Patient Perception Of Bladder Condition Score Research Articles

Efficacy and sex-specific outcomes after six episodes of percutaneous tibial nerve stimulation treatment on overactive bladder syndrome symptoms

ObjectiveThis study aimed to investigate the efficacy of six episodes of percutaneous tibial nerve stimulation (PTNS) treatment for overactive bladder (OAB) symptoms in men and women and to determine the duration of the effects over a 6-month period.MethodsWomen and men with OAB symptoms participated in the study, which was conducted in accordance with an approved ethical protocol (ISRCTN15733799). Patients underwent six 30-min PTNS sessions, twice per week. The symptoms of OAB were assessed using a voiding diary, the short form of the Overactive Bladder Symptom Score questionnaire (OAB-q SF), and the Patient Perception of Bladder Condition (PPBC), which were self-completed by patients before and after treatment (24 h and at 1, 3, and 6 months). The outcome data were compared for sex and time points using two-way ANOVA for repeated measures.ResultsPTNS treatment significantly improved the OAB symptoms and quality of life in men and women. PTNS increased the voided volume (p < 0.05) and decreased the frequency of voiding, nocturia, and urgency at 24 h and up to 6 months (p < 0.001). The OABq-SF and PPBC scores were significantly decreased after PTNS (p < 0.001). Urgency was greater in men than in women. The duration of PTNS clinical success on frequency and the perception of improvement in quality of life were greater in women than in men.ConclusionThe clinical effects of six sessions of PTNS strongly suggest its potential for shortening, from the standard 12 sessions, to effectively alleviate symptoms of OAB. This therapeutic procedure would reduce both the time and economic costs of OAB treatment.

Patient Perception of Bladder Condition after Treatment with Solifenacin and Tolterodine in Overactive Bladder Patients.

Solefinacin and Tolterodine are new generation antimuscarinics claimed to have bladder specific action and less adverse effect like dry mouth. The objective of the study was to compare the improvement in urinary symptoms among patients using solefinacin and tolterodine with overactive bladder symptoms. A hospital based cross-sectional comparative study was done for one year duration. All patients with overactive bladder symptoms were included and in every alternate patient's solefinacin and tolterodine were given after taking note of baseline OAB symptoms, PPBC score and UPS score. Participants were followed up after one month and noted improvement in endpoint OAB symptoms. Comparison of baseline to end-point symptoms changes among each group of participants were analyzed for statistical significance. Among 101 participants included in the study, 49 participants were in solefinacin group and 52 participants were in tolterodine group. The end-point comparison of urgency symptoms were improved by 20.1±6.76 (mean ± SD) units in solefinacin group and by 17.0 ± 9.18 units in tolterodine group. Urgency perception score improved to 2.1±0.66 for patients under solefinacin and 2±0.73 for tolterodine. Patient perception of bladder condition (PPBC) showed improvement in solefinacin group by 3.2±1.26 units and in tolteradine by 2.8±1.54 units (p = 0.165). Comparing the patient's perception of treatment outcome, massive improvement was reported by 81.6% of those receiving Solefinacinand 65.4% receiving tolterodine, though not statistically significant ( p = 0.131). Solefinacin and Tolterodine showed improvement in urinary symptoms, UPS and PPBC. Both showed comparable efficacy without significant superiority over one another.

Safety and short-term efficacy of mirabegron in children with valve bladder: a pilot study.

This pilot study aims to assess the short-term efficacy and safety of mirabegron in valve bladder, an important cause of persistent hydronephrosis after successful treatment of posterior urethral valves (PUV). Twenty-two patients with early valve bladder (no residual PUV; persistent hydronephrosis, wetting and urodynamic evidence of detrusor overactivity) were included. Three subjective parameters: frequency, wetting episodes; patient perception of bladder condition score (PPBC) and four objective parameters: uroflow index (UI = Qave/Qmax), voided volume (VV = voided volume/ expected bladder capacity), maximum filling pressure (P det-max) and society of fetal urology (SFU) hydronephrosis grading were analysed pre- and post-3-month treatment with mirabegron (0.5-1mg/kg/day). All patients were observed for heart rate, BP, ECG changes during therapy. There was significant reduction (p = 0.001) in mean frequency (pre 15; post 10), wetting episodes (pre 5; post 2) and PPBC (pre 4; post 3). There was significant improvement (p = 0.01) in mean UI (pre 0.3; post 0.5), VV (pre 0.54; post 0.72), Pdet-max (pre 42; post 25) and hydronephrosis grade (pre 3.5; post 2.2). There were no significant side effects. This pilot study establishes short-term efficacy and safety of mirabegron in valve bladder with overactivity. Further larger long-term studies are warranted.

Efficacy of cinnamon patch treatment for alleviating symptoms of overactive bladder: A double-blind, randomized, placebo-controlled trial

BackgroundCurrent treatments for overactive bladder (OAB) have limited efficacy, low persistence and a high rate of adverse events commonly leading to treatment cessation in clinical practice. Clinicians in Asia commonly use traditional Chinese medicine as an alternative for OAB treatment despite it having uncertain efficacy and safety. To evaluate the efficacy and safety of cinnamon patch (CP) treatment for alleviating symptoms of OAB, a double-blind randomized, placebo-controlled trial was conducted in the present study. Materials and MethodsIn this 6-week randomized clinical trial conducted in an outpatient setting, 66 subjects diagnosed as having OAB were enrolled and treated with a placebo (n=33) or CP (n=33). The OAB symptom score (OABSS) was selected as the primary end point, and a patient perception of bladder condition (PPBC), an urgency severity scale (USS), and post-voiding residual urine (PVR) volume were selected as secondary end points. Statistical analyses were performed with IBM SPSS Statistics 20. Groups were compared using an independent sample t-test, Fisher exact test, and Chi-squared test. ResultsIn total, 66 participants (40 women and 26 men), 60.35 ± 12.77 years of age, were included in the intention-to-treat analyses. Baseline characteristics were comparable between the CP (n ==33) and placebo (n ==33) groups. Treatment with a CP showed statistically significant differences in reductions in OABSS scores (9.70 ± 2.20 to 6.33 ± 2.42), PPBC scores (3.36 ± 0.60 to 2.15 ± 0.83), and USS scores (2.67 ± 0.54 to 1.64 ± 0.60). ConclusionsCompared to a placebo, treatment with CP might be considered an effective and safe complementary therapy for OAB. Further studies employing a positive control, different dosage forms, larger sample sizes, and longer treatment periods are warranted.

A randomized, controlled trial of transcutaneous tibial nerve stimulation to treat overactive bladder and neurogenic bladder patients.

We aimed to determine if transcutaneous tibial nerve stimulation (TTNS) is effective at treating overactive bladder (OAB) symptoms among neurogenic and non-neurogenic patients. We conducted a randomized, double-blind, sham-controlled study. Adult patients were recruited from one of two groups: 1) women with OAB; and 2) patients with neurogenic disease and bladder symptoms. The intervention was stimulation of the posterior tibial nerve, for 30 minutes, three times per week for 12 weeks at home using transcutaneous patch electrodes. The primary outcome was improvement of the patient perception of bladder condition (PPBC). We used ANCOVA (with adjustment for baseline values) and followed the intention-to-treat principle; we reported marginal means (MM) and a p<0.05 was considered significant. We recruited 50 patients (OAB n=20, neurogenic bladder n=30); 24 were allocated to the sham group and 26 to the active TTNS group. Baseline characteristics in both groups were similar. At the end of the study, there was no significant difference in the PPBC between sham or active groups: 13% (3/24) of sham patients and 15% (4/26) of active TTNS patients were responders (p=0.77), and the MM of the end-of-study PPBC score was 3.3 (95% confidence interval [CI] 2.8-3.7) vs. 2.9 (95% CI 2.5-3.4), respectively (p=0.30). Similarly, there were no significant differences in secondary outcomes (24-hour pad weight, voiding diary parameters, or condition-specific patient-reported outcomes). The results were similar within the OAB and neurogenic bladder subgroups. TTNS does not appear to be effective for treating urinary symptoms of people with OAB or neurogenic bladder dysfunction.

Efficacy and tolerability of mirabegron in female patients with overactive bladder symptoms after surgical treatment for stress urinary incontinence.

ABSTRACTPurpose To evaluate the efficacy and tolerability of mirabegron in females with overactive bladder (OAB) symptoms after surgical treatment for stress urinary incontinence (SUI).Materials and Methods The study was conducted with a prospective, randomized and double-blinded design. 62 patients over the age of 40 who met the inclusion-exclusion criterias of the study were enrolled and randomly divided into two groups as Group A (mirabegron 50mg) and B (solifenacin 5mg). Patients were compared based on efficacy of treatment [Patient Perception of Bladder Condition (PPBC) scale and micturition diaries], safety of treatment (heart rate, systolic and diastolic blood pressure, adverse events), number of micturitions per day, patient’s satisfaction status after treatment [Visual Analog Scale(VAS)] and quality of life.Results The mean age of the population was 48.2±3.8 years and the duration of OAB symptoms was 5.9±2.9 months. Baseline values for the mean number of micturitions, volume voided in each micturition, nocturia episodes, urgency and urgency incontinence episodes were 15.3±0.34, 128±3.88mL, 3.96±1.67, 5.72±1.35 and 4.22±0.69, respectively. After treatment, values for these parameters were 11.7±0.29, 164.7±2.9mL, 2.25±0.6, 3.38±0.71, 2.31±0.49 respectively. Quality of life score, symptom bother score, VAS for treatment satisfaction score, PPBC score after treatment were 66.1±0.85, 43.7±0.77, 4.78±0.14, 4.78±0.14, respectively. There were no significant differences between two groups on any parameter. However, mirabegron showed better tolerability than solifenacin, particularly after 6 months.Conclusion Mirabegron is safe, effective and tolerable in the long-term treatment of females with OAB symptoms after surgery for stress urinary incontinence.

Therapeutic efficacy of mirabegron 25 mg monotherapy in patients with nocturia-predominant hypersensitive bladder.

Objective:The objective of this study was to evaluate the efficacy of mirabegron 25 mg daily in patients with nocturia-predominant hypersensitive bladder (HSB).Materials and Methods:This study prospectively investigated 219 consecutive patients with nocturia-predominant HSB and treated with mirabegron 25 mg daily from July 2015 to 2016. Patient with nocturia episode decreased by ≥1/night after treatment was considered successful. The subjective symptom score, such as International Prostate Symptom Score (IPSS), Quality of life index, Overactive Bladder Symptom Score (OABSS), Urgency Severity Scale, patient perception of bladder condition (PPBC), and nocturia episodes per night, was assessed before and 1 month after mirabegron treatment and between successful and failed groups.Results:A total of 219 patients, including 51 women and 168 men, were enrolled. The mean age of the population was 72.3 ± 11.0 years. Totally, 58 (26.5%) of the patients had improvement in nocturia at 1 month after treatment. Among them, 14 (27.5%) women and 44 (26.2%) men had improvement in nocturia episodes after treatment (P = 0.858). Compared the clinical data between successful and failed group, the baseline symptom scores were more severe in successful group, including IPSS-storage subscore (4.84 ± 2.09 vs. 4.11 ± 2.19, P = 0.031), OABSS (3.21 ± 0.67 vs. 2.91 ± 1.00, P = 0.037), and nocturia episodes (3.81 ± 0.95 vs. 3.095 ± 1.32, P = 0.000). Multivariate analysis revealed only a higher nocturia episodes (P = 0.046) predict a successful treatment result. Mirabegron 25 mg daily significantly improved PPBC score along the 3 months' follow-up (P < 0.05), and postvoid residual volume did not increase after mirabegron treatment in overall patients.Conclusions:Mirabegron 25 mg daily treatment showed a limited therapeutic effect on nocturia-predominant HSB patients. The patients with higher OAB symptoms predict a successful result.

Effects of urine alkalinization with sodium bicarbonate orally on lower urinary tract symptoms in female patients: a pilot study.

In this study, we planned to explore the effects of sodium bicarbonate orally (NaHCO3) treatment on female patients with lower urinary tract symptoms (LUTS) who have acidic urine pH values (<6). NaHCO3 was given orally to 33 female patients for 4 weeks at a dose of 2×4 g/day. Laboratory values, bladder diary, the Patient Perception of Bladder Condition Score (PPBC), Patient Perception of Intensity of Urgency Scale (PPIUS), Overactive Bladder-Validated 8-question Awareness tool (OAB-V8), Pelvic Pain and Urgency & Frequency Patient Symptom Scale tests (PUFSS), and the King's Health Questionnaire (KHQ) scores before and after treatment were compared. A significant increase was detected in urine pH values measured after treatment (5.31±0.52 to 7.2±0.66, p<0.001), but not in blood pH values (7.369±0.33 to 7.384±0.28, p=0.14). After treatment, a significant decrease was detected in daily frequency, nocturia, urgency, and urge incontinence prevalence (p<0.001,p=0.003, p<0.001, p=0.002, respectively) and PPBC, PPIUS, PUFSS, and OAB-V8 symptom scores (p=0.004, p=0.002, p<0.001, p<0.001, respectively). A significant decrease was detected in all KHQ subunit scores. Urine alkalinization with NaHCO3 orally in female patients with LUTS and acidic urine pH has a significant level of positive effects on symptoms and symptom scores. Our results show that this new treatment modality-which is inexpensive, easy to use, and has a low side-effect profile is effective in this chronic patient group.

Patient-perceived effectiveness and impact on quality of life of solifenacin in combination with an α-blocker in men with overactive bladder in Sweden: a non-interventional study

Treating male lower urinary tract symptoms (LUTS) by targeting the prostate would have limited effect on overactive bladder (OAB) symptoms. This study assessed perceived symptoms and quality of life (QoL) of male patients with OAB treated with an α-blocker plus solifenacin in daily clinical practice. Male patients aged ≥40 years were included after the decision was made to initiate treatment with an α-blocker for LUTS plus solifenacin for OAB symptoms. The primary endpoint was change in patient perception of bladder condition (PPBC) questionnaire score over 6 months. Other assessments included the OAB-questionnaire short form (OAB-q SF) and International Prostate Symptom Score (IPSS). Interpretation of the study data was hindered by not meeting the enrollment target and a high dropout rate. In 36 evaluable patients, mean (SD) PPBC score improved from 4.3 (0.93) at baseline (“moderate” to “severe” problems) to 3.5 (1.06) at month 6 (“minor” to “moderate” problems). OAB-q SF scores and total IPSS also improved. In this patient population, treatment with solifenacin and an α-blocker resulted in improvements in male patient perception of their LUTS and QoL, although the results should be interpreted with caution due to the low number of patients with complete data.

Overactive Bladder Symptom Scores responsiveness before and after anticholinergic treatment in women with overactive bladder: The pilot study.

The aims of this study were: (i) to evaluate change of Overactive Bladder Symptom Scores (OABSS) from before to after solifenacin treatment; and (ii) to evaluate correlation between change of OABSS and 3-day micturition diary, International Prostate Symptom Score (IPSS), and Patient Perception of Bladder Condition (PPBC). Thirty-six women, aged>18 years, diagnosed as having overactive bladder (OAB) at King Chulalongkorn Memorial Hospital, with the symptoms of urgency, frequency with or without urge incontinence for more than 3 months, and at least three episodes of urgency with or without incontinence during the last 3 days prior to the study, were recruited during January 2010-May 2011. All cases received solifenacin 5-mg treatment once a day and were asked to record a 3-day micturition diary and to complete the Thai version of the OABSS, IPSS, and PPBC questionnaires at weeks 0, 4, and 12 after treatment. The OABSS, IPSS, and PPBC scores and all parameters of the 3-day micturition diary had changed significantly by weeks 4 and 12. The OABSS correlated significantly with IPSS score (r = 0.44), PPBC score (r = 0.39), and urgency episodes (r = 0.48). The OABSS had good responsiveness, similar to the other questionnaires (the IPSS and PPBC) and the 3-day micturition diary. The use of OABSS is recommended in OAB women for evaluation after anticholinergic drug treatment.

Validation of overactive bladder questionnaire (1-week recall version) in medically complex elderly patients with overactive bladder.

The 33-item Overactive Bladder questionnaire (OAB-q; 1-week recall version) has been psychometrically validated in middle-aged, generally healthy patients with overactive bladder. The present analysis was conducted to determine the psychometric validity of the OAB-q in medically complex elderly patients. OAB-q structure was evaluated using a second-order confirmatory factor analysis (CFA) model with five domains and one aggregated domain, using pooled data from two clinical trials (786 observations) for urgency urinary incontinence (UUI). Psychometric validity was evaluated with CFA, Cronbach coefficient α (CCA) for reliability, Spearman correlations for convergent validity, differences in OAB-q scores in relation to UUI severity and Patient Perception of Bladder Condition (PPBC) scores for known-groups validity, and effect size (ES) of differences in mean scores of OAB-q domains over time for treatment responsiveness. Participants were predominantly female (82.2%) and white (85.9%); mean age was 75.0years. The second-order CFA was confirmed with a Bentler's comparative fit index of 0.90, t values for path coefficients of >1.96, and standardized path coefficients of >0.40. OAB-q domains demonstrated good internal consistency (CCA >0.7). Convergent validity was supported by moderate correlations (0.4-0.7) between OAB-q domain and PPBC scores. Significant differences in OAB-q domain scores between groups with different symptom severity established known-groups validity. Significant changes in mean OAB-q scores from baseline to week 12 with moderate-to-large ES (0.50-0.80) demonstrated treatment responsiveness. The OAB-q demonstrates reliability, concurrent and discriminant validity, and responsiveness to treatment. The evidence shows that the OAB-q is psychometrically sound for use in medically complex elderly patients with overactive bladder.

Urinary incontinence in multiple sclerosis: prevalence, severity and impact on patients' quality of life.

Lower urinary tract symptoms (LUTS) including frequent urination, nocturia and urge urinary incontinence negatively impact quality of life. This project aimed at characterizing the prevalence and severity of urinary incontinence in multiple sclerosis (MS) patients and its association with demographic and clinical features. In all, 403 consecutive clinically stable MS patients answered the International Consultation on Incontinence Questionnaire (ICIQ) and the Patient Perception of Bladder Condition (PPBC) questionnaire. Demographic and clinical parameters including the Expanded Disability Status Scale (EDSS) were collected. Statistical analyses were performed using univariate and multivariate linear regression models. Females represented 72%, relapsing-remitting patients 82%. The mean (SD) disease duration and EDSS were 11.8 (8.6) years and 3.1 (1.9) respectively. Approximately 35% of patients reported urine incontinence. ICIQ scores were positively associated with EDSS, female gender, presence of LUTS therapies and absence of disease modifying treatments (P < 0.001). PPBC scores were positively associated with EDSS and the presence of LUTS therapies (P < 0.001). Urinary incontinence is frequent in MS, prevailing in more disabled and female patients. Currently available LUTS therapies appear insufficient in the treatment of this symptom. The negative impact of urinary incontinence on quality of life is high and requires more attention in clinical management and research.

PD27-12 MIRABEGRON DOES NOT DECREASE URINARY NEUROTROPHINS' LEVELS IN OVERACTIVE BLADDER PATIENTS DESPITE SYMPTOMATIC IMPROVEMENT

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Female Incontinence - Therapy I1 Apr 2015PD27-12 MIRABEGRON DOES NOT DECREASE URINARY NEUROTROPHINS' LEVELS IN OVERACTIVE BLADDER PATIENTS DESPITE SYMPTOMATIC IMPROVEMENT Tiago Antunes-Lopes, Ana Ferreira, Carvalho-Barros Sérgio, Daniel Costa, Rui Pinto, João Silva, Silva Carlos, and Francisco Cruz Tiago Antunes-LopesTiago Antunes-Lopes More articles by this author , Ana FerreiraAna Ferreira More articles by this author , Carvalho-Barros SérgioCarvalho-Barros Sérgio More articles by this author , Daniel CostaDaniel Costa More articles by this author , Rui PintoRui Pinto More articles by this author , João SilvaJoão Silva More articles by this author , Silva CarlosSilva Carlos More articles by this author , and Francisco CruzFrancisco Cruz More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.456AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Neurotrophins play a role in sensory neuron sensitization. High levels of nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF) were measured in the urine of OAB patients, and decreased after successful treatment with antimuscarinics. Mirabegron, a β3-adrenoceptor agonist recently approved for OAB, has a distinct mechanism of action. In this study we investigated, for the first time, urinary levels of NGF and BDNF in OAB patients treated with mirabegron. METHODS Twenty-two female OAB patients were enrolled. Those medicated with antimuscarinics and not satisfied with the treatment completed a washout period of 4 weeks. A group of 15 women without LUTS was used as control. At baseline urine samples were collected from all participants. Simultaneously, King's Health (KHQ) and Patient Perception of Bladder Condition (PPBC) questionnaires were completed. OAB patients were treated with mirabegron 50 mg once daily and reevaluated at 4 and 12 weeks. At these time points, urine sampling and completion of the same questionnaires were carried out. Urine samples were processed for ELISA analysis of NGF and BDNF and the values were normalized against creatinine (Cr) concentration. Neurotrophin concentration values were logarithmized to improve distribution characteristics. RESULTS At baseline, urinary NGF/Cr and BDNF/Cr were significantly higher in OAB patients compared to healthy controls (NGF/Cr: 3.3±0.6 vs. 2.4±0.5, p<0.01; BDNF/Cr: 2.9±0.5 vs. 2.6±0.4, p=0.028). After treatment with mirabegron there was a decrease in urinary NGF/Cr and BDNF/Cr, which however did not reach statistical significance. Eighteen out of 22 patients reported marked symptomatic improvement, reflected in the variations of KHQ and PPBC scores. Data are summarized in the table. CONCLUSIONS Mirabegron does not change urinary neurotrophins' levels in OAB patients, despite symptomatic improvement. A possible explanation for this finding might be the fact that mirabegron primarily acts on bladder smooth muscle, with a reduced effect on the urothelium, which is believed to release most of urinary neutrophins. Actually, up to now, functional β3-adrenoceptors have not been demonstrated in the human urothelium. Baseline (n=22) 4 weeks (n=21) p 12 weeks (n=20) p NGF/Cr pg/mg 3.3 ± 0.6 3.2 ± 0.5 >0.05 3.0 ± 0.8 >0.05 BDNF/Cr pg/mg 2.9 ± 0.5 2.7 ± 0.6 >0.05 2.7 ± 0.5 >0.05 PPBC Severity scale: 1 – 6 3.6 ± 0.9 2.4 ± 1.0 <0.05 2.4 ± 1.4 <0.05 Data is expressed as the mean ± standard deviation. Higher PPBC score indicates more severe bladder problems © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e576 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Tiago Antunes-Lopes More articles by this author Ana Ferreira More articles by this author Carvalho-Barros Sérgio More articles by this author Daniel Costa More articles by this author Rui Pinto More articles by this author João Silva More articles by this author Silva Carlos More articles by this author Francisco Cruz More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Superiority of fesoterodine 8 mg vs 4 mg in reducing urgency urinary incontinence episodes in patients with overactive bladder: results of the randomised, double‐blind, placebo‐controlled EIGHT trial

To assess the superiority of fesoterodine 8 mg vs 4 mg for improvement in urgency urinary incontinence (UUI) episodes and other diary variables, diary-dry rate (proportion of patients with >0 UUI episodes on baseline diary and 0 UUI episodes on post-baseline diary), and improvements in measures of symptom bother, health-related quality of life (HRQL), and other patient-reported outcomes (PROs). This was a 12-week, randomised, double-blind, placebo-controlled, multinational trial of men and women aged ≥18 years with overactive bladder (OAB) symptoms including UUI (ClinicalTrials.gov ID NCT01302067). Patients were randomised (2:2:1) to receive fesoterodine 8 mg, fesoterodine 4 mg, or placebo once daily; those randomised to fesoterodine 8 mg started with fesoterodine 4 mg once daily for 1 week, then 8 mg once daily for the remaining 11 weeks. Patients completed bladder diaries at baseline and weeks 4 and 12 and the Patient Perception of Bladder Condition (PPBC), Urgency Perception Scale (UPS), and Overactive Bladder Questionnaire (OAB-q) at baseline and week 12. The primary endpoint was change from baseline to week 12 in UUI episodes per 24 h. At week 12, patients receiving fesoterodine 8 mg (779 patients) had significantly greater reductions from baseline in UUI episodes, micturitions, and urgency episodes than patients receiving fesoterodine 4 mg (790) or placebo (386); diary-dry rate was significantly higher in the fesoterodine 8-mg group vs the fesoterodine 4-mg and placebo groups (all P < 0.05). At week 12, patients receiving fesoterodine 8 mg also had significantly greater improvements in scores on the PPBC, UPS, and all OAB-q scales and domains than patients receiving fesoterodine 4 mg or placebo (all P < 0.01). Patients receiving fesoterodine 4 mg had significantly greater improvements in UUI episodes, urgency episodes, and micturitions; significantly higher diary-dry rates; and significantly greater improvement in PPBC scores and OAB-q scores than patients receiving placebo (all P < 0.05). Dry mouth was the most commonly reported adverse event (AE) in the fesoterodine groups (placebo group, 3.4%; fesoterodine 4-mg group, 12.9%; fesoterodine 8-mg group, 26.1%); most cases were mild or moderate in all treatment groups. Rates of serious AEs and discontinuations due to AEs were low in all groups. In a 12-week, prospectively designed, superiority trial, fesoterodine 8 mg showed statistically significantly superior efficacy vs fesoterodine 4 mg and placebo, as measured by reductions in UUI episodes and other diary variables, diary-dry dry rate, and improvements in measures of symptom bother, HRQL, and other PROs; clear evidence of dose-dependent efficacy is unique to fesoterodine among antimuscarinics and other oral agents for the treatment of OAB. Fesoterodine 4 mg was significantly more effective than placebo on all outcomes except for improvements in UPS scores. These data support the benefit of having two doses of fesoterodine in clinical practice, with the recommended starting dose of 4 mg for all patients and the fesoterodine 8-mg dose available for patients who require a higher dose to achieve optimal symptom relief.

La définition de la maladie de Parkinson est-elle génétique ?

Current treatments for overactive bladder (OAB) have limited efficacy, low persistence and a high rate of adverse events commonly leading to treatment cessation in clinical practice. Clinicians in Asia commonly use traditional Chinese medicine as an alternative for OAB treatment despite it having uncertain efficacy and safety. To evaluate the efficacy and safety of cinnamon patch (CP) treatment for alleviating symptoms of OAB, a double-blind randomized, placebo-controlled trial was conducted in the present study.In this 6-week randomized clinical trial conducted in an outpatient setting, 66 subjects diagnosed as having OAB were enrolled and treated with a placebo (n=33) or CP (n=33). The OAB symptom score (OABSS) was selected as the primary end point, and a patient perception of bladder condition (PPBC), an urgency severity scale (USS), and post-voiding residual urine (PVR) volume were selected as secondary end points. Statistical analyses were performed with IBM SPSS Statistics 20. Groups were compared using an independent sample t-test, Fisher exact test, and Chi-squared test.In total, 66 participants (40 women and 26 men), 60.35 ± 12.77 years of age, were included in the intention-to-treat analyses. Baseline characteristics were comparable between the CP (n ==33) and placebo (n ==33) groups. Treatment with a CP showed statistically significant differences in reductions in OABSS scores (9.70 ± 2.20 to 6.33 ± 2.42), PPBC scores (3.36 ± 0.60 to 2.15 ± 0.83), and USS scores (2.67 ± 0.54 to 1.64 ± 0.60).Compared to a placebo, treatment with CP might be considered an effective and safe complementary therapy for OAB. Further studies employing a positive control, different dosage forms, larger sample sizes, and longer treatment periods are warranted.

Effect of fesoterodine 4 mg on bladder diary and patient-reported outcomes during the first week of treatment in subjects with overactive bladder

Objective:To assess the onset of efficacy of fesoterodine 4 mg versus placebo in subjects with overactive bladder (OAB) symptomsResearch design and methods:Subjects who reported OAB symptoms for ≥3 months and recorded ≥8 micturitions and ≥1 urgency urinary incontinence (UUI) episode per 24 hours in 3-day baseline diaries were randomized to fesoterodine 4 mg, tolterodine extended release (ER) 4 mg, or placebo. This is an analysis of first week data from a 12-week, double-blind trial.Main outcome measures:Baseline to week 1 changes in 3-day bladder diary variables, Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS) scores reported by subjects receiving fesoterodine 4 mg or placebo.Results:By week 1, fesoterodine 4 mg (n = 679) was associated with significantly greater improvements compared with placebo (n = 334) in micturitions, urgency, severe urgency and UUI episodes, frequency-urgency sum, and MVV per 24 hours and 3-day diary-dry rate (all p < 0.05), but not nocturnal micturitions per 24 hours (p = 0.273). These differences were significant as early as day 5 of treatment (i.e., day 1 of the 3-day diary) for all diary endpoints except nocturnal micturitions and MVV. Changes in PPBC scores were significantly more favorable with fesoterodine 4 mg versus placebo (p = 0.0143); changes in UPS scores were not significantly different (p = 0.077).Conclusion:The results provide evidence that patients receiving fesoterodine 4 mg for their OAB symptoms may expect to experience a response as early as 1 week after initiating treatment. One limitation is that, although 65% of subjects had received treatment with antimuscarinics before the study, whether subjects were dissatisfied with previous treatment and reasons for dissatisfaction were not collected. This might affect the magnitude of outcome improvements. Also, it is not known whether the UPS is sensitive enough to detect treatment differences as early as week 1.Trial registration: ClinicalTrials.gov identifier: NCT00444925.

Patient‐optimized doses of fesoterodine improve bladder symptoms in an open‐label, flexible‐dose study

To assess changes in overactive bladder (OAB) symptoms and patient-reported outcomes in a post hoc analysis in which subjects from a 12-week, open-label, flexible-dose fesoterodine study were stratified according to whether they opted for dose escalation. Subjects with OAB (eight or more micturitions and three or more urgency episodes per 24 h) who reported dissatisfaction with tolterodine within 2 years of screening received fesoterodine 4 mg once daily for 4 weeks, with an optional dose increase to 8 mg after week 4 based on discussion of efficacy and tolerability between the subject and investigator. Subjects completed 5-day diaries, the Patient Perception of Bladder Condition (PPBC) and Urgency Perception Scale (UPS) at baseline and weeks 4 and 12, and the Overactive Bladder Questionnaire (OAB-q) at baseline and week 12. Subjects rated treatment satisfaction at week 12. Dose escalation to 8 mg at week 4 was chosen by 255 (50%) of 513 subjects. At baseline, subjects who opted for dose escalation at week 4 (escalators) had significantly higher means for all diary variables except urgency urinary incontinence (UUI) episodes, significantly greater OAB-q Symptom Bother scores and significantly lower OAB-q health-related quality of life (HRQL) scores (all P < 0.05) compared to subjects who did not opt for dose escalation (non-escalators). There was no significant difference in the percentage of escalators (51%) and non-escalators (48%) who reported at least one UUI episode on baseline diary. At week 4 (before the decision to escalate was made), all outcomes were significantly improved vs baseline among both groups (all P < 0.0001), although non-escalators had significantly greater improvements in all diary variables and in PPBC and UPS scores than escalators (all P < 0.05), and the 5-day diary-dry rate (i.e. the percentage of subjects with at least one UUI episode on baseline diary and no UUI episodes on week 4 diary) was significantly higher (P = 0.0016) among non-escalators (62%) than among escalators (42%). At week 12, all outcomes were again significantly improved vs baseline among both groups (all P < 0.0001). There were no significant differences between non-escalators and escalators in week 12 improvements for most diary variables, UPS scores, OAB-q Symptom Bother scores, the diary-dry rate (68% vs 60%) or the percentage of subjects who reported treatment satisfaction (82% vs 78%). However, escalators still had significantly greater improvements from baseline in urgency episodes, PPBC scores and OAB-q total HRQL and Coping domains (P < 0.05). Adverse event rates were similar between non-escalators and escalators. Dry mouth was the most frequently reported adverse event; most cases were mild. Flexible-dose fesoterodine significantly improved OAB symptoms and patient-reported outcomes in subjects who chose to remain on the initial 4-mg dose, as well as in the 50% of subjects who escalated to the 8-mg dose after 4 weeks. Non-escalators had significantly fewer OAB symptoms at baseline and significantly greater improvements than escalators before dose escalation. Escalators showed increased symptom relief after dose escalation; improvements in most outcomes were similar among non-escalators and escalators by week 12. Flexible-dose fesoterodine was well tolerated, with similar adverse-event profiles observed in the escalator and non-escalator groups. These results may help clinicians to identify patients more likely to require fesoterodine 8 mg to achieve maximum relief of OAB symptoms and thus facilitate dose escalation in these patients.

Is the beneficial effect of antimuscarinics related to motor or sensory changes in the bladder?

The aim of the study was to assess the sensory and motor effects of antimuscarinic treatment on the bladder in women with overactive bladder, detrusor overactivity demonstrated on urodynamics and a mean bladder wall thickness (BWT) greater than 5 mm. Fifty-eight women underwent treatment with antimuscarinics in 12 weeks. Before treatment and at 1, 2, 6 and 12 weeks of treatment, women completed the patient perception of bladder condition (PPBC) single-item global questionnaire, indicated the severity of their urgency on a visual analogue scale (VAS) and underwent transvaginal ultrasound to determine mean bladder wall thickness (BWT). PPBC and VAS scores for urgency declined throughout the treatment course whereas mean BWT declined during the first 6 weeks of treatment and then reached a plateau after falling to below 5 mm. The mechanism of action of antimuscarinics appears to be a complex interaction of sensory and motor components.

Prevalence and Treatment Efficacy of Genitourinary Mycoplasmas in Women with Overactive Bladder Symptoms

PurposeTo evaluate the incidence of genitourinary mycoplasmas and the efficacy of antibiotics in women with overactive bladder (OAB) symptoms.Materials and MethodsWomen with OAB symptoms (micturition ≥8/24 hours and urgency ≥1/24 hours) for ≥3 months were screened for Mycoplasma hominis (M. hominis), Ureaplasma urealyticum (U. urealyticum), and Chlamydia trachomatis (C. trachomatis). Specimens from urethral and cervical vaginal swabs were examined for M. hominis and U. urealyticum by using the Mycoplasma IST2 kit and for C. trachomatis by using PCR. Women with positive results were treated with a 1 g dose of azithromycin. Persistent infection was treated with doxycycline. Changes in a 3-day bladder diary, Patient Perception of Bladder Condition (PPBC), and International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) were evaluated 4 weeks after negative conversion. Patient satisfaction was assessed.ResultsOf 84 women screened, 42.8% were positive (U. urealyticum, 40.5%; M. hominis, 7.1%; C. trachomatis, 3.6%; two organisms, 8.3%). After treatment, 82.7% obtained negative conversion, and their median number of micturition episodes decreased from 10.6/24 hours to 8.1/24 hours (p=0.002). PPBC and domain scores of the ICIQ-FLUTS (filling and quality of life) significantly improved. About 87.5% women with negative conversion were satisfied with the treatment.ConclusionsConsidering diagnostic tests and treatment for genitourinary mycoplasmas might be beneficial before invasive workup or treatment in women with OAB symptoms.

Solifenacin treatment in men with overactive bladder: effects on symptoms and patient-reported outcomes

Objective. In the few studies to evaluate antimuscarinics for overactive bladder (OAB) in men, safety has been the primary focus. In OAB efficacy trials, subject populations have been predominantly female and patient-reported outcomes (PROs) have been assessed only recently. We present a post hoc analysis of PRO-based findings from the subset of men (without presumed bladder outlet obstruction [BOO]) from two large, independent, open-label trials of solifenacin.Methods. Subjects with OAB for ≥3 months received flexibly dosed solifenacin for 12 weeks. At baseline and 4-week intervals, subjects completed the Patient Perception of Bladder Condition (PPBC) and Overactive Bladder Questionnaire (OAB-q). In one study, subjects also completed 3-day bladder diaries. At baseline, mean PPBC scores were similar in both studies and indicative of moderate-to-severe problems.Results. After 12 weeks of solifenacin, mean PPBC scores improved significantly (p < 0.0001); values were suggestive of minor-to-moderate problems. Mean scores on the OAB-q were also significantly improved after solifenacin (p values ≤0.001). In men without presumed BOO, solifenacin significantly improved PRO measures of symptom bother, health-related quality of life, and overall perception of bladder problems.Conclusion. Results from these two studies support the use of solifenacin as a well-tolerated and efficacious treatment option for providing symptom relief in men with OAB without BOO.