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Objectives: The aim of the publication was to present the Guideline of the Urogynecology Section of the Polish Society of Gynecologists and Obstetricians (PSGO) for the management of recurrent pelvic organ prolapse, based on the available literature, expert knowledge and opinion, as well as everyday practice., Material and Methods: In 2005, 2006 and 2010, the panel of PSGO experts published guidelines for the diagnosis and treatment of patients with lower urinary tract symptoms (LUTS). This publication presents an update of those recommendations and concerns recurrent POP treatment., Main Conclusion: The analysis of data revealed that sacrocolpopexy with the use of commercial sets or polypropylene hernia mesh is the method of choice for the surgical repair of recurrent vaginal vault prolapse. However, a significantly higher risk of surgical and postoperative complications after sacrocolpopexy, as compared to vaginal surgeries, should be considered when making treatment decisions. In other types of recurrent POP, the choice of surgery method should be tailored to the individual needs of each patient and may depend on the medical center.

Purpose: To evaluate whether ionophore application at the oocyte stage changes the morphokinetics of the associated embryos in cases of artificial oocyte activation., Methods: In a prospective sibling oocyte approach, 78 ICSI patients with suspected fertilization problems had half of their MII-oocytes treated with a ready-to-use ionophore (calcimycin) immediately following ICSI (study group). Untreated ICSI eggs served as the control group. Primary analyses focused on morphokinetic behavior and the presence of irregular cleavages. The rates of fertilization, utilization, pregnancy, and live birth rate were also evaluated., Results: Ionophore-treated oocytes showed a significantly earlier formation of pronuclei (t2PNa) and a better synchronized third cell cycle (s3) (P < .05). The rate of irregular cleavage was unaffected (P > .05). Ionophore treatment significantly improved the overall rates of fertilization (P < .01) and blastocyst utilization (P < .05)., Conclusion: Ionophore application does not negatively affect cleavage timing nor is it associated with irregular cleavage., (© 2021. The Author(s).)

There are still controversies around reconstructive surgeries used in POP treatment. The aim of this study was to compare the QoSL after VNTR vs. TVM surgery due to POP via the use of PISQ-12 and FSFI questionnaires. The study included a group of 121 sexually active patients qualified for reconstructive surgery due to symptomatic POP, and 50 control. The average results of PISQ-12 before and after surgery were compared using the t -test. The significance of the mean differences in demographic groups was measured using the t -test for independent samples and one-way ANOVA. The results in the demographic groups were compared using the Mann-Whitney U test and the Kruskal-Wallis test. Fifty-eight women had VNTR, while 63 had TVM. Results of PISQ-12 revealed significant improvement in the sexual life after reconstructive surgery (27.24 vs. 32.43; p < 0.001, t = 8.48) both after VNTR and TVM. There were no significant differences in the assessment of the QoSL according to PISQ-12 and FSFI results between both analyzed groups of patients (PISQ-12: VNTR vs. TVM; t -test p = 0.19 and FSFI: VNTR vs. TVM; Mann-Whitney U test p = 0.54). VNTR is the treatment of choice in the case of uncomplicated primary POP.

It is estimated that 31-44% of all patients with symptomatic POP and/or UI suffer from sexual dysfunction. We aimed to validate the PISQ-12 in pre-and postmenopausal women and to assess the sexual function before and after POP reconstructive surgery. One hundred and forty sexually active patients were hospitalized due to symptomatic POP and 50 healthy controls were enrolled into the study. The patients were asked to complete PISQ-12, the FSFI and Beck's depression scale questionnaires twice. The Cronbach's alpha (α) was used to estimate the internal consistency. The scores were compared using the Intraclass Correlation Coefficient (ICC). Improvement in the QoSL (quality of sexual life) was observed in each age group of women. Pre-menopausal patients' QoSL was much better, both before and after surgery (29.62 and 34.64 points, respectively). The correlation between questionnaires before surgery was 0.63, and after was -0.76. The α value for the PISQ-12 was 0.83 before the procedure and 0.80 afterwards. In all the groups, the test-retest reliability was good-ICC = 0.72. Vaginal reconstructive surgeries improve the QoSL. The only demographic factor influencing the QoSL was the menopausal status. The Polish version of the PISQ-12 is a reliable and responsive instrument for assessing the sexual function in patients with diagnosed POP and/or UI.

Purpose: Genome-wide association studies have not identified replicable genetic risk loci for stress or urgency urinary incontinence., Materials and Methods: We carried out a discovery stage, case control, genome-wide association study in 3 independent discovery cohorts of European women (8,979) for stress incontinence, urgency incontinence, and any incontinence phenotypes. We conducted replication in 6 additional studies of European ancestry (4,069). We collected bladder biopsies from women with incontinence (50) to further investigate bladder expression of implicated genes and pathways and used symptom questionnaires for phenotyping. We conducted meta-analyses using inverse variance fixed effects models and whole transcriptome analyses using Affymetrix® arrays with replication with TaqMan® polymerase chain reaction., Results: In the discovery stage, we identified 16 single nucleotide polymorphisms genotyped or imputed at 5 loci that reached genome-wide significance (p <5×10 -8 ). In replication, rs138724718 on chromosome 2 near the macrophage receptor with collagenous structure ( MARCO ) gene (replication p=0.003) was associated with stress incontinence. In addition, rs34998271 on chromosome 6 near the endothelin 1 ( EDN1 ) gene (replication p=0.0008) was associated with urgency incontinence. In combined meta-analyses of discovery and replication cohorts, associations with genome-wide significance for these 2 single nucleotide polymorphisms were confirmed. Transcriptomics analyses showed differential expression of 7 of 19 genes in the endothelin pathway between stress and urgency incontinence (p <0.0001)., Conclusions: We uncovered 2 new risk loci near the genes endothelin 1 ( EDN1 ), associated with urgency incontinence, and macrophage receptor with collagenous structure ( MARCO ), associated with stress incontinence. These loci are biologically plausible given their roles in smooth muscle contraction and innate host defense, respectively.

The aim of the study was to evaluate the influence of different types of hysterectomy on UI symptoms, quality of life and sexual functions using dedicated questionnaires. We investigated a correlation between the urethral length (UL), UI symptoms and the length of the cervix (left after LSH and SH) with sexual functions. The study enrolled 500 consecutive women referred for hysterectomy: 121 underwent VH, 171 underwent LSH, 96 underwent SH, 68 underwent TAH, and 44 underwent TLH. The patients filled in the UI-specific questionnaires and FSFI before and 12 months after hysterectomy. The UL was measured by introital ultrasound before and 12 months after hysterectomy. Before surgery, 137 out of 399 (34.3%) patients had UI symptoms; afterwards, 139 (34.8%) indicated the same ( p > 0.05). There was no statistically significant difference in the UL in the patients before and after the procedure, and the cervix length did not differ between patients after LSH and SH. When the entire investigated population was analyzed, a significant improvement of the QoL was found on the IIQ-7. Hysterectomy performed due to benign diseases has effects on UI regardless of the surgical technique used. The UI symptoms improved only in the patients after LSH. The UL measured 12 months after hysterectomy did not change.

Objectives: The degree of lymphoceles prevention was assessed using collagen patches coated with human coagulation factors (TachoSil, Nycomed International Management GmbH, Zurich, Switzerland). The study enrolled 50 consecutive patients with endometrial and cervical cancer stages IB to II who had undergone open hysterectomy and pelvic lymphadenectomy (PL). In addition, the drainage volumes of 22 patients with hypertension were compared to that of the rest of the study population. Furthermore, occurrence of lymphocele in patients with endometrial and cervical cancer were compared after completion of adjuvant treatment., Material and Method: s: Patients were simultaneously randomized in two groups: as a control (side without TachoSil applied) and study group (side with TachoSil applied). All surgical parameters were collected, and patients underwent ultrasound examination on postoperative days 1, 6, and 30, and at the end of treatment., Results: The TachoSil Group showed a lower drainage volume, 30 days after surgery, while outflow of fluid occurred in 11 (22%) of all TachoSil Group cases and 22 (44%) of all control group cases. Furthermore, two patients in the control group had symptomatic lymphocele, while the same number of cases was observed in the TachoSil Group. However, the TachoSil Group demonstrated a decreased tendency to lymphocele occurrence after the end of adjuvant therapy. Here, patients with the collagen patch developed lymphocele in 12% of all cases, as opposed to 18% without TachoSil., Conclusions: TachoSil is a useful support treatment option for reducing drainage volume and preventing lymphocele development after lymphadenectomy.

Purpose: Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7) and The International Consultation on Incontinence (ICIQ-SF) Short Form are used to diagnose individuals with urinary incontinence (UI) and to assess the impact of the dysfunction on patient quality of life. While ICIQ-SF has fixed cutoff values-UDI-6 and IIQ-7 do not. We aimed to find the cutoff scores for UDI-6 and IIQ-7 in women with UI., Methods: The study involved 205 women aged between 31 and 83 years-155 with, and 50 without UI symptoms. All participants completed all three questionnaires: ICIQ-SF, UDI-6 and IIQ-7. Patients were categorized according to their ICIQ-SF scores, as symptomatic ICIQ-SF ≥ 6 (n = 134) and asymptomatic ICIQ < 6 (n = 60). The Receiver Operating Characteristics (ROC) curve was used to test how well UDI-6 allowed a discrimination between patients suffering from UI and those who do not. Area under Curve (AUC) statistic was calculated to measure the UDI-6 and IIQ-7 Total Score efficiency., Results: The cutoff values were selected. On the basis of the ROC curve analysis, the UDI-6 Total Score of 33.33 and IIQ-7 Total Score of 9.52 were determined to be the optimal cutoff for distinguishing between symptomatic and asymptomatic women (AUC = 0.94-UDI-6 and 0.91-IIQ-7)., Conclusions: For UDI-6 scores more than 33.33 indicate higher distress caused by UI symptoms. Moreover, the higher impact of UI on health- related quality of life is seen in women who scored 9 or more in the IIQ-7 questionnaire, and such women felt impaired quality of life. Trial registration number NCT04433715, 11.06.2020 "retrospectively registered".

Objectives: The King's Health Questionnaire (KHQ) and the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form are widely used in clinical practice. The aim of this study was to assess the reliability of KHQ and ICIQ-SF in Polish women., Material and Methods: One hundred fifty-five women with urinary incontinence (UI) aged between 19-82 years underwent urodynamic investigation and completed both KHQ and ICIQ-SF. We performed Principal Component Analysis (PCA) using VARIMAX rotation for all questionnaire pieces to estimate the factor structure and construct the validity of the KHQ and ICIQ. PCA results were also confirmed by Spearman's correlations between KHQ and ICIQ items. Moreover, by Cronbach's alpha coefficient (α) we assessed the internal consistency of the KHQ and ICIQ. STATISTICA version 13.1 software (StatSoft, Poland), and open-source R software (version 3.4.4) were used for statistical analysis., Results: Of the study group, 77 (49.6 %) patients had stress urinary incontinence (SUI), 9 (5.8%) patients had Urgency, 10 (6.45%) had OAB and 21 (13.5 %) had MUI. The factor analysis of the KHQ questions showed four main components, and ICIQ-SF- two main components. Correlations between KHQ and ICIQ-SF were from weak (0.1-0.3) to high (0.5-0.7). The KHQ's Cronbach's alpha was 0.93 and the ICIQ- 0.7. The results obtained from the questionnaire forms did not differ among study groups., Conclusions: The Polish versions of the KHQ and ICIQ-SF questionnaires have good psychometric values and are useful diagnostic tools in the population of urinary incontinent women.

Objectives: The aim was to present an interdisciplinary Guideline of the Urogynecology Section of the Polish Society of Gynecologists and Obstetricians (PSGO) for the management of stress urinary incontinence (SUI)., Material and Methods: A review of the literature, including current international guidelines and earlier recommendations of the PSGO Urogynecology Section, about the treatment of SUI was conducted., Results: Management of SUI is presented. Four lines of therapy were identified: line 1 - the so-called 'conservative treatment', which should always be attempted, regardless of SUI symptom severity; line 2 - surgical intervention; lines 3 and 4 - reoperations after unsuccessful surgeries from line 2. The literature reports which provided supporting evidence for this Guideline, including the practical aspects, were discussed., Conclusions: A systematic review of the guidelines and an analysis of SUI management were conducted. The need for an individualized approach was emphasized.

Objectives: The aim of the publication was to present the interdisciplinary guidelines of the Urogynecology Section of the Polish Society of Gynecologists and Obstetricians (PSGO) for the treatment of overactive bladder (OAB) syndrome based on the available literature, expert knowledge, and everyday practice., Material and Methods: A review of the literature, including current recommendations for the treatment of overactive bladder syndrome, urinary incontinence, urgency and mixed urinary incontinence, as well as the earlier recommendations of the PSGO Urogynecology Section, was conducted., Results: Management of the patients with OAB is presented. Four lines of therapy were identified: 1) educating the patient, behavioral therapy with pelvic floor muscle training, 2) pharmacotherapy, 3) botulinum toxin injection and tibial nerve stimulation; and sacral nerve stimulation even though so far it has been used only in selected populations, 4) surgical intervention. The literature reports which provided supporting evidence and presented various aspects of the therapy were discussed. OAB pharmacotherapy-related issues which are vital in everyday clinical practice were presented., Conclusions: A systematic review of the available guidelines and an analysis of OAB (including urgency urinary incontinence) management were conducted. The Polish Society of Gynecologists and Obstetricians issued the guidelines for the therapeutic management of OAB patients. The need for an individualized approach was emphasized.

Objectives: The aim was to present an interdisciplinary Guideline of the Urogynecology Section of the Polish Society of Gynecologists and Obstetricians (PSGO) for the use of urodynamics (UDS) in the diagnostic process of patients with lower urinary tract symptoms (LUTS) based on the available literature, expert knowledge, and everyday practice., Material and Methods: A review of the literature concerning the use of UDS in women, including current international guidelines and earlier recommendations of the PSGO Urogynecology Section, was conducted., Results: Urodynamic testing allows to make the urodynamic diagnosis which, nevertheless, remains to be the preliminary diagnosis. Medical history, physical examination, and detailed analysis of the previous test results (laboratory, imaging, endoscopic) need to be taken into consideration before making the final diagnosis. Urodynamic testing before surgical treatment of SUI is allowable, but the decision remains at the discretion of the physician. Urodynamic testing is not necessary before primary surgical treatment of uncomplicated SUI, but it has been demonstrated to optimize the therapeutic methods in complicated SUI. The significance of UDS in the diagnostic process of patients with overactive bladder symptoms, voiding dysfunction, and bladder outlet obstruction was discussed., Conclusions: Urodynamic testing is a vital element of the urogynecological diagnostic process. The scope of UDS should reflect the individual needs and symptoms of each patient and be based on the current guidelines, expert knowledge and experience of the physician, indications, and eligibility, as well as additional test results of the affected patients. Due to formal and legal requirements, PSGO, in this Guideline, wishes to emphasize the need for an individualized approach to both, test performance and result interpretation.

Introduction: Vibegron is a very selective new β3-adrenergic receptor agonist introduced recently to clinical practice for OAB patients, which offers an alternative option for to antimuscarinic drugs., Areas Covered: This review presents the current knowledge concerning the mechanism of action, pharmacokinetics, and pharmacodynamics of vibegron. Moreover, it presents an overview of preclinical and phase II and phase III clinical studies on the efficacy, tolerability, and safety of this agent in patients suffering from OAB., Expert Opinion: Clinical studies confirmed efficacy and safety of vibegron in OAB patients. Vibegron differ from well-known mirabegron with regards to its pharmacological profile because it is metabolized independently from CYP3A4, 2D6, or 2C9 and therefore is less likely to cause a drug-drug interaction. Moreover, since this drug does not penetrate the blood-brain barrier, it could become the drug of choice in OAB patients with cognitive impairment. These properties have paved the way in near future for better-tailored treatments for OAB patients.

Objective: Advanced vaginal vault prolapse (VVP) can occur rarely after any type of hysterectomy. Several types of procedures have been applied to correct this defect, but optimal management is still pending. The aim of this study was to describe the surgical technique and results of four-arm transvaginal mesh (FATVM) application for advanced VVP., Study Design: We followed up for 24 months, 160 patients with VVP > II vc (according to the Pelvic Organ Prolapse Quantification Scale (POPQ)), who underwent FAMTVM from 2014 to2017. FAMTVM was inserted with the anterior arms through the obturator foramens and the posterior arms through the ischiorectal fossas and sacrospinal ligaments. Clinical data were prospectively collected in a customized database and retrospectively analyzed. To assess QoL SF 36, KHQ and FSFI questionnaires were used. POPQ was employed to measure degree of VVP. Non-parametric tests (The Wilcoxon signed-rank test) were applied to verify statistical hypotheses., Results: According to SF 36, significant improvement was evident in almost all aspects of general QoL (PCS p = 0.002, MCS p = 0.01). KHQ showed statistically significant improvement in all domains. FSFI scores after surgery indicated significantly improvement in all domains of the questionnaire, apart from lubrication (p = 0.02). Intraoperative bladder injury occurred in 3.75 % (n = 6) of all cases. Five patients (3.1 %) complained of de novo stress urinary incontinence. VVP reoccurred in nine cases (5.6 %). Only two patients (1.25 %) saw mesh exposure after 6 months postoperative recovery., Conclusion: We consider FAMTVM for VVP to be safe and effective. Hence, it applied as an optional treatment, especially in patients with contraindications to laparotomy and laparoscopy., Competing Interests: Declaration of Competing Interest The authors reported no declarations of interest., (Copyright © 2020 Elsevier B.V. All rights reserved.)

The purpose of this study was to investigate the association of iNKT (human invariant natural killer T) cells with the key marker of ovarian cancer (OC) - CA125 (cancer antigen125) in serum. The study reports the assessment of iNKT cells in peripheral blood and tissue of benign and borderline ovarian tumors (BOTs) and in the advanced-stage ovarian cancer. The study groups were as follows: 25 women with benign ovarian tumors, 11 women with BOTs, and 24 women with primary advanced-stage ovarian cancers. The control group consisted of 20 patients without the ovarian pathology. The rates of iNKT lymphocytes in the peripheral blood and tissue specimens were evaluated by a flow cytometry. Significant differences in the percentage of iNKT+/CD3+ of CD3+ lymphocytes, iNKT+/CD3+/CD161+ among CD3+ and iNKT+/CD3+/CD161+ among CD3+/iNKT+ between the control group and patients with ovarian tumors in the peripheral blood and tumor tissue were identified. Significant correlations were noticed between the proportion of lymphocytes iNKT+/CD3+/CD161+ among CD3+/iNKT cells in blood and in cancer tissue of both benign and malignant tumors. In the OC group, neither the ratio of iNKT cells in the blood (P = 0.07), nor the intra-tumor NKT-cell infiltration (P = 0.5) were independent prognostic factors for the follow-up. An increased rate of iNKT cells was detected in benign ovarian tumors compared to OCs. In patients with ovarian cancer, a higher rate of iNKT cells in tumor tissue was present related to that noted in the patient's blood. In addition, a correlation was discovered between the CA125 serum marker and NKT cells from the ovarian cancer tissue. This article has for the first time demonstrated a negative relationship between serum levels and NKT lymphocyte count from ovarian tissue. The inflammatory process in ovarian cancer tissue and the potential infiltration of endothelial immune cells, may result in a reduced number of NKT cells in the tumor microenvironment and increased circulation of the CA125 marker. Presented findings underscore new aspects of the iNKT cells involvement in the ovarian cancer development., (Copyright © 2020 Elsevier GmbH. All rights reserved.)

Urinary tract infections (UTIs) are one of the most common reasons for antibiotic prescriptions among women worldwide. UTIs are also associated with intra- and postoperative catheterization, which is an essential component of many gynecological surgical procedures, including midurethral sling (MUS) placement. The aim of this study was to compare the incidence of UTI subsequent to a MUS procedure. The study involved 562 female patients who underwent MUS procedures due to stress urinary incontinence (SUI). Patients were assigned in a 1:1 ratio to two study groups: patients receiving 500 mg of ciprofloxacin three times a day for 3 consecutive days after surgery or patients receiving 5 mL of Canephron taken orally three times a day for 3 weeks. After analyzing the collected data, it was found that in the group of patients receiving ciprofloxacin, 29 women (10.98%) had a UTI, whereas in the group of patients receiving Canephron, 36 women (13.64%) had a UTI within 6 months after the patient's MUS procedure. No statistically significant difference between the two groups was noted. Postoperative prophylaxis with a phytodrug can be perceived as an attractive option in the reduction of antibiotic consumption among female patients after a MUS procedure.

The purpose of the present study was to assess the association of regulatory T cells (Tregs; CD4 + FOXP3 + ) and helper T lymphocytes (Th17) releasing interleukin (IL)-21 and IL-22, with the Risk of Ovarian Malignancy Algorithm (ROMA). Similar association was made with two additional tumour markers, human epididymis protein 4 (HE4) and carbohydrate antigen 125 (CA125) from patients serum. The presence of Tregs and Th17 was determined both in the peripheral blood and in the tissue of epithelial ovarian tumors. Mononuclear cells obtained from patient's peripheral blood (PBMCs) and from ovarian tissue were isolated by density gradient centrifugation. As a control group patients who had undergone surgery for infertility without ovarian pathology were selected. The percentage of Tregs and Th17 releasing IL-21 or IL-22 cells from both peripheral blood and tumor tissue was measured by flow cytometry. No differences in demographic parameters like body mass index, age, or gravidity were observed among the studied groups. However, an increased concentration of marker HE4 and value of ROMA was identified in individuals with ovarian cancer when compared with women with cystadenomas. Furthermore, a negative correlation between the ROMA value in the serum and Tregs from the peripheral blood of patients with cystadenoma ovarian tumors was detected. The presented work documents, for the first time, the negative association between peripheral blood Tregs and ROMA evaluation based on the tumour markers present in the serum of women with ovarian cystadenoma. Such an effect might result from the negative impact of Tregs on the inflammation process and on tumorigenesis caused by the persistent inflammation., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Objective: To assess the efficacy of vilaprisan compared with placebo in the management of the symptoms of uterine fibroids (UF), with a secondary objective to provide a descriptive comparison with ulipristal acetate., Study Design: The randomized, parallel-group, double-blind, placebo- and active-controlled, multicenter ASTEROID 2 trial assessed the efficacy and safety of vilaprisan versus placebo and ulipristal acetate for two 12-week treatment periods in women with ≥1 UF experiencing heavy menstrual bleeding (HMB). The primary endpoint compared the efficacy of vilaprisan with placebo at 12 weeks, assessed as the absence of bleeding/spotting by bleeding diary. Secondary endpoints compared the efficacy of vilaprisan with ulipristal acetate. Results of the first 12-week treatment period are reported here., Results: Women (mean age 42.5 years) were enrolled from 1 June 2015. At baseline, mean menstrual blood loss per 28 days was 214.1 mL and the volume of the three largest UF was 106.2 mL. In total, 155 women completed the initial 12-week treatment period. Complete absence of bleeding/spotting until the end of the 12-week treatment period was achieved by 62.9 % of women receiving vilaprisan versus 0.0 % with placebo (p < .001); 55.4 % of women treated with ulipristal acetate reported absence of bleeding/spotting. The predefined HMB response (<80 mL and >50 % reduction from baseline during the last 28 days of treatment) was observed in 95.7 % of subjects treated with vilaprisan and 86.5 % of subjects treated with ulipristal acetate. Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group. No safety concerns, including multiple laboratory parameters, were identified., Conclusion: Daily administration of vilaprisan 2 mg induced amenorrhea, controlled bleeding, decreased UF size, and was well tolerated in women with HMB associated with UF., Clinical Trial Registration: ClinicalTrials.gov number: NCT02465814 https://clinicaltrials.gov/ct2/show/NCT02465814., (Copyright © 2020. Published by Elsevier B.V.)

It has been widely underlined that both gynaecological malignancies and urogynaecological disorders are often associated with high stress and have a negative impact on the quality of life and psychological well-being of women affected. Knowledge of the pelvic anatomy is crucial in recommending and carrying out the least harmful although successful treatment. Subsequent chemoradiation may also induce or exaggerate troublesome symptoms. The aim of the study was to establish the frequency of urogynaecological symptoms (stress urinary incontinence, urgency, pelvic organ prolapse) and to assess the impact of surgical treatment and additional oncological therapy: pelvic radiation, chemoradiation, chemotherapy, on the prevalence of pelvic floor dysfunctions (PFD) and lower urinary tract symptoms (LUTS) in patients suffering from gynecological malignancies. The study group consisted of 160 women, diagnosed with gynaecological malignancy, who underwent surgical treatment and additional adjuvant treatment as necessary. To establish the QoL and prevalence of PFD Urinary Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire 7 (II-Q7), King's Health Questionnaire (KHQ) and the SF-36 Questionnaire were used. Herein, 69 patients reported urinary incontinence (UI) and 67 reported symptoms of pelvic organ prolapse (POP). After the six months follow-up UI was found in 78 patients, 25 patients showed de novo symptoms, 65 patients reported POP and 10 patients demonstrated de novo POP. Our data show that urogynaecological symptoms are not correlated with the type of malignancy, but with the extensiveness of surgery., Competing Interests: The authors declare no conflict of interest.

Introduction and Hypothesis: Pelvic organ prolapse (POP) treatment has become more common in the world's health care systems, and the demand for pelvic floor disorder rehabilitation has been projected to increase by 35% between 2010 and 2030. Restitution procedures vary, but after the US Food and Drug Administration (FDA) notifications, the global use of mesh in vaginal surgeries has significantly decreased. The aim of this study is to show trends in urogynecological surgeries in Poland., Methods: Retrospective analysis was performed of data obtained between 2009 and 2017 from the National Health Fund Information Centre website. Vaginal hysterectomies (VH), POP and urinary incontinence (UI) surgeries were considered., Results: In the study, 327,294 hospitalizations between 2009 and 2017 were considered: 29,821 VH, 265,147 POP and 53,328 UI procedures. Between 2009 and 2015, a rapid increase in the number of POP procedures was observed (r 2  = 0.94, b = 1711, p < 0.001). The following years, however, were characterized by a marked decline in the number of POP surgeries. In addition, the number of vaginal suspensions with mesh dropped by 24.7%, posterior and anterior repair by 8.5%, and posterior repair by 7.5%, but the number of anterior repair procedures increased slightly by 1.5%. Moreover, between 2015 and 2017, the number of vaginal hysterectomies decreased by 9%. The number of UI surgeries had increased between 2011 and 2015 and then remained at a relatively stable level. A similar trend was observed for tape procedures, whereas the popularity of colposuspension has declined noticeably., Conclusions: The impact of FDA notifications has been observed in Poland as a decrease in TVM surgeries.

In view of the fact that GPR55 receptors are localized in brain areas implicated in the pathophysiology of depression, GPR55 gene expression is reduced in the dorsolateral prefrontal cortex of suicide victims, and GPR55 receptor agonism exerts an anxiolytic-like effect, GPR55 receptors have drawn our attention as a potential target in the treatment of mood disorders. Therefore, in the present study, we wanted to check whether a 7-day intravenous administration of O-1602 (0.25 mg/kg/day) - a phytocannabinoid-like analogue of cannabidiol that belongs to the agonists of GPR55 receptors, was able to reverse the corticosterone-induced depressive-like behavior accompanied by detrusor overactivity in female Wistar rats. Additionally, we tried to determine the influence of GPR55 stimulation on the bladder, hippocampal and urine levels of several biomarkers that play a role in the functioning of the urinary bladder and/or the pathophysiology of depression. Our experiments showed that O-1602 therapy improved signs of depression (measured by the forced swim test) and detrusor contractility (measured by conscious cystometry) in animals exposed to the corticosterone treatment. Moreover, the treatment reduced the oxidative damage in the urinary bladder and neuroinflammation (observed as the reduction of elevated levels of 3-NIT, MAL, and IL-1β, TNF-α, CRF, respectively). The O-1602 treatment also reversed the abnormal changes in the bladder, hippocampal or urine values of CGRP, OCT3, VAChT, BDNF, and NGF. The above-mentioned findings allow to suggest that in the future the modulation of atypical cannabinoid receptors GPR55 could have a potential role in the treatment of depression and overactive bladder., (Copyright © 2020 Wróbel, Serefko, Szopa, Ulrich, Poleszak and Rechberger.)

Pelvic organ prolapse (POP) and the associated functional disorders are a major epidemiological problem that compromises the quality of life (QoL). The aim of this study was to assess the impact of lower urinary tract symptoms (LUTS) related to POP and vaginal native tissue repair (VNTR) on QoL. Two hundred patients with symptomatic POP were stratified into four groups according to the dominant storage phase function disorders: Urgency; stress urinary incontinence (SUI); mixed urinary incontinence (MUI), and without clinically significant symptoms from lower urinary tract (LUT). They underwent VNTR from January 2018 to February 2019. After 12 months, the QoL was assessed by the Prolapse Quality of Life (P-QoL) and visual analogue scale (VAS) questionnaires. The data were analyzed with Statistica package version 12.0 (StatSoft, Krakow, Poland), using the Kalmogorow-Smirnoff, Shapiro-Wilk W and the one-way analysis of variance with post hoc Tukey tests. The results of P-QoL showed significant improvement ( p < 0.05) in all the study groups in most domains assessed before surgery and 12 months after surgery. Significant improvements in all the symptoms assessed by the VAS scale results were found in groups Urgency and MUI. The LUTS questionnaire revealed significant improvement in all voiding and post voiding symptoms in these groups. VNTR effectively eliminated LUTS and significantly improved the patients' QoL associated with POP.

Overactive bladder (OAB) is defined by International Urogynecological Association (IUGA)/ International Continence Society (ICS) as urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection (UTI) or other obvious pathology. The pathophysiology of OAB is not well understood, however a number of different proteins and cytokines including vascular cell adhesion molecule-1 (VCAM-1) were found to be important in regulating structural integrity of the bladder wall. Proteome analysis may thus provide significant information with regard to OAB and may help in discovering novel diagnostic disease biomarkers. Sixteen Caucasian women aged 32-78 were included in the study. Patients were placed within 2 groups: OAB group ( n = 8) and control group ( n = 8). Urine samples were collected, immediately preserved in a protease inhibitor mixture, and frozen at -80 ℃. All samples were then further processed according to the isobaric tags for relative and absolute quantification (iTRAQ) manual. Proteins were labeled and analyzed in the mass spectrometer conjugated with liquid chromatograph (data are available via ProteomeXchange with the identifier PXD017799). There were no statistically significant differences in demographic data between control and OAB groups. VCAM-1 was the only protein that reached statistical significance as a differentiating protein in both of our experiments assessing the proteomic constitution in OAB patients. Studies involving a larger group of patients may provide further information on urinary bladder proteomics.

The aim of this study was to assess the effectiveness of vaginal native tissue repair (VNTR) on preexisting Lower Urinary Tract Symptoms (LUTS) in women with symptomatic pelvic organ prolapse (POP). Two hundred patients who underwent VNTR for symptomatic POP from January 2018 to February 2019 were followed up for 6 months. All patients underwent VNTR, but in the posterior compartment, the rectovaginal fascia was reconnected to the uterosacral ligaments and additionally sutured to the iliococcygeus fascia and muscle. To assess the severity and change in storage phase LUTS before and after surgery, all participants were asked to complete 3 questionnaires: the International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF), Urogenital Distress Inventory-6 (UDI-6), and Incontinence Impact Questionnaire-7 (IIQ-7). The data were assessed with Statistica package version 12.0, using Kalmogorow-Smirnoff, W Shapiro-Wilk tests. Furthermore, one-way analysis of variance was applied with post-hoc Tukey test. The study results indicate that the majority of patients with advanced POP suffered from various LUTS. Among storage symptoms, the occurrence of urinary incontinence (UI) and urgency decreased significantly after surgery. Moreover, ICIQ-SF, UDI-6, and IIQ-7 results showed statistically significant improvement in the impact of UI on the quality of life (QoL) in the vast majority of patients after surgery. VNTR is an effective way to treat not only anatomical, but also functional problems in such patients., Competing Interests: The authors declare no conflict of interest.

The publication presents recommendations on the performance of surgical procedures in gynecology during the COVID- 19 pandemic. The recommendations were prepared by the Polish Society of Gynecologists and Obstetricians, based on current knowledge of SARS CoV-2. These recommendations contain the latest guidelines of scientific societies related to the subject of operational procedures.

Objectives: Urinary incontinence (UI) can affect up to 50% of the population of women over the age of 50. In order to objectively assess discomfort in women with UI prior to initiating treatment and monitoring the outcomes of the treatment, validated questionnaires need to be used to examine the impact of UI on health-related quality of life (HR-QoL). The Urogenital Distress Inventory - Short Form (UDI-6) and the Medical Epidemiologic and Social Aspects of Ageing (MESA) questionnaires are used typically. Assessment of the Polish translation of the MESA and UDI-6 questionnaires., Material and Methods: 155 patients with symptoms of UI were enrolled. Each of the patients completed the MESA and UDI questionnaires prior to being examined. The final diagnosis was made after diagnostic tests were carried out in the patients., Results: Principle component analysis showed division of the Polish versions of the questionnaires into domains identical to the original version. Analyses of internal consistency reliability revealed high internal consistency for the MESA questionnaire (0.90) and a low reliability of the UDI-6 questionnaire (0.44)., Conclusions: The Polish version of the MESA questionnaire was demonstrated to be a clinically useful diagnostic tool in the studied population, UDI-6 did not reached a sufficiently high reliability in the study group to be recommended as a diagnostic tool.

：Vesicovaginal fistula (VVF) is the nonphysiological communication between the bladder and vagina, and surgical closure is the gold treatment standard. Despite that successful closure occurs in around 85% of patients after the first repair, recurrence remains a highly distressing complication for patients and surgeons. The aim of our study was to evaluate the efficacy of a platelet-rich plasma (PRP) injection as a supportive treatment in the surgical repair of recurrent VVF. Between January 2018 and July 2019, 16 patients with recurrent VVF were injected with PRP in a tertiary gynecological department. Subsequently, a surgical Latzko procedure for VVF closure was scheduled 6-8 weeks after the PRP injection allowing proper neovascularization and remodeling of surrounding tissues. Patients were considered cured if no leakage was observed after surgery and negative dye test results were indicated at follow-up. All patients who were examined therein remained dry. To the best of our knowledge, this is the first study aiming to assess PRP injections as a supporting treatment prior to surgical procedure for recurrent VVF. Preliminary results are encouraging, and we incorporated this method in our clinical practice. Further reports on a larger group will follow., Competing Interests: The authors declare no conflicts of interest.

Introduction and Hypothesis: Overactive bladder (OAB) and mixed urinary incontinence (MUI) are significant problems worldwide. Their broad definition makes them difficult to diagnose; therefore, specialists need a tool to confirm diagnosis. The Overactive Bladder Symptom Score (OABSS) is used in the objective diagnosis of OAB. We aimed to develop and evaluate the effectiveness of OABSS for patients in Poland suffering from OAB and MUI and to correlate it with UDI-6 and IIQ-7., Methods: A total of 824 women suffering from urinary incontinence (UI) aged between 18 and 75 years were included. SUI (n = 290); OAB (n = 285) and MUI (n = 249) were confirmed by medical history and urodynamic study. Of the subjects, 821 women completed the Polish version of OABSS on two separate visits: weeks 0 and 2. In addition, they undertook UDI-6 and IIQ-7 during Week 2. The Cronbach's alpha (α) was used to estimate the internal consistency. Scores were compared using the intraclass correlation coefficient (ICC)., Results: We observed statistically significant differences (p < 0.0005) between mean scores of OABSS among patients from the study groups OAB-SUI and MUI-SUI. We did not observe statistically significant differences between patients from the MUI and OAB groups (p > 0.11). Analysis also did not show statistically significant differences between visits. The internal consistency was very good: α = 0.89 (SUI); = 0.9 (OAB); = 0.82 (MUI). In all groups, test-retest reliability was excellent; ICC was >0.99., Conclusions: The Polish version of the OABSS is a reliable tool for females suffering from UI. However, OABSS does not distinguish patients with MUI from patients with OAB.

Purpose: Urinary tract infections (UTIs) are one of the more common infections encountered in everyday clinical practice. They account for 10-20% of all infections treated in primary care units and 30-40% of those treated in hospitals. The risk of UTI in the female population is considered to be 14 times higher than in the male population. The prevalence of bacterial etiology results in a large consumption of broad-spectrum antibiotics, which in turn leads to increased rates of resistant uropathogens. Therefore, non-antibiotic prevention and treatment options are now of great importance., Methods: A systematic literature search was performed for the last 20 years (1999-2019) and the efficiencies of these eight different non-antibiotic interventions were analysed and discussed., Results: This article provides an overview on non-antibiotic options for management of UTI, including the application of cranberry products, the phytodrug Canephron N, probiotics, nonsteroidal anti-inflammatory drugs (NSAID), D-mannose, estrogens, vitamins, and immunotherapy., Conclusions: The last 20 years of research on non-antibiotic approaches in UTI have not brought conclusive evidence that antibiotic usage can be replaced completely by non-antibiotic options. Hence, antibiotics still remain a gold standard for UTI treatment and prevention. However, changing the therapeutic strategy by including non-antibiotic measures in the management of UTI could be successful in avoiding antimicrobial resistance at least to some extent.

Background: An intravenous (IV) formulation of meloxicam was developed for moderate-to-severe pain management. This study evaluated the safety and efficacy of meloxicam IV after open abdominal hysterectomy. Meloxicam IV is an investigational product not yet approved by the US Food and Drug Administration., Methods: Women (N = 486) with moderate-to-severe pain after open abdominal hysterectomy were enrolled in this multicenter, randomized, double-blind, placebo- and active-controlled trial. Subjects were randomized to receive a single dose of meloxicam IV (5-60 mg), placebo, or morphine (0.15 mg/kg) in ≤6 hours after morphine dosing on postoperative day 1 and were evaluated for 24 hours. Rescue morphine (≈0.15 mg/kg IV) was available if needed for pain not relieved by the study medication. In an open-label extension (N = 295), meloxicam IV was administered once daily for the remaining hospital stay (or per the investigator's discretion). The coprimary efficacy end points were the summed pain intensity difference (SPID24) and total pain relief (TOTPAR24) from hour 0 to 24 hours after dosing. Effect size, the standardized difference between means reported in standard deviation (SD) units, was calculated to indicate the magnitude of the difference in the mean analgesic effect measured for different intervention groups., Results: Subjects who received morphine or meloxicam IV had a median time to first perceptible pain relief within 6-8 minutes. Morphine and meloxicam IV 5-60 mg produced statistically significant differences than placebo in SPID24 and TOTPAR24. SPID24 (standard error [SE]) for meloxicam IV 5-60 mg ranged from -56276.8 (3926.46) to -33517.1 (3930.1; P < .001); SPID24 (SE) for morphine and placebo were -29615.8 (3869.2; P < .001) and 4555.9 (3807.1), respectively. SPID24 effect sizes (95% confidence intervals) for the 60, 30, 15, 7.5, and 5 mg meloxicam IV doses and morphine were 1.93 (1.61-2.25), 2.00 (1.65-2.35), 1.70 (1.35-2.05), 1.28 (0.95-1.60), 1.25 (0.90-1.61), and 1.12 (0.77-1.45) SDs, respectively. TOTPAR24 (SE) for meloxicam IV 5-60 mg ranged from 3104.5 (155.28) to 4130.4 (191.17; P < .001); TOTPAR24 (SE) for morphine and placebo were 2723.3 (188.4; P < .001) and 1100.6 (185.4), respectively. TOTPAR24 effect sizes (95% confidence interval) for the 60, 30, 15, 7.5, and 5 mg meloxicam IV doses and morphine were 2.03 (1.70-2.35), 2.05 (1.70-2.40), 1.78 (1.43-2.13), 1.35 (1.03-1.67), 1.37 (1.01-1.72), and 1.10 (0.75-1.45) SDs, respectively. The mean total opioid consumed (SD) during the double-blind phase was 4.6 (8.17), 5.3 (8.85), 5.9 (7.85), 8.5 (9.67), 9.3 (9.47), 9.6 (8.12), and 16.0 (10.15) mg for patients in the 60, 30, 15, 7.5, and 5 mg meloxicam IV, morphine, and placebo groups, respectively. Generally, meloxicam IV was well tolerated, evidenced by the incidence of adverse events compared to placebo and lack of deaths and treatment-related serious adverse events., Conclusions: A meloxicam IV dose of 5-60 mg was generally well tolerated and appeared to reduce opioid consumption in subjects with moderate-to-severe pain after open abdominal hysterectomy. Once-daily administration of meloxicam IV produced analgesic effect within 6-8 minutes postdose that was maintained over a 24-hour dosing interval.

Aim: Lower urinary tract symptoms (LUTS) frequently affect patients immediately after midurethral sling (MUS) placement. The objective of the study was to assess if solifenacin or mirabegron decreases incidence of LUTS in women who underwent transobturator MUS., Methods: A prospective randomized trial was conducted on patients undergoing ambulatory transobturator midurethral sling due to stress urinary incontinence (SUI). All participants were questioned before and after surgery for occurrence of bothersome LUTS. A total of 328 patients who underwent transobturator MUS were randomly assigned to one of three groups: prophylaxis with 10 mg of solifenacin, prophylaxis with 50 mg of mirabegron, or without any additional treatment. LUTS evolution and efficacy of solifenacin and mirabegron were analyzed based on results of assessments made during follow-up visits at 1 and 6 weeks after surgery. Comparison of the prevalence of LUTS was done using chi 2 test., Results: Prevalence of urgency and frequency episodes increased notably 1 week after sling placement and then came down to baseline levels. Solifenacin and mirabegron significantly reduced the incidence of urgency after 1 week, but after 6 weeks the beneficial effect was observed only in case of solifenacin. Treatment with mirabegron reduced the percentage of patients suffering from frequency after 6 weeks. Although prevalence of nocturia did not raise after sling placement, both treatments significantly reduced the incidence of this complaint after 6 weeks. Pharmacological treatment did not modulate the course of hesitancy and terminal dribbling., Conclusions: Treatment with solifenacin or mirabegron may significantly reduce the incidence of undesired LUTS after MUS.

Urinary incontinence, fecal incontinence and pelvic organ prolapse are one of the most prevalent gynaecological conditions and constitute a huge global problem affecting approximately 20% of women, increasing with age. Pelvic floor disorders can have negative influence on women's quality of life, decreasing social, psychological, occupational, physical and sexual well-being. Pelvic organ prolapse results in anatomical changes to the urogenital tract and it is perceived to be one of the main factor influencing sexual function. Because treatment of pelvic organ prolapse and complications related to it may cause discomfort, the most important outcome of the therapy, including anatomical restoration, is relief in symptoms and improvement in quality of life. Psychometrical instruments for measuring health-related quality of life are essential during evaluation of women with pelvic floor disorders. Assessing severity of pelvic organ prolapse, its' impact on quality of life, therapy planning and the inclusion of sexuality questionnaires as an outcome measure in urogynecological patients allows to analyze impact of surgical treatment on women's sexual life. For this purpose, condition - specific instruments were developed and published. The aim of this study is to present particular questionnaires and their proper practical application in clinical practice, especially before surgical treatment and follow-up. Furthermore, those questionnaires are essential in order to describe patients' expectations during tailored clinical management., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Hypothesis/aims of Study: Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome is the second most common cause of primary amenorrhea. The ESHRE/ESGE categorizes this disorder within the class 5 uterine malformation of the female genital tract anomalies. It is characterized by congenital absence of the uterus, cervix, and upper part of the vagina in otherwise phenotypically normal 46XX females. These patients have normal ovaries, biphasic ovarian cycle, and female psychosexual identification. Laparoscopic Vecchietti's operation-surgical method in which the vagina increases in size by gradually applying traction to the vaginal vault-is one of the methods used to treat MRKH. The aim of this study was to establish the urogynecological and sexual functions after Vecchietti's operation., Study Design Materials and Methods: Fifteen patients with MRKHS who underwent laparoscopic Vecchietti's operation were included. A control group of 15 age-matched, childless, sexually active women were examined during the same period. All patients underwent the basic evaluation of anatomical outcomes. Sexual outcomes were established by the Polish validated Female Sexual Function Index (FSFI) questionnaire. Continence status was assessed by Polish validated Urinary Distress Inventory (UDI-6) and the Incontinence Impact Questionnaire (IIQ-7)., Results: Mean age of MRKH group was 22.06±5.13 yrs. Mean follow-up after surgery was 8.02±3.43 yrs. Mean age of women from control group was 22.4±4.35. Mean FSFI scores show good quality of sexual life in both groups. UDI-6 scores showed that patients after Vecchietti surgery have urogynecological problems significantly more often than healthy women do. Based on the IIQ-7, it is evident that one patient from the MRKH group (6,6%) suffers from stress urinary incontinence and the rest (20%) have rather irritative problems with the functioning of the lower urinary tract., Conclusion: Quality of sexual life after the Vecchietti's operation in long-term follow-up does not differ from that of healthy women, but these patients suffer more frequent from urogynecological complaints. The trial is registered with NCT03809819.

Aims: SYNERGY II was a 12-month phase III trial in patients with overactive bladder (OAB) symptoms that investigated the safety and efficacy of the combination of mirabegron and solifenacin in comparison with each monotherapy. This analysis evaluated the trial findings using four age subgroups (<65, ≥65, <75, and ≥75 years)., Methods: Eligible patients were ≥18 years with symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for ≥3 months. Patients were randomized to receive once-daily solifenacin succinate and mirabegron (5 mg/50 mg; combination), solifenacin succinate, or mirabegron (4:1:1). Safety evaluations: treatment-emergent adverse events (TEAEs), vital signs, and electrocardiogram, post-void residual volume, and laboratory assessments. Primary efficacy variables: change from baseline to end of treatment in number of incontinence episodes/24 h and micturitions/24 h., Results: Of 1794 patients (full analysis set), 614 (34.2%) and 168 (9.4%) were ≥65 and ≥75 years old, respectively. Overall, 856 (47.2%) patients experienced ≥1 TEAE. Higher TEAE incidences were typically observed for the combination versus both monotherapies (eg, constipation) and in the older versus younger age groups (eg, urinary tract infection). Increases in mean pulse rate from baseline of >1 bpm were noted in the combination and mirabegron younger age groups only. No clinically significant findings were observed in the other safety parameters. The efficacy variables improved with all treatments and the greatest improvements were typically observed with combination therapy., Conclusions: Mirabegron and solifenacin combination therapy was a well-tolerated and effective treatment for patients with OAB symptoms irrespective of their age., (© 2019 The Authors. Neurourology and Urodynamics Published by Wiley Periodicals, Inc.)

Chronic graft-versus-host disease is the most common late complication following allogeneic hematopoietic stem cell transplantation. The aim of this study was to present the outcomes of two successful vaginal reconstructions. Patient 1 received chemotherapy for leukemia and underwent bone marrow transplantation (BMT). The patient was sexually inactive for 9 years. In 2012, she was diagnosed with complete vaginal obliteration and underwent vaginal reconstruction. Patient 2 underwent chemotherapy (myeloablative therapy), was sexually inactive for 3 years and was then diagnosed with complete vaginal obliteration. In January 2013, she had vaginal reconstruction with cervical dilatation. Hormonal replacement therapy was administered to both patients. The results of dedicated questionnaires revealed decent quality-of-life and normal sexual functioning and continence status after surgery. Obliteration of the vagina after BMT can be prevented, but if it occurs, vaginal reconstruction surgery should be offered to any patients suffering from obliteration. Our results show that this therapy enables patients to have normal sexual lives without compromising their continence status.

Overactive bladder (OAB) coexists with depression in women. Here, we assessed the effects of a 1-week treatment with blebbistatin, a myosin II inhibitor, on changes in behavior and detrusor overactivity (DO) symptoms induced by a 6-week administration of 13-cis-retinoic acid (13-cis-RA), with the aid of the forced swim test (FST), spontaneous locomotor activity test, and in vivo cystometric investigations in female Wistar rats. 13-cis-RA-induced depressive-like behavior and DO symptoms were associated with increased corticotropin-releasing factor (CRF) level in the plasma, prefrontal cortex (PFC), hippocampus (Hp), Barrington's nucleus (BN), and urinary bladder. Moreover, 13-cis-RA decreased brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF) levels in plasma, PFC, Hp, and BN, while it increased BDNF and NGF levels in urinary bladder. Blebbistatin exerted antidepressant-like effect and attenuated changes in the cystometric parameters as well as the central and peripheral levels of CRF, BDNF, and NGF that were induced by 13-cis-RA, while it did not affect urine production, mean, systolic or diastolic blood pressure, or heart rate. The results point to blebbistatin as a potential treatment option for OAB coexisting with depression.

Objectives: The paper is a ten case series study presenting women with complex pelvic floor disorders involving fecal incontinence (FI) with stress urinary incontinence or pelvic organ prolapse. Our study aimed at ascertaining whether FI-induced sphincteroplasty with an additional secure circular suture around the external anal sphincter muscle (EAS) may improve long term success rates., Materials and Methods: Twelve patients had scheduled urogynecological surgery and overlapping sphincteroplasty with the placement of an additional circular suture around the EAS. Of these, the status of ten women was established by way of the Cleveland Clinic Fecal Incontinence Score/Wexner Score before and about 70 months after surgery., Results: Statistical analysis of fecal incontinence score showed that patients were not completely cured from FI, but were significantly better (p = 0.011)., Conclusions: A circular secure suture around the external anal sphincter in FI patients may help to improve anal sphincter function.

Aim: The aim of this observational study was to evaluate the effectiveness of a phytotherapic drug (Canephron N) in preventing urinary tract infection (UTI) in high-risk women undergoing urodynamic studies (UDS)., Methods: The study protocol was approved by the local institutional ethical committee. Adult women with at least one risk factor for acquiring UTI (defined as: age over 70, elevated postvoid residual urine>100 ml, recurrent UTI, pelvic organ prolapse (POP) ≥II in POP-Q scale, and neurogenic bladder) had received after UDS either a single oral dose of fosfomycin trometamol (FT) (3 grams) or a phytodrug containing centaury herb, lovage root, and rosemary leaves (5 ml taken orally three times daily for one week). All patients included in the study had no pyuria according to urine dipstick (nitrite and/or blood and/or leukocyte esterase) and negative urine culture (CFU < 10 3 /ml) before UDS. Urine samples were also tested 7 days after UDS., Results: Seventy-two high-risk participants completed the study. Seven days after urodynamic studies UTI symptoms, pyuria (nitrite and/or blood and/or leukocyte esterase) and bacteriuria with E. coli occurred in two patients (one (2.8%) in the FT and one (2.7%) in the phytodrug group, respectively). No statistical differences in UTI incidence were found between both treatment groups. We did not observe any additional adverse events in both groups. The major disadvantage of prophylaxis with the phytodrug as compared to FT was the necessity of continuing therapy for 7 days., Conclusion: Prophylaxis of UTI with a phytodrug (Canephron N) may be considered a good alternative to antibiotic prophylaxis use after UDS in high-risk female patients.

Literature data give clear evidence that upregulated RhoA/Rho-kinase signalling is one of the factors that may lead to the development of detrusor overactivity and various disorders of the central nervous system. Therefore, the main objective of our study was to investigate whether administration of a Rho-kinase inhibitor - GSK 269962 could reverse corticosterone-induced depressive-like behaviour and changes in cystometric parameters associated with detrusor overactivity, as well as undo the alterations of several biomarkers related to both disorders (i.e., pro-inflammatory/anti-inflammatory cytokines and neurotrophins) in serum, urinary bladder, and different brain structures. The experiments were carried out on female Wistar rats. Surgical procedures, cystometric investigations, biochemical analyses, and behavioural studies (measurement of the locomotor activity and the forced swim test) were performed according to the published literature. As expected, administration of corticosterone at a daily dose of 20 mg/kg for 14 days increased the immobility time of animals in the forced swim test, induced changes in the cystometric parameters specific to bladder overactivity, reduced levels of neurotrophins, and elevated concentrations of the pro-inflammatory cytokines. Inhibition of Rho-kinase by 7-day treatment with GSK 269962 (10 mg/kg/day) reversed the symptoms of both detrusor overactivity and depression as well as normalized levels of the tested biomarkes. Our findings encourage the idea of Rho-kinase inhibitors as a potential future treatment option for overactive bladder accompanied by depression., (Copyright © 2018. Published by Elsevier B.V.)

Background: The long-term potential of solifenacin and mirabegron combination treatment for patients with overactive bladder (OAB) has not been previously assessed., Objectives: To evaluate the safety and efficacy of solifenacin succinate 5mg plus mirabegron 50mg tablets (combination treatment) versus solifenacin or mirabegron monotherapy in patients with OAB over 12 mo., Design, Setting, and Participants: Randomised, double-blind, multicentre, phase 3 trial (SYNERGY II) of patients with "wet" OAB symptoms (urinary frequency and urgency with incontinence) for ≥3 mo. The study was conducted from March 2014 to September 2016; with 1829 patients randomised. The full analysis set was comprised of 1794 patients., Outcome Measurements and Statistical Analysis: The primary objective was safety, measured as treatment-emergent adverse events (TEAEs). Efficacy was measured as the change from baseline to the end of treatment in the mean number of incontinence episodes/24h and micturitions/24h., Results and Limitations: The median age was 60 yr (range 19-86 yr) and 1434 patients (80%) were female. Overall, 856 patients (47%) experienced ≥1 TEAE. TEAE frequency was slightly higher in the combination group (596 patients, 49%; mirabegron 126 patients, 41%; solifenacin 134 patients, 44%). Serious TEAEs were reported by 67 patients (3.7%); one was considered possibly treatment-related (mirabegron group, atrial fibrillation). Dry mouth was the most common TEAE (combination 74 patients, 6.1%; solifenacin 18 patients, 5.9%; mirabegron 12 patients, 3.9%). Combination therapy was statistically superior to mirabegron and solifenacin for the number of incontinence episodes (vs mirabegron: adjusted mean difference [AMD] -0.5, 95% confidence interval [CI] -0.7 to -0.2, p<0.001; vs solifenacin: AMD -0.1, 95% CI -0.4 to 0.1, p=0.002) and micturitions (vs mirabegron: AMD -0.5, 95% CI -0.8 to -0.2, p<0.001; vs solifenacin: AMD -0.4, 95% CI -0.7 to -0.1, p=0.004)., Conclusions: Mirabegron and solifenacin combination treatment for OAB symptoms was well tolerated over 12 mo and led to efficacy improvements over each monotherapy. This innovative combination is a treatment option that could become widely used in the clinic., Patient Summary: This study looked at the safety and efficacy of a combination of solifenacin succinate 5mg plus mirabegron 50mg tablets over 12 mo in patients with the overactive bladder (OAB) symptoms of increased urination frequency, heightened urgency to urinate, and unintentional passing of urine. We compared this treatment with solifenacin succinate 5mg or mirabegron 50mg alone, and found that the combination treatment was well tolerated by patients and led to greater improvements in symptoms. This novel combination could be an improved treatment option in the clinical setting for patients with OAB. This study is registered at ClinicalTrials.gov as NCT02045862., (Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.)

The prevalence of overactive bladder (OAB) increases with age and can be associated with other co-morbidities, such as cardiac arrhythmia. Unfortunately, commonly used anticholinergic drugs for OAB can affect the cardiovascular system, leading to tachycardia. However, there are no data, which consider the influence of intradetrusor onabotulinumtoxinA injections on heart function in idiopathic OAB patients. The aim of the present study was to evaluate the influence of intradetrusor onabotulinumtoxinA injections on electrocardiogram (ECG) parameters. Additionally, changes in ECG were analyzed in OAB patients without cardiac arrhythmia. Thirty-one patients with cardiac arrhythmia and 31 participants without irregular heart rate (HR) completed the study. ECG measurements were performed in supine positions 2 h before onabotulinumtoxinA injections, 1 h after treatment, and at 2 weeks of follow-up. At week 6, a phone-call survey was conducted to collect data about adverse events. OnabotulinumtoxinA injections were performed with rigid cystoscopy under local anesthesia. We did not observe any clinically significant changes in the analyzed ECG parameters between consecutive measurements. While a slight increase of HR was observed in patients without cardiac arrhythmia, it remained within normal range. Intravesical onabotulinumtoxinA injections are, hence, safe for female patients with cardiac arrhythmia and do not significantly influence changes in ECG.

Paraoxonase 1 plays an important role in protection from oxidative stress and also decomposes homocysteine thiolactone, the toxic metabolite of homocysteine. A limited number of reports evaluated the role of paraoxonase 1 in women affected by female genital tract neoplasms, including endometrial cancer. This study aimed to analyze the paraoxonase activity in the group of endometrial cancer patients (n = 48) who underwent primary surgery and to compare the data available with a well-matched control group (n = 30). Due to the role of paraoxonase 1 in the metabolism of homocysteine (Hcy) thiolactone, the amount of Hcy-thiolactone as well as total serum Hcy concentrations was also measured. Serum paraoxonase 1 activity toward synthetic substrates, paraoxon and phenyl acetate, in the study group was significantly lower compared to the control one. The mean paraoxonase 1 activity toward homocysteine thiolactone tended to be lower in the endometrial cancer group but this difference was not significant. There was no relationship between endometrial cancer and Q192R polymorphism of PON1 assessed by the dual substrate method. No differences in paraoxonase 1 activity between endometrial cancer subgroups according to clinico-pathological features were detected. Total serum homocysteine and protein-bound homocysteine thiolactone did not differ between control and cancer groups. In conclusion, reduced paraoxonase 1 activity suggests diminished important antioxidant mechanisms during the development of primary endometrial cancers in humans. PON1 Q192R polymorphism is not associated with the risk of endometrial cancer. Despite lower paraoxonase 1 activity, homocysteine concentration, and protein N-homocysteinylation in endometrial cancers do not differ from matched controls.

Objective: To evaluate the efficacy and safety of elagolix, an oral, nonpeptide gonadotropin-releasing hormone antagonist, over 12 months in women with endometriosis-associated pain., Methods: Elaris Endometriosis (EM)-III and -IV were extension studies that evaluated an additional 6 months of treatment after two 6-month, double-blind, placebo-controlled phase 3 trials (12 continuous treatment months) with two elagolix doses (150 mg once daily and 200 mg twice daily). Coprimary efficacy endpoints were the proportion of responders (clinically meaningful pain reduction and stable or decreased rescue analgesic use) based on average monthly dysmenorrhea and nonmenstrual pelvic pain scores. Safety assessments included adverse events, clinical laboratory tests, and endometrial and bone mineral density assessments. The power of Elaris EM-III and -IV was based on the comparison to placebo in Elaris EM-I and -II with an expected 25% dropout rate., Results: Between December 28, 2012, and October 31, 2014 (Elaris EM-III), and between May 27, 2014, and January 6, 2016 (Elaris EM-IV), 569 participants were enrolled. After 12 months of treatment, Elaris EM-III responder rates for dysmenorrhea were 52.1% at 150 mg once daily (Elaris EM-IV 550.8%) and 78.2% at 200 mg twice daily (Elaris EMIV 575.9%). Elaris EM-III nonmenstrual pelvic pain responder rates were 67.5% at 150 mg once daily (Elaris EM-IV 566.4%) and 69.1% at 200 mg twice daily (Elaris EM-IV 567.2%).”After 12 months of treatment, Elaris EM-III dyspareunia responder rates were 45.2% at 150 mg once daily (Elaris EM-IV=45.9%) and 60.0% at 200 mg twice daily (Elaris EM-IV=58.1%). Hot flush was the most common adverse event. Decreases from baseline in bone mineral density and increases from baseline in lipids were observed after 12 months of treatment. There were no adverse endometrial findings., Conclusion: Long-term elagolix treatment provided sustained reductions in dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia. The safety was consistent with reduced estrogen levels and no new safety concerns were associated with long-term elagolix use., Clinical Trial Registration: ClinicalTrials.gov, NCT01760954 and NCT02143713.

Introduction and Hypothesis: The aim of this study was to assess the efficacy of duloxetine in an animal model of detrusor overactivity induced by depression., Methods: After 6 weeks of 13-cis-retinoic acid administration at a dose of 1 mg/kg/day, rats were given duloxetine at a dose of 1 mg/kg. This was followed by conscious cystometry, a forced swim test, and locomotor activity measurement. The levels of corticotropin-releasing factor (CRF) in the hypothalamus, amygdala and plasma were also determined., Results: Duloxetine treatment led to a reduction in detrusor overactivity symptoms induced by the retinoid. Decreases were observed in cystometric parameters including the detrusor overactivity index, and the amplitude and frequency of nonvoiding contractions, while increases were seen in bladder compliance and the volume threshold to elicit nonvoiding contractions. No statistically significant differences were found in basal pressure, threshold pressure, micturition voiding pressure, postvoid residual , volume threshold, voiding efficiency, intercontraction interval, bladder contraction duration or relaxation time. Duloxetine also reduced the immobility time to that observed in control animals, while it did not affect locomotor activity. Its effects also included lowering of the CRF levels in the hypothalamus, amygdala and plasma, which increased following the prior administration of the retinoid. The plasma level of 13-cis-retinoic acid in rats corresponded to the levels found in humans., Conclusions: This is the first study showing the efficacy of duloxetine in an animal model of detrusor overactivity induced by depression. Further studies in patients with detrusor overactivity and coexisting depression are warranted to confirm these experimental results.

The underlying cause of stress urinary incontinence (SUI) is an anatomical abnormality associated with paraurethral connective tissue dysfunction. The question as to whether estrogens affect the quality of that tissue remains unexplained. Samples of paraurethral connective tissue from 81 women were examined (the SUI's n = 49; the control's n = 32). In both groups, the patients were subdivided into pre- and postmenopausals. Primary study outcome was comparison of the estrogen receptor alpha (ERα) and the estrogen receptor beta (ERβ) gene and protein in paraurethral tissue between SUI and control group. Secondary study outcome was comparison of these receptors according to hormonal status of the patients and their age. In both examined groups, we found both ER proteins. The ERα gene expression was detected in-19/32 (SUI) samples and in 24/31 (control), and ERβ gene expression 31/32 and 30/31 samples, respectively. The SUI's had significantly lower ERa gene expression premenopausally than the control's. The analysis found considerably lower ERβ and reduced ERα gene expression in postmenopausals, approaches the significance level. There was also significant decrease in both receptors' genes expression in post-53 women, compared to younger patients. Spearman's correlation test revealed a statistically significant decrease in ERβ gene with age. Both estrogen receptors are found in women's paraurethral tissue, so this tissue is an estrogen target. No correlation between ERβ gene expression and immunoexpression and SUI was found. The ERα gene seems to play a key role in SUI in the premenopausal period, but ERβ gene expression in the paraurethral connective tissue decreases with age.

Introduction and Hypothesis: Midurethral sling (MUS) surgeries are minimally invasive procedures; however, they are not free of postoperative complications. The aim of the study was to assess the occurrence of lower urinary tract symptoms (LUTS) (urgency, nocturia, frequency, splitting/spraying, hesitancy, terminal dribbling, and subjective feeling of postvoid residual) in patients suffering from stress (SUI) or mixed (MUI) urinary incontinence with a predominant SUI component before and after transobturator MUS placement., Methods: The study group consisted of 88 women with SUI and 18 with MUI who underwent transobturator MUS. All participants were questioned with a self-developed questionnaire before and after surgery regarding the presence of LUTS., Results: Seven days after surgery, 62 patients (58.5%) noted voiding and postmicturition symptoms, whereas 67 (63.2%) reported problems in storage. The more commonly reported LUTS at week 1 after surgery were urgency (52.8%), splitting/spraying (41.5%), and feeling of incomplete bladder emptying (34.0%). Patients perceived that splitting/spraying was the most bothersome. After 6 months, the most common LUTS reported were hesitancy (14.1%), terminal dribbling (10.4%), and splitting/spraying (9.4%). We noticed a decrease in the number of urgency episodes >2.7 times (p < 0.001) compared with baseline. After 6 months, 97 (91.5%) patients reported the lack of incontinence episodes., Conclusions: A vast majority of patients after MUS suffer from LUTS in the early postoperative period; however, the majority of undesired symptoms resolve spontaneously within the first 6 months postsurgery.