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Objectives: This TRIPLE study was aimed to evaluate the efficacy of polycarbophil vaginal gel (PCV) in treating symptoms of vaginal atrophy (VA) of peri- and post-menopausal women., Materials and Methods: Sexually active women in peri- (n = 29) and post-menopause (n = 54) suffering from VA, were progressively enrolled and treated for 30 days with PCV. Those wishing to continue (n = 73) were treated for additional 180 days. PCV was administered as one application twice a week. The vaginal health index (VHI; range 5 to 25) and the visual analogue score (VAS range for 0 to 100 mm for each item) for vaginal dryness, irritation, and pain at intercourse, along with the global symptoms score (GSS; range 1 to 15) and treatment safety, were evaluated at baseline and after 30 days. In those continuing the treatment an evaluation was performed after additional 180 days., Results: Women in peri and post-menopause were of 48.7 ± 3.3 years and 57.5 ± 5.7 years old., respectively. At baseline all outcomes were significantly worse (p<0.002) in postmenopausal group, except the VHI (p < 0.056). After 30 days VHI increased (p < 0.001) of 4.1 ± 0.5 (mean ± SE), and 5.1 ± 0.4 in peri- and post-menopausal women respectively. VAS of vaginal dryness decreased (p < 0.001) of -24.4 ± 3.6, and -52.7 ± 2.6 (p < 0.001), VAS of irritation decreased (p<0.001) of -18.6 ± 4.4 and -47.8 ± 3.2, VAS of pain decreased (p < 0.001) of -26.2 ± 4.3 and -55.6 ± 3.1 and the GSS decreased (p < 0.001) of -3.9 ± 0.3, and -4.9 ± 0.2, in peri and post-menopausal women, respectively. All the modifications were significantly greater (p < 0.001)(p < 0.032 for GSS) in postmenopausal women, and after 30 days all outcomes were similar in the two groups of women. In comparison to baseline, after 210 days of treatment VHI increased of 7.7 ± 0.3 (p < 0.001), VAS of vaginal dryness decreased of -53.6 ± 1.9 (p < 0.001) VAS of irritation of -42.6 ± 1.4 (p < 0.001) VAS of pain of -46.7 ± 2.3 (p < 0.001) and the GSS of -6.5 ± 0.2 ± 0.2 (p < 0.001). All outcomes improved (p < 0.001) over the values observed after 30 days of treatment (p < 0.001). No side effect was reported., Conclusions: In peri- and post-menopausal women PCV administration rapidly improves VA symptoms, and its prolongation up to 6 months further increases its efficacy., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Angelo Cagnacci received a fee as invited speaker for Italfarmaco, Shionogi, Bayer, Gedon-Richter, Theramex, MSD and Exeltis. Dionisio Franco Barattini is employed at Opera CRO, the Contract Research Organization that managed the study. Elena Casolati is a medical consultant for Italfarmaco SpA. Alberto Pecoroni and Mario Mangrella are employed at Italfarmaco SpA. Serban Marius Rosu and Liviu Cristian Patrascu certifies that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

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., Competing Interests: Declaration of conflicting interestsFM, PI, MB, DS, SMR, and CC declare no conflict of interest. DFB is employed at Opera CRO, the Contract Research Organization that managed the study. EC is a medical consultant for Italfarmaco SpA. LIA and MM are employed at Italfarmaco SpA.

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., Competing Interests: Declaration of Competing Interest Serena Tinti, Francesca Praticò, Veronica Bonaldo, Marika Ylenia Rovetto, Marco Liberati,  Mariavittoria Locci, and Irene Cetin declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Dionisio Franco Barattini is employed at Opera CRO, the Contract Research Organization that managed the study. Elena Casolati is a medical consultant for Italfarmaco SpA. Elena Piccolo, and Roberto Piazza are employed at Italfarmaco SpA., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

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., (©Filippo Murina, Paolo Inghirami, Marius Biriș, Daniela Sîrbu, Dionisio Franco Barattini, Federica Sbrocca, Luca Ivan Ardolino, Mario Mangrella, Elena Casolati, Serban Roșu, Ciprian Doru Crișan. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 20.07.2023.)

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/m 2 . 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., (Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.)

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 12 th and the 24 th 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.

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., ((c) 2007 Wiley-Liss, Inc.)

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

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.

465 intravenous drug abuser (IVDA) women were studied to evaluate the prevalence of sexually transmitted diseases, 2207 university students have been considered as control group. A complete gynecological evaluation with Pap smear and cervico-vaginal cultures were performed. Informations on sexual and behavioural patterns were collected using a standard questionnaire. IVDAs show early onset of sexual activity (15 vs. 18 yrs) and many sexual partners; just a small percentage of them use condom, efficacious in the protection against venereal diseases. These peculiar behavioural patterns and the immunodeficiency ascribable to the drug abuse may condition the high frequency of viral and bacterial infections of lower genital tract (53% vs 0.8% and 67% vs 10% respectively). Cervical intraepithelial neoplasia has been found significantly more frequently in IVDA women (16%) than in control group (1%) p less than .01.

The Authors carried out a random double-blind trial on 30 patients affected by idiopathic urge incontinence with oxybutynin chloride (15 mg/die) and placebo for two 20 day therapeutical cycles. The 24 patients who completed the trial oxybutynin chloride induced statistically significant effects--compared to placebo too--both on the subjective symptoms (reduction or disappearance of the urgency in 14 cases - 60.8% - and of urge incontinence in 16 cases - 76.1%) and on the objective symptoms showed by cystomanometry (increased bladder capacity at the FD and VSD in 14 and 15 cases, respectively; absence of involuntary contraction in 9 cases and normal or reduced detrusor pressure at the VSD in 13 out of 16 cases). Improvements, though less significant, were also obtained with the placebo.

The Authors review their series of pre- and post-operatory urethrocystographies in SUI and discuss their data according to the interpretative criteria proposed by the leading authors. None of the suggested criteria seems satisfactory at all; however, cystography seems undoubtedly useful in the overall comprehension of SUI pathogenesis; moreover, when it is supported with a complete urodynamic evaluation, it can lead to the most exact diagnosis and permit the most proper therapeutical approach.