Safety and efficacy of a class II medical device based on highly purified and standardized plant extracts in the management of post-menopausal patients with vulvar and vaginal atrophy: a single-center prospective observational study.

BACKGROUND: Despite the gold standard treatment for genitourinary syndrome of menopause (GSM) is based on the use of local or systemic estrogen-containing products, the typical long-term side effects of hormonal treatments and, most importantly, the contraindications in patients with history of breast and endometrial neoplasms do limit in some extent its use. As hyaluronic acid and some highly purified botanicals have clearly demonstrated their anti-inflammatory and mucosa-protecting properties, we have tested, in women with GSM, a class II vaginal medical device containing hyaluronate gel and a mucoadhesive active enriched with purified alkylamides from Zanthoxylum bungeanum, triterpenes from Centella asiatica and high molecular weight polysaccharides from Tamarindus indica. METHODS: Our single-center, open-label, prospective and observational study was conducted on 50 menopausal women enrolled at the Department of Maternal-Fetal Medicine at Umberto I Polyclinic Hospital in Rome, Italy. Gel administration lasted 150 days and was performed daily for the first 12 days and every 48 hours for the remaining 138 days. Clinical evaluations were performed at baseline and after 12, 57 and 150 days. Besides product safety, main outcomes of our study were: 1) vaginal health (by Vaginal Health Index score [VHI]); 2) sexual quality of life (by Female Sexual Distress Scale [FSDS]); and 3) percentage of women declaring regular sexual activity. RESULTS: The product was safe with no specific adverse events reported. It significantly improved VHI (about 5% after 57 days and 8% after 150 days), FSDS (about 7% after 57 days and 10% after 150 days), and sexual activity (about 20% after 150 days). It also reduced dryness, dyspareunia, burning, itching, and dysuria incidence, respectively by about 18%, 14%, 14%, 27% and 11% after 150 days. CONCLUSIONS: In women with GSM, the intravaginal administration of a hyaluronate-based gel enriched with purified botanical actives endowed with anti-inflammatory and mucosal-protecting properties, reduced painful sensation during sexual acts and increased regular sexual activity.

Long-term Quality of Life and Sexual Function After Neoadjuvant Chemotherapy and Radical Surgery for Locally Advanced Cervical Cancer.

BACKGROUND: Cervical cancer survivors report the worst quality of life (QoL) among all cancer survivors and this is mainly due to their younger age and the long-term treatment sequelae. AIM: The purpose of this study is to assess the long-term QoL and sexual function of locally advanced cervical cancer (LACC) patients treated with neoadjuvant chemotherapy (NACT) and radical hysterectomy (RH) instead of the standard chemoradiotherapy. METHODS: This is a retrospective case-control study including LACC patients (FIGO stage IIB-IVA) treated with the NACT-RH strategy and a control group of healthy women undergoing hysterectomy for uterine fibromatosis in the same period. OUTCOMES: Main outcome measures were the EORTC QLQ-C30 and EORTC QLQ-CX24 for quality of life and Female Sexual Function Index (FSFI) for sexual function. RESULTS: Overall, 96 patients were included: 48 LACC and 48 controls. The mean age at diagnosis was 45.5 ± 9.0 and 47.0 ± 7.8, respectively (P = .38). Compared to controls, LACC patients reported lower mean scores for the global health status (69.4 ± 22.6 vs 81.2 ± 24.3; Mean Difference (MD): -11.80 [95% CI: -21.19, -2.41]; P = .016), QLQ-C30 functional scale (80.1 ± 22.6 vs 92.4 ± 14.9; MD: -12.30 [95% CI: -19.96, -4.64]; P = .002), QLQ-Cx24 functional scale (55.5 ± 25.0 vs 80.4 ± 22.4; MD: -24.00 [95% CI: -34.40, -15.40]; P < .001), and the total FSFI (19.3 ± 9.6 vs 26.2 ± 9.9; MD: -6.90 [95% CI: -10.80, -3.00]; P < .001). On the other hand, LACC patients reported higher mean scores on the QLQ-C30 (16.9 ± 22.1 vs 8.4 ± 16.6; MD: 8.50 [95% CI: 0.68, 16.32]; P = .03) and QLQ-CX24 (26.0 ± 28.8 vs 15.0 ± 11.7; MD: 11.00 [95% CI: -2.21, 19.79]; P = .01) symptoms scales. CLINICAL IMPLICATIONS: The confirmed poor quality of life even in surgically treated LACC survivors underlines the importance of tailoring parametrectomy based on lymph node status and developing personalized strategies. STRENGTHS AND LIMITATIONS: The study assessed the long-term QoL and sexual function in the specific subpopulation of LACC patients treated with NACT-RH. Main limitations include the small sample size and the retrospective design. CONCLUSION: LACC long-term survivors treated with NACT-RH experience poor QoL and sexual dysfunction. Palaia I, Santangelo G, Caruso G, et al. Long-term Quality of Life and Sexual Function After Neoadjuvant Chemotherapy and Radical Surgery for Locally Advanced Cervical Cancer. J Sex Med 2022;19:613-619.

Urinary incontinence in women: state of the art and medical treatment.

INTRODUCTION: Urinary incontinence, the involuntary loss of urine, is a common condition that affects approximately 50% of adult women. This condition increases with age, affecting 10% to 20% of all women and up to 77% of elderly women residing in nursing homes. EVIDENCE ACQUISITION: Systematic data search performed using PubMed/MEDLINE database up to July 20, 2020. Focus was only for English language publications of original studies on urinary incontinence. EVIDENCE SYNTHESIS: Given the basis of published evidence and the consensus of European experts, this study provides an updated overview on clinical applications and surgical procedures of urinary incontinence. CONCLUSIONS: Urinary incontinence is an underestimated health problem. Patients need an overview of their health condition through a detailed anamnestic collection and physical examination to identify the type of incontinence and offer the best treatment.

Relationship between cervical excisional treatment for cervical intraepithelial neoplasia and obstetrical outcome.

INTRODUCTION: The aim of our systematic review was the assessment of effects of excisional treatments for the management of cervical intraepithelial neoplasia (CIN) on preterm delivery (PD), lower birth weight (LBW), preterm premature rupture of membrane (PPROM) and obstetrical outcomes. EVIDENCE ACQUISITION: A structured search was carried out in PubMed-Medline, Embase, and Cochrane Controlled Trials Register databases through November 30, 2019. The search included a combination of the following terms: "loop electrosurgical excision procedure (LEEP)," "large loop excision of transformation zone (LLETZ)," "cold-knife conization (CKC)," "laser cervical conization (CLC)," "preterm delivery" and "neonatal outcome." EVIDENCE SYNTHESIS: Thirty-two of 561 publications considered were included: 28 retrospective series, 2 prospective studies and 2 multicenter trials. Globally in several studies there was a significant increase in PD, measured by the relative risk, in the women underwent a surgical procedure for the CIN. In their majority, the studies were retrospective and therefore a high risk of bias. CONCLUSIONS: This systematic review shows that the surgical treatment of the CIN was associated with an increased risk of PD, LBW and pPROM before 37 pregnancy weeks compared to untreated women, especially in a CKC and LLETZ procedure. Moreover, the increase of the of PD was associated with cone size, cervical length, repeated treatment and a short conization-to-pregnancy interval.

Epirubicin: a new entry in the list of fetal cardiotoxic drugs? Intrauterine death of one fetus in a twin pregnancy. Case report and review of literature.

BACKGROUND: Current knowledge indicate that epirubicin administration in late pregnancy is almost devoid of any fetal cardiotoxicity. We report a twin pregnancy complicated by breast cancer in which epirubicin administration was causatively linked to the death of one twin who was small for gestational age (SGA) and in a condition of oligohydramnios and determined the onset of a transient cardiotoxicity of the surviving fetus/newborn. CASE PRESENTATION: A 38-year-old caucasic woman with a dichorionic twin pregnancy was referred to our center at 20 and 1/7 weeks for a suspected breast cancer, later confirmed by the histopathology report. At 31 and 3/7 weeks, after the second chemotherapy cycle, ultrasound examination evidenced the demise of one twin while cardiac examination revealed a monophasic diastolic ventricular filling, i.e. a diastolic dysfunction of the surviving fetus who was delivered the following day due to the occurrence of grade II placental abruption. The role of epirubicin cardiotoxicity in the death of the first twin was supported by post-mortem cardiac and placental examination and by the absence of structural or genomic abnormalities that may indicate an alternative etiology of fetal demise. The occurrence of epirubicin cardiotoxicity in the surviving newborn was confirmed by the report of high levels of troponin and transient left ventricular septal hypokinesia. CONCLUSION: Based on our findings we suggest that epirubicin administration in pregnancy should be preceded by the screening of some fetal conditions like SGA and oligohydramnios that may increase its cardiotoxicity and that, during treatment, the diastolic function of the fetal right ventricle should be specifically monitored by a pediatric cardiologist; also, epirubicin and desamethasone for lung maturation should not be closely administered since placental effects of glucocorticoids may increase epirubicin toxicity.

Transabdominal ultrasound-guided injection of methotrexate in the treatment of ectopic interstitial pregnancies.

PURPOSE: In a retrospective observational study, we evaluated the feasibility and safety of medical therapy with transabdominal ultrasound-guided injection of methotrexate (MTX) into the gestational sac (GS) in patients with interstitial ectopic pregnancies. METHODS: Fourteen interstitial ectopic pregnancies were treated with transabdominal ultrasound-guided injection of MTX (25 mg). All patients were hemodynamically stable. In all patients, the 10-cm distance between the GS and vaginal fornices was ≥10 cm, making transvaginal injection difficult. To evaluate feasibility and safety of the procedure, we assessed complications clinically and with imaging during a 1-year follow-up. RESULTS: In all 14 patients, MTX injected locally into the GS successfully terminated the interstitial pregnancy, thereby avoiding surgery. There was no complications during follow-up. CONCLUSIONS: The successful outcome in our patients suggests that the transabdominal route is feasible and safe as a nonsurgical option for terminating an ectopic interstitial pregnancy in patients in whom the transvaginal route is contraindicated or difficult, provided the patients are properly selected and operators have sufficient experience with the technique.