Impact of vulvovaginal atrophy of menopause: prevalence and symptoms in Italian women according to the EVES study.

This cross-sectional study included postmenopausal women, aged 45-75 years, with the aim to assess the presence of vulvovaginal atrophy (VVA) confirmed by a clinical assessment in the Italian population attending menopausal/gynecological centers. Apart from baseline variables, women scored vaginal, vulvar and urinary VVA symptoms. Impact of VVA on sexual function and quality of life (QoL) was assessed thorough EuroQoL questionnaire (EQ5D3L), Day-to-Day Impact of Vaginal Aging (DIVA), Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-revised (FSDS-R). A physical examination was carried out in accordance with routine gynecological practice. VVA was confirmed in 90% of the 1226 evaluable patients (aged 59.0 ± 7.3 years). The prevalence of postmenopausal women with VVA confirmed by gynecological clinical assessment was 75.3%. The patients with VVA confirmed (n = 926) had more severe symptoms (p < .0005), lower QoL (EQ-visual analog scale, p = .008 and DIVA, p < .0005) and worsened sexual function (FSFI and FSDS-R, p < .0005 for both) when compared with the patients having nonconfirmed VVA (n = 140). VVA is highly prevalent among postmenopausal Italian women. The objective of VVA confirmation is associated with severe symptoms and impaired QoL and sexual function. A proactive approach of Italian clinicians to promote regular and early gynecological evaluation should be performed in order to delay the advancing of the disorder.

Monurelle Biogel® vaginal gel in the treatment of vaginal dryness in postmenopausal women.

OBJECTIVES: To evaluate efficacy, tolerability and safety of Monurelle Biogel® vaginal gel for treatment of vaginal dryness. METHODS: Multicenter, national, randomized, controlled vs. no-treatment, open-label study. Ninety-five postmenopausal women were randomized (48 to Monurelle Biogel® and 47 to no treatment). Primary endpoint was the change of Verbal Rating Scale (VRS) total score of vaginal atrophy (VA) symptoms after 8-week treatment. The main secondary endpoints were VRS single-item score, Vaginal Health Index (VHI) score, Maturation Index (MI), Female Sexual Function Index (FSFI), and Female Sexual Distress Scale-Revised (FSDS-R). RESULTS: The VRS total score was statistically significant in favor of the treatment group on day 28 (p = 0.001) but not on day 56 (p = 0.064). By excluding women who were not sexually active, the total VRS scores reached the criteria for clinical success in 27/43 subjects (62.8%) in the control arm and in 38/46 subjects (82.6%) in the treatment arm (p = 0.035) on day 56. The VHI score significantly changed in the active arm (4.71 ± 4.85 vs. 0.28 ± 1.71) (p < 0.001) on day 56. Even the MI significantly improved, with an increase in the percentage of superficial cells (p = 0.01). The improvements in both VHI and MI were still present at the follow-up visit after the discontinuation of the treatment (day 84). Sexual function and distress showed a statistical significant difference on day 56. CONCLUSIONS: Monurelle Biogel® vaginal gel applied twice daily for 8 weeks is effective in relieving vaginal dryness and other VA symptoms. Such a clinical meaningful effect persists at least 4 weeks and is supported by an improvement in the vaginal environment. Trial Registration clinicaltrials.gov Identifier: NCT02994342.

Polyurethane-based cell-free scaffold for the treatment of painful partial meniscus loss.

PURPOSE: The aim of this study was to document, at mid-term follow-up, the clinical and MRI outcome of a polyurethane-based cell-free scaffold implanted to treat painful partial meniscus loss. METHODS: Eighteen consecutive patients were enrolled and treated with arthroscopic polyurethane meniscal scaffold implantation and, in case of other comorbidities, with concurrent surgical procedures: 16 patients (9 men and 7 women, mean age 45 ± 13 years, mean BMI 25 ± 3, 12 medial and 4 lateral implants) were prospectively evaluated with the subjective and objective IKDC and the Tegner scores at 24, 36, 48, 60, and 72 months of follow-up. Eleven patients were also evaluated by 1.5-T MRI at the final follow-up. RESULTS: The IKDC subjective score showed a significant improvement from baseline to 24 months (45.6 ± 17.5 and 75.3 ± 14.8, respectively; p = 0.02) and subsequent stable results over time for up to 72 months (final score 75.0 ± 16.8). The Tegner score improvement between pre-operative status and final follow-up was also significant (p = 0.039). Nevertheless, the final score remained significantly lower than the pre-injury sports activity level (p = 0.027). High-resolution MRIs documented the presence of abnormal findings in terms of morphology, signal intensity, and interface between the implant and the native meniscus. Implant extrusion and bone oedema at the treated compartment were also observed in most of the cases, even though no correlation was found between imaging findings and clinical outcome. CONCLUSIONS: The present study reports satisfactory clinical outcomes at mid-term follow-up after polyurethane-based meniscal cell-free scaffold implantation. The treatment was effective both in cases of isolated partial meniscal lesions and in complex cases requiring the combination with other surgical procedures. On the other hand, a high rate of altered MRI aspects was documented. However, no correlation was found between the altered imaging parameters and the overall positive clinical findings, thus supporting the use of this procedure to treat painful partial meniscus loss. LEVEL OF EVIDENCE: Case series, Level IV.

Dietary habits and supplement use in relation to national pregnancy recommendations: data from the EuroPrevall birth cohort.

Assessing maternal dietary habits across Europe during pregnancy in relation to their national pregnancy recommendations. A collaborative, multi-centre, birth cohort study in nine European countries was conducted as part of European Union funded EuroPrevall project. Standardised baseline questionnaire data included details of food intake, nutritional supplement use, exposure to cigarette smoke during pregnancy and socio-demographic data. Pregnancy recommendations were collected from all nine countries from the appropriate national organisations. The most commonly taken supplement in pregnancy was folic acid (55.6 % Lithuania-97.8 % Spain) and was favoured by older, well-educated mothers. Vitamin D supplementation across the cohort was very poor (0.3 % Spain-5.1 % Lithuania). There were significant differences in foods consumed in different countries during pregnancy e.g. only 2.7 % Dutch mothers avoided eating peanut, while 44.4 % of British mothers avoided it. Some countries have minimal pregnancy recommendations i.e. Lithuania, Poland and Spain while others have similar, very specific recommendations i.e. UK, the Netherlands, Iceland, Greece. Allergy specific recommendations were associated with food avoidance during pregnancy [relative rate (RR) 1.18 95 % CI 0.02-1.37]. Nutritional supplement recommendations were also associated with avoidance (RR 1.08, 1.00-1.16). Maternal dietary habits and the use of dietary supplements during pregnancy vary significantly across Europe and in some instances may be influenced by national recommendations.

Clinical efficacy and metabolic impact of two different dosages of ethinyl-estradiol in association with drospirenone in normal-weight women with polycystic ovary syndrome: a randomized study.

BACKGROUND: The estrogenic component of estro- progestin (EP) is responsible for a negative impact on the metabolic and lipid assessment in women with polycystic ovary syndrome (PCOS). AIM: To evaluate the risk/benefit ratio of two EP combinations, containing the same progestin (3 mg drospirenone) and a different dose of ethinyl-estradiol (EE) (20 vs 30 µg) and to compare their effects on the clinical and endocrine-metabolic parameters in normal-weight PCOS women. MATERIAL/SUBJECTS AND METHODS: In this randomized pilot study, we enrolled 30 young normal-weight PCOS women. Fifteen subjects were allocated to group A (20 µg EE) and 15 PCOS subjects to group B (30 µg EE). Hirsutism score, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinemic clamp and lipid profile were performed at baseline, and after 6 and 12 months of therapy. Main outcome measures were signs of hyperandrogenism, glucose and insulin metabolism, lipid profile. RESULTS: Both treatment regimens induced a significant improvement in hirsutism score, testosterone, DHEAS, and SHBG levels. Androstenedione significantly dropped only in patients of Group A, while 17(OH)P only in those from Group B. Both the formulations did not significantly modify gluco-insulinemic metabolism. Total cholesterol, LDL cholesterol, and HDL cholesterol levels significantly increased in both groups. Triglycerides levels, which increased as well, resulted more markedly influenced by the formulation with 30 µg EE. CONCLUSIONS: In association with drospirenone, 20 µg EE results as effective as 30 µg in improving clinical and hormonal features of normal-weight PCOS women, while exhibiting a milder influence on lipidic parameters.

Preliminary experience with electromagnetic navigation system in TKA.

Accuracy of implant positioning and precise reconstruction of leg alignment offers the best way to achieve good long-term results in total knee arthroplasty. Computer instrumentation was developed to improve the final position of the component and restore the mechanical axis. Current navigation systems use either optical or electromagnetic tracking. The advantage of the Electromagnetic (EM) navigation system is that no line-of-sight issues are present. However, special iron-free instruments are required. This report analyzes the postoperative radiological results of 32 knees treated using an EM system. All the measurements were recorded using software able to subtend angles automatically by five physicians, three radiologist and two orthopedic residents not involved with the surgery. Each radiograph was measured three times, in random order, and at delayed intervals. We found an ideal alignment for the mechanical axis (180+/-3 degrees ) in 30 out of 32 cases, whereas all the patients achieved a value of 90 degrees +/-3 degrees for both femoral and tibial frontal component angles. An apparently over-corrected implant position for the sagittal femoral component was reported, with a mean value of 11.2 degrees +/-3.6. The mean position of the tibial component was 90.6 degrees +/-2.8; just four measurements were outside of the +/-3 degrees of the desired value. EM is safe and there were no complications related to this system. An almost perfect correlation was found between the mechanical axis value of the EM navigation system (179.8 degrees +/-1.8) and the median value of the all reviewers (180.3 degrees +/-1.9) with a difference of 0.5 degrees .

Partial ACL tears augmented with distally inserted hamstring tendons and over-the-top fixation: an MRI evaluation.

This study evaluated the mid-term MRI appearance of partial ACL tear augmentation with quadrupled distally inserted hamstrings, while preserving the intact ACL bundle. Twenty-eight patients with ACL partial tear underwent augmentation. After 15-40 months follow-up, patients were evaluated clinically and by MRI. The mean IKDC score at follow-up was 93.8. Twenty-five patients were rated as excellent, three as fair. The mean tibial tunnel section area decreased by 27%. A correlation was noted between the clinical and MRI results: the graft was not visible or continuous with high intensity areas and the mean decrease in the tunnel section area was 3% in the three cases rated as fair. The graft appeared continuous and low intensity and the reduction in tibial tunnel section area was 30% in the cases with excellent clinical results. The residual part of the ACL was still recognizable in 79% of cases. The tibial hamstring attachment appeared normal in 93% of cases. In conclusion, excellent results correlated with a decrease in tunnel size and normal graft appearances on MRI. The poor results showed that the graft was not visible or not continuous, with high intensity areas and intra-ligamentous cystic formation within the tunnel. MRI scanning is useful in evaluating hamstring ACL grafts after reconstruction.

Expression of GnRH receptor gene in human ectopic endometrial cells and inhibition of their proliferation by leuprolide acetate.

The present study was conducted to investigate whether GnRH-receptor (GnRH-R) gene is expressed in endometriosis ovarian implants and whether a GnRH-analogue (GnRH-a) may exert an effect on endometriosis cell proliferation in vitro. The presence of GnRH-R transcripts in ovarian endometriosis cells was assessed by reverse transcription-polymerase chain reaction (RT-PCR) and further confirmed by Southern blot analysis. GnRH-R mRNA was detected in all the 13 samples examined. In contrast, GnRH-R transcripts were not detectable in endometriosis-free peritoneal tissue. In the second part of the study, endometriosis cells were cultured for 9 days with different doses of leuprolide acetate (ranging from 0 to 10(-5) M). In 4 out of 13 cases, a significant anti-proliferative effect was observed at doses of leuprolide acetate ranging from 10(-9) to 10(-5) M. In one case, a significant inhibition of cell proliferation was observed only at 10(-5) M leuprolide acetate concentration. In contrast, the GnRH-a did not affect cell growth, regardless of the expression of GnRH-R transcripts and the given doses, in the remaining 8 experiments. To date, this is the first evidence indicating that GnRH-R mRNA is expressed in human ovarian endometriomas. Moreover, the inhibition of endometriosis cell proliferation induced by the GnRH-a in vitro suggests that, at least in some cases, this compound might exert a direct effect on endometriosis lesions.

Gestrinone inhibits macrophage function and mitogen-stimulated lymphocyte proliferation in vitro.

Clinical and experimental evidence supports the hypothesis that some steroidal drugs with androgenic effects might influence the immune system. The present study investigated whether gestrinone is able to affect macrophage and lymphocyte activity in vitro. Macrophage function was determined by phagocytosis of fluorescent microspheres, whilst lymphocyte proliferation was assessed by cell counting. Macrophage phagocytosis was evaluated after an overnight incubation in the presence or absence of gestrinone at serial dilutions; lymphocyte proliferation was detected in basal conditions and after stimulation with Concanavalin A (Con A) in the presence or absence of gestrinone. The results of this study showed that gestrinone significantly inhibited macrophage phagocytosis at the concentrations of 10(-8), 3 x 10(-8) and 10(-7) M. Furthermore, a significant suppression of lymphocyte blastogenesis was observed when lymphocytes were incubated with gestrinone at the concentration of 10(-7) M for 6 days. The biological significance of gestrinone as an inhibitor of immune functions under experimentally defined conditions is discussed in relation to its potential mechanism for fertility enhancement.

Endometrial release of soluble intercellular adhesion molecule 1 and endometriosis: relationship to the extent of the disease.

OBJECTIVE: To relate endometrial release of the soluble form of intercellular adhesion molecule 1 with extent of endometriosis. METHODS: Samples of endometrium were collected from 23 women with endometriosis. Soluble intercellular adhesion molecule 1 was quantified in conditioned medium from 48-hour endometrial stromal cell cultures with use of a specific enzyme-linked immunosorbent assay. Levels were correlated with revised American Society for Reproductive Medicine classification score for adhesions, implants, and cysts and total score; number of endometriotic implants; cyst diameter; and presence or absence of pelvic pain symptoms and previous surgical procedures for endometriosis. RESULTS: Endometrial release of soluble intercellular adhesion molecule 1 directly correlated with number of implants (r = .64, P < .005) and score for implants (r = .61, P < .005). There was no significant correlation between levels of the soluble molecule and score for adhesions or total score. Soluble intercellular adhesion molecule 1 shed by endometrium did not correlate with the score for ovarian cysts, although an inverse relationship was found with ovarian cyst diameter (r = -0.52, P < .05). No differences were detected between women who had pelvic pain and those who did not and between those who had previous surgery for endometriosis and those who had not. CONCLUSION: The association between endometrial release of soluble intercellular adhesion molecule 1 and the number and score of endometriotic implants suggests that the molecule might be of value in evaluating spread potential of refluxed endometrium.

Effect of cigarette smoking on plasmatic regulation of vascular prostacyclin in pregnancy and puerperium.

Prostaglandins, particularly prostacyclin, participate in the control of fetal and maternal circulations. In the present study the effect of cigarette smoking on plasma prostacyclin-stimulating activity during late pregnancy and the puerperium (four to six months) and in the newborns was assessed. Plasma samples from 22 apparently healthy nonsmokers and 17 smokers (more than 15 cigarettes per day) were obtained twice during pregnancy and once after delivery. Plasma samples from nine infants born to smokers and seven infants born to nonsmokers were obtained 72 to 96 hours after birth. Plasma activity was evaluated by incubating the plasma samples with cultured rat aortic smooth muscle cells and measuring the prostacyclin released in the culture medium by specific radioimmunoassay of its stable metabolite, 6-keto-prostaglandin F1 alpha. In all of the women, plasma activity did not change significantly during pregnancy or after delivery. In smokers, plasma activity was always lower than in nonsmokers, but not significantly so. The plasma activity of infants born to smokers was significantly lower than that of infants born to nonsmokers.

Laparoscopic-ultrasonographic combined technique for the creation of a neovagina in Mayer-Rokitansky-Kuster-Hauser syndrome.

OBJECTIVE: To create a neovagina using a combined laparoscopic and ultrasonographic technique in Mayer-Rokitansky-Kuster-Hauser syndrome by modification of Vecchietti's operation. DESIGN: Case report. SETTING: Division of Physiopathology of Reproduction, University of Palermo, Palermo, Italy. MAIN OUTCOME MEASURE(S): The advancement of the needle from the pseudohymen, through the vesicorectal space using a triple contrast ultrasonographic technique. RESULT(S): The ultrasonographic scanning guides the accurate transit from external genitalia to the peritoneal cavity. CONCLUSION(S): This original approach allowed a safe and rapid creation of a neovagina in a case of Mayer-Rokitansky-Kuster-Hauser syndrome.

Effects of the coculture with human endometrial cells on the function of spermatozoa from subfertile men.

OBJECTIVE: To evaluate the effects of a coculture with human endometrial cells on the function of spermatozoa from samples obtained from infertile couples. DESIGN: In a prospective study, human spermatozoa selected by swim-up from fresh samples were cultured on human endometrial feeder layers. Thereafter, their viability, motility, acrosome integrity, and ability to penetrate zona-free hamster oocytes were evaluated. Spermatozoa from the same samples incubated under the same conditions but in the absence of endometrial cells, as well as in the medium previously spent for cell culture, were used as controls. SETTING: Andrology Laboratory of the Infertility Center of San Raffaele Hospital. PATIENTS: Spermatozoa were obtained from 17 infertile men attending the Infertility Center at our hospital. RESULTS: Spermatozoa incubated in the presence of endometrial cell feeder layers did not differ from controls with regard to their viability or motility. Conversely, the percent spontaneous acrosome reactions after 18 hours of incubation was significantly higher for spermatozoa cocultured (19.7 +/- 2.2 versus 11.2 +/- 1.9; mean +/- SE). The mean number of spermatozoa penetrating hamster oocytes was also significantly improved (1.24 +/- 0.3 versus 0.68 +/- 0.24). This effect did not seem to be solely due to the secretion of soluble factors by endometrial cells in the medium, in that spermatozoa incubated in the medium spent for endometrial cell culture had a similar acrosome reaction percentage but a lower rate of hamster egg penetration. CONCLUSIONS: The coculture with human endometrial cells appeared to be beneficial for improving the sperm function. This effect partially may be due to the secretion of steroids in the medium, which increases the quota of spontaneous acrosome reaction and in part due to the direct contact of cells with spermatozoa, maybe for the detoxification of the medium or the release of trophic factors. Coculture might be a promising approach to preparing spermatozoa for assisted fertilization in cases of subfertile males.

Danazol versus a gonadotropin-releasing hormone agonist as preoperative preparation for hysteroscopic metroplasty.

OBJECTIVE: To compare the efficacy of danazol and a GnRH agonist as preoperative preparation for hysteroscopic metroplasty in women with septate uterus. DESIGN: Prospective randomized clinical study. SETTING: Tertiary care center. PATIENTS: Thirty patients with septate uterus. INTERVENTIONS: The patients were randomized to treatment with danazol 600 mg/d for 2 to 4 weeks (n = 15) or with leuprolide acetate depot 3.75 mg for 2 months (n = 15) as preoperative therapy for hysteroscopic metroplasty. MAIN OUTCOME MEASURES: At the intervention the hysteroscopist evaluated difficulty in dilation of the cervical canal, presence of endometrial fragments, bleeding, difficulty in maneuvering the resectoscope, and operating time. RESULTS: Both the treatments were well tolerated. Metroplasty was simpler overall in the danazol group and also faster in introducing the resectoscope through the cervical canal and maneuvering it in the uterine cavity were both easier. Bleeding was modest in both groups and the anatomic outcome of the operation was similar. CONCLUSION: Short preoperative preparation with danazol results in favorable operating conditions at limited costs with minimal side effects.

Randomized clinical trial of two laparoscopic treatments of endometriomas: cystectomy versus drainage and coagulation.

OBJECTIVE: To assess the efficacy of two laparoscopic methods for the management of endometriomas with regard to pain relief, pregnancy rate, and disease recurrence. DESIGN: Prospective, randomized clinical trial. SETTING: Tertiary care hospital. PATIENT(S): Sixty-four patients with advanced stages of endometriosis. INTERVENTION(S): Patients were randomly allocated at the time of laparoscopy to undergo either cystectomy of the endometrioma (group 1) or drainage of the endometrioma and bipolar coagulation of the inner lining (group 2). MAIN OUTCOME MEASURE(S): Pain relief and pregnancy rate. RESULT(S): Thirty-two patients were enrolled in each group. The 24-month cumulative recurrence rates of dysmenorrhea, deep dyspareunia, and nonmenstrual pelvic pain were lower in group 1 than in group 2 (dysmenorrhea: 15.8% versus 52.9%; deep dyspareunia: 20% versus 75%; nonmenstrual pelvic pain: 10% versus 52.9%). The median interval between the operation and the recurrence of moderate to severe pelvic pain was longer in group 1 than in group 2 (19 months [range, 13.5-24 months] versus 9.5 months [range, 3-20 months]). The 24-month cumulative pregnancy rate was higher in group 1 than in group 2 (66.7% versus 23.5%). CONCLUSION(S): For the treatment of ovarian endometriomas, a better outcome with a similar rate of complications is achieved with laparoscopic cystectomy than with drainage and coagulation.

Use of growth hormone-releasing factor in ovulation induction in poor responders.

OBJECTIVE: To evaluate the effect of growth hormone-releasing factor (GRF), given in addition to follicle-stimulating hormone (FSH), after pituitary down-regulation, on follicular development in poor responders. GRF was added in a prospective, randomized manner to an existing stimulation protocol. STUDY DESIGN: Forty-two women, demonstrated to be poor responders in previous attempts at induction of ovulation, were included in the study. Follicular stimulation with FSH was started after pituitary downregulation obtained using gonadotropin-releasing hormone agonist (GnRH-a). GRF, 1,000 mg/day, was given in addition to FSH to 22 patients randomly chosen until human chorionic gonadotropin administration. RESULTS: The number of ampules of FSH needed to obtain follicular growth was significantly reduced in the group of women who received GRF. Also, the number of follicles obtained was higher and the days of treatment generally reduced. However, a greatly beneficial effect for some women was observed, while a second subgroup did not have any. No differences were observed in follicular steroid and insulin growth factor 1 (IGF-1) between GRF patients and controls or in serum IGF-1 between the two subgroups of patients who received GRF. CONCLUSION: In vivo administration of GRF with FSH after pituitary down-regulation may be beneficial for some poor responders, although prognostic criteria could not be established. However, the use of GRF does not seem to influence the chance of obtaining pregnancy; it remains low in these patients.

Accelerations in "intra-partum" cardiotocographic recording II. Present contemporaneously to prognostically unfavourable cardiotocographic aspects.

The Authors examine 1994 cardiotocographic recordings during labour, equivalent to 89% of all deliveries of the same period. They evaluate the acceleratory activity in the tract of recording presenting alterations considered expression of foetal distress (bradycardia, severe tachycardia, loss of cyclic variations, variable and late decelerations), and compare both parameters with the perinatal outcome. The presence of accelerations seems to allow a more oculate evaluation of the cardiotocogram and, in particular, a decreased incidence of hurried instrumental foetal extractions.

Accelerations in greater than intra-partum greater than cardiotocographic recording I. Correlation with perinatal outcome.

The authors examine 1994 cardiotocographic recordings during labour, equivalent to 89% of all deliveries of the same period. They evaluate the tendency of the acceleratory activity in the single recordings during their whole lenght, comparing it with the perinatal outcome, evaluated by the perinatal mortality and the Apgar score at 1' and 5'. They conclude that the presence of accelerations could be considered, when present in a certain degree, a sure index of foetal well-being or of good possibility of foetal reactions to hypoxic stimuli, allowing a more cautious evaluation of the cardiotocogram.

Modern diagnostic imaging of lumbar spondylosis.

The authors retrospectively analyzed 205 patients affected with low back pain and submitted to conventional radiology, CT scan, MR. The purpose of the study was that of gaining a better understanding of the mechanisms caused by the occurrence of spondylosis and its evolution. In light of the most recent literature, the authors conclude: 1) the degenerative process nearly always initiates with laceration of the anulus; 2) dysfunction of the disc then has repercussions on the posterior structures at varying times and with different modalities; 3) symptoms do not always coincide with radiological findings. Thus, the authors believe that for a more complete understanding of the etiopathogenesis and the evolution of spondylosis, further studies involving long-term follow-up of a young population, in relation to clinical and MR findings are needed. MR is the method of choice in determining disc degeneration.