Exploring the rationale of performing vaginal hysterectomy under local anaesthesia: A single-centre experience.

INTRODUCTION: Vaginal hysterectomy (VH) is usually performed under general (GA) or regional anaesthesia. In recent years, the possibility of performing vaginal hysterectomy under local anaesthesia (LA) has also been explored. Our aim was to compare intraoperative and early postoperative outcomes in women who underwent VH under LA with intravenous sedation or GA. METHODS: In this retrospective study, we collected data of patients who underwent VH at our department from June 2021 to December 2022. For every patient, the following data was obtained: hospitalisation duration, type of anaesthesia (LA or GA), accompanying procedures, the dosage of used local anaesthetic in the LA group, maximal pain score for each day of hospitalisation after the procedure, procedure duration, intraoperative blood loss, and postoperative complication rate. Data was analysed using the SPSS Statistics programme. Statistical significance was set at p < 0.05. RESULTS: Seventy patients were included in the study. The mean age was significantly higher in the LA group compared to GA group (73.8 ± 8.0 years vs. 67.1 ± 9.3 respectively, p-value = 0.003). LA was associated with statistically lower pain scores in the first two days after the procedure (p = 0.003), and shorter procedure duration (p-value <0.001) as well as hospitalisation duration (p < 0.001). Furthermore, the cumulative dosage of different analgesics used during hospitalisation was higher in the GA group. CONCLUSIONS: Our results show that LA is a feasible option for patients undergoing VH. Vaginal surgical procedures under LA could be especially beneficial for older patients with medical comorbidities in whom GA would be particularly hazardous.

Modulation of sHLA-G, PD-1, and PD-L1 Expression in Cervical Lesions Following Imiquimod Treatment and Its Association with Treatment Success.

(1) Background: Cervical intraepithelial neoplasia (CIN) is a precancerous condition linked to human papillomavirus (HPV) infection, often necessitating surgical interventions carrying the risk of subsequent preterm births. This study explores the potential of imiquimod (IMQ), as a non-invasive alternative treatment. The focus is on understanding IMQ impact on immune checkpoint molecules, particularly PD-1, PD-L1, and sHLA-G, which play pivotal roles in shaping immune responses and cancer progression. (2) Methods: Forty-three patients diagnosed with a high-risk squamous intraepithelial lesion (HSIL, p16-positive) self-applied 5% IMQ encapsulated in sachets containing 250 g of cream into the vaginal cavity three times a week for 16 weeks. The impact of IMQ therapy on cervical lesion regression was assessed through immunohistochemistry (IHC), examining changes in sHLA-G, PD-L1, and PD-1 levels. The antiviral activity of IMQ was evaluated through HPV-E7 immunofluorescence. Ethical considerations were adhered to, and the research methods were based on a previously approved clinical trial (clinicaltrials.gov Identifier: NCT04859361). (3) Results: IMQ treatment demonstrated efficacy, leading to lesion regression. sHLA-G levels in CIN before starting IMQ application were associated with unsuccessful treatment (p = 0.0036). IMQ did not significantly alter the expression of PD-1. We observed a decrease in PD-L1 levels in those who were successfully treated (p = 0.0509) and a reduction in HPV burden. (4) Conclusions: IMQ exhibits promise as a non-invasive treatment for CIN, emphasising its potential to modulate the immune microenvironment. Baseline sHLA-G levels emerge as potential predictors of treatment response. Understanding the nuanced dynamics of immune checkpoints sheds light on IMQ mechanism of action. Further exploration is warranted to decipher the intricate mechanisms underlying IMQ treatment in the context of cervical lesions.

The Impact of Extracorporeal Magnetic Stimulation as Addition to Mirabegron in Overactive Bladder Treatment in Women: A Single-Centre Randomized Sham-Controlled Study.

(1) Background: The purpose of our prospective, single-blinded, randomized, sham-controlled study was to investigate the effect of the additional extracorporeal magnetic stimulation (ExMI) to pharmacological treatment in overactive bladder syndrome (OAB) in women. (2) Methods: We recruited 56 women with OAB, who were allocated into two study groups: the active group received mirabegron 50 mg daily and a total of 16 sessions of ExMI in 8 weeks, whereas the sham group received mirabegron 50 mg daily and sham stimulation following the same treatment protocol. Treatment success was evaluated after 4 and 8 weeks. (3) Results: Both groups experienced significant reduction in daytime urinary frequency, nocturia, and number of weekly incontinence episodes after 8 weeks. There were no statistically significant differences in end-point daytime urinary frequency and nocturia between groups. However, the overall average reduction rate in weekly number of incontinence episodes was 43.7% in treatment group and 24.2% in the control group. The number of urinary incontinence episodes in the treatment and control group was reduced for 3.8 ± 11.8 vs. 2.5 ± 4.3 episodes at week 4 and additional 3.3 ± 6 vs. 0.4 ± 3.2 episodes at week 8, respectively (p = 0.013). Moreover, IIQ-7 score showed a significantly greater score reduction and patients' evaluated improvement of symptoms was higher in the active group. (4) Conclusions: The addition of ExMI to mirabegron in OAB treatment further improves the weekly incontinence episode reduction rate and also leads to grater improvement in symptoms.

Measurement of extraction forces of non-absorbable suture and different anchoring systems used for pelvic organ prolapse surgery using soft-embalmed cadavers: A feasibility study.

OBJECTIVE: Success of pelvic organ prolapse (POP) mesh procedures also depends on reliable anchoring systems (AS). Our primary aim was to assess the use of soft-embalmed cadavers in testing of different AS and our secondary aim was to compare extraction forces (EF) of different AS and non-absorbable suture (NAS). STUDY DESIGN: IRB approval was obtained. NAS (Ti-cron®) and different AS were attached to force-measuring instrument (Dynamometer SS25LA) and anchored to anterior longitudinal (ALL) and pectineal ligament (PL) (Protack®, Uplift®, NAS), and sacrospinous ligament (SSL) (Surelift®, Elevate PC®, NAS) of Thiel soft-embalmed cadavers. EF were measured 2-4 times in each cadaver. Data were compared using non-parametric tests. Statistical significance was set at p < 0.05. RESULTS: Three female cadavers (age 59, 77 and 87) were used. NAS EF were significantly higher than AS EF for ALL and SSL, but not PL. Thiel soft-embalmed cadavers proved to be useful in testing of different AS. CONCLUSIONS: Use of soft-embalmed cadavers in testing of different AS is feasible. According to our results, the NAS provides most reliable intra-corporeal fixation. However, significant inter- and intra-subject variability indicates that results may also be dependent on the tissue properties and anchoring procedure. Further testing using soft-embalmed cadavers could help optimise mesh procedures and establish a threshold EF necessary for reliable fixation.

Comparison of Conservative Treatment of Cervical Intraepithelial Lesions with Imiquimod with Standard Excisional Technique Using LLETZ: A Randomized Controlled Trial.

(1) Background: There are limited data on the success of conservative treatment of high-grade cervical squamous intraepithelial lesions (HSIL) with imiquimod directly compared to standard of treatment with LLETZ. (2) Methods: Patients aged 18-40 with histological HSIL (with high-grade cervical intraepithelial neoplasia, CIN2p16+ and CIN3), were randomly assigned to treatment with imiquimod or LLETZ. The primary outcome was defined as the absence of HSIL after either treatment modality. The secondary outcomes were the occurrence of side effects. (3) Results: 52 patients were allocated in each group and were similar regarding baseline characteristics. In the imiquimod group, 82.7% of patients completed treatment, which was successful in 51.9%. All patients in the LLETZ group completed treatment, which was successful in 92.3% (p < 0.001). In the subgroup of CIN2p16+ patients, treatment with imiquimod was not inferior to LLETZ (73.9% vs. 84.2%, p = 0.477). During and after treatment, no cases of progression to cancer were observed. Side effects and severe side effects (local and systemic) were more prevalent in the imiquimod than in the LLETZ group (88.5% vs. 44.2% (p-value < 0.001) and 51.9% vs. 13.5% (p-value < 0.001), respectively). (4) Conclusion: Generally, in patients with HSIL, LLETZ remains the gold standard of treatment. However, in a subgroup analysis of patients with CIN2p16+, the success rate was comparable between the two treatment modalities. Due to the prevalence of side effects, the treatment compliance with imiquimod use may, however, present a clinically important issue.

Dysregulation of Synaptic Signaling Genes Is Involved in Biology of Uterine Leiomyoma.

Uterine leiomyomas are tumors, which are hormone driven and originate from the smooth muscle layer of the uterine wall. In addition to known genes in leiomyoma pathogenesis, recent approaches also highlight epigenetic malfunctions as an important mechanism of gene dysregulation. RNA sequencing raw data from pair-matched normal myometrium and fibroid tumors from two independent studies were used as discovery and validation sets and reanalyzed. RNA extracted from normal myometrium and fibroid tumors from 58 Slovenian patients was used as independent confirmation of most significant differentially expressed genes. Subsequently, GWA data from leiomyoma patients were used in order to identify genetic variants at epigenetic marks. Gene Ontology analysis of the overlap of two independent RNA-seq analyses showed that NPTX1, NPTX2, CHRM2, DRD2 and CACNA1A were listed as significant for several enriched GO terms. All five genes were subsequently confirmed in the independent Slovenian cohort. Additional integration and functional analysis showed that genetic variants in these five gene regions are listed at a chromatin structure and state, predicting promoters, enhancers, DNase hypersensitivity and altered transcription factor binding sites. We identified a unique subgroup of dysregulated synaptic signaling genes involved in the biology and pathogenesis of leiomyomas, adding to the complexity of tumor biology.

Lower urinary tract symptoms in adolescent girls: a questionnaire-based study.

OBJECTIVE: To determine the prevalence of lower urinary tract symptoms (LUTS) in female adolescent population. STUDY DESIGN: We performed a questionnaire-based study in nine randomly selected high schools in our country. Our primary aim was to evaluate the prevalence of certain LUTS in adolescent girls: frequency, urgency, nocturia, feeling of incomplete bladder emptying, dysuria, and urinary incontinence. The secondary aim was to investigate the effect of some possible risk factors on LUTS prevalence. Statistical analysis was performed using SPSS Statistics Programme. Descriptive statistics were calculated. Non-parametric test was used for comparison of numerical and Pearson's Chi-square test for categorical data. Logistic regression was performed to identify the independent prognosticators for LUTS presence. Statistical significance was set at p < 0.05. RESULTS: We included 2745 adolescent girls. Their average age was 16.8 ± 1.2 years and 17.8 % of them regularly experienced at least one LUTS. The frequency of occasional LUTS was even higher. The most common symptom was urinary incontinence (5.9 %), followed by frequency (5.1 %), feeling of incomplete bladder emptying (4.8 %), urgency (3.1 %), and nocturia (2.6 %). Risk factors for LUTS presence were girls' school success, frequent pelvic pain, previous cystitis, history of night enuresis in childhood, and sexual intercourses in the last three months. CONCLUSIONS: According to our results, the prevalence of LUTS amongst female adolescents is high and can be associated with certain risk factors. In our opinion, further research should be directed into determining the effect of LUTS on adolescents' quality of life.

Is the fixation of single incision TVT-S tape as good as that of transobturator tape? An ultrasound study of randomized trial results.

INTRODUCTION: TVT-Secur (TVT-S) was the first single-incision sling available on the market and was soon found to have less efficacy than mid-urethral slings. Our aim was to assess the position and tape descent following TVT-O and TVT-S H in a U procedure and, based on this evaluation, to find the possible reason for lower TVT-S surgery efficacy. METHODS: We conducted an ultrasound study of a randomised trial with a 3-year follow-up that took place between 2007 and 2009 and included 197 women with urodynamic stress urinary incontinence. Of these, 67 were allocated to receive the TVT-O procedure, 64 to TVT-S in the H position, and 65 in the U position. Patients underwent a complete urogynaecological and ultrasound examination. The positions of the bladder neck and the tape after surgery were assessed and the data obtained compared between groups. RESULTS: Our primary study showed a significantly higher rate of positive stress tests in the TVT-S groups compared to the TVT-O group. After surgery, there was no difference between the position of the tape at rest and at maximal Valsalva between the groups. In TVT-O patients, the mean length of the upper tape margin descent increased from 6 mm on the 1st day after surgery to 9 mm 3 months after surgery and remained stable afterwards. For TVT-S patients, there was a further increase of up to 15 mm in tape descent after 3 months. CONCLUSIONS: Our results show that the lower efficacy of TVT-S might be due to inadequate fixation and increasing tape descent.

Polymorphism on chromosome 20p13 near the IDH3B gene is associated with uterine prolapse.

OBJECTIVES: Previous studies have found evidence for a genetic basis for pelvic organ prolapse (POP), but no genetic studies have differentiated between types of POP. This study investigated whether genetic variants in six previously suggested candidate loci for POP modify the risk of uterine prolapse (UP). STUDY DESIGN: One hundred patients, aged 30-55 years, who had undergone surgery due to total UP and 105 healthy controls were included in this study. After extracting the genomic DNA from peripheral blood, six single nucleotide polymorphisms (SNPs) previously identified for POP were genotyped, and association analysis was performed for contributing risk factors. RNA expression was determined from sacrouterine ligaments of patients and controls using quantitative reverse transcription polymerase chain reaction. RESULTS: The dominant genotype model for the T allele for SNP rs6051098 at the chromosome 20p13 locus was significant, and this remained significant with the risk factor regression model (p=0.046; odds ratio 1.93, 95 % confidence interval 1.01-3.66). The isocitrate dehydrogenase 3 beta (IDH3B) gene was the only potential candidate gene in the 20p13 locus that was significantly upregulated in sacrouterine biopsies in women with UP compared with controls (p = 0.034). CONCLUSION: To the best of the authors' knowledge, this is the first study to show that genetic risk factors contribute to UP, and suggested rs6051098 as the best candidate risk factor associated with UP. According to expression data in sacrouterine tissue, this study suggests that the IDH3B gene plays a role in the pathogenesis of UP.

Long-term follow-up of native tissue anterior vaginal wall repair: does the POP-Q stage really reflect patients' satisfaction rate?

INTRODUCTION: Anterior colporrhaphy (AC) is one of the most commonly performed surgical procedures for pelvic organ prolapse treatment; however, there are only few data in the literature regarding its long-term outcomes. Our aim was to assess the long-term efficacy and satisfaction rate after AC. METHODS: Patients who underwent AC at our institution from 2011 to 2014 were invited to this follow-up study, which took place in January-February 2019. Medical history and gynaecological examination with POP-Q assessment were performed. Patients filled out validated questionnaires UIQ-7, CRAIQ-7, POPIQ-7, PFIQ-7, POPDI-6, CRADI-8, and UDI-6 and evaluated their satisfaction with the procedure. Objective success was defined as anterior wall prolapse stage 0 or 1 assessed by the POP-Q system. Subjective success was defined as the absence of bulging sensation or a sense of falling out that can be felt or seen in the vaginal area. Data were analysed using descriptive statistics and non-parametric tests. RESULTS: Seventy out of 137 (51.1%) patients attended the follow-up. Mean follow-up period up was 74.1 ± 12.6 months. Two patients were excluded from the analysis because they had another surgical procedure due to central compartment prolapse. Of the remaining patients, 50 had AC and 18 had AC and posterior colporrhaphy (PC). Objective success rate was 13.2% and subjective success rate was 68.7%. Almost all patients (98.5%) were satisfied with the procedure. In the group of patients with objective recurrence, 66.1% had no prolapse symptoms. CONCLUSION: Despite having a low objective success rate, patients' satisfaction with AC is very high.

A Novel in situ Approach to Studying Detrusor Smooth Muscle Cells in Mice.

The aim of our study was to develop a novel approach to investigating mouse detrusor smooth muscle cell (SMC) physiological activity, utilizing an acute tissue dissection technique and confocal calcium imaging. The bladder of a sacrificed adult female NMRI mouse was dissected. We used light and transmission electron microscopy to assess morphology of SMCs within the tissue. Calcium imaging in individual SMCs was performed using confocal microscopy during stimulation with increasing concentrations of carbamylcholine (CCh). SMCs were identified according to their morphology and calcium activity. We determined several parameters describing the SMC responses: delays to response, recruitment, relative activity, and contraction of the tissue. CCh stimulation revealed three different SMC phenotypes: spontaneously active SMCs with and without CCh-enhanced activity and SMCs with CCh-induced activity only. SMCs were recruited into an active state in response to CCh-stimulation within a narrow range (1-25 µM); causing activation of virtually all SMCs. Maximum calcium activity of SMCs was at about 25 µM, which coincided with a visible tissue contraction. Finally, we observed shorter time lags before response onsets with higher CCh concentrations. In conclusion, our novel in situ approach proved to be a robust and reproducible method to study detrusor SMC morphology and physiology.

Laparoscopic sacrocolpopexy: A comprehensive literature review on current practice.

Sacrocolpopexy is considered the preferred treatment for vaginal vault. However, numerous technical variants are being practiced. We aimed to summarize the recent literature in relation to technical aspects of laparoscopic sacrocolpopexy (LSC). We focused on surgical technique, mesh type, concomitant surgeries, and training aspects. We performed 2 independent literature searches in Medline, Scopus, the Cochrane library, and Embase electronic databases including the keywords: 'sacrocolpopexy', 'sacral colpopexy' and 'promontofixation'. Full text English-language studies of human patients, who underwent LSC, published from January 1, 2008 to February 26, 2019, were included. Levels of evidence using the modified Oxford grading system were assessed in order to establish a report of the available literature of highest level of evidence. Initially, 953 articles were identified. After excluding duplicates and abstracts screening, 35 articles were included. Vaginal fixation of the mesh can be performed with barbed or non-barbed (level 1), absorbable or non-absorbable sutures (level 2). Fixation of the mesh to the promontory can be performed with non-absorbable sutures or non-absorbable tackers (level 2). The current literature supports using type 1 mesh (level 2). Ventral mesh rectopexy can safely be performed with LSC while concurrent posterior repair has no additional benefit (level 2). There is no consensus regarding the preferred type of hysterectomy or the benefit of an additional anti urinary incontinence procedure. A structured learning program, as well as the number of procedures needed in order to be qualified for performing LSC is yet to be established. There are numerous variants for performing LSC. For many of its technical aspects there is little consensus.

Long-term results of two different trans-obturator techniques for surgical treatment of women with stress and mixed urinary incontinence: a 10-year randomised controlled study follow-up.

INTRODUCTION: Our aim was to compare the long-term results and complications of the outside-in (Monarc®) versus inside-out (TVT-O®) trans-obturator approaches. METHODS: We performed a 10-year follow-up of our randomised study from 2007 in which we compared short-term outcomes of both procedures in 120 women. Patients were examined at our department in a tertiary centre between March and December 2016. The primary aim of the study was to compare the cure and satisfaction rates of both procedures. The secondary aim was to determine the incidence of vaginal tape exposures, dyspareunia and LUTS. Statistical analysis was performed using SPSS Statistics Programme 21.0. Descriptive statistics were calculated based on basic patient characteristics. Non-parametric tests were used for comparisons of numerical and Pearson's chi-square for categorical data. Statistical significance was set at p < 0.05. RESULTS: Of 114 living patients, 82.5% responded. Average follow-up time was 10.2 years. There were no statistically significant differences between the objective (84.6% for Monarc vs. 94.6% for TVT-O) and subjective cure rates (67.9% vs. 68.3%) or satisfaction rates (83.9% vs. 78.7%). We found no cases of vaginal tape exposure; 6.4% of all (10.3% of sexually active) patients reported dyspareunia and 34% reported LUTS with no significant differences between groups. DISCUSSION: According to our study, both the inside-out and outside-in procedures showed comparable long-term efficacy with low complication rates. To our knowledge, this is the longest randomised study follow-up comparing the cure and satisfaction rates of these two techniques.

A new affordable and easy-to-make pelvic model for training in complex urogynecological laparoscopic procedures.

INTRODUCTION AND HYPOTHESIS: Our aim was to introduce a new affordable and easy-to-make pelvic model for training in complex urogynecological laparoscopic procedures. METHODS: We modified a commercial female pelvic model consisting of sacrum, coccyx, two hip bones, the pubic symphysis, the fifth lumbar vertebra with intervertebral disc, and certain pelvic ligaments. We used sponge foam paper, felt fabric pieces, chenille stems, foam, plastic ties, fabric glue, and a thick, coated wire to create pelvic floor, uterus/vaginal cuff, bladder, both ureters, and anterior longitudinal and pectineal ligaments. RESULTS: We created two different pelvic models: one with the uterus and one with the vaginal cuff. They enable training for laparoscopic pectopexy and hysteropexy/sacrocolpopexy. Trainees can practice proper mesh placement and suture the mesh to the corresponding anatomical structures. Because of the wire inserted in the uterus/vaginal cuff, it is possible to move the uterus/vaginal cuff in the anterior-posterior direction, thus mimicking the use of the manipulator during surgery. Besides the basic pelvis, all other parts of the model can be easily replaced when necessary. CONCLUSIONS: We believe that our pelvic model could provide a valuable tool for training complex urogynecological laparoscopic procedures and help to reduce the long learning curve of these procedures.

Anterior compartment descent: A new measure in the assessment of urethral hypermobility in women with urinary incontinence.

OBJECTIVES: To introduce a new, simple, non-invasive test to quantify urethral hypermobility. METHODS: We reviewed data of women with urinary incontinence who were examined at the Department for General Gynaecology and Urogynaecology, Clinic for Gynaecology and Perinatology, Maribor, Slovenia, between October 2010 and March 2014. Patients' age, diagnosis, results of the Q-tip test and Pelvic Organ Prolapse Quantification measurements were collected. In addition, a new parameter was defined as anterior compartment descent, a midline distance between the external urethral meatus and maximum descent of the anterior vaginal wall when performed the Valsalva maneuver. Statistical analysis was performed with spss software using the Mann-Whitney test, correlation, regression and receiver operating characteristic curve analysis. The analysis was also carried out separately for patients with anterior compartment prolapse stage 0 or I. RESULTS: A total of 472 women were included, 323 of them with anterior compartment prolapse stage 0 or I. Women with urethral hypermobility had significantly higher anterior compartment descent values than patients without urethral hypermobility (3.7 cm vs 2.6 cm, P < 0.001). A moderate correlation was found between anterior compartment descent and the Q-tip test (Spearman's rho = 0.55, P < 0.001). Age and anterior compartment descent were identified as independent variables for the presence of urethral hypermobility. When the cut-off value is set at 3.5 cm, anterior compartment descent represents a test for urethral hypermobility assessment with sensitivity of 65.2%, specificity of 88.6%, positive predictive value of 97.0% and negative predictive value of 30.7%. Anterior compartment descent values were also significantly higher in patients with anterior compartment prolapse stage 0 or I (3.4 ± 0.7 cm vs 2.6 ± 0.7 cm, P < 0.001). CONCLUSIONS: The anterior compartment descent could be a valuable tool for the assessment of urethral hypermobility. Further effort should be directed into the standardization of the technique, determination of the normal range of anterior compartment descent, and its intra- and interobserver reliability.

Regret following female sterilization in Slovenia.

OBJECTIVE: To estimate the regret rate and risk factors for regret among women who have undergone sterilization. METHODS: A retrospective study was conducted among all women who underwent a sterilization procedure at the University Medical Center Maribor, Maribor, Slovenia, in 2008-2012. Identified women were contacted and asked to complete an online questionnaire assessing regret and symptoms associated with depression. RESULTS: Among 714 identified women, 308 (43.1%) completed the questionnaire. Four (1.3%) participants reported regret, and 9 (2.9%) reported that they would not opt for sterilization again, all of whom had post-sterilization problems. Such problems were significantly associated with participants reporting that they would not opt for sterilization again (P=0.003). Additionally, women who would not choose sterilization again had significantly higher scores on the depressive scale used than did those who would undergo sterilization again (P=0.028). CONCLUSION: Few women report regret after tubal sterilization in Slovenia. However, an additional consultation on post-sterilization problems and depressive disorder before sterilization might minimize the risk of regret.

Patient-reported outcome of solifenacin treatment among women experiencing urinary urgency and urgency incontinence.

OBJECTIVE: To evaluate treatment success and tolerability of solifenacin among women with urinary urgency (UU) and urgency urinary incontinence (UUI). METHODS: In a prospective, observational, multicenter pilot study in Slovenia and Croatia, 100 women with UU and UUI were enrolled between January 2011 and July 2011. Patients received 5mg of solifenacin once daily for 12 weeks and completed a 3-day bladder diary, urgency questionnaire, Urogenital Distress Inventory (UDI), and Incontinence Impact Questionnaire (IIQ). RESULTS: Overall, 91 women completed 12 weeks of treatment. Severity, frequency, and bother of UU significantly had decreased at weeks 4 and 12 (P<0.001). Improvement in UU led to an improvement in mean IIQ score: a reduction in UU frequency had the greatest impact (P=0.006). The mean treatment success rate was 74.2% (by visual analog score) and was closely related to the mean change in irritative UDI score (r=0.39; P<0.001). Treatment success was greatest for patient perception of intensity of urgency scale (PPIUS; P=0.003), UU bother (P=0.017), and micturition frequency (P<0.026). Dry mouth occurred in 35.2% of women at 4 weeks, and 27.7% at week 12. CONCLUSION: Solifenacin treatment was effective and well-tolerated among women with UU and UUI. All overactive bladder symptoms had improved by week 12.

The efficacy and safety of solifenacin in patients with overactive bladder syndrome.

The aim of the randomised, double blind, placebo controlled study was to evaluate the efficacy, tolerability and safety of solifenacin, a once-daily M3 selective receptor antagonist, in patients with overactive bladder syndrome. Following a single blind 2-week placebo run in period, patients who complained from symptoms of OAB for at least 6 months, were randomized to 4 weeks of solifenacin in 5 mg once daily doses or placebo. 171 patients were enrolled in the study and 157 patients completed the study. Patients with solifenacin had significantly improved micturitions per 24 hours after first week of treatment (1.75 +/- 0.63 vs. 2.64 +/- 0.48, p < 0.001), and after four weeks (1.56 +/- 0.58 vs. 2.71 +/- 0.45, p < 0.001) compared to placebo group. The mean number of urgency episodes per 24 hours had significantly decreased in patients with solifenacin compared to placebo after first week (5.75 +/- 1.43 vs. 6.65 +/- 0.65, p < 0.001), and after four weeks of treatment (5.77 +/- 1.33 vs. 6.54 +/- 0.50, p < 0.001). Solifenacin was also significantly more effective than placebo in reducing the mean number of episodes of severe urgency from baseline to end point (5.83 +/- 1.16 vs. 6.48 +/- 0.50, p < 0.001). Compared with changes obtained with placebo, episodes of urinary frequency were significanlty reduced after first week (0.3 vs. -0.5, p < 0.001) and four weeks check up periods in patients treated with solifenacin (0.19 vs. -0.15, p < 0.001). Episodes of nocturia was significantly reduced in patients treated with solifenacin after first week (0.3 vs. -0.5, p < 0.001), and after four weeks treatment period (0.45 vs. -0.50, p < 0.001). The number of incontinence episodes was also significantly decreased in solifenacin group compared to placebo group after first week (1.06 +/- 0.57 vs. 2.74 +/- 0.47, p < 0.001) and four weeks check up (0.96 +/- 0.57 vs. 2.75 +/- 0.43, p < 0.001). The most common adverse effects with solifenacin were dry mouth and constipation. Adverse effects were mild or moderate severity. The discontinuation rate owing to adverse effects was 4.5%-6.7% with solifenacin and 3.8%-6.1% with placebo, respectively. According to subjective estimation, significant improvement was achieved in 71 (92.21%) of patients treated with solifenacin and in 68 (85%) patients treated with placebo there was no change in OAB symptoms compared to baseline values. UDI score was significantly improved after solifenacin (22.26 +/- 5.91 vs. 29.61 +/- 8.45, p < 0.001) compared to placebo. IIQ score was significantly decreased in patients with solifenacin (36.25 +/- 10.34 vs. 46.86 +/- 6.81, p < 0.001) compared to placebo. In conclusion, solifenacin is a safe and effective treatment alternative for patients with overactive bladder symptoms.

Comparison of two selective muscarinic receptor antagonists (solifenacin and darifenacin) in women with overactive bladder--the SOLIDAR study.

Overactive bladder (OAB) is a common, often debilitating, condition defined as urgency and urge incontinence, usually with frequency and nocturia. The use of muscarinic receptor antagonists are the mainstay of treatment, but their non-selectivity can result in unacceptable adverse effects that limit their usefulness. The purpose of this study was to evaluate 2 of the newer antimuscarinic agents, solifenacin and darifenacin, which demonstrate greater selectivity, in order to compare their tolerance and effectiveness. This was a multicentre, prospective, randomised, comparative (1:1) open-label study conducted in 4 centres comprising Slovenian gynaecologists and urologists. A total of 77 female patients with OAB were enrolled who received either solifenacin 5 mg or darifenacin 7.5 mg once daily. Study measurements consisted of changes in OAB symptoms and quality of life (QOL) evaluations after 1 and 3 months of treatment. Both treatment groups showing a reduction in all OAB symptoms but with no notable difference being seen between the 2 groups. Solifenacin though showed statistically greater improvements in QOL, better overall treatment satisfaction, and a decreased incidence of dry mouth after 3 months of treatment compared to the darifenacin group. This study demonstrates interesting initial results and indicates that these 2 drugs have a different profile that may confer an advantage to patients, but further methodologically rigorous studies comparing the use of solifenacin and darifenacin in OAB are required to establish the differences between these drugs over longer periods of treatment.