Clinical manifestations and evaluation of postmenopausal vulvovaginal atrophy.

INTRODUCTION: It is estimated that 50% of women will suffer a severe form of vulvovaginal atrophy (VVA) related to menopause. Equally, young women may temporarily present this clinical problem while receiving various pharmacological or endocrine treatments or radiotherapy. AIM: To determine clinical and diagnostic exams required to confirm the presence of VVA (also referred to as atrophic vaginitis, urogenital atrophy, or genitourinary syndrome of menopause) and rule out other genital or pelvic clinical conditions. MATERIALS AND METHODS: Literature review searches were carried out on the main scientific article search engines (PubMed, SciELO, Cochrane) using different clinical terms, treatments or interventions and comorbidity related to VVA. RESULTS: The development and severity of VVA depend mainly on the duration of hypoestrogenism. Hypoestrogenism causes changes in the urogenital tissue, generating signs and symptoms, such as dryness, burning, soreness, itching, and irritation of the genital skin. The diagnosis can be made through anamnesis (patient history), questionnaires, physical exam, and, sometimes, complementary exams. Objective vaginal assessment is essential and can be completed with the Vaginal Health Index, the Vaginal Maturation Index, or vaginal pH in the absence of infection or semen. The exclusion of other vulvovaginal organic pathology is essential to reach an accurate diagnosis and provide adequate treatment. CONCLUSIONS: The specialist should be able to identify VVA, rule out other pathologies that make a differential diagnosis and conduct proper management.

Potential effectiveness of Ospemifene on Detrusor Overactivity in patients with vaginal atrophy.

OBJECTIVES: To report the effects on the urinary function of ospemifene prescribed for vulvovaginal atrophy (VVA) in patients with overactive bladder (OAB) symptoms refractory to the first line of pharmacologic treatment with antimuscarinic or ß3-agonists drugs. We also try to identify any predictors of response to the ospemifene treatment. STUDY DESIGN: Twenty-five patients with OAB confirmed by detrusor overactivity at urodynamics, refractory to first-line therapy for OAB, were enrolled for the study. All of them received ospemifene 60 mg for 12 weeks because of concomitant VVA. We performed a clinical examination, a 3-day voiding diary, ultrasound examination of bladder wall thickness (BWT), and evaluation by Visual Analogic Scale (VAS) of vaginal dryness at baseline and at 12 weeks. We evaluated urinary symptoms and their impact on the quality of life with UDI-6 SF and OAB-Q (Qol, sf) questionnaires. RESULTS: After 12 weeks of treatment, we observed a significant reduction in the daily (24 h) numbers of episodes of micturition, of nocturia, of urgency and of incontinence. We also found a significant reduction in BWT and vaginal dryness, together with an improvement of OAB-Q and UDI6 SF scores. Among patients who subjectively benefited from the treatment, we found a baseline lower prevalence of constipation and a higher degree of vaginal dryness. CONCLUSIONS: Ospemifene might be a useful option for postmenopausal women with VVA and OAB symptoms, refractory to the first line of treatment with ß3-agonists or antimuscarinic drugs, before considering invasive options.

Optical Vaginal Biopsy Using Optical Coherence Tomography.

OBJECTIVE: Optical coherence tomography is a noninvasive technology that visualizes tissue microstructure with high spatial resolution. We designed a novel vaginal system that demonstrates a clear distinction between vaginal tissues planes. In this study, we sought to compare vaginal tomographic images of premenopausal, perimenopausal, and postmenopausal women, demonstrate feasibility of tracking vaginal tissue changes after treatment with fractional-pixel CO2 laser therapy, and obtain a histologic correlation of these findings. METHODS: Enrolled subjects underwent imaging and were divided into 3 groups based on menopausal status. Women with genitourinary syndrome of menopause who received fractional-pixel CO2 laser therapy were assessed before and after treatment. A cadaveric vagina was used to obtain tomographic and histologic images to assess for accuracy. Our primary outcome was mean vaginal epithelial thickness. Statistical analysis was performed using analysis of variance and t tests, respectively. RESULTS: Among 6 women, the mean vaginal epithelial thickness decreased with menopause (P < 0.01). Although change in epithelial thickness after fractional-pixel CO2 laser treatment varied between the 2 subjects evaluated, it increased significantly for the subject who reported improvement of vaginal symptoms (P < 0.01). Using a cadaveric specimen, optical biopsy was correlated to an hematoxylin and eosin-stained biopsy of the same vaginal site. CONCLUSIONS: This study establishes feasibility of optical coherence tomography in providing an optical biopsy of the vaginal epithelium and lamina propria. In addition, it demonstrates vaginal changes as women enter menopause. This report is the initial phase of a longitudinal cohort study to evaluate changes in vaginal microstructure after energy-based treatment.

Functional outcome and quality of life evaluation of graciloplasty for the treatment of complex recto-vaginal and recto-urethral fistulas.

Recto-vaginal (RVF) and recto-urethral (RUF) fistulas are infrequent but disabling conditions that severely affect patients' quality of life. Considering the high recurrence rate after conservative approaches, the best surgical treatment is still challenging. The aim of this study was to evaluate the outcome of graciloplasty to treat patients with complex RVF or RUF, and to investigate its effect on the quality of life. Fourteen patients with RVF and RUF who underwent graciloplasty between 2003 and 2017 were retrospectively enrolled. The main outcome was the healing rate of fistulas. Postoperative patients satisfaction was evaluated administering the Clinical Patient Grading Assessment Scale (CPGAS), SF-36 questionnaires and Changes in Sexual Functioning (CSF) questionnaires. The Wexner score was calculated in case of preoperative faecal incontinence. RVF and RUF were iatrogenic in 11 patients and due to Crohn's disease in 3 cases. After 1 year of follow-up (IQR 10-14 months), the success rate of the procedure was 78%. Out of three patients with RVF due to Crohn's disease, two healed after the procedure. Six months after surgery, all eight SF-36 domains significantly improved except for "body pain"; CSF score significantly increased from 35.5 (IQR 31-38.7) to 44 (IQR 37.7-48.5); CPGAS score improved from a median value of 0 (IQR 0-0) to 4 (IQR 3.2-4). The Wexner score was calculated only in 5 patients with preoperative faecal incontinence and it significantly decreased from a median value of 12 (IQR 11-14) to 5 (IQR 4-5). Graciloplasty could be considered as a first option treatment for complex or recurrent RVF and RUF. It shows a good healing rate even in case of unfavourable factors like Crohn's disease.

The effect of vulvovaginal atrophy on women's quality of life from an Italian cohort of the EVES study.

Vulvovaginal atrophy (VVA) has an impact on the quality of life (QoL) of women. This post hoc analysis of the EVES study provides an overview of the QoL in postmenopausal Italian women in relation with VVA severity. We included 1066 women attending menopause/gynaecologic centres. A face-to-face survey (including QoL and sexual life questionnaires), joining an objective gynaecological examination to confirm VVA, were performed. The 65.5% of the participants presented severe vaginal, vulvar and/or urinary symptoms; an 86.9% had an objective confirmed VVA. Women with severe symptoms presented with significantly worse QoL scores than the women without. We found there were moderately significant correlations between vaginal and vulvar symptoms' severity and lower overall DIVA QoL scores (p<.0005, in both cases). Women with a confirmed VVA presented worse QoL scores than women without confirmation. Our data suggest a clear relationship between VVA severity and a decrease in QoL in postmenopausal Italian women.IMPACT STATEMENTWhat is already known on this subject? Vulvovaginal atrophy (VVA) appears as a common chronic disorder in postmenopausal women that, as soon as the oestrogen levels decrease, becomes a severe condition affecting their quality of life (QoL).What do the results of this study add? We provide new insight about QoL related to VVA severity in Italian postmenopausal women. Our local data demonstrates that QoL in Italian women suffering from menopause is directly related to the severity of vaginal and vulvar symptoms. The same correlation exists for urinary symptoms. QoL is also reduced in patients with an objectively confirmed VVA diagnosis.What are the implications of these findings for clinical practice and/or further research? The implications of our findings involve the need for a better management, not only of the physical aspects of VVA, but also of the non-physical dimensions. Clinicians should ask for the impact of VVA on QoL aspects, making postmenopausal women aware about the possible affected spheres. Medical personnel should conduct future campaigns in the Italian general population, not only in those asking for medical help, to make all women conscious about this silent disorder affecting physical and non-physical dimensions and in order to treat it at early stages.

Structural and Functional Bases of Genitourinary Syndrome of Menopause.

We performed a comprehensive clinical and morphological examination of 70 menopausal patients aged 42-62 years with dysuria and chronic pelvic pain. Assessment of the bladder and vaginal microcirculation by laser Doppler flowmetry in menopausal patients with genitourinary syndrome revealed reduced (by 12-65%) microcirculation parameters. Analysis of the quantitative and qualitative composition of the bacterial microflora of the urethra and vagina revealed abnormalities of microbiota of varying severity, which can be the cause of infectiousinflammatory processes in the pelvic organs leading to chronic pelvic pain syndrome and incontinence. During menopause, the genitourinary syndrome in women is associated with the combined development of atrophic changes in the bladder and uterine mucosa that by their morphological characteristics differ from age-related involutive changes. Atrophy (hypoplasia) of the endometrium and bladder mucosa develops against the background of pronounced fibrosis and is accompanied by hyperemia and hemorrhages.

Critical analysis of methods for assessing genitourinary syndrome of menopause used in clinical trials.

OBJECTIVE: The aim of the study was to determine the most used methods for assessing genitourinary syndrome of menopause by the latest studies on the subject, and to critically assess their differences and comparability. METHODS: A narrative review of the literature was conducted, employing the terms genitourinary syndrome, vaginal atrophy, urogenital atrophy, and atrophic vaginitis, to analyze methods used to assess treatment efficacy. Only controlled randomized clinical trials assessing improvement of genitourinary syndrome of menopause, conducted in the last 5 years, and considering all types of treatment, were selected. RESULTS: Of the 37 studies included, 24 combined both objective and subjective methods thereby ensuring reproducibility and efficacy of symptom relief of the treatment analyzed. The vaginal maturation index was the most used objective method, followed by vaginal pH. One study used histological and immunohistochemistry tests. Regarding subjective methods, the "Most bothering Symptom" and other questionnaires as the Female Sexual Function Index for sex life, the Verbal Rating Scale, among others, were used. CONCLUSIONS: Despite the heterogeneity observed, particularly for subjective assessment of symptoms, there was a tendency to standardize methods and to use an objective method together with a subjective, which seems to be fundamental to guarantee reproducibility and comparability of results of each treatment analyzed. Histological and immunohistochemistry tests may be an option as an objective method in further studies, to better assess thickness, vascularization, among other parameters.

Topical treatment of vaginal dryness with a non-hormonal cream in women undergoing breast cancer treatment - An open prospective multicenter study.

This open, prospective, multicenter, observational study was performed to investigate the efficacy and safety of a non-hormonal cream in women undergoing breast cancer treatment and experiencing vulvovaginal dryness symptoms. Overall, 128 patients from 22 study centers participated. The cream was applied to the vagina and vulva for 28 days. For the efficacy analysis, changes in subjective symptoms (feeling of dryness, itching, burning, pain independent of sexual intercourse, dyspareunia, urinary incontinence) were evaluated. Additionally, the following objective diagnostic findings were assessed by a physician: thinning of vaginal epithelium, redness, petechiae, and discharge. Safety and tolerability were assessed by evaluating type and frequency of adverse events, including adverse medical device-related effects. The frequency and intensity of all subjective symptoms significantly improved from baseline at 28 days (p<0.0001). Additionally, 21.4% of patients were completely free of symptoms (p<0.0001) and urinary incontinence was improved or eliminated in 30.8% of women. The overall sum score for all four objective findings was significantly improved from baseline at 28 days (p<0.0001). The frequency of petechial bleedings was significantly reduced (p<0.0001). Further, significant decreases in the severity of vaginal epithelium thinning, redness and petechiae were observed (p<0.0001). More than 88% of patients and investigators assessed the efficacy and tolerability as being good or very good. No serious adverse events were documented. This study demonstrates that the investigated cream is an effective and safe non-hormonal, topical option in the treatment of vulvovaginal dryness symptoms in patients undergoing breast cancer treatment for. However, the study duration and follow-up time of 4 weeks as well as the non-randomized trial design are limitations of the study.

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

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

Can We Improve Vaginal Tissue Healing Using Customized Devices: 3D Printing and Biomechanical Changes in Vaginal Tissue.

BACKGROUND: Determining biomechanical changes in vaginal tissue with tissue stretch is critical for understanding the role of mechanotransduction on vaginal tissue healing. Noncontact dynamic optical coherence elastography (OCE) can quantify biomechanical changes in vaginal tissues noninvasively. Improved vaginal tissue healing will reduce postoperative complications from vaginal surgery. AIMS: (1) To complete dimensional assessments (DAs) of the vaginal tract. (2) To elucidate biomechanical properties (BMP) of porcine vaginal tissues (PVT). (3) Compare BMPs of piglet and adult PVTs after placement of customized vaginal dilators (VD) by OCE and uniaxial mechanical testing (MT). METHODS: Pilot study using adult nulliparous pig and piglet PVTs (n = 20 each). DA of PVTs was performed using silicone molding. 3D-printed VDs were used to achieve different Relative Diameter Change (RDC) of the PVTs (no dilatation, and -50%, 0%, 50% RDC). Elastographic testing using OCE and MT. RESULTS: Using OCE, no significant differences (SD) were noted between adult and piglet PVT (p = 0.74) or by stretch direction (p = 0.300). SD was noted with increasing RDC (p = 0.023). Using MT, there were SD in tissue stiffness between adult and piglet PVT (p = 0.048), but no SD as a function of RDC (p = 0.750) or stretch direction (p = 0.592). CONCLUSIONS: This study quantified biomechanical changes in PVT with customized stretching by 3D printed VD using both OCE and MT. This work has implications for the mechanotransduction of vaginal wound healing and noninvasive assessment of vaginal diseases.

Use of Growth Factors for Vulvo/Vaginal Bio-Stimulation.

Vulvo-vaginal atrophy as a main symptom of the Genito Urinary Syndrome of Menopause (GSM) is a consequence of aging, particularly after menopause as a result of follicular ovarian follicle depletion and consequently low estrogen levels. Anatomical structures derived from the urogenital sinus, such as the distal urethra trigone and vestibule, are the most affected areas because of the high concentrations of alfa- and beta-estrogen receptors. The most common symptoms associated with vulvo-vaginal atrophy are dyspareunia, vaginal dryness, irritation, recurrent urinary tract infection and urinary incontinence, which negatively affect the patient's quality of life and sexuality. The purpose of this pilot study was to evaluate a protocol with topical growth factors that seeks to activate collagen and elastin at a molecular level, and thus restore all vaginal functions such as secretion, absorption, elasticity, lubrication and vaginal epithelium thickness.

Primavera: A new therapeutical approach to vulvo-vaginal atrophy.

Vulvovaginal atrophy is a condition that affects women, although it is mainly associated with the onset of menopause mainly due to hormonal changes vulvovaginal laxity and mucosal atrophy can also affect women at different life stages such as after pregnancy or for cancer patients who have undergone chemo or endocrine therapy. This condition negatively influence quality of life, sexual desire, and self-confidence. Many therapies have been considered mainly with inconclusive or transient results in terms of benefit factor. Recently, a new non-invasive product, containing hyaluronic acid, oligopeptides, and antioxidants was introduced to the market. Its name is "Primavera," by Renaissance, Italy. The aim of this product is to allow a vulvo-vaginal biostimulation and considered simple, safe, and satisfactory.

Self-Reported Vaginal Laxity-Prevalence, Impact, and Associated Symptoms in Women Attending a Urogynecology Clinic.

INTRODUCTION: Vaginal laxity is increasingly recognized as an important condition, although little is known regarding its prevalence and associated symptoms. AIM: To report the prevalence of self-reported vaginal laxity in women attending a urogynecology clinic and investigate its association with pelvic floor symptoms and female sexual dysfunction. METHOD: Data were analyzed from 2,621 women who completed the electronic Personal Assessment Questionnaire-Pelvic Floor (ePAQ-PF). MAIN OUTCOME MEASURE: Response data from ePAQ-PF questionairre. RESULTS: Vaginal laxity was self-reported by 38% of women and significantly associated with parity, symptoms of prolapse, stress urinary incontinence, overactive bladder, reduced vaginal sensation during intercourse, and worse general sex life (P < .0005). CLINICAL IMPLICATIONS: Clinicians should be aware that vaginal laxity is prevalent and has an associated influence and impact on sexual function. STRENGTH & LIMITATIONS: The main strength of this study is the analysis of prospectively collected data from a large cohort of women using a validated questionnaire. The main limitation is lack of objective data to measure pelvic organ prolapse. CONCLUSION: Vaginal laxity is a highly prevalent condition that impacts significantly on a woman's sexual health and quality of life. Campbell P, Krychman M, Gray T, et al. Self-reported vaginal laxity-Prevalence, impact, and associated symptoms in women attending a urogynecology clinic. J Sex Med 2018;15:1515-1517.

The European Vulvovaginal Epidemiological Survey (EVES): prevalence, symptoms and impact of vulvovaginal atrophy of menopause.

OBJECTIVES: The primary objective of the European Vulvovaginal Epidemiological Survey (EVES) was to assess, at a country level, the prevalence of postmenopausal women with vulvovaginal atrophy (VVA) confirmed by gynecological clinical assessment among all postmenopausal women attending menopause centers. METHOD: Women aged 45-75 years old with their last menstrual period more than 12 months before and who attended menopause or gynecology centers were included. If they had at least one VVA symptom, women filled a number of questionnaires including the EuroQoL-EQ-5D3L and Day-to-Day Impact of Vaginal Aging (DIVA). Then a gynecological examination was performed to confirm the VVA diagnosis. RESULTS: A total of 2160 evaluable patients were included in the study. VVA was confirmed in 90% of the patients. Compared with patients without confirmed VVA (n = 206), patients with confirmed VVA (n = 1954) were significantly older (p < 0.001), had more severe symptoms (p < 0.001 for vaginal and vulvar symptoms, p < 0.05 for urinary ones) and had a lower quality of life as assessed by EQ-5D3L (p = 0.012) and DIVA (p < 0.001). CONCLUSION: VVA is highly prevalent among postmenopausal women. Gynecological clinical assessment of VVA is associated with severe symptoms and impaired quality of life and therefore should be promoted for appropriate clinical assessment and early therapeutic intervention.

Norethindrone acetate versus extended-cycle oral contraceptive (Seasonique®) in the treatment of endometriosis symptoms: A prospective open-label comparative study.

INTRODUCTION: This patient preference prospective study was designed to compare patients' satisfaction in women with endometriosis treated either by an extended-cycle oral contraception (OC) or by norethindrone acetate (NETA). METHODS: This patient preference prospective study included women of reproductive age with endometriosis. Patients were submitted to one of the following 12 months' treatments: Group A, continuous oral treatment with NETA (2.5 mg/day) and Group B, a 91-day extended-cycle OC (LNG/EE 150/30 mcg for 84 days and EE 10 mcg for 7 days). Patient satisfaction was the primary endpoint. RESULTS: There was no statistically significant difference in the rate of satisfied patients at 12-month follow up between the two study groups, 82.2% and 68.4% in Group A and Group B respectively (p = 0.143). At 6 and 12-months, there was a significant amelioration in the intensity of all pain in both groups. The median number of days of unscheduled bleeding during the first cycle was significantly higher in Group B compared to Group A. CONCLUSION: Both NETA and extended-cycle OC are effective in treating pain symptoms related to endometriosis. Extended-cycle OC may cause more unscheduled bleeding, but the rate of satisfaction for those who completed the treatment was similar in the two groups.

Management of Menopausal Symptoms for Women Who Are at High Risk of Thrombosis.

For women at elevated risk of thrombosis, clinicians are challenged to relieve menopausal symptoms without increasing the risk of thrombosis. Oral menopausal hormone therapy increases the risk of venous thromboembolism by 2-fold to 3-fold. Observational studies suggest less thrombotic risk with transdermal therapies and with progesterone over synthetic progestogens (progestins), but the data are limited. Beneficial nonpharmacologic therapies include cognitive behavioral therapy and clinical hypnosis, whereas beneficial nonhormonal pharmacologic therapies include selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors. For treatment of the genitourinary syndrome of menopause, vaginal lubricants and moisturizers, low-dose vaginal estrogen, and intravaginal dehydroepiandrosterone are options.

Is pH a vaginal health marker? Phemale Study.

BACKGROUND: Epidemiological data regarding vaginal pH in Spain are scarce. An epidemiological study was therefore undertaken to confirm the physiological pattern of vaginal pH in Spanish women. The primary outcome measure was vaginal pH. Secondary outcomes included the relationship between vaginal pH and BMI, physical activity, working status, contraceptive use, sexual intercourse in the two days prior to the visit and clinical vaginal symptoms. METHODS: Cross-sectional study in which 2136 healthy women over 18 years of age who requested a check-up were recruited. Vaginal pH was determined using specific for pH testing. Results were compared using Spearman's correlation test and ANOVA. RESULTS: The mean vaginal pH observed in the different age groups was 4.82 in women aged under 30, 5.10 in those aged between 30 and 35, 5.11 in those aged 36 to 40, and 6.48 in those aged over 55. No association was found between vaginal pH and BMI or sexual intercourse in the two previous days. Lower vaginal pH values were observed in women with some degree of physical activity and in contraceptive users, with higher vaginal pH values observed in women who presented clinical symptoms (P<0.01). CONCLUSIONS: This study confirms the physiological patterns of vaginal pH changes in Spanish women. Any degree of physical activity and the use of contraceptives were associated with lower pH values. The presence of vulvo-vaginal symptoms was related with higher vaginal pH values. Vaginal pH is a marker of vaginal health.

Association between vaginal bulge and anatomical pelvic organ prolapse during pregnancy and postpartum: an observational study.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) is defined as the coexistence of anatomical POP and relevant symptoms. Vaginal bulge is the symptom most closely associated with the anatomical condition in nonpregnant women. Even if childbearing is a major risk factor for the development of POP, there is scant knowledge on the prevalence of specific POP symptoms, and how these symptoms relate to anatomical POP during pregnancy and postpartum. The aim of this study was to explore whether vaginal bulge symptoms were associated with anatomical POP in pregnancy and postpartum, and to present the prevalence of vaginal bulge symptoms throughout this period. METHODS: A prospective observational study was carried out following 300 nulliparous pregnant women with repeat assessments from mid-pregnancy until 1 year postpartum. Symptoms of vaginal bulge defined as the sensation of a vaginal bulge inside and/or outside the vagina were assessed by electronic questionnaires. Anatomical POP defined as pelvic organ prolapse quantification system (POP-Q) stage ≥2 has been presented in a previous publication and showed a range of 1-9%. The association between the symptom vaginal bulge and anatomical POP at the various visits was analyzed using Fisher's exact test. RESULTS: Prevalence of vaginal bulge ranged between 16 and 23%. At 6 weeks postpartum the symptom was associated with anatomical POP; otherwise, these two features were unrelated. CONCLUSIONS: The symptom vaginal bulge was barely associated with anatomical POP, and cannot identify anatomical POP in pregnancy or postpartum.

Randomized crossover study investigating daily versus on-demand vulvar Visnadine spray in women affected by female sexual arousal disorder.

The aim of the study was to verify the efficacy of vulvar Visnadine spray in premenopausal women affected by female sexual arousal disorder (FSAD). Thirty-eight women aged 25-40 years affected by FSAD were enrolled in the randomized crossover study, by two possible sequences: on-demand, washout, daily (A sequence); and daily, washout, on-demand (B sequence). The Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale (FSDS) were used to assess sexual function and sexual distress, respectively. Color Doppler ultrasonography was used to measure clitoral blood flow. The study had two follow-ups at 30 (T1) and 60 days (T2). Thirty-one women completed the study. Mean (SD) sexual activity and vulvar Visnadine spray usage was 1 ± 0.9 weekly during on-demand administration for both the sequences (Vs T0, p = NS). The mean sexual activity during daily usage was 2 ± 0.9 (Vs T0, p < .004) and 2 ± 0.8 (Vs T0, p < .001) for A and B sequences, respectively. FSFI total score, particularly genital arousal, improved more during the daily than during on-demand phases of both sequences (p < .001). Finally, clitoral blood flow improved significantly during daily usage of both the sequences (p < .001). Our study suggests that vulvar Visnadine spray could improve sexual performance of women affected by FSAD, producing changes in subjective and objective sexual aspects.