Publications by authors named "Salvatore Caruso"

86 Publications

Efficacy and safety of a new vaginal gel for the treatment of symptoms associated with vulvovaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled study.

Maturitas 2021 May 4;147:34-40. Epub 2021 Mar 4.

Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, Obstetrics and Gynecology Unit, IRCCS S. Matteo Foundation, Department of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, Viale Camillo Golgi, 19, 27100 Pavia, Italy. Electronic address:

Objective: The aim of the present randomized placebo-controlled single-center study was to assess the efficacy and safety of a new vaginal gel (Meclon Idra - Alfasigma) in the treatment of vulvovaginal atrophy (VVA). The gel is composed of sea buckthorn (Hippophaë rhamnoides) oil, aloe vera, 18β-glycyrrhetic acid, hyaluronic acid and glycogen. The study assessed whether the gel can reduce VVA symptoms (vaginal dryness, itching, burning sensation) and improve sexual function in postmenopausal women over 12 weeks.

Study Design: Postmenopausal women (n° = 60) reporting VVA symptoms were recruited and randomized in a 1:1 ratio to the gel or placebo. Active vaginal gel or placebo was applied for 14 days and then twice a week for 90 consecutive days.

Main Outcome Measure: The Vaginal Health Index (VHI), including vaginal pH, was used to assess changes in objective signs, whereas the self-reported Female Sexual Function Index (FSFI) was used to investigate sexual function.

Results: Meclon Idra was effective in reducing vaginal pain, dyspareunia and vaginal pH, with the VHI showing significant improvement at day 90 (P < .0001), and in reducing each VVA symptom (vaginal dryness, vaginal itching, burning sensation) at weeks 2 and 4, and the end of the study (P < .0001). The analysis of FSFI scores showed, after the end of treatment, an improvement of sexual function in the active-treatment group, with a statistically significant increase (P < 0.001) in all domains scores and total score (P < 0.001).

Conclusions: The present single-center randomized clinical trial demonstrated the efficacy, tolerability and safety of 12-week treatment with a new vaginal gel in postmenopausal women with symptoms associated with VVA. Based on this trial, the gel seems to be a valid choice as a single, local agent for relieving VVA symptoms and improving sexual function, and to have good compliance. This trial is registered prospectively with the Clinical Trials Registry - India, number CTRI/2019/05/01911.
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http://dx.doi.org/10.1016/j.maturitas.2021.03.002DOI Listing
May 2021

Comparison of three biopsy forceps for hysteroscopic endometrial biopsy in postmenopausal patients (HYGREB-1): A multicenter, single-blind randomized clinical trial.

Int J Gynaecol Obstet 2021 Mar 8. Epub 2021 Mar 8.

Department of Obstetrics and Gynecology, "Filippo Del Ponte" Hospital, University of Insubria, Varese, Italy.

Objective: To compare three types of biopsy forceps for hysteroscopic endometrial biopsy in postmenopausal women.

Methods: Postmenopausal women undergoing operative hysteroscopy with endometrial biopsy for abnormal uterine bleeding or endometrial thickness (≥5 mm) were included. Operative hysteroscopy with endometrial biopsy was performed by hysteroscopic forceps. Women were randomized (1:1:1 ratio) in three groups and allocated to undergo endometrial biopsy by hysteroscopy using spoon, alligator, or snake forceps.

Results: Seventy-five women were included in the study, 25 in each group. The duration of the biopsy was comparable between the three groups (P = 0.334) with a median of 180 seconds (range 20-480 seconds). No differences were observed about the number of attempts (P = 0.602), the use of another instrument (P = 0.276), and the biopsy appropriateness (P = 0.592). The spoon forceps group reported higher levels of pain compared to the alligator and snake forceps groups (P < 0.001). The spoon forceps received significantly lower scores by the operator compared to the alligator and snake forceps (P < 0.001). The alligator and snake forceps reported wider biopsy than the spoon forceps (P < 0.001).

Conclusion: Snake and alligator hysteroscopic forceps may be considered the first choice to perform an endometrial biopsy in postmenopausal women. ClinicalTrials.gov: NCT03427957.
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http://dx.doi.org/10.1002/ijgo.13669DOI Listing
March 2021

Dissipation Function: Nonequilibrium Physics and Dynamical Systems.

Entropy (Basel) 2020 Jul 30;22(8). Epub 2020 Jul 30.

Department of Mathematical Sciences Politecnico di Torino, Corso Duca degli Abruzzi 24, I-10129 Torino, Italy.

An exact response theory has recently been developed within the field of Nonequilibrium Molecular Dynamics. Its main ingredient is known as the Dissipation Function, Ω. This quantity determines nonequilbrium properties like thermodynamic potentials do with equilibrium states. In particular, Ω can be used to determine the exact response of particle systems obeying classical mechanical laws, subjected to perturbations of arbitrary size. Under certain conditions, it can also be used to express the response of a single system, in contrast to the standard response theory, which concerns ensembles of identical systems. The dimensions of Ω are those of a rate, hence Ω can be associated with the entropy production rate, provided local thermodynamic equilibrium holds. When this is not the case for a particle system, or generic dynamical systems are considered, Ω can equally be defined, and it yields formal, thermodynamic-like, relations. While such relations may have no physical content, they may still constitute interesting characterizations of the relevant dynamics. Moreover, such a formal approach turns physically relevant, because it allows a deeper analysis of Ω and of response theory than possible in case of fully fledged physical models. Here, we investigate the relation between linear and exact response, pointing out conditions for the validity of the response theory, as well as difficulties and opportunities for the physical interpretation of certain formal results.
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http://dx.doi.org/10.3390/e22080835DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7517435PMC
July 2020

Myo-inositol supplementation to prevent gestational diabetes in overweight non-obese women: bioelectrical impedance analysis, metabolic aspects, obstetric and neonatal outcomes - a randomized and open-label, placebo-controlled clinical trial.

Int J Food Sci Nutr 2020 Nov 25:1-10. Epub 2020 Nov 25.

Department of Obstetrics and Gynecology, University of Messina, Messina, Italy.

This study aims to evaluate the effects of myo-inositol supplementation on gestational diabetes mellitus (GDM) rates and body water distribution in overweight non-obese women. 223 overweight non-obese women pregnant were randomly assigned to the treatment group (2 g of myo-inositol plus 200 µg of folic acid) or to the placebo one (200 µg of folic acid). The treatment lasted until three weeks after delivery. A tetrapolar impedance analyser was used to study body composition. The incidence of GDM was significantly reduced in the myo-inositol group compared with the placebo group. There was a significant increase in TBW, ECW and ICW values in the placebo group compared to the myo-inositol group. We have recorded a significant reduction in the overall incidence of pregnancy-induced hypertension in the myo-inositol group compared with the placebo group. Our results demonstrate the effectiveness of myo-inositol supplementation in preventing GDM in overweight non-obese pregnant women.
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http://dx.doi.org/10.1080/09637486.2020.1852191DOI Listing
November 2020

Quality of life and sexual functioning of patient affected by endometrial cancer.

Minerva Med 2021 Feb 26;112(1):81-95. Epub 2020 Oct 26.

Department of General Surgery and Medical Surgical Specialties, University of Catania, Catania, Italy.

Introduction: Thanks to timely diagnosis and medical advancement the number of endometrial cancer (EC) patients achieving long term survival is constantly increasing and here comes the necessity to move forward with the understanding of post-treatment sexual adjustment and with the strategies to enhance sexual functioning (SF) and quality of life (QoL) in this population. In this scenario we designed this study aiming to summarize and analyze the available scientific evidence regarding QoL and especially SF in patients affected by EC who underwent surgical and adjuvant treatment.

Evidence Acquisition: A preliminary research was conducted using Pubmed database with specific keywords combinations regarding SF, QoL and endometrial cancer. The main findings considered in the present review were: the study design, the number of patients included in each study, the information about pathology (histology and stage of disease), the questionnaires administered and the principal results concerning SF and QoL.

Evidence Synthesis: A total of thirteen studies, between 2009 and 2018, treating the aspects of SF and QoL in patients affected by EC were extracted. The principal findings of different studies were organized in the following sections: 1) overall SF in EC patients (reasons for sexual inactivity); 2) impact of EC on SF when compared to benign gynecological disease or healthy controls-focus on surgery; 3) minimally invasive surgery versus classical laparotomic approach and SF of EC patients; 4) surgery alone versus VBT versus EBRT and SF of EC patients; 5) focus on RT; 6) the mutual correlation between sociodemographic, relational, psychological, clinical/metabolic factors and the SF of EC patients.

Conclusions: Considering the widespread diffusion of female sexual dysfunction among EC patients and the relatively good prognosis, especially in early stage disease, it undoubtedly looms the need for proactive countermeasures to maximize the sexual well-being and QoL of these patients. A wide range of intervention in a multi-modal physical and mental perspective should be considered.
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http://dx.doi.org/10.23736/S0026-4806.20.07081-0DOI Listing
February 2021

Sexual activity and contraceptive use during social distancing and self-isolation in the COVID-19 pandemic.

Eur J Contracept Reprod Health Care 2020 Dec 12;25(6):445-448. Epub 2020 Oct 12.

Sexology Research Group, Gynaecology Clinic, Department of General Surgery and Medical-Surgical Specialties, School of Medicine, University of Catania, Catania, Italy.

Objectives: The aims of the study were to investigate the effects of social distancing during the COVID-19 pandemic on the use of hormonal contraceptives, their discontinuation and the risk of unplanned pregnancy.

Methods: The study enrolled 317 women listed in the database of the Department of General Surgery and Medical-Surgical Specialties, University of Catania, Italy, family planning clinic who were known to be using hormonal contraceptives. The women were contacted by telephone and asked whether they would like to participate in the study. If they agreed, they were then emailed a questionnaire about their social behaviour and sexual activity during the pandemic, according to their cohabiting status, i.e., whether they were continuing to use their hormonal contraception and whether they had had an unplanned pregnancy.

Results: The questionnaire was completed by 175 (81.8%) women who were using short-acting reversible contraception (SARC) and by 90 (87.4%) women who were using long-acting reversible contraception (LARC). All married and cohabiting women were continuing to use their contraceptive method. None had had an unplanned pregnancy. On the other hand, 51 (50.5%) non-cohabiting or single women had discontinued their SARC method while social distancing, for non-method-related reasons; however, 47 (46.5%) non-cohabiting or single women had continued their sexual activity, infringing social distancing rules, and 14.9% had had an unplanned pregnancy, for which they had sought a termination.

Conclusion: Several non-cohabiting women using SARC had discontinued their contraceptive method during the pandemic but had continued to engage in sexual activity and had had an unplanned pregnancy. Clinicians should counsel women about what they should do in regard to contraception in the event of new, future social distancing measures.
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http://dx.doi.org/10.1080/13625187.2020.1830965DOI Listing
December 2020

Analysis of the Impact of the Confinement Resulting from COVID-19 on the Lifestyle and Psychological Wellbeing of Spanish Pregnant Women: An Internet-Based Cross-Sectional Survey.

Int J Environ Res Public Health 2020 08 15;17(16). Epub 2020 Aug 15.

Departamento de Medicina, Facultad de Ciencias de la Salud, Universidad Cardenal Herrera-CEU, CEU Universities, C/Ramón y Cajal, 20, Alfara del Patriarca, 46115 Valencia, Spain.

(1) Background: This study aimed to analyze the impact of the confinement due to the COVID-19 pandemics on the eating, exercise, and quality-of-life habits of pregnant women. (2) Methods: This was an internet-based cross-sectional survey which collected information about adherence to the Mediterranean diet, physical exercise, health-related quality of life (HRQoL), and perceived obstacles (in terms of exercise, preparation for delivery, and medical appointments) of pregnant women before and after the confinement. The survey was conducted in 18-31 May 2020. (3) Results: A total of 90 pregnant women participated in this study. There was a significant decrease in the levels of physical activity ( < 0.01) as well as in HRQoL ( < 0.005). The number of hours spent sitting increased by 50% ( < 0.001), 52.2% were unable to attend delivery preparation sessions because these had been cancelled. However, there were no significant differences in the eating pattern of these women ( = 0.672). : These results suggest the need to implement specific online programs to promote exercise and reduce stress, thus improving the HRQoL in this population, should similar confinements need to occur again for any reason in the future.
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http://dx.doi.org/10.3390/ijerph17165933DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7460363PMC
August 2020

Sexual dysfunctions in female university students and the correlation with body image: a cross-sectional study.

J Psychosom Obstet Gynaecol 2020 Aug 19:1-6. Epub 2020 Aug 19.

Postgraduate Program in Rehabilitation Sciences, Federal University of Health Sciences of Porto Alegre, Porto Alegre, Brasil.

Purpose: This study aims to correlate female sexual dysfunctions and dissatisfaction with female university students' body image.

Methods: 276 female university students completed an online questionnaire, including sociodemographic data, the Female Sexual Function Index, and the Body Shape Questionnaire.

Results: 31.1% reported some degree of dissatisfaction with body image, and 39.5% had a risk of female sexual dysfunction. The majority of women with a risk of female sexual dysfunctions (69.4%) had no concerns with shape, and the majority of women without sexual problems (67.7%) had no concerns with shape. Pearson's coefficient underlined no correlation between Body Shape Questionnaire and Female Sexual Function Index domains.

Conclusion: The body image perception did not seem to affect the sexual function of female university students in our sample. However, it is important to further investigate these variables to improve women's quality of life.
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http://dx.doi.org/10.1080/0167482X.2020.1806818DOI Listing
August 2020

Does Nomegestrol Acetate Plus 17β-Estradiol Oral Contraceptive Improve Endometriosis-Associated Chronic Pelvic Pain in Women?

J Womens Health (Larchmt) 2020 09 14;29(9):1184-1191. Epub 2020 Jul 14.

Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli," Naples, Italy.

To evaluate the effects of a 24/4 regimen combined oral contraceptive (COC) containing 1.5 mg 17β-estradiol (E2) and 2.5 mg nomegestrol acetate (NOMAC) compared to on-demand nonsteroidal anti-inflammatory drugs (NSAIDs) on women affected by endometriosis-associated chronic pelvic pain (the primary end point) and their quality of life (QoL) and sexual function (the secondary end points). Ninety-nine women on E2/NOMAC constituted the study group; and 63 women on NSAIDs constituted the control group. The visual analogic scale was used to measure the levels of pelvic pain, dysmenorrhea, and dyspareunia. To assess their QoL, sexual function, and sexual distress, the Short Form-36 (SF-36), the Female Sexual Function Index (FSFI), and the Female Sexual Distress Scale (FSDS) were used, respectively. The study included two follow-ups at 3 and 6 months. Improvement in chronic pelvic pain was observed in the study group at both the 3- and 6-month follow-ups ( < 0.001). SF-36, FSFI, and FSDS had a similar trend at the 3- and 6-month follow-ups ( < 0.001). Women on NSAIDs did not report any reduction in pain symptoms or improvement in QoL ( ≤ 0.4). However, they had a limited improvement of their FSFI and FSDS ( < 0.001). The improvement of the pain symptoms, QoL, FSFI, and FSDS, was more evident in women on E2/NOMAC than in those on NSAIDs, when the study group and control group values were compared at the 3- and 6-month follow-ups ( < 0.001). Women on E2/NOMAC COC showed a better reduction of endometriosis-associated chronic pelvic pain and an improvement of their QoL and sexual activity than those of the women on NSAIDs.
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http://dx.doi.org/10.1089/jwh.2020.8291DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7520912PMC
September 2020

Precision metabolome reprogramming for imprecision therapeutics in retinitis pigmentosa.

J Clin Invest 2020 08;130(8):3971-3973

Jonas Children's Vision Care and Bernard and Shirlee Brown Glaucoma Research Laboratory.

Retinitis pigmentosa (RP), the most common form of rod-cone dystrophy, is caused by greater than 3100 mutations in more than 71 genes, many of which are preferentially expressed in rod photoreceptors. Cone death generally follows rod loss regardless of the underlying pathogenic mutation. Preventing the secondary loss of cone photoreceptors would preserve central visual acuity and substantially improve patients' quality of life. In this issue of the JCI, Wang et al. demonstrate that adeno-associated virus-mediated overexpression of TGF-β1 promoted cone survival and function in 3 distinct RP models with rod-specific mutations. TGF-β1 induces microglia to metabolically tune from a glycolytic phenotype (M1) to an oxidative phenotype (M2), which associates with neuroprotection and the antiinflammatory ecosystem. Consolidating the results of this study with our current understanding of how TGF-β1 regulates microglia polarization, we highlight cell-specific metabolome reprogramming as a promising non-gene-specific therapeutic avenue for inherited retinal degenerations.
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http://dx.doi.org/10.1172/JCI139239DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7410039PMC
August 2020

Religiosity among women undergoing pregnancy termination for medical reasons: the experiences and views of Polish women.

Eur J Contracept Reprod Health Care 2020 Oct 9;25(5):381-386. Epub 2020 Jul 9.

I Department of Obstetrics and Gynaecology, Centre of Postgraduate Medical Education, Warsaw, Poland.

Objectives: The study aimed to determine the influence of religious and moral beliefs on contraceptive use, assisted reproduction and pregnancy termination in Polish women requesting a termination of pregnancy for medical reasons.

Methods: Between 1 June 2014 and 31 May 2016, women deemed eligible for a termination of pregnancy for medical reasons at a Polish tertiary care centre received an anonymous questionnaire comprising 65 items. A total of 150 completed questionnaires were collected.

Results: Of the respondents, 95% described themselves as Catholics, including 60% practising Catholics. The study revealed a discrepancy between respondents' beliefs and the teachings of the Catholic Church: an overwhelming majority of respondents used contraception, and 79% were in favour of fertilisation and believed the treatment should be refunded by the state. Interestingly, 66% of the respondents who attended confession did not perceive abortion as sinful.

Conclusion: The study detected a considerable discrepancy between declared religiosity and individual interpretations of the commandments and teachings of the Catholic Church. Despite stating they were Catholics, most women did not perceive abortion as sinful and did not follow the teachings of the Catholic Church regarding the sacraments for deceased children.
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http://dx.doi.org/10.1080/13625187.2020.1783652DOI Listing
October 2020

Quality of life of women using the etonogestrel long-acting reversible contraceptive implant after abortion for unplanned pregnancy.

Eur J Contracept Reprod Health Care 2020 Aug 21;25(4):251-258. Epub 2020 May 21.

Department of Woman, Child and General and Specialised Surgery, University of Campania 'Luigi Vanvitelli', Naples, Italy.

Objectives: The aims of the study were to investigate the effect of a subcutaneous etonogestrel-containing contraceptive implant on the quality of life (QoL) and sexual function of women who had undergone termination of an unplanned pregnancy.

Methods: At pregnancy termination 140 women received contraceptive counselling on the etonogestrel implant. The Short Form-36 questionnaire, the Female Sexual Function Index and the Female Sexual Distress Scale were used to investigate, respectively, the QoL, sexual function and sexual distress of the women at baseline and at 6, 12, 24 and 36 months of follow-up.

Results: The study group comprised 86 (61.4%) women who chose to use the contraceptive implant. The control group comprised 28 (20.0%) women who chose to use short-acting reversible contraception (SARC) and 26 (18.6%) women who chose not to use hormonal contraception. In the women not using hormonal contraception there were 23 (88.5%) unintended pregnancies before the end of the 3 year study period. QoL, sexual function and sexual distress improved in the study group from the 6 months follow-up until the end of the study ( < 0.001). QoL ( < 0.02) and sexuality ( < 0.001) gradually improved in the control group after 24 and 12 months of follow-up, respectively. None of the women using the etonogestrel implant became pregnant during the study. Inter-group analysis showed better improvement in QoL, sexual function and sexual distress in the study group than in the control group from 6 months ( < 0.004) until the end of the study ( < 0.001).

Conclusion: Compared with SARC and non-hormonal contraception, the contraceptive implant promoted better QoL and sexuality in users and reduced the incidence of unplanned pregnancy. However, the women who opted for SARC or non-hormonal contraception did so because of the lower cost compared with that of the contraceptive implant.
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http://dx.doi.org/10.1080/13625187.2020.1760240DOI Listing
August 2020

Scoring systems for the evaluation of adnexal masses nature: current knowledge and clinical applications.

J Obstet Gynaecol 2021 Apr 29;41(3):340-347. Epub 2020 Apr 29.

Obstetrics and Gynecology Unit, Department of General Surgery and Medical Surgical Specialties, University of Catania, Catania, Italy.

Adnexal masses are a common finding in women, with 20% of them developing at least one pelvic mass during their lifetime. There are more than 30 different subtypes of adnexal tumours, with multiple different subcategories, and the correct characterisation of the pelvic masses is of paramount importance to guide the correct management. On that basis, different algorithms and scoring systems have been developed to guide the clinical assessment. The first scoring system implemented into the clinical practice was the Risk of Malignancy Index, which combines ultrasound evaluation, menopausal status, and serum CA-125 levels. Today, current guidelines regarding female patients with adnexal masses include the application of International Ovarian Tumours Analysis simple rules, logistic regression model 1 (LR1) and LR2, OVERA, cancer ovarii non-invasive assessment of treating strategy, and assessment of Different Neoplasias in the adnexa. In this scenario, the choice of the scoring system for the discrimination between benign and malignant ovarian tumours can be complex when approaching patients with adnexal masses. This review aims to summarise the available evidence regarding the different scoring systems to provide a complete overview of the topic.
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http://dx.doi.org/10.1080/01443615.2020.1732892DOI Listing
April 2021

Management of anxiety and pain perception in women undergoing office hysteroscopy: a systematic review.

Arch Gynecol Obstet 2020 04 5;301(4):885-894. Epub 2020 Mar 5.

Obstetrics and Gynecology Unit, Department of General Surgery and Medical Surgical Specialties, University of Catania, Catania, Italy.

Purpose: The aim of this review is to provide an overview of the literature about the perception and management of anxiety and pain in women undergoing an office hysteroscopic procedure.

Methods: We performed a systematic literature search in Embase, PubMed/MEDLINE, Cochrane Library and Web of Science for original studies written in English (registered in PROSPERO 2019-CRD42019132341), using the terms 'hysteroscopy' AND 'pain' AND 'anxiety' published up to January 2019. Only original articles (randomized, observational and retrospective studies) about management of anxiety and pain related to the hysteroscopic procedure were considered eligible.

Results: Our literature search produced 84 records. After exclusions, 11 studies including 2222 patients showed the following results: (a) pain experienced during hysteroscopy is negatively affected by preprocedural anxiety; (b) pharmacological interventions seem to be help in reducing pain during hysteroscopy; (c) waiting time before the procedure is a significant factor affecting patients' anxiety; (d) music during the procedure may be helpful in reducing anxiety.

Conclusions: The utilization of office hysteroscopy is hampered by varying levels of anxiety and pain perceived by women who are candidates for the procedure. For these reasons, it is essential to identify effective pharmacological and non-pharmacological strategies to alleviate these factors. We recommend further studies especially focusing on non-pharmacological interventions to facilitate the dissemination of good clinical practices among hysteroscopists.
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http://dx.doi.org/10.1007/s00404-020-05460-2DOI Listing
April 2020

Ulipristal Acetate Before Hysteroscopic Myomectomy: A Systematic Review.

Obstet Gynecol Surv 2020 Feb;75(2):127-135

Full Professor, Obstetrics and Gynecology Unit, Department of General Surgery and Medical Surgical Specialties, University of Catania, Catania, Italy.

Importance: Uterine leiomyomas, also referred to as myomas or fibroids, are the most common benign tumors of the reproductive tract. Ulipristal acetate (UPA) is an active selective progesterone receptor modulator used as preoperative treatment for uterine myomas.

Purpose: The aim of this review is to provide an overview of the literature about the effects of UPA administration before hysteroscopic myomectomy. The clinical question in "PICO" format was in patients affected by uterine myomas undergoing operative hysteroscopic management, "Does UPA impact the surgical outcomes?"

Evidence Acquisition: We performed a systematic literature search in PubMed/MEDLINE and Embase for original studies written in English (registered in PROSPERO CRD42018092201), using the terms "hysteroscopy" AND "ulipristal acetate" published up to March 2019. Original articles about UPA treatment before hysteroscopic myomectomy (randomized, observational, retrospective studies) were considered eligible.

Results: Our literature search produced 32 records. After exclusions, 4 studies were considered eligible for analysis. Results show that UPA does not worsen the overall technical difficulty of hysteroscopic myomectomy. Moreover, it may increase the chance of complete primary myomectomy in complex hysteroscopic procedures.

Conclusions And Relevance: Despite the positive results presented in this systematic review, low-quality evidence exists yet on the impact of UPA treatment before hysteroscopic myomectomy. High-quality prospective randomized controlled trials are required to establish the impact of UPA on surgical outcomes of patients treated for uterine myomas by hysteroscopy. Moreover, long-term outcomes of myomectomies after UPA treatment (such as frequency of myoma recurrence, recovery time, and quality of life) should be determined.
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http://dx.doi.org/10.1097/OGX.0000000000000764DOI Listing
February 2020

The effect of obesity on the onset of spontaneous labor and scheduled delivery rates in term pregnancies.

Taiwan J Obstet Gynecol 2020 Jan;59(1):34-38

Department of Obstetrics and Gynecology, Health Sciences University Diyarbakır Gazi Yaşargil Education and Research Hospital, Diyarbakır, Turkey.

Objective: To determine the effect of obesity on the onset of spontaneous labor, scheduled delivery rates and perinatal outcomes in term pregnancies.

Material And Methods: 242 obese and 244 non-obese pregnant women ≥37 gestational weeks were compared in terms of the onset of spontaneous labor, scheduled delivery rates and perinatal outcomes.

Results: Obese pregnant women had statistically significantly lower onset of spontaneous labor and higher rates of scheduled delivery. No difference was determined in respect of the type of delivery, 1st and 5th minutes APGAR scores and the need for intensive care. Higher values of birth weight, large for gestational age, macrosomia, gestational diabetes mellitus and preeclampsia were determined in obese women.

Conclusion: The onset of spontaneous labor rates in term obese pregnancies were lower and scheduled delivery rates were higher than in the non-obese pregnancies. However, more extensive studies are needed to better understand this relationship.
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http://dx.doi.org/10.1016/j.tjog.2019.10.002DOI Listing
January 2020

Vilaprisan, a New Selective Progesterone Receptor Modulator in Uterine Fibroid Pharmacotherapy-Will it Really be a Breakthrough?

Curr Pharm Des 2020 ;26(3):300-309

First Department of Obstetrics and Gynecology, Center of Postgraduate Medical Education, Warsaw, Poland.

Background: Vilaprisan (VPR) is a new orally available selective progesterone receptor modulator (SPRM), with anti-proliferative activity against uterine fibroids (UFs). It definitively causes suppression of ovulation and inhibition of proliferation of endometrial, myometrial and UF cells.

Purpose: This review aims to summarize current knowledge on VPR from all studies, including clinical trials, conducted to date and to contextualize the potential role of VPR in future medical regimens for the treatment of UFs.

Methods: We performed a literature search in PubMed US National Library of Medicine and Google Scholar databases. Both databases were extensively searched for all original and review articles/book chapters as well as congress abstracts published in English until July 2019. The use of VPR for UF therapy was identified by using the keywords: "uterine fibroids" and "vilaprisan".

Results: In phase I and II clinical trials, VPR was shown to be effective in ameliorating UF-related clinical symptoms, especially abnormal or excessive uterine bleeding and in shrinking UFs. The tolerability of VPR is roughly similar to that of ulipristal acetate (UPA) and it tends to be more favorable than that of GnRH-agonists.

Conclusion: Presently, all trials examining the utility of VPR for the treatment of UF are halted; likely, due to the recently reported cases of hepato-toxicity with UPA, in addition to non reassuring toxicology results from preclinical long-term testing on rodents, carried out in parallel with late stage testing on humans. An accurate summary of robust data related to the safety of VPR is urgently needed to draw definitive conclusions on the future clinical development of this drug for UF therapy.
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http://dx.doi.org/10.2174/1381612826666200127092208DOI Listing
November 2020

Ultralow 0.03 mg vaginal estriol in postmenopausal women who underwent surgical treatment for stress urinary incontinence: effects on quality of life and sexual function.

Menopause 2020 02;27(2):162-169

Department of General Surgery and Medical Surgical Specialties, Gynecological Clinic.

Objective: To evaluate the efficacy of low-dose, intravaginal estriol ovules in postmenopausal women with stress urinary incontinence (SUI) before and after transobturator tape (TOT) placement, assessing vaginal health, quality of life (QoL), and sexual function.

Methods: Ninety-six postmenopausal women affected by SUI and scheduled for TOT placement were enrolled. Women were randomized and divided into two groups through 1:1 at baseline (T0): study group (group A, n = 48) and control group (group B, n = 48). Group A was treated daily for 16 weeks with an intravaginal ovule containing 0.03 mg estriol. Vaginal epithelium maturation, QoL, and sexual function were investigated by using the Vaginal Maturation Index (VMI), Short Form-36 (SF-36) questionnaire, and Female Sexual Function Index (FSFI) questionnaire at baseline (T0), before surgery (T1), and 8 weeks after surgery (T2), respectively.

Results: Thirty-six women from group A and 44 women from group B completed the study. The VMI improved in group A at T1 (T1 [43.1] vs T0 [38.1]; P = 0.04) and T2 (T2 [47.8] vs T0 [38.1]; P = 0.001). The physical index score of the QoL improved only after surgery in group A (T2 [49.4] vs T0 [39.7]; P = 0.001). On the contrary, the mental index score improved at T1 [T1 (41.9) vs T0 (37.9), (P = 0.02)] and at T2 [T2 (49.6) vs T0 (37.9), P = 0.001]. Group B had improvement of the physical (45.6 vs 39.4; P = 0.001) and mental (43.6 vs 38.9; P = 0.002) index scores at T2. Sexual function improved in group A at T1 (13.9 vs 18.6; P = 0.001) and at T2 (13.9 vs 25.2; P = 0.001), and in group B at T2 (14 vs 17.2; P = 0.001). Moreover, it improved after TOT placement more in group A than in group B (P = 0.001).

Conclusions: Ultralow-dose topical vaginal ovules containing 0.03 mg estriol administrated before and after TOT placement could improve the vaginal epithelium maturation of postmenopausal women affected by SUI. Moreover, vaginal estriol ovules also improved the surgical outcome investigated by SF-36 and FSFI.
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http://dx.doi.org/10.1097/GME.0000000000001446DOI Listing
February 2020

Female sexuality and vaginal health across the menopausal age.

Menopause 2020 01;27(1):14-19

Obstetrics and Gynecology Unit, Department of Obstetrics and Gynecology, University of Catania, Catania, Italy.

Objective: The primary aim was to evaluate changes in female sexuality across the menopausal period, and the secondary objective was to test the associations of female sexuality domains with vaginal atrophy and its symptoms.

Methods: A cross-sectional multicenter study was performed involving 518 women, 40 to 55 years of age, consulting outpatient gynecological services at 30 centers across Italy. Vaginal atrophy was identified by the contemporaneous presence of a pH >5, subjective vaginal dryness, and an objective sign. The relationships between vaginal atrophy and its main symptoms (vaginal dryness and dyspareunia), and Female Sexual Function Index (FSFI) score and its domains (desire, arousal, orgasm, dyspareunia, lubrication, and sexual satisfaction) were analyzed.

Results: The prevalence of sexual dysfunction, as defined by a FSFI score <26.55, was 70.6%, increasing from 55% in the years 40 to 45, to 82.8% (P < 0.01) in the years 52 to 55 of age. Mean FSFI score decreased from 40 to 45, to 46 to 48 years of age (23.13 ± 9.76 vs 19.49 ± 9.88; P < 0.05), and from 48 to 51, to 52 to 55 years of age (21.3 ± 8.06 to 17.59 ± 9.11; P < 0.01). Independent determinants of FSFI were age, vaginal atrophy, and the presence of vaginal dryness and dyspareunia (R2 0.208; P = 0.011). FSFI score was independently correlated (R2 0.116) with weight (CR -0.067; 95% confidence interval [CI] -0.126, -0.006; P < 0.032), menopausal status (CR -2.406; 95% CI -4.180, -0.63; P < 0.008), and vaginal dryness (CR -5.647; 95% CI -7.677, -3.618; P < 0.0001). Vaginal dryness was the only variable correlated independently with each FSFI domain, including desire (also correlated with menopausal status), arousal (with age and menopausal status), lubrication (with age), orgasm (with age), satisfaction (with vaginal atrophy and being an ex-smoker), and dyspareunia (with age and spontaneously referred dyspareunia).

Conclusions: In the perimenopausal years, FSFI score decreases and sexual dysfunction increases by about 30%. Vaginal dryness is the symptom of vaginal atrophy most closely related to all domains of female sexuality.
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http://dx.doi.org/10.1097/GME.0000000000001427DOI Listing
January 2020

Effects of long-term treatment with Dienogest on the quality of life and sexual function of women affected by endometriosis-associated pelvic pain.

J Pain Res 2019 29;12:2371-2378. Epub 2019 Jul 29.

Department of General Surgery and Medical Surgical Specialties, University of Catania, Catania, Italy.

Purpose: The aim of this prospective study was to evaluate quality of life (QoL) and sexual function of women affected by endometriosis pain treated with Dienogest (DNG) for 24 months.

Patients And Methods: Fifty-four women constituted the study group and were given DNG 2 mg/daily; 38 women were given non-steroidal anti-inflammatory drugs (NSAIDs) and constituted the control group. To define endometriosis-associated pelvic pain, dysmenorrhea and dyspareunia the Visual Analogic Scale (VAS) was used. The Short Form-36 (SF-36), the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale (FSDS) were used to assess the QoL, sexual function and the sexual distress, respectively. The study included five follow-ups at 3, 6, 12, 18 and 24 months.

Results: Slight improvements in chronic pelvic pain, dysmenorrhea and dyspareunia were observed in the study group at 3 months (<0.05) and improved more from 6 to 24 months of DNG treatment (<0.001). QoL improved with a similar trend: at 3 months the improvement was significant in several categories (<0.05), and from 6 to 24 months in all categories (<0.001). The FSFI score did not change at the 3 month follow-up (=not significant [NS]) but it improved from 6 to 24 months (<0.001). A similar trend was observed for the FSDS score (<0.001). No change was observed in the control group (=NS).

Conclusion: Long-term treatment with DNG 2 mg once-daily in women with endometriosis-associated pelvic pain may have positive effects on the QoL and sexual life, confirming the observations of the previous study on the first 6 months of treatment.
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http://dx.doi.org/10.2147/JPR.S207599DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6681157PMC
July 2019

The value of virtual reality simulators in hysteroscopy and training capacity: a systematic review.

Minim Invasive Ther Allied Technol 2020 Aug 6;29(4):185-193. Epub 2019 Jun 6.

Department of General Surgery and Medical Surgical Specialties, University of Catania, Catania, Italy.

The aim of this study is to summarize evidence on the effectiveness of virtual reality simulators for experienced and novice surgeons in improving their hysteroscopic skills. Three types of hysteroscopic simulators were evaluated: Hyst Sim VR, Virtual Reality Uterine Resectoscopic Simulator, Essure Sim TM. Virtual reality simulators have been assessed to be highly relevant to reality and all surgeons attained significant improvements between their pre-test and post-test phases, independent of their previous level of experience, demonstrating more improvement among novices than experts. Available evidence supports the effectiveness of virtual simulators in increasing the diagnostic and surgical skills of gynaecologists, independent from their starting level of expertise.
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http://dx.doi.org/10.1080/13645706.2019.1625404DOI Listing
August 2020

Collagenase-assisted wound bed preparation: An in vitro comparison between Vibrio alginolyticus and Clostridium histolyticum collagenases on substrate specificity.

Int Wound J 2019 Aug 31;16(4):1013-1023. Epub 2019 May 31.

Fidia Farmaceutici S.p.A., Local Unit Fidia Research Sud, Siracusa, Italy.

Bacterial collagenase from the aerobic non-pathogenic Vibrio alginolyticus chemovar iophagus is an extracellular metalloproteinase. This collagenase preparation is obtained through a fermentation process and is purified chromatographically, resulting in a highly purified 82-kDa single-band protein that does not contain non-specific proteases or other microbial impurities. V. alginolyticus collagenase was added to a hyaluronan (HA)-based device to develop a novel debriding agent to improve the treatment of ulcers, necrotic burns, and decubitus in the initial phase of wound bed preparation. In this study, an in vitro biochemical characterisation of V. alginolyticus collagenase versus a commercial preparation from a Clostridium histolyticum strain on various dermal extracellular matrix (ECM) substrates was performed. V. alginolyticus collagenase demonstrated its ability to carry out the enzymatic cleavage of the substrate, allowing a selective removal of necrotic tissues while sparing healthy tissue, as reported in clinical studies and through routine clinical experience. in vitro tests under physiological conditions (pH, presence of Ca++, etc.) have demonstrated that V. alginolyticus collagenase exhibits very poor/limited non-specific proteolytic activity, whereas the collagenase preparation from C. histolyticum is highly active both on collagen and on non-collagenic substrates. This finding implies that while the V. alginolyticus enzyme is fully active on the collagen filaments that anchor the necrotic tissue to the wound bed, it does not degrade other minor, but structurally important, components of the dermal ECM. This feature could explain why collagenase preparation from V. alginolyticus has been reported to be much gentler on perilesional, healthy skin.
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http://dx.doi.org/10.1111/iwj.13148DOI Listing
August 2019

Maternal abdominal subcutaneous fat thickness as a simple predictor for gestational diabetes mellitus.

J Perinat Med 2019 Aug;47(6):605-610

Department of General Surgery and Medical Surgical Specialties, University of Catania, Catania, Italy.

Background To date, only a limited number of studies have evaluated the importance of abdominal subcutaneous fat thickness (ASFT) on gestational diabetes mellitus (GDM) screening. The aim of this study was to investigate the effectiveness of ASFT measurement during routine obstetric ultrasound performed between 24 and 28 weeks of gestation in predicting cases with GDM. Methods This prospective comparative study was conducted on 50 cases with GDM and 50 cases without GDM in the GDM screening program at 24-28 gestational weeks between January 2018 and May 2018. The most accurate ASFT cut-off point values were determined for the prediction of cases with GDM by performing receiver operator characteristic (ROC) curve analysis. Results The ASFT was higher in those with GDM compared to those without GDM (P < 0.05). For an ASFT cut-off point value of 18.1 mm for the prediction of cases with GDM, the sensitivity, specificity, negative and positive predictive values were 72.0%, 60.0%, 64.2% and 68.1%, respectively. The risk of GDM increased 3.86-fold in those with ASFT level >18.1 mm (P = 0.001). Conclusion The ASFT value measured by routine obstetric ultrasound performed at 24-28 weeks of gestation was found to be significantly higher in patients with GDM in comparison to those without GDM. However, further multi-centered and comprehensive prospective studies are required to better demonstrate this relationship.
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http://dx.doi.org/10.1515/jpm-2018-0431DOI Listing
August 2019

Maternal abdominal subcutaneous fat thickness as a simple predictor for gestational diabetes mellitus.

J Perinat Med 2019 Aug;47(6):605-610

Department of General Surgery and Medical Surgical Specialties, University of Catania, Catania, Italy.

Background To date, only a limited number of studies have evaluated the importance of abdominal subcutaneous fat thickness (ASFT) on gestational diabetes mellitus (GDM) screening. The aim of this study was to investigate the effectiveness of ASFT measurement during routine obstetric ultrasound performed between 24 and 28 weeks of gestation in predicting cases with GDM. Methods This prospective comparative study was conducted on 50 cases with GDM and 50 cases without GDM in the GDM screening program at 24-28 gestational weeks between January 2018 and May 2018. The most accurate ASFT cut-off point values were determined for the prediction of cases with GDM by performing receiver operator characteristic (ROC) curve analysis. Results The ASFT was higher in those with GDM compared to those without GDM (P < 0.05). For an ASFT cut-off point value of 18.1 mm for the prediction of cases with GDM, the sensitivity, specificity, negative and positive predictive values were 72.0%, 60.0%, 64.2% and 68.1%, respectively. The risk of GDM increased 3.86-fold in those with ASFT level >18.1 mm (P = 0.001). Conclusion The ASFT value measured by routine obstetric ultrasound performed at 24-28 weeks of gestation was found to be significantly higher in patients with GDM in comparison to those without GDM. However, further multi-centered and comprehensive prospective studies are required to better demonstrate this relationship.
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http://dx.doi.org/10.1515/jpm-2018-0431DOI Listing
August 2019

Comparative randomized study on the sexual function and quality of life of women on contraceptive vaginal ring containing ethinylestradiol/etonogestrel 3.47/11.00mg or 2.7/11.7mg.

Gynecol Endocrinol 2019 Oct 16;35(10):899-903. Epub 2019 Apr 16.

Departemt of General Surgery and Medical Surgical Specialties, University of Catania-Italy Research Group for Sexology, Catania, Italy.

The objective of the study was to evaluate the sexual function and quality of life (QoL) of healthy women on a new contraceptive vaginal ring (CVR) containing ethinylestradiol (EE) 3.47 mg and etonogestrel (ENG) 11.00 mg (study group) manufactured with a new polymer composition compared to EE 2.7 mg/ENG11.7 mg CVR (control group). Fifty-eight women were randomly allocated to the study group and the control group. The Female Sexual Function Index (FSFI), the Female Sexual Distress Scale (FSDS) and the Short Form-36, were used to assess sexual function, sexual distress and QoL, respectively. The study included two follow-ups, at 90 days and at 180 days. The control group reported more adverse events, mainly breakthrough bleeding, than the study group. The sexual function scores in the women in the study group improved with respect to those of the control group both at the 1st (FSFI,  = .009; FSDS,  = .001) and at the 2 (FSFI,  = .001; FSDS,  = .002) follow-up. QoL of the study group improved at the 1 follow-up ( < .05) and 2 ( < .01) follow-up. The control group improved their QoL at the 2nd follow-up ( < .01). The more gradual EE release of the new polymer composition could justify the behavioral differences of the women of the two groups.
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http://dx.doi.org/10.1080/09513590.2019.1603290DOI Listing
October 2019

Sexual Behavior of Women With Diagnosed HPV.

J Sex Marital Ther 2019 11;45(7):569-573. Epub 2019 Apr 11.

Department of General Surgery and Medical Surgical Specialties, Gynecological Clinic , Catania , Italy.

One hundred twenty-one women of reproductive age with suspected human papillomavirus (HPV) infection were studied. HPV-DNA testing was performed to determine HPV positivity and genotype. The Female Sexual Function Index was administrated before and three months after the diagnosis was communicated to the patient. Eighty-six women were HPV-positive and had a significant worsening of sexual function over the next three months. The women receiving information that they were HPV-negative did not experience a worsening of sexual function. Clinicians need to be aware of the possible adverse effects on sexual behavior of the diagnosis of HPV.
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http://dx.doi.org/10.1080/0092623X.2019.1586019DOI Listing
February 2020

Non-pharmacological pain control in outpatient hysteroscopies.

Minim Invasive Ther Allied Technol 2020 Feb 22;29(1):10-19. Epub 2019 Feb 22.

Department of Medicine, Universidad Cardenal Herrera-CEU CEU Universities, Valencia, Spain.

Outpatient hysteroscopy has become the standard technique for gynaecological exploration of the uterine cavity. The most common reason for failure of the procedure is pain. During the last decade many studies were carried out to improve the equipment as well as the procedural technical aspects. Even so, hysteroscopy is still painful for many patients. Pharmacological pain control has been widely used for hysteroscopy, but these modalities can be invasive, have side effects and are contraindicated in many women. This review examines current literature on non-pharmacological interventions (pressure, stretching, heat, electricity, music and hypnosis) on the pain experienced during outpatient hysteroscopy.
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http://dx.doi.org/10.1080/13645706.2019.1576054DOI Listing
February 2020

Ultrastructural Study of Clitoral Cavernous Tissue and Clitoral Blood Flow From Type 1 Diabetic Premenopausal Women on Phosphodiesterase-5 Inhibitor.

J Sex Med 2019 Mar 14;16(3):375-382. Epub 2019 Feb 14.

Unit of Ultrastructural Pathology, Department of Human Pathology, University of Messina, Messina, Italy.

Background: The effects of phosphodiesterase-type 5 (PDE5) inhibitors on the in vivo clitoral structure of women with diabetes have never been investigated.

Aim: To study the in vivo structural and hemodynamic changes of the clitoris in premenopausal women with type 1 diabetes on PDE5 inhibitors.

Methods: 38 premenopausal women with type 1 diabetes aged 36 -46 years. A randomized 1:1 study design was used: Study Group (group A) on Tadalafil 5 mg daily, and control group (group B). Blood samples were taken from each woman to measure HbA1c, testosterone, and Free Androgen Index. The women underwent microbiopsy of the clitoral body by means of semiautomatic gun during total anesthesia for surgery therapy of a benign gynecological pathology. The tissue removed was processed for electron microscopy. Translabial color Doppler ultrasound was used to measure the peak systolic velocity (PSV), the end diastolic velocity (EDV), and the pulsatility index (PI) of clitoral arteries.

Main Outcome Measures: Micro-ultrastructure observation of clitoral tissue and color Doppler sonography of clitoral blood flow.

Results: Of the 38 women, 13 (68.4%) of group A and 15 (78.9%) of group B completed the study. Group A showed a mean PSV and EDV increase, and a mean PI decrease with respect to baseline (P < .001). Group B did not show any change in both the parameters (P = NS). By a quantitative study in both groups a variable degree of ultrastructural abnormalities of smooth muscle cells (SMCs) was observed, consisting in increased glycogen and lipoic deposits, cytoplasmic vacuoles, and focal increase of electron density of SMCs. Moreover, the mean SMC thickness of group A (1.83 ± 0.68 µm) was larger than that of group B (1.3 ± 0.41 µm) (P = .02).

Clinical Implications: PDE5 inhibitors could be used to treat diabetic women with genital arousal disorder.

Strengths & Limitations: The study shows a clear effect of PDE5 inhibitors on clitoral SMCs. However, a limit was to not have investigated the sexual function/behavior of women of both groups, this was because of the short time of the study.

Conclusion: This study could help to understand in what way PDE5 inhibitors act on the ultrastructural pathophysiological clitoral cavernous tissue of women with diabetes. It could support PDE5 inhibitor usage in women with genital sexual arousal disorder due to metabolic diseases. Caruso S, Cianci A, Cianci S, et al. Ultrastructural Study of Clitoral Cavernous Tissue and Clitoral Blood Flow From Type 1 Diabetic Premenopausal Women on Phosphodiesterase-5 Inhibitor. J Sex Med 2019;16:375-382.
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http://dx.doi.org/10.1016/j.jsxm.2019.01.003DOI Listing
March 2019

35-Week twin delivery after embryo reduction at 11 weeks and subsequent expulsion of a dead foetus at 20.

J Obstet Gynaecol 2019 May 27;39(4):539-540. Epub 2018 Oct 27.

a Department of General Surgery and Medical Surgical Specialties , Obstetrics and Gynecology Unit, Policlinico G. Rodolico , University of Catania , Catania , Italy.

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http://dx.doi.org/10.1080/01443615.2018.1496075DOI Listing
May 2019

Non-Coding RNAs in Endometrial Physiopathology.

Int J Mol Sci 2018 Jul 20;19(7). Epub 2018 Jul 20.

Department of Biomedical and Biotechnological Sciences, Biology and Genetics Section G. Sichel, University of Catania, 95123 Catania, Italy.

The Human Genome Project led to the discovery that about 80% of our DNA is transcribed in RNA molecules. Only 2% of the human genome is translated into proteins, the rest mostly produces molecules called non-coding RNAs, which are a heterogeneous class of RNAs involved in different steps of gene regulation. They have been classified, according to their length, into small non-coding RNAs and long non-coding RNAs, or to their function, into housekeeping non-coding RNAs and regulatory non-coding RNAs. Their involvement has been widely demonstrated in all cellular processes, as well as their dysregulation in human pathologies. In this review, we discuss the function of non-coding RNAs in endometrial physiology, analysing their involvement in embryo implantation. Moreover, we explore their role in endometrial pathologies such as endometrial cancer, endometriosis and chronic endometritis.
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http://dx.doi.org/10.3390/ijms19072120DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6073439PMC
July 2018