Michele Carlo Schiavi

Retrospective analysis in 46 women with vulvovaginal atrophy treated with ospemifene for 12 weeks: improvement in overactive bladder symptoms

Abstract Aims: The aim of this study was to assess the effectiveness and safety of ospemifene in the improvement of overactive bladder (OAB) symptoms in postmenopausal women affected by vulvovaginal atrophy (VVA). Methods: Forty-six postmenopausal patients affected by VVA with OAB syndrome were enrolled for the study. All patients received Ospemifene 60 mg for 12 weeks. Clinical examination, 3-day voiding diary, urodynamic testing, ultrasound measurement of endometrial and bladder wall thickness (BWT) and the Vaginal Health Index (VHI) were performed at baseline and 12 weeks. Patients completed the OAB-Q SF and UDI-6. Results: After 12-weeks, the number of patients with detrusor overactivity decreased from 39% to 13% (p = 0.04). The reduction in the mean number in 24 h of voids (9.57 ± 2.12 vs. 6.63 ± 1.22, p < 0.0001), urgent micturition episodes/24 h (5.63 ± 1.46 vs. 1.44 ± 1.31, p < 0.0001), nocturia episodes (3.17 ± 0.85 vs. 1.11 ± 1.18, p < 0.0001), urinary incontinence episodes/24 h (0.85 ± 0.96 vs. 0.33 ± 0.64, p = 0.003) was observed. The UDI-6, OAB-Q symptoms, OAB-Q (HRQL) scores were 8.95 ± 0.91 vs. 5.56 ± 1.40, 62.60 ± 14.70 vs. 20.08 ± 10.83 and 18.71 ± 7.41 vs. 79.45 ± 14.47 (p < 0.001) before and after 12 weeks. Conclusion: Ospemifene is an effective potential therapy for postmenopausal women with VVA improving OAB symptoms and quality of life.

Alpha lipoic acid in obstetrics and gynecology

Abstract Alpha-Lipoic acid (ALA) is a natural antioxidant synthetized by plants and animals, identified as a catalytic agent for oxidative decarboxylation of pyruvate and α-ketoglutarate. In this review, we analyzed the action of ALA in gynecology and obstetrics focusing in particular on neuropathic pain and antioxidant and anti-inflammatory action. A comprehensive literature search was performed in PubMed and Cochrane Library for retrieving articles in English language on the antioxidant and anti-inflammatory effects of ALA in gynecological and obstetrical conditions. ALA reduces oxidative stress and insulin resistance in women with polycystic ovary syndrome (PCOS). The association of N-acetyl cysteine (NAC), alpha-lipoic acid (ALA), and bromelain (Br) is used for prevention and treatment of endometriosis. In association with omega-3 polyunsaturated fatty acids (n-3 PUFAs) with amitriptyline is used for treatment of vestibulodynia/painful bladder syndrome (VBD/PBS). A promising area of research is ALA supplementation in patients with threatened miscarriage to improve the subchorionic hematoma resorption. Furthermore, ALA could be used in prevention of diabetic embryopathy and premature rupture of fetal membranes induced by inflamation. In conclusion, ALA can be safely used for treatment of neuropatic pain and as a dietary support during pregnancy.

A medical device containing purified bovine colostrum (Monurelle Biogel) in the treatment of vulvovaginal atrophy in postmenopausal women: Retrospective analysis of urinary symptoms, sexual function, and quality of life

This study assessed the effectiveness and safety of a medical device containing purified bovine colostrum (Monurelle Biogel; Zambon, Bresso, Italy) in improving vulvovaginal atrophy (VVA), sexual function, urinary symptoms, and quality of life (QoL) in postmenopausal women.

Efficacy and tolerability of treatment with mirabegron compared with solifenacin in the management of overactive bladder syndrome: A retrospective analysis

The aim of this study was to compare the efficacy and tolerability of solifenacin and mirabegron in patients with overactive bladder (OAB) syndrome.

Prevention of recurrent lower urinary tract infections in postmenopausal women with genitourinary syndrome: outcome after 6 months of treatment with ospemifene

Abstract Aim of this study was to evaluate the efficacy of ospemifene in the prevention of recurrent lower urinary tract infections in postmenopausal women with vulvovaginal atrophy. The study have a retrospective design. Thirty-nine patients were enrolled. Patients underwent clinical examination and urine culture. The urinary symptoms and the quality of life were evaluated with UTISA score, PUF and SF-36 questionnaires before and after treatment. All 39 patients received ospemifene 60 mg one tablet/daily for 6 months. Adverse effects and complications were assessed. Thirty-nine patients were enrolled in the study. Two patients experienced one new UTI episode and the mean number of positive urine culture decreased significantly after 6 months (3.65 ± 2.12 vs 0.25 ± 0.17, p < .0001). The mean number of urinary infection symptoms decreased significantly after treatment; dysuria reduced (4.76 ± 2.45 vs 0.89 ± 1.12). PUF score and SF-36 showed a statistically significant change (22.43 ± 5.89 vs 12.14 ± 3.21) and (52.86 ± 9.21 vs 83.43 ± 10.76). No adverse effects were reported and the total success rate was the 92.3% after 6 months at PGI-I. Ospemifene is a valid alternative with excellent tolerability for the UTIS prevention in postmenopausal patients.

Comparison of Anogenital Distance and Correlation with Vulvo-vaginal Atrophy: A Pilot Study on Premenopausal and Postmenopausal Women

Objectives Anogenital distance (AGD) represents the space between labia posterior commissure and anus. This was pilot study to investigate how menopause and so lack of oestrogens affects AGD. Methods A total of 109 patients were enrolled. AGD was measured in lithotomy position using sterile paper ruler. Anogenital index (AGI) was used to control 2 variables of height and weight (body mass index, kg/m2). Vaginal health index (VHI) was used to evaluate vaginal wellness. Female sexual function index (FSFI) questionnaire was administered to all women to evaluate the impact of menopause on their sexual function. Results AGD (30.87 ± 2.98 vs. 17.57 ± 2.18; P = 0.0001) and AGI (1.40 ± 0.21 vs. 0.70 ± 0.15; P = 0.0001) were both significantly lower in the postmenopausal group. Postmenopausal women were affected by vulvovaginal atrophy (VVA) significantly. Thus, VHI scores were dramatically worse in postmenopausal group (23.95 ± 1.28 vs. 10.75 ± 3.41; P = 0.0001) as well as FSFI results (32.68 ± 2.25 vs. 19.78 ± 5.46; P = 0.0001). Conclusions This study confirms that AGD in post-menopausal women was significantly shorter than AGD in premenopausal women, correlating with an increase of VVA and sexual impairment. Changes of AGD and AGI demonstrated to predict hormonal changes that may occur after menopause.

Overactive bladder syndrome treatment with ospemifene in menopausal patients with vulvovaginal atrophy: improvement of sexuality?

Abstract The aim of this study was to assess the effectiveness of ospemifene in the improvement of sexual function in postmenopausal women with vulvovaginal atrophy (VVA) affected by overactive bladder syndrome (OAB) or urge urinary incontinence (UUI). One hundred five postmenopausal patients with VVA affected by OAB and/or UUI were enrolled for the study. All patients received ospemifene 60 mg for 12 weeks. Clinical examination, 3-d voiding diary and the vaginal health index (VHI) were performed at baseline and at 12 weeks. Patients completed the OAB-Q SF, FSFI, FSDS, and SF-36 questionnaires. The patient’s satisfaction was also calculated. After 12 weeks, the reduction of urinary symptoms was observed. The OAB-Q symptoms, OAB-Q (HRQL) score were (55.34 ± 13.54 vs. 23.22 ± 9.76; p < .0001) and (22.45 ± 9.78 vs. 70.56 ± 15.49; p < .0001), before and after treatment. SF-36 questionnaire showed a significant improvement (p < .0001). VHI score increased and the women who regularly practice sexual activity increased after treatment. The total FSFI score increased significantly and the FSDS score changed after 12 weeks (p < .0001). The PGI-I after 12 weeks showed a total success rate of 90.5%. Ospemifene is an effective potential therapy for postmenopausal women with VVA affected by OAB or UUI improving sexual function and quality of life.

Long-term experience of vaginal vault prolapse prevention at hysterectomy time by modified McCall culdoplasty or Shull suspension: Clinical, sexual and quality of life assessment after surgical intervention

OBJECTIVES The aim of this study was to evaluate the effectiveness of modified McCall culdoplasty or Shull suspension in preventing vaginal vault prolapse after vaginal hysterectomy and the long-term impact on quality of life and sexual function. STUDY DESIGN Retrospective analysis in 414 patients underwent vaginal hysterectomy for pelvic organ prolapse (POP) and vaginal suspension through modified McCall culdoplasty (group A) or Shull suspension (group B) was evaluated. Clinical features and concomitant surgical procedures were assessed. Surgical data and perioperative and postoperative complications have also been analyzed. Clinical characteristics, urinary symptoms, POP-Q score classification, Quality of Life and Sexual Function were evaluated at baseline and at median follow up with P-QoL, ICIQ-UI-SF, PISQ-12, FSFI, FSDS questionnaires. RESULTS The median follow up was 8.9 year (5.1-14.2 years). 200 women in group A and 214 in group B were evaluated. Vaginal vault prolapse occurred in 2 patients in group A and in 2 patients in group B. POP-Q score for all compartments showed a significant (p < 0.001) decrease for both groups without significant differences between the 2 groups. The total vaginal length (TVL) was reduced in greater proportion in McCall group (p < 0.001). P-QoL and ICIQ-UI-SF questionnaires documented an improvement for both groups (p < 0.001). The number of patients who regularly practice sexual activity increased in both groups, but patients in group B experienced a better quality of sexual life evaluated with PISQ-12 and FSFI. CONCLUSIONS Both surgical techniques showed effectiveness and safety in preventing vaginal vault prolapse in women who underwent vaginal hysterectomy, with a significant improvement in quality of life and sexuality. Shull technique demonstrated greater improvement in sexual function.

Therapeutic vaccines and immune checkpoints inhibition options for gynecological cancers

Treatments for gynecological cancer include surgery, chemotherapy, and radiation. However, overall survival is not improved, and novel approaches are needed. Immunotherapy has been proven efficacious in various types of cancers and multiple approaches have been recently developed. Since numerous gynecological cancers are associated to human papilloma virus (HPV) infections, therapeutic vaccines, targeting HPV epitopes, have been developed. The advancing understanding of the immune system, regulatory pathways and tumor microenvironment have produced a major interest in immune checkpoint blockade, Indeed, immune checkpoint molecules are important clinical targets in a wide variety of tumors, including gynecological. In this review, we will describe the immunotherapeutic targets and modalities available and review the most recent immunotherapeutic clinical trials in the context of gynecological cancers. The synergic results obtained from the combination of HPV therapeutic vaccines with radiotherapy, chemotherapy, or immune checkpoint inhibitors, may underlie the potential for a novel therapeutic scenario for these tumors.

Pelvic Inflammatory Disease: Possible Catches and Correct Management in Young Women

The incidence of adnexal masses increases exponentially with age and the most frequent causes in young women are physiologic cysts and pelvic abscesses with pelvic inflammatory disease (PID). Clinical examination can direct physicians to an appropriate management of adnexal mass, but the role of transvaginal ultrasound is crucial for diagnosis and treatment decision, even if it sometimes can be misleading, especially in young women. Ca 125, blood count, and CRP are useful to clarify suspected etiology of a pelvic mass, but specificity and positive predictive value are low because elevation of laboratory tests may occur in several benign conditions. In our work we present four cases of suspected pelvic masses. Despite guidelines for management of PID, the right timing to switch to surgical therapy is not clear. Therefore, the treatment decision should be based on a careful evaluation of various parameters such as signs symptoms and above all age. Moreover, we believe that, for a correct diagnosis and for the best fertility sparing treatment, it is also extremely important to refer to a gynecological oncology unit with an expert surgeon.