Italian multicenter mid-term analysis of laparoscopic lateral suspension in women with pelvic organ prolapse: clinical, sexual and Quality of Life assessment after surgical intervention.

BACKGROUND: The aim of this study was to evaluate effectiveness and safety of laparoscopic lateral suspension in women affected by high grade uterine prolapse associated to anterior defect. The secondary endpoint is to evaluate mid-term impact on Quality of Life and sexual function. METHODS: A multicenter retrospective study on women undergoing laparoscopic lateral suspension for uterine prolapse ≥III stage was performed. We included 174 women, but due to exclusion criteria, 134 patients were enrolled for this study. Preoperative evaluation consisted of an urogynecological interview, clinical exam, 3-day voiding diary and urodynamic testing; the prolapse Quality of Life Questionnaire was used to quantify the impact of prolapse symptoms on Quality of Life and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form, the Female Sexual Function Index and the Female Sexual Distress Scale were administered to evaluate sexual function before surgical intervention and at median follow-up of 3.8 years. RESULTS: We included 134 women with uterine prolapse ≥III stage. All patients underwent laparoscopic lateral suspension, 8 also posterior colporrhaphy and 5 also transobturator tape insertion. POP-Q classification score for anterior and apical compartment showed a significant average decrease. The surveys administered to patients showed an improvement in Quality of Life, an increase in the number of monthly intercourses and a significant improvement in sexual life after surgery. CONCLUSIONS: Laparoscopic lateral suspension for pelvic organ prolapse correction is a safe and effective technique for uterine and anterior associated defect. Quality of Life and sexual function significantly improved after surgery.

Menstrual cycle alterations in reproductive age women after anti COVID-19 vaccination. A survey in 419 Italian women and quality of life and sexual function evaluation.

BACKGROUND: Pharmacovigilance agencies did not collect data regarding menstrual changes after COVID-19 vaccination even if many women experienced it. Our aim was to evaluate whether COVID-19 vaccination is associated with secondary changes in menstrual cycle and to assess both quality of life (QoL) and sexual function (SF). METHODS: This study is a retrospective analysis referred to our Department from January 2021 to December 2021. The study cohort responded to same questionnaires before the second dose of vaccination (referring to previous 3 months) and 3 months after that (referring to three menstrual cycles after full-dose vaccination). The surveys administered were FSFI, FSDS, SF-36, MEDI-Q and the VAS-scale for dysmenorrhea. RESULTS: Four-hundred-nineteen vaccinated women were included in the study. The survey did not show a significant change in menstrual cycle length before and after COVID-19 vaccine (5.88±3.67 vs. 4.97±2.89, P=0.21); the interval between periods was significantly higher after a full-cycle vaccination (28.32±7.34 vs. 32.38±7.45, P<0.02); 32 patients (7.6%) developed amenorrhea after the second dose; VAS Scale did not change significantly (median range 3 (3-5) vs. 4 (3-6), P=0.20). MEDI-Q did not show significant variations before and after the vaccination (43.21±11.65 vs. 40.28±9.88, P=0.35). QoL and SF did not change significantly (FSFI median 27 [24-29] vs. 28 [25-30], P=0.12, FSDS median 9 [5-11] vs. 8 [4-12], P=0.22), SF-36 median 81 [70-85] vs. 82 [72-86], P=0.43). CONCLUSIONS: COVID-19 vaccination is associated with a significant change in intervals between menstrual cycles without other alterations in menstrual characteristics, in QoL or SF.

Combined treatment with vaginal native tissue repair plus mid-urethral sling or pelvic floor muscle training in patients with anterior defect and occult stress urinary incontinence: quality of life and sexual function analysis.

BACKGROUND: The aim of this study was to compare the efficacy of vaginal native tissue repair (VNTR) combined with tension-free transobturator tape (TVT-O) or pelvic floor muscle training (PFMT) in terms of quality of life (QoL) and sexual function (SF) in women affected by anterior defect and occult stress urinary incontinence (OSUI). METHODS: One hundred forty-seven patients with symptomatic anterior defect with OSUI underwent VNTR. In 71 patients TVT-O was inserted and 76 underwent PFMT after surgery. Clinical exam, 3-day voiding diary and urodynamic testing were evaluated in preoperative and postoperative times. Specific questionnaires were also administered, in order to indagate disease perception and the impact on QoL and SF. RESULTS: Nine patients had postoperative pain in the TVT-O group vs. 0 patients in the PMFT group (P=0.001) and 7 patients reported de novo urgency vs. 3 in the two groups, respectively. At 12 weeks follow-up (FU), the first voiding desire was at 88.12+19.70 mL in VNTR+TOT vs. 102.29+19.13 (P=0.03); the mean number of voids (24 hours) was 9.95±2.66 vs. 6.14±1.77 (P=0.04), respectively. No significant differences in terms of QoL and SF were shown. CONCLUSIONS: This retrospective study suggests that VNTR+TVT-O and VNTR+PMFT have the same efficacy in terms of QoL and SF, with several post-operative complications, even if minor, in patients treated with combined surgery.

Quality of life and sexual function evaluation in women with urogynecological diseases analyzed with telemedicine during the COVID-19 period: the beginning of a new era?

BACKGROUND: The aim of this study was to demonstrate that the implementation of remote medical care in the management of patients suffering from specific urogynecological diseases can be a valid alternative to outpatient visits leading to a huge saving of resources which can be used for real emergencies. Therefore, the primary aim of this study was to demonstrate that patients treated with telehealth had the same improvement in symptoms and Quality of Life as those treated with outpatient visits. METHODS: Observational analysis on women with urogynecological diseases was performed during restrictive measures period. One group of patients was assessed in the clinic and one group by video consultations. The population answered Female Sexual Function Index (FSFI), Female Sexual Distress Scale (FSDS), the Overactive Bladder Questionnaire Symptoms and Health-Related Quality of Life Short-Form Symptoms (OAB-Q), Prolapse Quality of Life Questionnaire (P-QoL), the Pelvic Pain and Urinary/Frequency Patient Symptom Scale (PUF) scores, the Short Form Health Survey questionnaires (SF-36) during the first visit and after 12 weeks. The primary endpoint was to evaluate the change in symptoms after the outpatient and telemedicine visit. The secondary endpoint was the evaluation of the telemedicine impact on the Quality of Life and sexual function. RESULTS: One hundred twenty-five patients were considered. Symptoms of overactive bladder, genitourinary syndrome, and recurrent urinary infections improved significantly in both groups with no significant differences. Sexual activity increased significantly in both groups with a significant change in FSFI and FSDS values. The SF-36 showed a significant change 12 weeks after the visit in both groups. CONCLUSIONS: Telemedicine is equally useful and effective as the outpatient visits in patients suffering from urogynecological diseases.

Sexual function analysis and clitoral vascularization in postmenopausal women with genitourinary syndrome treated with ospemifene.

BACKGROUND: The aim of this study was to evaluate the efficacy of ospemifene in the Vaginal Health Index (VHI), in the vulvovaginal vascular perfusion, and to assess its impact on quality of life and sexual function. METHODS: Among 52 eligible patients, 43 consecutive postmenopausal patients affected by vulvo-vaginal atrophy (VVA), or genitourinary syndrome (GSM) were evaluated. VVA evaluation and ultrasound of the vulvo-vaginal vascularization by sampling the Pulsatility Index (PI) of clitoris dorsal artery were performed before and after 3 months-treatment with ospemifene. The 36-Item Short Form Survey (SF-36) for the quality-of-life assessment before and after 3 months were available for all women; instead, Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale (FSDS) questionnaires for the sexual function evaluation were performed for sexually active women in the study. The Patient Impression of Global Improvement (PGI-I) after 3 months of treatment was also calculated. RESULTS: The number of sexually active women significantly increased after 3 months (26 [60.46%] vs. 35 [81.39%]; P=0.01). The mean number of intercourses during the treatment increased (12.87±3.43 vs. 15.79±3.12, P=0.03). The PI of clitoris dorsal artery has significantly changed before and after treatment respectively (PI [1.69±0.42 vs. 1.28±0.45, P=0.001] RI [0.74±0.11 vs. 0.54±0.15, P=0.001]). The FSFI, FSDS and SF-36 Questionnaires scores showed a significant improvement after 3 months. VHI and PI were the independent factors of a lower FSFI after 3 months of treatment at multivariate analysis. CONCLUSIONS: Ospemifene improve the VHI and vulvovaginal vascular perfusion demonstrating a positive impact on sexual function and quality of life.

Sequential combined approach in patients with mixed urinary incontinence: surgery followed by posterior tibial nerve stimulation.

AIM: The aim of the study is to demonstrate the efficacy of sequential combined treatment with Transobturator Tape (TOT) followed by Posterior Tibial Nerve Stimulation (PTNS) in patients with Mixed Urinary Incontinence (MUI); quality of life and patients' satisfaction was also assessed. METHODS: Retrospective analysis on women affected by MUI with prevalent Stress Urinary Incontinence (SUI) component. Women, divided in 2 groups, underwent different treatments, TOT vs TOT+PTNS. Population was assessed by medical history, previous pelvic surgery, clinical exam, urodynamic exams, pelvic ultrasound examination, and questionnaires (The International Consultation on Incontinence Questionnaire Short Form, Overactive Bladder Questionnaire, Health Related Quality of Life) comparing them before and after 12 weeks after treatment. RESULTS: 112 women were enrolled in the study. The mean age was 57.96±7.34 in the first group(N=60) and 58.29±6.14 in the second group(N=52). Peak flow (ml/s) statistically improved after treatment, 22.23±4.29 (TOT) vs 24.81±5.8 (TOT+PTNS). First voiding desire(ml) improved significantly between the two groups 108.72±19.24 vs 142.43±19.98. Maximum cystometric capacity (ml) in the TOT group at 12-weeks was 328.76±82.44 vs TOT+PTNS group of 396.26±91.21. Detrusor pressure at peak flow(cmH2O) showed a greater improvement in TOT+PTNS than TOT alone 14.45±6.10 vs 11.89±54.49. At 12-week, urinary diary and quality of life improved in terms of urgent urination events, mean number of voids, urge symptoms and nocturia events. The Patient Impression of Global Improvement (PGI-I) after 3 months was better in combined group. CONCLUSIONS: Combined and sequential TOT+PTNS is more effective compared to TOT alone in MUI patients with prevalent SUI component.

Laparoscopic stripping versus endometrioma ethanol sclerotherapy in women with endometrioma awaiting IVF: a long-term analysis of ovarian reserve and pregnancy outcome.

BACKGROUND: The aim of this study was to compare ovarian reserve, oocytes quality and pregnancy outcome of endometrioma treatment by laparoscopic stripping (LS) versus endometrioma ethanol sclerotherapy (EST) in infertile women awaiting in-vitro fertilization (IVF). METHODS: Retrospective analysis was performed. Twenty-three women underwent EST and 26 women LS. Intra- and postoperative complications were recorded. The women were followed-up for 36 months for cyst recurrence, oocytes quality and pregnancy outcome. Serum anti-Müllerian hormone (AMH) levels after treatment were measured to observe the impact on the ovarian reserve. Women's satisfaction was investigated with PGI-I. RESULTS: During follow-up, there were 3 endometriomas recurrences after LS and none after EST. Six months after treatment AMH was 3.17±2.15 in EST vs. 2.22±1.97 in LS, P=0.045. Symptoms' improvement was comparable. No intraoperative complications occurred. In the LS group the postoperative complications were significantly higher. After IVF cycles, the quality of the retrieved oocytes was the same. In EST group, clinical pregnancy (48.1% vs. 19.6%) and live birth rates (36.5% vs. 14.3%) were significantly increased compared to LS. Women's satisfaction was comparable at PGI-I. Both EST and the presence of an endometrioma sized 6 cm or less proved to be independent factors of a better live birth rate in multivariate analysis. CONCLUSIONS: EST efficacy was greater than LS for endometrioma. Ovarian function was well preserved. Hospital stay was shorter, fewer complications occurred. Pregnancy outcome was better after EST.

Management of women with uterine fibroids in reproductive center: retrospective analysis of clinical and reproductive outcomes.

BACKGROUND: Uterine fibroids are the most common benign tumor in women. According to literature, submucosal myomas have a negative effect on reproductive outcomes in women undergoing assisted reproductive techniques (ART) but there are fewer data concerning intramural fibroids. During last years, ulipristal acetate (UPA) 5 mg was widely used as medical option of fibroid's treatment, but from 2020, the Pharmacovigilance Risk Assessment Committee (PRAC) has revoked the marketing authorization after some cases of liver toxicity. METHODS: In this observational, retrospective study we collected data from a sample of 23 women affected by symptomatic uterine fibroids (from type 1 to type 7 according FIGO classification) followed in our center for assisted reproduction from 2016-2019. All patients received 5 mg/day UPA for three months, followed by two months of wash-out therapy. A group of 13 women treated with UPA, with intramural fibroid not distorting the uterine cavity, after wash-out therapy, affected by tubal or idiopathic factors of infertility too, underwent ART. We also evaluated a control group of women, not affected by fibroids, randomly selected from a general group of our ART patients, similar by age, BMI, and cause of infertility only idiopathic or tubal factors. We evaluated the impact of UPA on reduction of fibroid volume, symptomatology and distortion of the cavity in all the women treated, and the IVF (in-vitro fertilization) outcome between the fibroid group of women affected by intramural fibroids who underwent ART, and the control group. RESULTS: In all the women treated with UPA the overall median fibroid volume pretreatment was 45.168±35.360 mm3, that decreased to a mean value of 22.592±22.116 mm3 post one cycle of UPA, with an overall mean decrease of -22.586 mm3 (of 49%) statistically significant (P=0.00001). After treatment, the distortion of the uterine cavity reduced in high percentage of cases: 85,71% (type 1-2), χ2 difference in respect to the value pretreatment of 0.3941, and 86.96% of patients subjectively referred an improvement in the symptomatology. In the group of 13 women that undergone ART, after one IVF cycle for each patient, we obtained 61% of positivity of dosage of beta human chorionic gonadotropin (hCG) after UPA treatment, and we obtained a similar value in the control group. CONCLUSIONS: In our little sample we have observed that UPA represented a valid non-invasive medical treatment strategy for fibroids in women candidate for (IVF, not only in women affected by sub-mucosal, but also by intramural fibroids not distorting uterine cavity. After a single, three months course of treatment, we obtained good results in terms of reduction of fibroid's volume and improvement of symptomatology, without side effects, preparing a more favorable environment for ART.

Predictors of postoperative overall and severe complications after surgical treatment for endometrial cancer: The role of the fragility index.

OBJECTIVE: To evaluate the predictive value of obesity, comorbidities, and fragility on overall and severe complication rate and survival among patients surgically treated for endometrial cancer. METHODS: Consecutive patients with endometrial cancer treated at the Royal Infirmary Hospital of Edinburgh from June 1, 2015, to June 30, 2017, were retrospectively enrolled in an observational study. Considering pre-existing medical conditions, comorbidities, and complications, modified fragility index (mFI) was calculated. Logistic regression was used to evaluate predicting variables of overall (G1-G4) and severe (G3-G4) complication rate. RESULTS: One hundred patients were surgically treated for endometrial cancer. Elevated mFI >3 was related to a statistically higher access rate to the high dependency unit (HDU) or intensive care unit (ITU) (33.3% vs 6.6%, P=0.013). Overall, 31 women had postoperative complications. Using multivariate analysis, it was shown that undergoing laparotomy (odds ratio [OR] 7.06, 95% confidence interval [CI] 2.52-19.71; P<0.001) and having an mFI >3 (OR 7.19, 95% CI 1.43-36.25; P=0.021) were independent predictors of overall complications (G1-G4). Moreover, only smoking (OR 5.01, 95% CI 1.15-21.75; P=0.031) and mFI >3 (OR 5.16, 95% CI 1.07-24.94; P=0.047) were independent factors for severe complications (G3-G4). CONCLUSION: Modified fragility index was an important predictor of complications among patients treated for endometrial cancer and could be a useful tool for assisting clinicians in perioperative management.

Immunotherapy in endometrial cancer: new scenarios on the horizon.

This extensive review summarizes clinical evidence on immunotherapy and targeted therapy currently available for endometrial cancer (EC) and reports the results of the clinical trials and ongoing studies. The research was carried out collecting preclinical and clinical findings using keywords such as immune environment, tumor infiltrating lymphocytes, programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1) expression, immune checkpoint inhibitors, anti-PD-1/PD-L1 antibodies and others' on PubMed. Finally, we looked for the ongoing immunotherapy trials on ClinicalTrials.gov. EC is the fourth most common malignancy in women in developed countries. Despite medical and surgical treatments, survival has not improved in the last decade and death rates have increased for uterine cancer in women. Therefore, identification of clinically significant prognostic risk factors and formulation of new rational therapeutic regimens have great significance for enhancing the survival rate and improving the outcome in patients with advanced or metastatic disease. The identification of genetic alterations, including somatic mutations and microsatellite instability, and the definition of intracellular signaling pathways alterations that have a major role in in tumorigenesis is leading to the development of new therapeutic options for immunotherapy and targeted therapy.

Effectiveness, quality of life and sexual functions in women with anterior compartment prolapse treated by native tissue repair.

Anterior compartment defect is the most common pelvic organ prolapse. It is defined as the descent of the bladder into the anterior vaginal wall. The etiology is multifactorial and the main risk factors are vaginal delivery and conditions associated with increased abdominal strain. Aging is significantly associated with the prevalence and severity of pelvic organ prolapse. Treatment may be conservative or surgical according to symptoms, prolapse degree and not forgetting both patient and doctor preferences. The aim of this work is to identify the most efficient surgical treatment of cystocele and its recurrences. There are two different surgical approaches for the treatment of cystocele: traditional repair and mesh repair. Prosthetic treatment gives higher anatomical success rate but traditional anterior repair has less complication demonstrating a lower risk of reoperation. Surgical treatment in general improves both the quality of life (QoL) and the sexual function. We carried out a research on the impact of the anterior defect before and after native tissue surgery on QoL and sexual function. The efficacy and complications of the treatment were also assessed.

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

AIM: The aim of this study was to compare the efficacy and tolerability of solifenacin and mirabegron in patients with overactive bladder (OAB) syndrome. METHODS: We carried out a retrospective analysis in 342 women affected by OAB syndrome; 168 were treated with solifenacin 5 mg/daily and 174 with mirabegron 50 mg/daily. A clinical evaluation, 3-day voiding diary, and urodynamic testing was performed. Patients completed the Overactive Bladder Questionnaire - Short Form, the King's Health Questionnaire, and the Patient Global Impression of Improvement questionnaire. The adverse effects were evaluated. The two groups were compared at baseline and at 12 weeks. RESULTS: After 12 weeks, a significant reduction in the mean number/24 h of voids and urgent micturition episodes/24 h was observed in both groups. Detrusor overactivity decreased from 58.3% to 13.1% in the solifenacin group and from 58% to 11% in the mirabegron group. Twenty (12%) and 18 (10.7%) patients taking solifenacin reported constipation and dry mouth, respectively, versus four (2.3%) and five (2.9%) patients taking mirabegron, respectively, but there was no difference between the groups in the change in vital signs. The Overactive Bladder Questionnaire - Short Form and King's Health Questionnaire scores did not demonstrate significant differences and the abandonment rates in the solifenacin and mirabegron groups were 25.5% and 20%, respectively. CONCLUSION: Solifenacin and mirabegron showed the same efficacy in the treatment of OAB but solifenacin had more adverse effects.