POLARIS: efficacy and safety of a vaginal medical device in recurrent bacterial vaginosis-a multicenter, open-label, non-controlled, study with 10 months of follow-up.

OBJECTIVE: Recurrent bacterial vaginosis (RBV) after antibiotic treatment has relapse rates of 35% within 3 months and 60% within 12 months. A medical device containing polycarbophil, lauryl glucoside, and glycerides (PLGG) inhibits bacterial growth and has mucoadhesive properties. This study examined the efficacy of the device in women with RBV. METHODS: This post-market clinical follow-up study comprised two phases. The first phase was an interventional, open-label, non-controlled, multicenter study enrolling 56 women. The second phase was an observational 10-month follow-up without treatment. RESULTS: After three cycles of PLGG treatment, recurrence was identified in 8 of 54 evaluable patients (14.81%). A positive effect on lactobacilli in the vaginal secretions was observed in 26 of 39 patients (66.67%). Among 35 patients observed after stopping PLGG treatment, one case of RBV (2.86%) was observed after 4 months, and an additional six cases (17.14%) were observed after 10 ± 2 months. Therefore, no recurrence was evidenced in 12 subjects (34.28%) at the end of the study. CONCLUSION: The use of PLGG vaginal ovules in the treatment of BV reduces the rate of recurrence and apparently produces a positive effect on the vaginal microbiota.

Prevalence and burden of nausea and vomiting in pregnant women: Interim analysis of the PURITY survey.

OBJECTIVES: Nausea and vomiting in pregnancy is a common and invalidating condition in early pregnancy. However, no data are available on its prevalence in Italy. This survey aims to evaluate the prevalence and impact of nausea and vomiting during pregnancy on the quality of life of Italian women. STUDY DESIGN: The survey was performed in three Italian public University Hospitals in two distinct periods: a first interview took place between the 18th and 22nd week of pregnancy, using the Questionnaire for Pregnancy Period (14 questions regarding demographic data and 30 questions about nausea and vomiting in pregnancy, including Pregnancy-Unique Quantification of Emesis questionnaire), and a follow-up interview, by telephone call, took place immediately after giving birth and in any case within 14 days of delivery, using the Questionnaire for Post-Pregnancy (9 questions). Included women were Caucasian, in physiological pregnancy and between the 18th and 22nd week (time of morphological ultrasound), able to communicate adequately with the interviewer, understand the questionnaires and able to provide valid informed consent. Twin pregnancies and women who recurred to medically assisted procreation were excluded. This is an interim report on data collected from 232 of the planned 600 women. RESULTS: Mean age of the recruited subjects was 32.6 ± 4.6 years, with approximately 60% primiparous. The prevalence of nausea and vomiting in pregnancy in the sample examined was 65.5% overall (152 out of 232 subjects). Of these 152 women, 63 (41.4%) experienced only nausea, 6 (3.9%) only vomiting, and 83 (54.6%) reported both. Symptoms were reported to begin at 7.2 ± 2.7 weeks, lasted 10.2 ± 5.6 weeks, and persisted at the time of the interview in 32.2% of cases. Overall, over 50% of the women interviewed experienced a negative impact of nausea and vomiting in pregnancy on social relationships and work activity. CONCLUSIONS: A high prevalence of nausea and vomiting in pregnancy, 65.5% overall, was found in this interim analysis. These symptoms appeared capable of negatively influencing women quality of life. Screening procedures should be offered during pregnancy and measures that address nausea and vomiting in pregnancy impact warranted.

Performance and Safety of a New Medical Device (Polybactum) for Reducing the Recurrence Rate of Bacterial Vaginosis: Protocol for a Multicenter, Open-Label, Noncontrolled International Clinical Trial (POLARIS Study).

BACKGROUND: The medical literature has reported that recurrent bacterial vaginosis (RBV) has a relapse rate of 35% within 3 months and 60% within 12 months after antibiotic administration. Products that are able to provide a barrier effect against the biofilm produced by Gardnerella vaginalis could play a role in improving the results of bacterial vaginosis (BV) treatment. OBJECTIVE: This study aims to assess the performance and safety of a medical device (Polybactum) containing polycarbophil, lauryl glucoside, and glycerides (PLGG) for reducing the rate of recurrence of BV. METHODS: The study includes women who are aged above 18 years, are willing to provide signed informed consent, have a diagnosis of BV according to the Amsel criteria, and have been affected by at least 2 episodes of RBV in the last 12 months. The trial includes 2 phases. In the first phase (according to an open-label noncontrolled design), the treatment involving PLGG is administered for 3 cycles and is followed by a 1-month period of follow-up without treatment. In the second phase, a 9-month follow-up period is envisaged. Thus, for each patient, a 10-month follow-up period without treatment is planned. The study involves 5 centers (2 in Italy and 3 in Romania). We calculated a sample size of 44 pairs to achieve a power of 80% and a 1-sided significance of 5% for detecting a difference of 0.25 between marginal proportions, in comparison with the mean recurrence rate of BV reported in the medical literature. We estimated a potential dropout rate of 20%, and thus, we decided to enroll 55 patients (1-group chi-square test). RESULTS: The study received ethics approval in 2016 in Romania and 1 year later in Italy. Recruitment started in September 2016. An interim analysis was performed in 2019, and full study analysis results are expected in July 2023. CONCLUSIONS: The tested medical device involving PLGG could modify the mechanisms involved in the pathogenesis of BV and could improve microbiological parameters owing to the acidifying effect on vaginal pH. We believe that the findings of our study could be useful for other investigators who want to test different products against RBV using a standardized protocol and standardized procedures. TRIAL REGISTRATION: ClinicalTrials.gov NCT02863536; https://clinicaltrials.gov/ct2/show/NCT02863536. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/42787.

Polycarbophil vaginal moisturizing gel versus hyaluronic acid gel in women affected by vaginal dryness in late menopausal transition: A prospective randomized trial.

OBJECTIVES: During menopausal transition, women are frequently affected by vulvovaginal atrophy (VVA), due to the decline of estrogen levels. Resulting symptoms are itching, burning, dyspareunia, and vaginal dryness (reported in up to 85%). The aim of this trial was to verify if medical device polycarbophil vaginal (PCV) moisturizer gel is not less effective than hyaluronic acid (HA) gel in treating vaginal dryness. MATERIAL AND METHODS: This was a multicenter, open label, randomized, parallel group, comparative study with non-inferiority design. Female included were ≥45 to ≤55 years in the menopausal transition, with subjective dryness, any objective sign of VVA, pH > 5, and body mass index of ≥18.5 to ≤36 kg/m2. Subjects were randomized to 1 g of PCV gel twice a week for 30 days or 3 g of HA vaginal gel every 3 days for 30 days. RESULTS: 53 subjects (mean age 49.45 ± 2.96 years) were analyzed. Vaginal health index showed an improvement (p < 0.001) in both groups (from 12.54 ± 1.37 to 16.36 ± 2.66 for PCV, from 12.00 ± 1.91 to 16.60 ± 2.50 for HA), but the difference between final means (95%CI: -1.66 to 1.18) evidenced that PCV is non-inferior to HA treatment. Similarly, an improvement was evidenced in vaginal maturation index (p = 0.005 for PCV, ns. for HA), female sexual function index (p < 0.001 for PCV, p < 0.001 for HA), and SF-12 (p < 0.001 for PCV, p < 0.001 for HA), with no difference between groups. Safety was optimal and no adverse events were reported. CONCLUSIONS: The use of HA gel does not give additional benefits to those that are already provided by the moisturizing PCV.

Efficacy and safety of a novel vaginal medical device in recurrent bacterial vaginosis: a multicenter clinical trial.

BACKGROUND: The effectiveness of a new vaginal medical device, which contains polycarbophil, 0.04% lauryl glucoside and glycerides (Polybactum®, Effik Italia Spa, Cinisello Balsamo, Milan, Italy), in reducing BV recurrence rate was investigated. METHODS: This was a multicenter, open label, not comparative study. Women over 18 years old affected by recurrent BV were included. The latest episode was diagnosed by Amsel criteria 6-9 days before the start of the study and treated with vaginal metronidazole (gel 0.75% mg for 5 days or ovules 500 mg for 7 days). The recurrence was defined by at least 2 episodes in the previous 12 months. Polybactum® vaginal ovules, day 1-4-7, were started within the 12th and the 24th hour after the end of metronidazole therapy and repeated monthly for 3 cycles. RESULTS: The first 41 patients enrolled were evaluated for an interim analysis 6 months after the study started; 2 patients interrupted the trial, leaving 39 evaluable subjects. The recurrence rate was significantly reduced compared to previous published data (10.26% vs. 40% P<0.001). In 35 patients without recurrence, the assessment of Lactobacillus vaginal flora performed by phase contrast microscopy evidenced a significant improvement form baseline (P=0.022) The investigator global assessment of tolerability was excellent in 38 out of 39 cases. CONCLUSIONS: Our research showed that 3 monthly cycles of Polybactum® ovules administered after one course of metronidazole vaginal therapy can reduce the rate of Bacterial vaginosis recurrence and improve the vaginal milieu, favoring the growth of vaginal lactobacillus species.

Colposcopy is not necessary to assess the risk to the cervix in HIV-positive women: an international cohort study of cervical pathology in HIV-1 positive women.

The objectives of this prospective multicentre international cohort study are to describe the characteristics of a cohort of HIV-1 positive women and determine the best management system by comparing cervical pathology according to results of cytology, colposcopy and human papillomavirus (HPV) testing at baseline and throughout follow-up. A. Cohorts of known HIV-positive women were recruited from 6 hospital-based European centres and a community-based South African centre. Following registration, women were reviewed every 6 months to undergo cervical surveillance including cytology, colposcopy, histopathology and HPV testing, using the HPV hybrid capture assay. Independent risk factors for the incidence of cytological abnormality and acquisition/clearance of HPV infection during follow up were identified. A total of 1,534 women were recruited, 400 of which were from South Africa. At baseline, among European women, 66% had normal cytology and half were HPV negative and among South African women, 45% had normal cytology and one third (32%) were HPV negative. The sensitivity of cytology (>/=ASCUS) matched with that of colposcopy to detect CIN2+. Rate of detection of high grade CIN at 2 years was similar in European and South African women (11 and 9.3%, respectively). Cytology and HPV testing alone were each sufficiently sensitive as a screening test at 2 yearly intervals. Our data confirm the high prevalence of low-grade cytological abnormalities and high-risk HPV infection. Cytology appears to be sufficient for cervical surveillance, with HPV testing being less specific with poor positive predictive value. There appears to be no additional benefit from routine colposcopy.

Survivin as a marker of cervical intraepithelial neoplasia and high-risk human papillomavirus and a predictor of virus clearance and prognosis in cervical cancer.

We analyzed survivin as a marker of cervical intraepithelial neoplasia (CIN) and high-risk human papillomavirus (HR-HPV) and a predictor of HPV clearance and disease outcome in cervical cancer in 302 samples (squamous cell carcinomas [SCCs], 150; CIN lesions, 152) by immunohistochemical staining with survivin antibody and HPV testing using polymerase chain reaction. HR-HPV types were associated closely with CIN and SCC. There was a significant linear relationship between grade and intensity of survivin expression (P = .0001). Survivin overexpression also was associated strongly with HR-HPV type (P = .0001). Multivariate regression analysis revealed survivin and p16(INK4a) as equally strong independent predictors of HR-HPV. Deregulated survivin expression did not predict clearance or persistence of HR-HPV after treatment of CIN or survival in cervical cancer in univariate (P = .417) or multivariate analysis. After adjustment for HR-HPV, stage, age, and tumor grade in the Cox regression model, only stage (P = .0001) and age (P = .0001) remained independent prognostic predictors. Survivin seems to be an early marker of cervical carcinogenesis. Up-regulated survivin expression was an independent predictor of HR-HPV in cervical lesions, most plausibly explained by its normal transcriptional repression by wild-type p53 being eliminated by HR-HPV E6 oncoprotein.

Vulvar neoplasia in HIV positive women: a review.

Among genital malignancies, vulvar cancer and its precursor, Vulvar Intraepithelial Neoplasia (VIN), is less commonly encountered than cervical neoplasia. According to R.W. Jones (2001) vulvar cancer represents about 3-5% of all genital neoplasms and its peak of incidence is between 60 and 80 years of age. Risk factors for vulvar carcinoma are: smoking and immune depression, which expose to a higher risk of vulvar HPV infection caused by high risk strains. In recent years, increased prevalence and incidence of high grade VIN and vulvar invasive carcinoma in young patients (below 45 years of age) have been reported. The main group of affected cases is represented by HIV infected women. Data about the severity of immune depression, expressed by CD4 cell count, as an adjunctive risk factor for persistence, recurrence or progression, are conflicting and scanty. Moreover, information about the effect of Highly Active Antiretroviral Therapy (HAART) on the natural history of VIN are inconclusive. So far, a thorough examination of the vulvar region, associated with colposcopy and biopsy when indicated, should be considered a routine procedure in the gynaecological surveillance of HIV positive women.

Mucosal immune response to Human Papilloma Virus (HPV) infection in HIV positive women.

Mucosal immunity plays a central role in the control of genital human papilloma virus (HPV) infection. HIV infection is associated with higher risks of HPV-induced neoplasias. Prevalence, incidence and evolution of genital HPV lesions are correlated with the level of immunodepression. Several changes of the local immune response in the genital tract of HIV infected women have been demonstrated. The influence of HIV on the production of some immunoregulatory cytokines appears of particular interest. The shift from the helper T cells type 1 (Th1) to the helper T cells type 2 (Th2) immune response, which determines the downregulation of the cell-mediated immunity, may explain the frequent loss of immunologic control of HPV and its oncological complications