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.

The Role of ß1 Integrin/CD29 as a Potential Prognostic Factor for the Risk of Progression to Cervical Carcinoma in HPV-Associated Lesions.

Background and Objectives: Available evidence reports the overexpression of ß1 integrin in dysplastic rather than normal cervical tissue. We aimed to evaluate the involvement of ß1 (CD29) integrin in the progressive pathogenesis of cervical intraepithelial neoplasia (CIN). Materials and Methods: From January 2019 to December 2021, we prospectively enrolled women undergoing a colposcopy with a cervical biopsy for abnormal cervical cytology and/or undefined cytology with a positive HPV DNA test and women with relapsing cervical inflammatory disorders. Based on the histopathological results, women were divided into four groups: group A (CIN1), group B (CIN2), group C (CIN3), and group D (no CIN diagnosis) as a control group. Subsequently, cytofluorimetry and immunohistochemical analysis (based on the identified positive cell ratios as follows: ≤10%, negative; 10-25%, 1+ (weak); 25-50%, 2+ (medium); ≥50%, and 3+ (high)) for ß1 integrin were carried out. Results: In total, 154 women were included. The average fluorescence intensity in the four groups was 2.35 ± 1.37, 2.73 ± 1.56, 3.09 ± 1.56, and 2.13 ± 1.25 UA from groups A to D, respectively; this figure was significantly different for CIN3 (group C) women relative to the other groups (p = 0.0132). Higher ß1 integrin/CD29 concentrations in the CIN groups with HR-HPV 16 and 18 were also detected (p = 0.0292, 0.0367, and 0.0357 respectively for CIN3, CIN2, and CIN1). Immunohistochemistry analysis showed higher results for the CIN3 group compared to controls and all the other groups (p < 0.001). Conclusions: ß1/CD29 integrin expression increased with CIN grade, and it was significantly higher in CIN3 lesions. This could be used as a promising screening tool to identify women prone to developing high-grade cervical lesions. However, additional evidence is needed to strengthen these findings.

Spotlight on Compounded Bioidentical Hormones.

BACKGROUND: The role of hormonal replacement therapy in menopause is under debate. The premature closure of the Women's Health Initiative (WHI) study in 2002 is still a source of concern among treating physicians. OBJECTIVES: The interest in alternatives to conventional hormone therapy has significantly increased. The adoption of personalized steroid hormone galenic preparations, formulated by compounding pharmacies, has recently spread. METHODS: In June 2023, an extensive literature search was conducted by different authors to identify relevant studies in various databases (MEDLINE, Embase, PubMed, and Cochrane). The studies that met the inclusion and exclusion criteria were further analyzed, and relevant data were extracted and analyzed for each paper. Any discrepancies between the investigators were resolved through a consensus approach. OUTCOMES: The primary outcomes observed included the clinical utility of CBHT. This study reviewed the current evidence on the utility of compounded bioidentical hormones, concluding that improving knowledge and awareness of bioidentical hormones is necessary to consider their use in clinical practice. CONCLUSION AND OUTLOOK: These formulations might provide effective options to best tailor therapies to each patient.

Effectiveness of Two Transcutaneous Electrical Nerve Stimulation (TENS) Protocols in Women with Provoked Vestibulodynia: A Randomized Controlled Trial.

BACKGROUND: Vestibulodynia (VBD) is the most common form of vulvodynia. Because VBD is a pain disorder, transcutaneous electrical nerve stimulation (TENS) can be used as treatment. This study aims to evaluate the effects of two-parameter combinations (frequency and pulse duration) of TENS in reducing pain intensity and dyspareunia in VBD. METHODS: A randomized, double-blind, controlled trial was conducted to study the effect of two different electrical stimulation treatment regimens on women with VBD receiving domiciliary TENS. Outcomes were the mean change from baseline at 60 and 120 days of burning/pain and dyspareunia (VAS), Vulvar Pain Functional Questionnaire (V-Q), Female Sexual Functioning Index (FSFI) and vaginal electromyography measurements. RESULTS: A total of 78 subjects, 39 in each group, completed the trial. Patients in Groups 1 and 2 received a mean of 46.9 and 48.4 TENS sessions. By day 120, there was a 38.2% reduction in the burning/pain and a 52.1% reduction in the dyspareunia VAS scores in Group 1, as compared to 21.3% (p = 0.003) and 23.1% in Group 2 (p = 0.01), respectively. FSFI, V-Q, and muscle-strength measures also improved but were not statistically significant. CONCLUSIONS: Our findings showed the potential of TENS in the treatment of VBD.

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.

The impact of combined contraceptive vaginal ring on vaginal environment: an observational, longitudinal study.

PURPOSE: To assess the relationship between combined contraceptive vaginal ring (CVR) and vaginal microbiome using 16S rRNA gene sequencing. MATERIALS AND METHODS: We enrolled 20 women for 8 weeks in an open-label study using CVR (NuvaRing®) that delivered 15 mcg ethinylestradiol and 120 mcg etonogestrel daily. The vaginal microbiome was assessed at baseline and after 2 months by sequencing the 16S rRNA genes amplified from the total genomic DNA isolated from the sample. RESULTS: Bacterial distribution richness and equity did not significantly change after 2 months, and the dominant bacterial strain was Lactobacillus crispatus. Only one woman with a history of vestibulodynia and recurrent vulvovaginitis showed an increase in bacterial biodiversity, with a switch to the relative abundance of anaerobic bacteria. CONCLUSIONS: Our results suggest that CVR does not adversely affect the composition and structure of the vaginal microbiome. However, special care should be taken in patients with a history of vestibulodynia and/or recurrent vulvovaginal infections.

Contraceptive vaginal ring does not adversely affect vaginal microbiome except in the case of recurrent vulvovaginal infections or vestibulodynia.

Vulvodynia: A practical guide in treatment strategies.

Vulvodynia is a debilitating condition characterized by chronic vulvar pain, with a detrimental impact on the patient's overall quality of life. Its etiology is multifactorial, but still in the process of being clearly outlined. Vulvodynia is not a single entity. It is a heterogeneous condition characterized by multiple triggers, making it challenging to define a reference standard for its treatment. In this manuscript we selected all articles including the following key criteria: "vulvodynia". The primary outcomes observed included the resolution of chronic pelvic pain, dyspareunia and sexual satisfaction, psychological well-being, and overall quality of life. Most pharmacologic treatments require further evidence to be recommended. On the other hand, non-pharmacologic approaches such as psychotherapy, physical therapy, and surgery have received stronger support. This review summarizes pros and cons of adopting available treatments. Multimodal approaches should be introduced to improve patient outcomes. Further investigations are warranted to improve patients' quality of life.

Safety and efficacy of fractional CO2 laser treatment to the vestibule: a randomized, double-blind, sham-controlled, prospective 3-site clinical study in women with vestibular pain.

BACKGROUND: Data are limited regarding fractional CO2 laser as a nonhormonal treatment for vestibular pain. AIM: We sought to perform what is, to our knowledge, the first multisite prospective randomized, double-blind, sham-controlled clinical trial to assess the safety and efficacy of fractional CO2 laser treatment to the vestibule in women with vestibular pain. METHODS: Subjects (n = 70) meeting inclusion/exclusion criteria at each of 3 sites were randomized 2:1 to active or sham (zero energy) fractional CO2 laser treatment using the vestibular probe (SmartXide2 V2LR - MonaLisa Touch, DEKA, Florence, Italy). Subjects in each treatment arm received 3 treatments 4 weeks apart. At the initial follow-up (week 12), subjects were unblinded and those initially assigned to sham started active treatment. OUTCOMES: Outcome measures included changes from baseline in sexual activity diaries and scores for the Vulvoscopic Genital Tissue Appearance Scale (VGTA), vestibular cotton-tipped swab testing, McGill Pain Questionnaire, Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS-R), and the O'Leary-Sant voiding and pain indices, the Interstitial Cystitis Symptom Index (ICSI) and Interstitial Cystitis Problem Index (ICPI). RESULTS: After active treatment, VGTA scores significantly improved in 5 parameters. Pain associated with cotton-tipped swab testing was significantly reduced at weeks 4 through 16 (mean change from baseline -0.64 [95% CI, -0.79 to -0.50] and -1.31 [95% CI, -1.46 to -1.16], respectively). FSFI pain domain scores improved significantly at weeks 12 and 16 (mean change from baseline 0.925 [95% CI, 0.10-1.75] and 1.22 [95% CI, 0.40-2.05], respectively). FSFI total scores increased significantly at weeks 12 and 16 (mean change from baseline 6.24 [95% CI, 2.64-9.85] and 4.96 [95% CI, 1.36-8.57], respectively). FSDS-R scores decreased significantly at weeks 12 and 16 (mean change from baseline -5.84 [95% CI, -8.80 to -2.87] and -9.15 [95% CI, -12.11 to -6.18], respectively). ICSI scores decreased significantly at weeks 12 and 16 (mean change from baseline -0.91 [95% CI, -1.65 to -0.18] and -0.754 [95% CI, -1.49 to -0.02], respectively). ICPI scores decreased significantly at week 16 (mean change from baseline -0.99 [95% CI, -1.63 to -0.34]). In contrast, there were no significant changes in outcomes in the sham arm. No serious adverse events occurred. CLINICAL IMPLICATIONS: Fractional CO2 laser treatment in women with vestibular pain resulted in improvement from baseline in multiple key outcome measures of vestibular health. STRENGTHS AND LIMITATIONS: Strengths of the study were that it was a multisite prospective randomized double-blind, sham-controlled clinical trial that included multiple measures related to vestibular pain and sexual function. Limitations were the nonvalidated primary outcome measure and limited study cohort. CONCLUSION: Fractional CO2 laser therapy is a safe and effective nonhormonal treatment for vestibular pain.

New medical device coating mouth gel for temporary relief of teething symptoms: a pilot randomized, open-label, controlled study.

BACKGROUND: This study verified the feasibility of the monthly recruitment rate, tested the Face, Legs, Activity, Cry and Consolability Pain Assessment Tool (FLACC) for pain in infants and collected preliminary efficacy and safety data of a new proprietary oral gel formulation of high-molecular-weight hyaluronan (HMWHA) for the relief of teething. Results will support the design a future main trial vs. local anesthetic, that is currently the only clinically proven pain reliever. METHODS: This was a pilot, randomized, controlled, multicenter, open-label, and parallel-group trial. It was performed in two Romanian clinics recruiting infants from 3 to 36 months. Teething diagnosis was based on a minimum of three symptoms such as: local pain, swelling, erythema, hyper-salivation, and depth characteristics of unerupted tooth. Absence of subcutaneous mucosal laceration was also required. The children were assigned either to HMWHA (HABPX V 3.3, Bioplax Ltd, Wallington, UK), or to standard drug (Dentinox®-Gel N; Dentinox, Berlin, Germany) and treated for 7 consecutive days. Investigators recorded the primary endpoints: swelling, redness and pain (by FLACC method), on days 0, 3 and 7. Changes in crying, mouth spasms, salivation, local pain, swelling, and redness were the secondary endpoints, recorded daily by the parents, on diary cards. Tolerability was assessed on day 14, too. RESULTS: Twenty-seven Infants were allocated in HMWHA, and 30 in standard drug. Enrolment rate was 9 patients/month/site. A significant reduction for HMWHA group was evidenced in pain, swelling (from day 0 to 7, P=0.034 between groups), redness (from day 0 to 3, P=0.045 and from day 0 to 7, P<0.001 between groups) and confirmed by the parents' diary records. Pain measurements obtained by FLACC method are consistent with the data belonging to other parameters. Investigator's global assessment of performance was in favor of the HMWHA (P<0.005). Only two patients, both belonging to standard drug group, experienced adverse events (fever, not related to treatment) and dropped out of the study. CONCLUSIONS: The results solve the feasibility questions and clearly evidence the performance of HABPX V 3.3 in teething symptoms, exceeding the objectives of a simple pilot trial to some extent. Coating oral gels containing HMWHA could be a therapeutic solution for both parents and physicians in managing the irritation and pain resulting from tooth eruption in children.

The role of female intimate hygiene practices in the management of vulvovaginal candidiasis: A randomized, controlled open-label trial.

In this multicenter, observational, controlled open-label trial, researchers randomized 200 women with vulvovaginal candidiasis (VVC) to: Group 1, 6-days clotrimazole 2% vaginal cream once-daily plus 15-days concomitant acid pH thymol and zinc-containing cleansing wash (SaugellaActi3) twice-daily; Group 2, 6-days clotrimazole treatment alone. In both groups, pruritus and burning VAS scores improved from baseline at Days 6, 10 and 15. On Day 10 and Day 15, the pruritus score was significantly lower in Group 1 versus Group 2 (P <0.005 at both timepoints), suggesting acid pH thymol and zinc-containing cleansing wash ameliorates VVC-associated pruritus as part of a female hygiene regimen.

Looking for Responders among Women with Chronic Pelvic Pain Treated with a Comicronized Formulation of Micronized Palmitoylethanolamide and Polydatin.

Background: Palmitoylethanolamide is reported to solve pain and neuroinflammation in different models of chronic and neurodegenerative diseases. Some concerns have been illustrated for cautiously interpreting the available literature on the topic. Specifically, there is a lack of evidence about palmitoylethanolamide and female chronic pelvic pain. Concerns will be best solved by randomized trials. The present study was aimed at finding the best responders to micronized palmitoylethanolamide in female patient with chronic pelvic pain, using the existing literature at individual patient level, to help further randomized trial planning. Methods: After a systematic research, eligible studies (the ones enrolled female patients treated for chronic pelvic pain or for dyspareunia, dysuria, dyschezia, and dysmenorrhea with or without chronic pelvic pain) were assessed at individual patient data level. Conditional probabilities were calculated to assess variables conditioning the rates of good responders (pain score points more or equal to 3 reduction), poor responders (2 pain score reduction), and nonresponders at a three-month follow-up. Results: Only cases treated with palmitoylethanolamide comicronized with polydatin for a short period can be assessed. Good responders are more than 50%. In chronic pelvic pain, there is a 19.0% conditional probability to find good responders among patients with pain score at enrolment of 6 to 8 and of 6.8% to find poor responders among patients with a pain score at enrolment of 6 to 8. Painful disease does not matter on responders' rates. Conclusion: Best responders to comicronized palmitoylethanolamide/polydatin are patients with pain score higher than 6 at enrolment, irrespective of other variables.

The "CIV Classification," a New Proposal for the Architectural Grading of Vulvar Lichen Sclerosus.

OBJECTIVES: The purpose of this cross-sectional study was to prepare a reliable and easy-to-use architectural classification for vulvar lichen sclerosus (VLS) aimed at defining the morphological patterns of this condition. MATERIALS AND METHODS: An expert panel composed by 7 physicians with expertise in clinical care of vulvar conditions outlined the architectural criteria for the definition of VLS severity (phimosis of the clitoris, involvement of the interlabial sulci, narrowing of the vulvar introitus), identifying 5 grades to build up a classification. Thirteen physicians with 2-30 years expertise in vulvar diseases (nonexpert group) were asked to evaluate 3-5 pictures from 137 patients. Each physician individually assigned a grade to each case, according to the previously mentioned criteria. Interrater reliability was analyzed by means of intraclass correlation coefficient (ICC). The reliability concerning the 2 classifications of each rater was analyzed by means of κ statistic. Intraobserver and interobserver reliability in vivo was analyzed by means of κ index. RESULTS: This study provides a new classification of VLS, based on defined anatomical criteria and graded into mutually exclusive progressive classes.The ICC analysis showed a substantial interrater reliability of the classification, ICC = 0.89 (0.87-0.91), both in the expert panel and in the nonexpert group (ICC = 0.92 and 0.87, respectively). An "almost perfect" intraobserver and interobserver reliability was achieved among physicians in vivo (κ = 0.93). CONCLUSIONS: Our classification showed a high reliability. It is easy to use, and it can be applied in clinical practice and eventually, in the evaluation of regenerative and cosmetic surgery.

Vestibular Mucosa Thickness Measured by Ultrasound in Patients Affected by Vestibulodynia: A Case-Control Study.

INTRODUCTION: A multifactorial etiology has been implicated in the development and maintenance of vestibulodynia (VBD), and atrophic changes of the vestibular mucosa have been observed in many patients. AIM: To assess the vestibular mucosa thickness in patients with VBD by comparing this sample with a control group of healthy fertile women and postmenopausal patients with symptoms of genitourinary syndrome of menopause (GSM). METHODS: Vestibular mucosa thickness was measured with a 20 MHz ultrasound probe (DermaScan C, Cortex Technology, Denmark), including both the epidermis and dermis. MAIN OUTCOME MEASURES: All women were evaluated by anamnesis, physical examination, and self-report symptoms. Thickness of the vestibular mucosa (expressed in micrometers) was determined by the B-mode, excluding the hyperechogenic entrance echo and hypoechogenic subcutis. Clinical data related to VBD and GSM were recorded using a 0- to 10-point visual analog scale related to dyspareunia and vulvar pain/burning (0 = no pain; 10 = worst possible pain). RESULTS: A total of 85 patients were recruited: 24 with VBD, 20 with GSM-related symptoms, and 20 matched controls. Vestibular mucosa thickness measurements were not significantly different between the VBD (mean ± DS: 1,092.5 ± 226.1 µm) and GSM groups (1,059.7 ± 221.5 µm), while the parameter was significantly lower (P < .01) than the control group (1,310.6 ± 250.0 µm). Correlation analysis in the VBD and GSM groups between low vestibular mucosa thickness and symptom intensity (burning/pain and dyspareunia) showed a significant correlation. CONCLUSION: Patients with VBD have a vestibular mucosa with a lower thickness than healthy women of the same age, with an almost identical value to that found in postmenopausal women. Furthermore, a low vestibular mucosa thickness in the VBD and GSM groups showed a significant correlation with burning/pain intensity and dyspareunia severity. F Murina, S Barbieri, C Lubrano, MD, et al. Vestibular Mucosa Thickness Measured by Ultrasound in Patients Affected by Vestibulodynia: A Case-Control Study. Sex Med 2021;9:100320.

Efficacy of an orally administered combination of Lactobacillus paracasei LC11, cranberry and D-mannose for the prevention of uncomplicated, recurrent urinary tract infections in women.

BACKGROUND: Most women experience a urinary tract infection (UTI) at least once in their lifetime. The present study determined the efficacy and safety of a combination of Lactobacillus paracasei LC11, cranberry and D-mannose (Lactoflorene Cist®) in the prophylaxis of recurrent uncomplicated UTIs in premenopausal women. METHODS: This single-centre study enrolled premenopausal women aged 18-50 years with an acute UTI and a history of recurrent uncomplicated UTIs. Patients were first treated with fosfomycin (3 g once a day for 2 days) to eliminate any underlying infection, followed by treatment with Lactoflorene Cist® once a day for 10 days/month for 90 days (Group 1), Lactoflorene Cist® once daily for 90 days (Group 2) or no treatment (Group 3; control). The main study endpoint was the rate of UTI recurrence during the study period. Any adverse events with treatment were also recorded. RESULTS: A total of 55 women (mean age 39.3 years; range: 20-46) were enrolled in the study. A significantly higher proportion of patients in the control group experienced UTIs during the study period compared with the two treatment groups (52.9% vs 16.0% in Group 1 and 15.5% in group 2; p < 0.01). Similarly, a higher proportion of patients in Group 1 (65.8%) and Group 2 (68.7%) remained UTI-free during the study versus the control group. No adverse events were reported in the treated patients. CONCLUSION: Prophylactic treatment with Lactoflorene Cist® was effective and safe in the management of recurrent uncomplicated UTIs in premenopausal women.

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.

Fractional Pixel CO2 laser treatment for decubitus ulcer in advanced pelvic organ prolapse: a case report.

OBJECTIVE: Cervicovaginal decubitus ulceration is a complication of advanced pelvic organ prolapse that is very difficult to manage. Here, we report on the effectiveness of fractional CO2 laser treatment for a wide decubitus ulcer over an apical vaginal vault prolapse. METHODS: We report a case of a postmenopausal woman with a wide decubitus ulcer over a vaginal vault prolapse. A fractional microablative CO2 Pixel laser system (Alma Lasers, Cesarea, Israel), equipped with an appropriate probe for the vulva, was used to treat the ulceration of a 78-year-old patient across three laser sessions with 30-day intervals. RESULTS: A significant improvement in the decubitus ulcer was noted in a check-up held 2 months after the final laser session, with approximately 95% wound healing observed. No side effects were reported during or after the laser therapy. CONCLUSIONS: This case demonstrates that fractional Pixel CO2 laser treatment is a viable option for managing decubitus ulcers before definitive surgery in postmenopausal women with advanced pelvic organ prolapse.

Vulvar pain: The revealing scenario of leading comorbidities in 1183 cases.

OBJECTIVES: This study set out to investigate the epidemiological characteristics and comorbidities of chronic vulvar pain. Secondary goals were to identify the preferred approaches for managing vulvodynia in Italy. STUDY DESIGN: A cross-sectional study (the VuNet -Vulvodynia Network project) was performed in consecutive female patients with chronic vulvar pain attending 21 Italian medical centers (public hospitals, university clinics and private outpatient services) in the period December 2016 to November 2018. Study data were entered by healthcare professionals in a special web-based medical record system (PRIDE- Progetto Rete Italiana Dolore vulvarE). These data covered epidemiological aspects, demographic characteristics, obstetric and gynecological history, presence and duration of current and/or past symptoms, associated disorders, details of physical examination and treatment approaches. RESULTS: A total of 1183 subjects with a diagnosis of chronic vulvar pain were included in the study. The main reason for consultation was superficial dyspareunia, present in 64.2 % of the women. 43.4 % of the sample reported comorbid sexual disorders (of desire in 22.1 % and arousal in 21.3 %). 48.3 % of the patients reported prolonged pain lasting between one and five years. Factors associated with vulvar pain included a relatively high family history of diabetes mellitus (father = 8.6 %; mother = 8.4 %), recurrent vulvovaginal candidiasis (32 %), and urinary tract infections (37.4 %: recurrent cystitis in 19.5 % and post-coital cystitis in 17.9 %). Irritable bowel syndrome (28 %), constipation (23.5 %), headache (25.7 %: migraine in 18.0 % and menstrual headache in 7.7 %), allergies (17.5 %: food allergies in 10.1 %, respiratory allergies in 7.4 %), anxiety (15.0 %), dyschezia (11.7 %), invalidating dysmenorrhea/endometriosis (11.1 %), and major depression (7.6 %) were also reported. Vestibulodynia was diagnosed in 837 of the 1183 patients (70.8 %) and generalized vulvodynia in 323 (27.3 %). Notably, 69.1 % of the patients stated that previous therapies had not changed their pain. CONCLUSIONS: The diagnoses of vestibulodynia and vulvodynia must be considered in patients with chronic vulvar pain. The VuNet study contributes to a more comprehensive reading of the predisposing, precipitating and maintaining factors that contribute to vulvar pain, and of the key comorbidities.

Characterization of female intimate hygiene practices and vulvar health: A randomized double-blind controlled trial.

BACKGROUND: Inappropriate feminine hygiene practices are related to vulvar unpleasant symptoms (such as skin changes, lesions, burning, pruritus, fissures, and dyspareunia). AIMS: We assessed the daily use effects of intimate cleansers on vulvar skin by comparing two specific products for intimate care: Saugella Hydraserum (SIS), based on natural extracts, and a standard product based on lactic acid, such as Lactacyd Feminine Hygiene (LTC). Forty healthy women were enrolled in this double-blind controlled study. METHODS: After randomization, the cleansers were used twice daily for 30 days. The hydration level was determined using the Corneometer® CM 825, the pH using the Skin-pH-Meter PH 905® and the sebum level using the Sebumeter SM815® . Measurements were performed at baseline and on day 30 on the labia majora and labia minora. RESULTS: Both cleansers showed a reduction in the hydration level, but this was much less evident in the SIS group (-6.3% SIS vs -23,7% LTC). The pH values of the SIS group were lower than those of the LTC group, especially on the labia minora (5.27 ± 0.08 and 5.6 ± 0.1, respectively, P = .025). The sebum increased in both groups, but in the LTC group, it was higher on the labia majora (+96.2% vs +46.8%, respectively, P = .003), while on the labia minora, it was higher in the SIS group (+24.7% vs +17.1%, respectively P = NS). CONCLUSIONS: Both cleansers tested showed high performance for safety and tolerability on vulvar skin, but SIS showed better efficacy than LTC on some parameters.