interview and clinical examination for vaginal livability. RESULTS: 184 patients constituted the final study group: 128 women were spontaneous menopause and 56 were oncological menopause. 117 women were nulliparous and 36 had previous hysterectomy. 95.4% (172/184) of the patients declared that they were satisfied or very satisfied with the procedure at 4 weeks after treatment. At 6 months 92% (170/184) patients were satisfied; at 12 months 72% (118/162) were satisfied; at 18 months 63% (60/94) were satisfied; at 24 months 25% (4/16) of patients answered they were still satisfied. We observed a decline in patient's satisfaction between 18 and 24 months after laser therapy. Data showed that the time interval from onset of menopause was a statistically significant factor (p < 0.05) for treatment satisfaction in oncological group. CONCLUSION: Long-term data showed that the improvement of vaginal health may continue up to 24 months after fractional CO2 laser treatment although between 18 and 24 months benefits decline, and approximately 80% of women decide to start a new treatment cycle of laser applications.

Fractional CO2 laser for vulvovaginal atrophy (VVA) dyspareunia relief in breast cancer survivors.

PURPOSE: The aim of this study was to evaluate the efficacy of fractional CO2 laser therapy in breast cancer survivors as a therapeutic method for vulvovaginal atrophy (VVA) dyspareunia. METHODS: 50 patients (mean age 53.3 years) underwent fractional microablative CO2 laser treatment for dyspareunia in oncological menopause (mean time of menopause 6.6 years). The Gloria Bachmann's Vaginal Health Index (VHI) score was chosen as system to evaluate the presence of VVA and its improvement after the treatment. Intensity of dyspareunia was evaluated using a visual analog scale (VAS). RESULTS: Data indicated a significant improvement in VVA dyspareunia (p < 1.86e-22) in breast cancer survivors who had undergone 3 sessions of vaginal fractional CO2 laser treatment. Moreover, VHI scores were significantly higher 30 days post-treatment (T4) (p < 0.0001). 76 % of patients were satisfied or very satisfied with the treatment results. The majority (52 %) of patients were satisfied after a long-term follow-up (mean time 11 months). No adverse events due to fractional CO2 laser treatment occurred. CONCLUSIONS: The treatment with fractionated CO2 laser appeared to be a feasible and effective treatment for VVA dyspareunia in breast cancer survivors with contraindications to hormonal treatments.

HPV-related cervical disease and oropharyngeal cancer.

Human papillomavirus (HPV), especially HPV 16, is associated with the development of both cervical and oral cancer. We show the case of a woman affected by HPV-related cervical disease and oropharyngeal squamous cell carcinoma (OPSCC). A 41-year-old woman arrived at our Colposcopy Center following an abnormal Pap smear result (ASC-H) and a diagnosis of moderate cervical dysplasia obtained by a cervical biopsy. She underwent a colposcopy that showed a cervical abnormal transformation zone grade 2. A laser conization was performed in November 2010. Histology reported a moderate/severe dysplasia. The cone resection margins were free. Follow-up colposcopy and cytology were negative. The HPV testing showed an infection by HPV 16. In October 2012, the patient presented to the Head-Neck ER after episodes of hemoptysis; a lesion was found in the left tonsillar lodge. A biopsy was performed with a result of squamous cell carcinoma with low-grade differentiation. The HPV testing detected a high-risk HPV and the immunohistochemical analysis was positive for p16. She was treated by chemotherapy and brachytherapy. She was followed at the head-neck center with monthly visits with oral visual inspection that showed complete absence of mucosal abnormalities. HPV-related OPSCC and cervical precancerous/cancerous lesions have significant similarities in terms of pathogenesis. They are both caused largely by HPV 16, as in the present case. In conclusion, because of this association found in literature and in our case, we think that women with HPV cervical lesions should have regular surveillance for oropharyngeal cancer, whereas women with OPSCC should be encouraged to have diligent cervical screening.

Vulvar paget disease: a large single-centre experience on clinical presentation, surgical treatment, and long-term outcomes.

OBJECTIVE: Our aim was to add information to the current literature on vulvar Paget disease by reviewing a consistent number of patients who have been all diagnosed, treated, and followed up by the same group of physicians at a single medical institution. METHODS: Clinical, surgical, histological, and follow-up data of 34 patients (mean [SD] age at diagnosis = 68.7 [10.1] years) with vulvar Paget disease were reviewed during a 27-year period. RESULTS: Primary symptoms were itching (76.5%) and burning (58.8%). Clinical manifestations were present for a mean (SD) of 17.8 (7.2) months before the diagnosis was made. Multifocal lesions were observed in 17 patients (50%) and were associated with a delay in diagnosis exceeding 12 months (p = .03). Of the patients, 10 (29.4%) presented a history of malignancy in other sites. Surgery with various extent of resection was performed as primary treatment in all patients. Definitive histological examination revealed positive surgical margins in 15 cases (44.1%), stromal invasion in 4 (11.7%), and associated adenocarcinoma in 2 (5.9%). Of the patients, 6 (17.6%) underwent reconstructive technique at their primary surgery or radicalization. During a mean (SD) follow-up of 76.9 (51.3) months, 15 patients (44.1%) experienced local recurrence (1 recurrence in 29.4%, 2 recurrences in 5.9%, and 3 recurrences in 8.8%). First recurrence appeared after a mean (SD) time of 45.7 (25.1) months and was associated with multifocal lesions (p = 0.005) and surgical margins involvement (p = 0.03). One patient (2.6%) died of the disease. CONCLUSIONS: Vulvar Paget disease is a chronic disease with high recurrence rate and low mortality. Early diagnosis, minimal surgery with free margins, and long-term follow-up are the cornerstones of treatment.