Overactive Bladder Population Research Articles

Shifts in patient preference of third-line overactive bladder therapy after introduction of the implantable tibial nerve stimulator.

Third-line therapies for overactive bladder (OAB) that are currently recommended include intravesical Onabotulinumtoxin-A injections (BTX-A), percutaneous tibial nerve stimulation (PTNS), and sacral neuromodulation (SNM). The implantable tibial nerve stimulator (ITNS) is a novel therapy that is now available to patients with OAB. The objective of this study was to analyze shifts in patient preference of third-line therapies for OAB after introducing ITNS as an option amongthe previously established therapies for non-neurogenic OAB. A survey was designed and distributed via SurveyMonkey to the platform's audience of U.S. adults of age 18 and older. Screening questions were asked to include only subjectswho reported symptoms of OAB. Descriptions of current AUA/SUFU guideline-approved third-line therapies (BTX-A, PTNS, and SNM) were provided, and participants were asked to rank these therapies in order of preference (stage A). Subsequently, ITNS was introduced with a description, and participants were then asked to rank their preferences amongst current guideline-approved therapies and ITNS (stage B). Absolute and relative changes in therapy preferences between stage A and stage B were calculated. Associations between ultimate therapy choice in stage B and participant characteristics were analyzed. A total of 485 participants completed the survey (62.5% female). The mean age was 49.1 ± 36.5 years (SD). The most common OAB symptoms reported were urgency urinary incontinence (UUI) (73.0%) and urinary urgency (68.0%). 29.2% of patients had tried medication for OAB in the past, and 8.0%-10.3% of patients were previously treated with a third-line therapy for OAB. In stage A, participants ranked their first choice of third-line therapy as follows: 28% BTX-A, 27% PTNS, and 13.8% SNM. 26.6% of participants chose no therapy, and 4.5% chose all three equally. In stage B, participants ranked their first choice as follows: 27.6% BTX-A, 19.2% PTNS, 7.8% SNM, and 19.2% ITNS. 21.9% of participants chose no therapy and 4.3% chose all four equally as their first choice. There were both absolute and relative declines in proportions of patients interested in BTX-A, SNM, and PTNS as their first choice of third-line therapy with the introduction of ITNS. Patients originally interested in PTNS in stage A had the greatest absolute change after the introduction of ITNS with 7.8% of participants opting for ITNS in stage B. Those interested in SNM in stage A had the largest relative change in interest, with 43.5% of those originally interested in SNM opting for ITNS in stage B. Finally, with the introduction of ITNS, the number of participants initially not interested in any third-line therapy declined by an absolute change of 4.7% and relative change of 17.6%. Participants experiencing concurrent stress urinary incontinence (SUI) symptomswere more likely to choose a current guideline-approved third-line therapy than ITNS or no therapy at all (p = 0.047). Those who had prior experience with third-line therapies were more likely to choose a third-line therapy other than ITNS as their ultimate choice of therapy in stage B. Of those who had chosen a guideline-approvedthird-line therapy in stage B (not ITNS), 13.6% had prior experience with BTX-A, 14.7% with PTNS, and 32 (11.2%) with SNM (p < 0.001, p < 0.001, p = 0.009, respectively). From our study, it appears that ITNS may attract a subset of patients who would not have otherwise pursued current guideline-approved third-line therapies for OAB. When patients are provided with descriptions of third-line OAB therapies including ITNS as an option, ITNS appears to compete with SNM and PTNS. It is possible that ITNS will provide patients with a different phenotype of neuromodulation therapy that can appeal to a niche OAB population. Given that ITNS devices have been introduced relativelyrecently to the market, their application will largely depend on cost and payer coverage, provider bias, and patient comorbidities. Further study is needed to understand how these factors interact with and influence patient preference of advanced OAB therapy to understand which patients will most benefit from this treatment modality.

MP74-12 THE URINARY MICROBIOME IN THOSE WITH OVERACTIVE BLADDER IS MORE ABUNDANT IN ESCHERICHIA AND LESS ABUNDANT IN LACTOBACILLUS RELATIVE TO THAT OF HEALTHY CONTROLS

You have accessJournal of UrologyCME1 Apr 2023MP74-12 THE URINARY MICROBIOME IN THOSE WITH OVERACTIVE BLADDER IS MORE ABUNDANT IN ESCHERICHIA AND LESS ABUNDANT IN LACTOBACILLUS RELATIVE TO THAT OF HEALTHY CONTROLS Glenn Werneburg, Daniel Hettel, Madison Lyon, Ava Adler, Peace Orji, Suruchi Ramanujan, Jacqueline Zillioux, Bradley Gill, Howard Goldman, Sandip Vasavada, and Aaron Miller Glenn WerneburgGlenn Werneburg More articles by this author , Daniel HettelDaniel Hettel More articles by this author , Madison LyonMadison Lyon More articles by this author , Ava AdlerAva Adler More articles by this author , Peace OrjiPeace Orji More articles by this author , Suruchi RamanujanSuruchi Ramanujan More articles by this author , Jacqueline ZilliouxJacqueline Zillioux More articles by this author , Bradley GillBradley Gill More articles by this author , Howard GoldmanHoward Goldman More articles by this author , Sandip VasavadaSandip Vasavada More articles by this author , and Aaron MillerAaron Miller More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003348.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The urinary tract harbors its own microbiota. Overactive bladder (OAB) is a common urologic diagnosis, with predominant symptoms being urinary urgency and frequency. We sought to characterize the urinary microbiome of the overactive bladder population and compare that with healthy controls. We hypothesized that the population with OAB would harbor unique patterns of microbiota relative to healthy controls. Understanding the microbiota associated with OAB could open new avenues toward the investigation of alteration of microbiota as a therapeutic strategy for overactive bladder and other urologic conditions. METHODS: Female patients age 18 and over with overactive bladder by AUA/SUFU criteria were included, as were a group of control adult female patients without urologic diagnoses. Participants provided a clean catch urine specimen. Samples were subjected to next-generation sequencing, and microbial diversity was determined. Diversity and taxonomic profiles were compared between groups by two-tailed t-tests and PERMANOVA. RESULTS: 46 patients with OAB and 32 healthy controls were included. The OAB group median age was 65.7 (IQR 14.3), and the healthy control group median age was 60.4 (IQR 38.6) and. Microbiota were detected in all urine samples. Beta diversity and phylum profiles differed significantly between groups (Top, p=0.005). Specifically, Firmicutes were less abundant and Proteobacteria were more abundant in the OAB group than the control group (Bottom, p<0.05). 5 Escherichia/Shigella taxa were more abundant in the OAB group (p<0.001), and 6 Lactobacillus taxa were more abundant in the control group (p<0.05). There were no Escherichia/Shigella taxa more abundant in the control group, and no Lactobacillus taxa more abundant in the OAB group. CONCLUSIONS: The urinary microbiome differed significantly between the selected population with OAB and a healthy control population. Specifically, Lactobacillus genera were more abundant in healthy controls, and Escherichia more abundant in individuals with OAB. Additional study is needed to further delineate the relationship between the microbiome and OAB, whether it may be a cause or effect of the OAB symptom complex, and whether it can be modulated to improve OAB treatment. Source of Funding: N/A © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1074 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Glenn Werneburg More articles by this author Daniel Hettel More articles by this author Madison Lyon More articles by this author Ava Adler More articles by this author Peace Orji More articles by this author Suruchi Ramanujan More articles by this author Jacqueline Zillioux More articles by this author Bradley Gill More articles by this author Howard Goldman More articles by this author Sandip Vasavada More articles by this author Aaron Miller More articles by this author Expand All Advertisement PDF downloadLoading ...

PD19-08 THE URINARY FUNGAL MICROBIOME IN THOSE WITH OVERACTIVE BLADDER IS LESS ABUNDANT IN MALASSEZIA AND MORE ABUNDANT IN ASPERGILLUS RELATIVE TO HEALTHY CONTROLS

You have accessJournal of UrologyCME1 Apr 2023PD19-08 THE URINARY FUNGAL MICROBIOME IN THOSE WITH OVERACTIVE BLADDER IS LESS ABUNDANT IN MALASSEZIA AND MORE ABUNDANT IN ASPERGILLUS RELATIVE TO HEALTHY CONTROLS Glenn Werneburg, Daniel Hettel, Madison Lyon, Ava Adler, Peace Orji, Suruchi Ramanujan, Jacqueline Zillioux, Bradley Gill, Howard Goldman, Sandip Vasavada, and Aaron Miller Glenn WerneburgGlenn Werneburg More articles by this author , Daniel HettelDaniel Hettel More articles by this author , Madison LyonMadison Lyon More articles by this author , Ava AdlerAva Adler More articles by this author , Peace OrjiPeace Orji More articles by this author , Suruchi RamanujanSuruchi Ramanujan More articles by this author , Jacqueline ZilliouxJacqueline Zillioux More articles by this author , Bradley GillBradley Gill More articles by this author , Howard GoldmanHoward Goldman More articles by this author , Sandip VasavadaSandip Vasavada More articles by this author , and Aaron MillerAaron Miller More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003285.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The urinary tract harbors its own microbiota, but fungi composition remains poorly characterized. Overactive bladder (OAB) is a common urologic diagnosis, with predominant symptoms being urinary urgency and frequency. We sought to investigate the urinary fungal microbiome of the overactive bladder population and compare that with healthy controls. We hypothesized that the population with OAB would harbor unique patterns of fungi relative to healthy controls. Understanding the fungi associated with OAB could open new avenues toward the investigation of fungi in disease manifestation and treatment response. METHODS: Female patients age 18 and over with overactive bladder by AUA/SUFU criteria were included, as were a group of control adult female patients without urologic diagnoses. Participants provided a clean catch urine specimen. Samples were subjected to next-generation sequencing using ITS primers to capture fungii, and fungal diversity was determined. Diversity and taxonomic profiles were compared between groups by two-tailed t-tests and PERMANOVA. RESULTS: 46 patients with OAB and 32 healthy controls were included. The OAB group median age was 65.7 (IQR 14.3), and the healthy control group median age was 60.4 (IQR 38.6) and. Fungi were detected in all urine samples. The predominant phylum was Ascomycota in overactive bladder patients and Basidiomycota in healthy controls. Malassezia taxa was less (12% OAB, 18% other, p<0.05) abundant in the overactive bladder group and Aspergillus was more abundant in the OAB group (14% OAB versus 7% healthy, p<0.05). CONCLUSIONS: The urinary fungal microbiome, or “mycobiome” differed significantly between the selected population with OAB and a healthy control population. Ascomycota was the predominant phylum. Malassezia was less abundant in those with OAB and Aspergillus more abundant. Additional study is needed to further delineate the relationship between the fungal microbiome and OAB, whether it may be a cause or effect of the OAB symptom complex, and whether it can be modulated to improve OAB treatment. Source of Funding: N/A © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e580 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Glenn Werneburg More articles by this author Daniel Hettel More articles by this author Madison Lyon More articles by this author Ava Adler More articles by this author Peace Orji More articles by this author Suruchi Ramanujan More articles by this author Jacqueline Zillioux More articles by this author Bradley Gill More articles by this author Howard Goldman More articles by this author Sandip Vasavada More articles by this author Aaron Miller More articles by this author Expand All Advertisement PDF downloadLoading ...

Insights from the AQUA Registry: a retrospective study of anticholinergic polypharmacy in the United States.

Anticholinergic (ACH) burden is a risk factor for negative health outcomes among older adults. Several medications contribute to ACH burden, including antimuscarinics used to manage overactive bladder (OAB). This study aimed to understand the extent of ACH burden in an OAB population in the United States. Non-interventional retrospective analysis. Adults with OAB whose care providers participated in the American Urological Association Quality (AQUA) Registry between 2014 and 2020 were included in this study. An adapted version of the Pharmacy Quality Alliance (PQA) measure of anticholinergic polypharmacy (poly-ACH) was used to assess ACH burden. The primary outcome was the annual prevalence of poly-ACH, and a secondary outcome was the percentage of patients taking 0, 1, 2, 3, 4, or ⩾ 5 ACH medications by calendar year. Analyses were stratified by age category at diagnosis and sex. The sample comprised 552,840 patients with OAB. The mean age at initial OAB diagnosis was 65.7 years (58.2% male; 57.4% white). Prevalence of poly-ACH was highest in 2015 (3.7%) and lowest in 2020 (1.9%). Patients prescribed no ACH medications made up the largest proportion of each cohort, while those prescribed five or more comprised the smallest. The trend of decreasing proportions of patients taking increasing numbers of ACH medications was consistent. The proportion of patients prescribed no ACH medications increased from 63.3% in 2014 to 74.6% in 2020. The percentage of those prescribed three or more ACHs remained largely unchanged. Poly-ACH was highest among younger individuals (< 65 years of age) and females; temporal trends were similar overall and within each age and sex stratum. In this study, poly-ACH in patients with OAB was relatively infrequent and decreased over the study period. Further evaluation of poly-ACH is needed to assess whether the study findings reflect increased awareness of the negative effects of poly-ACH.

Clustering of patients with overactive bladder syndrome

BackgroundOveractive bladder is a heterogenous condition with poorly characterized clinical phenotypes. To discover potential patient subtypes in patients with overactive bladder (OAB), we used consensus clustering of their urinary symptoms and other non-urologic factors.MethodsClinical variables included in the k-means consensus clustering included OAB symptoms, urinary incontinence, anxiety, depression, psychological stress, somatic symptom burden, reported childhood traumatic exposure, and bladder pain.Results48 OAB patients seeking care of their symptoms were included. k-means consensus clustering identified two clusters of OAB patients: a urinary cluster and a systemic cluster. The systemic cluster, which consisted of about half of the cohort (48%), was characterized by significantly higher psychosocial burden of anxiety (HADS-A, 9.5 vs. 3.7, p < 0.001), depression (HADS-D, 6.9 vs. 3.6, p < 0.001), psychological stress (PSS, 21.4 vs. 12.9, p < 0.001), somatic symptom burden (PSPS-Q, 28.0 vs. 7.5, p < 0.001), and reported exposure to traumatic stress as a child (CTES, 17.0 vs. 5.4, p < 0.001), compared to the urinary cluster. The systemic cluster also reported more intense bladder pain (3.3 vs. 0.8, p = 0.002), more widespread distribution of pain (34.8% vs. 4.0%, p = 0.009). The systemic cluster had worse urinary incontinence (ICIQ-UI, 14.0 vs. 10.7, p = 0.028) and quality of life (SF-36, 43.7 vs. 74.6, p < 0.001). The two clusters were indistinguishable by their urgency symptoms (ICIQ-OAB, OAB-q, IUSS, 0–10 ratings). The two OAB clusters were different from patients with IC/BPS (worse urgency incontinence and less pain).ConclusionsThe OAB population is heterogeneous and symptom-based clustering has identified two clusters of OAB patients (a systemic cluster vs. a bladder cluster). Understanding the pathophysiology of OAB subtypes may facilitate treatments.

Anticholinergic burden in the Japanese elderly population: Use of antimuscarinic medications for overactive bladder patients.

To assess anticholinergic use, especially the use of antimuscarinics, in the elderly (aged ≥65years) Japanese overactive bladder and non-overactive bladder populations. Patient records were sourced from a large, nationwide Japanese pharmacy claims database. Anticholinergic use on a random day in 2016 (index date) was investigated through the Anticholinergic Cognitive Burden scale (primary scale), the Anticholinergic Drug Scale, the Anticholinergic Risk Scale and Beers criteria. The prevalence of anticholinergic use and anticholinergic scores at the index date were summarized descriptively. The overactive bladder population was defined as patients who had at least one prescription record for any antimuscarinic (fesoterodine, imidafenacin, oxybutynin, propiverine, solifenacin or tolterodine) or the β3-adrenoreceptor agonist, mirabegron, within the 1-year pre-index period. Among 1216126 outpatients, 35138 (2.9%) were included in the overactive bladder group. In total, 112 (68.7%) of the anticholinergics listed in the scales were identified. In those who received any Anticholinergic Cognitive Burden scale-listed anticholinergic, the mean scores were higher in overactive bladder patients versus non-overactive bladder patients (3.2±1.3 and 1.6±1.1, respectively). Similarly, overactive bladder patients who received antimuscarinics had higher Anticholinergic Cognitive Burden scores (3.3±1.2) than patients who received mirabegron only (1.7±1.1). In 58.8% of the overactive bladder patients, ≥80% of the total Anticholinergic Cognitive Burden score was exclusively attributable to antimuscarinics. Anticholinergic use was higher in overactive bladder patients versus non-overactive bladder patients. This increased use was largely attributable to antimuscarinics. The alternative use of mirabegron could therefore be considered to reduce the burden experienced by patients in Japan.

Effectiveness and safety of acupuncture for elderly overactive bladder population in Hong Kong: study protocol for a randomized controlled trial

BackgroundOveractive bladder (OAB) is defined as “urgency, with or without urge incontinence, usually with frequency and nocturia”. Acupuncture is one of the most popular alternative treatment methods for OAB. Little established evidence is available to support the effectiveness of acupuncture for OAB. This study is a pioneer randomized, double-blinded, sham-controlled trial to assess the effectiveness and safety of acupuncture in the elderly population with overactive bladder in Hong Kong.Methods/designThis is a randomized, double-center, patient and outcome assessor blinded, sham-controlled trial. The study sample size is 100 patients. Eligible subjects aged between 60 to 90 years old will be recruited into this study. All subjects will be randomly allocated into the active acupuncture group or sham acupuncture group in a 1: 1 ratio. Participants who are allocated into the active acupuncture group will receive a standardized 30-min real acupuncture treatment session for a total of 16 sessions on the top of standard routine care, whilst those who are randomized to the sham acupuncture arm will receive sham acupuncture in addition to standard routine care. Non-penetrating needles will be utilized as sham acupuncture. The primary outcome measure is the 7-day voiding diary and the secondary outcome measures are urine nerve growth factor (NGF) level, the Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6) and OAB Symptom Score (OABSS). All outcome measures will be collected at baseline, the end of treatment and 3 months after treatment completion.DiscussionThe objectives of this study include (1) to evaluate the effectiveness and safety of acupuncture treatment in patients with OAB on reduction in the frequency of incontinence episodes as derived from a 7-day voiding diary, (2) to evaluate whether acupuncture treatment could improve subjective symptoms in patients with OAB and (3) to examine the feasibility of using NGF as a biomarker for overactive bladder and test correlation with the effectiveness of acupuncture intervention. The finding of this study will provide preliminary evidence on the effectiveness and safety of acupuncture for treatment of OAB.Trial registrationChinese Clinical Trial Registry, ChiCTR-INR-16010048. Registered on 29 Nov 2016.

Is it Safe to Reduce Water Intake in the Overactive Bladder Population? A Systematic Review

Overactive bladder imposes a significant socioeconomic burden on the health care system. It is a commonly held belief that increased fluid intake (8glasses of water per day) is beneficial for health. However, increased fluid intake exacerbates overactive bladder symptoms. Thus, it is imperative that clinicians appropriately educate patients for whom increased water intake may be detrimental (women with overactive bladder), in contrast to patients with comorbidities that necessitate increased water intake (nephrolithiasis). We systematically reviewed the literature to determine the potential health advantages of increased water intake and identify specific subpopulations that need increased hydration. We systematically reviewed published articles from 1972 through 2017 on PubMed® and the Cochrane Library. The data were reviewed independently by 2 individuals. Studies were included if they explored water intake in relation to the risk of a particular disease. Level 1 evidence supported increased fluid intake in patients with nephrolithiasis. There was no available evidence to support increased fluid intake in patients with cardiovascular disease, constipation, venous thromboembolism, headaches, cognitive function or bladder cancer. Dehydration may exacerbate some conditions, specifically chronic constipation and headache intensity. Increased fluid intake may have a role in preventing stroke recurrence but not in preventing primary stroke. The available reviewed literature suggests no benefit to drinking 8 glasses of water per day in patients without nephrolithiasis. Also, excess fluid intake can exacerbate symptoms of overactive bladder.

Editorial Comment

The authors should be congratulated for publishing an excellent study on the impact of percutaneous tibial nerve stimulation (PTNS) on a refractory overactive bladder population. Including both subjective (questionnaires) and objective measures (diaries and urodynamics) was a unique aspect to this trial. Their definition of success was more stringent than previous studies and included >50% improvement in daytime urinary frequency, nighttime urinary frequency, reduction in OAB-q and the ICIQ-SF and at least a 50% improvement in a minimum of two urodynamic parameters. According to this criteria, 73.5% achieved success and another 20.5% were improved. Only 6 patients were considered failures. If one looked only at clinical success, PTNS was successful in 90.5% of patients, much higher than has been previously reported.

Efficacy and safety of daily mirabegron 50 mg in male patients with overactive bladder: a critical analysis of five phase III studies.

Oral pharmacotherapies to treat overactive bladder (OAB) are used less in men despite a similar prevalence of storage symptoms as women. The efficacy and safety of once-daily mirabegron 50 mg was evaluated in male OAB patients from five phase III studies that included placebo or antimuscarinic (tolterodine ER 4 mg or solifenacin 5 mg) as a comparator. Three pooled 12-week placebo-controlled studies (mirabegron 50 mg versus placebo) and one 12-week non-inferiority phase IIIb study (BEYOND; mirabegron 50 mg versus solifenacin 5 mg) were used for efficacy (daily micturition frequency, urgency and incontinence episodes) and safety analyses. An additional 52-week active-controlled phase III safety study (mirabegron 50 mg versus tolterodine ER 4 mg) was included in the safety analysis. Male patients aged ⩾18 years with OAB for ⩾3 months were included in the analyses. Patients may also have a history of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH)/benign prostatic enlargement (BPE) or concomitant use of α1-blockers. In the pooled studies, mirabegron 50 mg demonstrated superiority versus placebo (treatment difference: -0.37 [95% confidence interval (CI): -0.74, -0.01]) for reducing micturition frequency; improvements in urgency and incontinence were not significantly different between mirabegron 50 mg and placebo. In BEYOND, mirabegron 50 mg was comparable with solifenacin 5 mg for reducing micturition frequency, urgency, and incontinence episodes. Mirabegron was well tolerated at 12 and 52 weeks and overall treatment-emergent adverse events (AEs) were similar to those with placebo. In a male OAB population with or without LUTS associated with BPH/BPE, mirabegron 50 mg provided similar improvements in urgency, frequency, and incontinence as solifenacin 5 mg, and is a well-tolerated alternative to antimuscarinics. In the three pooled 12-week studies, significant differences were not seen for urgency and incontinence versus placebo, although mirabegron 50 mg did demonstrate significant improvements versus placebo for frequency.

The relationship between depression and overactive bladder/urinary incontinence symptoms in the clinical OAB population.

BackgroundTo investigate the relationship between depression and overactive bladder (OAB)/urinary incontinence symptoms among the clinical OAB population.MethodsPatients who were diagnosed with overactive bladder (OAB) and age-matched control subjects without OAB were enrolled. Depression symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS-D). OAB/incontinence symptoms were assessed using the validated questionnaires: ICIQ-UI, ICIQ-OAB, UDI-6, IIQ-7, and OAB-q.Results27.5 % of OAB patients in our study had depression (HADS ≥8), and 12 % of OAB patients had moderate to severe depression (HADS-D ≥11). OAB patients reported significantly higher HADS-D depression scores compared to age-matched controls (5.3 ± 3.9 versus 2.8 ± 3.9, p = 0.004). OAB patients with depression reported more severe incontinence symptoms (ICIQ-UI), greater bother and more impact on quality of life (UDI-6, IIQ-7) compared to OAB patients without depression (p = 0.001, 0.01, <0.001, respectively). However there were no differences in ICIQ-OAB and OAB-q. Among OAB patients, there were positive correlations between the severity of depression symptoms and OAB/incontinence symptoms (p-values <0.001 to 0.035).Conclusions27.5 % of OAB patients have depression. OAB patients with depression reported more severe urinary incontinence symptoms, greater bother and more impact on quality of life compared to those without depression. Future studies are needed to further examine the mechanistic links between depression and OAB/urinary incontinence.

Estimated Budget Impact of Increased Use of Mirabegron, A Novel Treatment for Overactive Bladder.

BACKGROUND: Oral pharmacological treatment for overactive bladder (OAB) consists of antimuscarinics and the beta-3 adrenergic agonist mirabegron. Antimuscarinic adverse events (AEs) such as dry mouth, constipation, and blurry vision can result in frequent treatment discontinuation rates, leaving part of the OAB population untreated. Antimuscarinics also contribute to a patient’s anticholinergic cognitive burden (ACB), so the Beers Criteria recommends cautious use of antimuscarinics in elderly patients who take multiple anticholinergic medications or have cognitive impairment. Since mirabegron does not affect the cholinergic pathways, it is unlikely to contribute to a patient’s ACB. OBJECTIVE: To estimate the health care costs associated with the pharmacological treatment of OAB with mirabegron and antimuscarinics from U.S. commercial payer and Medicare Advantage perspectives, using a budget impact model. METHODS: For this budget impact model, 2 analyses were performed. The primary analysis estimated the b...

Clinical characteristics, beliefs, and coping strategies among older patients with overactive bladder.

To describe clinical characteristics and assess beliefs and coping strategies in older patients with overactive bladder (OAB) attending urology and gynecology clinics in Spain. This non-interventional, multicenter, cross-sectional study collected demographic and clinical details from individuals aged ≥60 years with a diagnosis of OAB and score ≥3 on the Patient Perception of Intensity of Urgency Scale. Symptoms were assessed using the Bladder Control Self-Assessment Questionnaire (B-SAQ) and Health-Related Quality of Life (HRQoL) rated using a simple visual analogue scale. Coping strategies and OAB beliefs were assessed using two specially designed questionnaires. Patients (n = 786) reported a mean (±SD) of 4.9 ± 2.9 urinary urgency episodes and 2.9 ± 2.3 urgency urinary incontinence (UUI) episodes per 24 hr. Mean times since diagnosis and symptom onset were 18 ± 34 and 38 ± 46 months, respectively. B-SAQ symptom and bother scores were 7.5 ± 2.3 and 8.3 ± 2.5, respectively. Most patients (92%) reported worse HRQoL after symptom onset. Approximately, 50% of patients considered their symptoms normal for their age/gender and most (71.5%) expected symptoms to worsen with age/time. However, 80% believed that symptoms would improve with treatment. For coping strategies, 81% of patients changed their urinary frequency, 71% controlled fluid intake, and 64% used pads. Use of coping strategies was associated with UI severity. Many older individuals view their OAB symptoms as a normal feature of age, which may delay diagnosis. Reduced HRQoL and adoption of coping strategies are also common. The results support the need for improved patient education, earlier recognition, and effective intervention in the older OAB population. Neurourol. Urodynam. 36:774-779, 2017. © 2016 Wiley Periodicals, Inc.

A novel approach to overactive bladder syndrome treatment.

Overactive bladder (OAB) symptoms are among the most bothersome complaints of our elderly patients. They have substantial impact on all aspects of patients’ well–being and reduce their quality of life. This condition affects almost 12% of the adult population of Europe. The prevalence is constantly rising with age and reaches 36% in the group of patients above 75 years of age. The incidence of overactivity related incontinence reaches 28.7% and 50% respectively in men and women [1]. Muscarinic receptor antagonists still constitute the mainstay of the OAB pharmacotherapy. The efficacy of different antimuscarinics is comparable; they relieve symptoms partially and their efficacy is at best moderate. The adverse reaction profiles of muscarinic receptor antagonists used as first line treatment are comparable except for higher oral doses of oxybutynine and propiveryne [2]. The results of clinical trials show really high discontinuation rates – from 4% to 31% in 12 weeks observation. Furthermore, 43% to 81% of patients discontinue their treatment within 30 days, according to the medical claims studies [3]. Professor Kosilov and the co–authors, whose paper appeared in this edition of CEJU address the important clinical problem that is safe and effective treatment of the Overactive Bladder Syndrome (OAB) in the elderly [4]. The Vladivostok team describes the placebo controlled study that analyzes the effects of a novel scheme of treatment with anticholinergic agents (combined high dose pulse anticholinergic therapy) in elderly patients with detrusor overactivity related urinary incontinence. The authors used two compounds with antimuscarinic activity, which are currently not being studied as extensively, as those, having different mechanisms of action. The authors observed a reduction of incontinence events (IE) and urgency episodes lasting until the end of the observation in the group assigned to the double pulse treatment arm in both incontinence severity subgroups. Similar reduction of IE and urgency episodes was observed in patients assigned to single pulse treatment arm, but only in the moderate incontinence severity subgroup. Particularly interesting is why the severtiy of symptoms remains reduced, even after treatment cessation. When the subjects are at least in their sixties and the study drug has relatively narrow therapeutic window, the key question is the safety. The study results revealed a low rate of adverse reactions (AR) – below 12% of patients experienced ARs. These ARs were classified as moderate. The authors provide only an overall percentage of episodes. Taking into account the high doses of study medications and the age of subjects, it is particularly important to show a detailed list of ARs, grouped by treatment arms. Due to intermittent modes of drug administration, it would also be interesting to know the ARs incidence according to the corresponding study phases. The authors claim they showed acceptable tolerance of higher doses of anticholinergics in a previous paper [5]. Unfortunately, the results of this study could be biassed by the patient selection criteria. The next question is why the authors limited the study population to elderly patients with urge incontinence only? Wouldn't it have been safer to choose an idiopathic OAB population not narrowed to those with “wet” OAB in the elderly? The incidence of IE is not the only reliable outcome measure in OAB studies. Invasive urodynamic studies (UDS) were performed at the beginning and the end of the evaluation. UDS results presented in the paper did not reveal much more than the clinical data and the patient reported outcomes. Please, accept this opinion from the point of view of an urodynamics enthusiast. Overall, the authors did a real piece of work trying to look for the new possibilities in OAB treatment. They entered a good number of 313 patients into the prospective placebo controlled study. We are looking forward to see results longer than 6 months and we are also curious what there is behind the prolonged action of anticholinergics.

PUK14 - Estimation and comparison of utilities generated from a generic (EQ-5D) and disease-specific (OAB-5D) instrument in an overactive bladder population

PUK14 - Estimation and comparison of utilities generated from a generic (EQ-5D) and disease-specific (OAB-5D) instrument in an overactive bladder population

1352 FESOTERODINE IS EFFECTIVE AND WELL TOLERATED IN VULNERABLE ELDERLY SUBJECTS WITH URGENCY INCONTINENCE: A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Incontinence - Evaluation & Therapy III1 Apr 20121352 FESOTERODINE IS EFFECTIVE AND WELL TOLERATED IN VULNERABLE ELDERLY SUBJECTS WITH URGENCY INCONTINENCE: A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY Catherine DuBeau, Stephen R. Kraus, Tomas L. Griebling, Diane Newman, Jean Wyman, Joseph Ouslander, Franklin Sun, Joseph Catuogno, and Tamara Bavendam Catherine DuBeauCatherine DuBeau Worcester, MA More articles by this author , Stephen R. KrausStephen R. Kraus San Antonio, TX More articles by this author , Tomas L. GrieblingTomas L. Griebling Kansas City, KS More articles by this author , Diane NewmanDiane Newman Philadelphia, PA More articles by this author , Jean WymanJean Wyman Minneapolis, MN More articles by this author , Joseph OuslanderJoseph Ouslander Boca Raton, FL More articles by this author , Franklin SunFranklin Sun New York, NY More articles by this author , Joseph CatuognoJoseph Catuogno New York, NY More articles by this author , and Tamara BavendamTamara Bavendam New York, NY More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.1735AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Despite the high rate of overactive bladder (OAB) symptoms, including urgency urinary incontinence (UUI) in medically complex vulnerable elderly (VE), there are no data on the efficacy, safety and tolerability of antimuscarinics in this group. We therefore investigated the efficacy and safety of flexible-dose fesoterodine (FESO) vs placebo (PBO) in VE subjects with UUI. METHODS This was a 12-wk, randomized, double-blind, placebo-controlled, trial. Subjects were aged ≥65 y with a score ≥3 on the Vulnerable Elders Survey, a score ≥20 on the Mini Mental State Examination, and ≥2 but ≤15 UUI episodes and ≥ 8 micturitions per 24 h on 3-d baseline diaries. Subjects were randomized to flexible-dose FESO or PBO. Subjects receiving FESO started on 4 mg/d for 4 wk after which they could escalate to 8 mg based on a discussion with the investigator. Subjects receiving the 8-mg dose could de-escalate to 4 mg at any time during the remaining 8 wk (sham escalation and de-escalation for PBO). Primary endpoint was change from baseline to wk 12 in UUI episodes/24 h. Change from baseline to wk 12 in micturitions/24 h was also evaluated. Self-reported adverse events (AEs) were monitored. RESULTS 562 patients were randomized (281 per group); mean age was 75 y; 50.4% were aged ≥75 y. Mean reductions in UUI episodes and micturitions/24 h at wk 12 were significantly greater in the FESO group vs PBO (Figure). Dry mouth and constipation were the most common AEs (Table). Rates of discontinuation due to AEs were 5.0% (n=14) for PBO and 9.3% (n=26) for FESO. Serious AEs occurred in 6 (2.1%) subjects receiving PBO and 8 (2.8%) receiving FESO; none were considered treatment-related by the investigators. 9 subjects receiving FESO (3.2%) had urinary retention; 3 required catheterization. Table. Treatment-Emergent Adverse Events (All Causes; Incidence > 2% and Higher in the FESO Group) N (%) PBO n=281 FESO n=281 Subjects with AEs 120(42.7) 158(56.2) Discontinued due to AEs 14(5.0) 26(9.3) Dry mouth 17(6.0) 66(23.5) Constipation 12(4.3) 31(11.1) Urinary Retention⁎ 0 9(3.2) Diarrhea 7(2.5) 8(2.8) Fatigue 3(1.1) 8(2.8) Dyspepsia 1(0.7) 7(2.5) Headache 5(1.8) 7(2.5) Cough 2(0.7) 7(2.5) ⁎ 3 of the 9 subjects required catheterization. CONCLUSIONS This is the first antimuscarinic study in a medically complex VE OAB population with UUI. Subjects receiving flexible-dose FESO for 12 wk had significantly greater reduction in UUI episodes and micturitions vs the PBO group. FESO was overall well tolerated. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e548-e549 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Catherine DuBeau Worcester, MA More articles by this author Stephen R. Kraus San Antonio, TX More articles by this author Tomas L. Griebling Kansas City, KS More articles by this author Diane Newman Philadelphia, PA More articles by this author Jean Wyman Minneapolis, MN More articles by this author Joseph Ouslander Boca Raton, FL More articles by this author Franklin Sun New York, NY More articles by this author Joseph Catuogno New York, NY More articles by this author Tamara Bavendam New York, NY More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

1501 SANCTURA XR A MUSCARINIC ANTAGONIST RESISTS TRANSPORT (SMART) ACROSS THE BLOOD-BRAIN BARRIER (BBB): A PROSPECTIVE NEUROCOGNITIVE, BIODISTRIBUTION AND PHARMACOKINETIC STUDY OF EXTENDED RELEASE TROSPIUM CHLORIDE (TRCL)

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Female Urology I1 Apr 20101501 SANCTURA XR A MUSCARINIC ANTAGONIST RESISTS TRANSPORT (SMART) ACROSS THE BLOOD-BRAIN BARRIER (BBB): A PROSPECTIVE NEUROCOGNITIVE, BIODISTRIBUTION AND PHARMACOKINETIC STUDY OF EXTENDED RELEASE TROSPIUM CHLORIDE (TRCL) David Staskin, Gary Kay, Howard B. Goldman, John Ling, Kavitha Bashi, and Michael G. Oefelein David StaskinDavid Staskin Boston, MA More articles by this author , Gary KayGary Kay Tampa, FL More articles by this author , Howard B. GoldmanHoward B. Goldman Cleveland, OH More articles by this author , John LingJohn Ling Irvine, CA More articles by this author , Kavitha BashiKavitha Bashi Irvine, CA More articles by this author , and Michael G. OefeleinMichael G. Oefelein Irvine, CA More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.1239AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Anti-muscarinic treatment of overactive bladder (OAB) has been reported to cause clinically relevant impairment of CNS function, and preclinical data strongly support the different propensities of OAB drug to cross the BBB (tertiary > quaternary amine). The specific aims of this study are: 1) to determine if TrCl crosses the BBB and 2) to determine if TrCl demonstrates a clinically significant memory effect. METHODS This is an open-label, non-comparator, evaluation of TrCl XR to penetrate the BBB at plasma steady state (Day 10). TrCl levels (time 0, 2, 5, 7, 12 and 24 hr post dose) in cerebrospinal fluid (CSF) and steady-state (day 10) peak and trough plasma levels (time 0, 5 and 24 hr) were measured in non-demented elderly (mini-mental state score > 25) human volunteers (n=12) 65-75 years of age (NCT00863551). Pre-TrCl dose and day 10 post-TrCl dose testing {Hopkins Verbal Learning Test-Revised (HVLT-R)} were compared using a reliable change index (RCI) to assess if any study subject shows evidence of a change in learning or memory. RESULTS Study subjects (mean age=68ys) reported no serious adverse events. The primary outcome (TrCl concentration in CSF at steady state peak plasma concentration 5 hours post dose) achieved undetectable TrCl concentration (<40 pg/ml) despite measureable peak plasma steady state values (Cmax=964 pg/mL, AUC=18,600 pg hr/mL). A total of 72 CSF samples were evaluated all of which fell below the BLQ (<40 pg/ml) for TrCl. The secondary end point (RCI pre- and 10 days post-dose neurocognitive measurements HVLT-R: total recall=-1.5, and delayed recall-0.25) revealed minimal improvement, but no clinically meaningful net drug effect. CONCLUSIONS TrCl is undetectable at multiple time points in the CSF of elderly OAB patients despite day 10 steady state peak plasma TrCl levels. No change in memory as assessed by the RCI of the HVLT-R was identified. These pharmacological and behavioral results support a lack of CNS penetration and clinical CNS safety in a neuro-cognitively vulnerable elderly OAB population. Parameter Mean ± SD CV% Minimum Maximum Median PLASMA Cmax(pg/mL) 964±440 45.7 385 1820 787 Tmax (hr) 8.17±7.40 90.6 5 24 5 Cmin(pg/mL) 503±329 65.3 158 1210 455 Tmin (hr) 6±10.9 181 0 24 0 AUC0-24 (pg*hr/mL) 18600±9110 49.0 7800 39000 14100 CSF AUC0-24 (pg*hr/mL) 0 0 <40 <40 0 © 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e578-e579 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.MetricsAuthor Information David Staskin Boston, MA More articles by this author Gary Kay Tampa, FL More articles by this author Howard B. Goldman Cleveland, OH More articles by this author John Ling Irvine, CA More articles by this author Kavitha Bashi Irvine, CA More articles by this author Michael G. Oefelein Irvine, CA More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Preserving cognitive function for patients with overactive bladder: evidence for a differential effect with darifenacin

Background:Antimuscarinic agents used in the treatment of overactive bladder (OAB) differ in their potential to impair cognitive function. It is hypothesised that low brain concentrations and relatively low selectivity for the M1 muscarinic receptor may reduce the potential for adverse central nervous system (CNS) effects with darifenacin, compared with other antimuscarinics, particularly oxybutynin.Methods:Cognitive function studies evaluating darifenacin, oxybutynin, tolterodine, solifenacin and/or trospium were identified from publications databases (Medline, Biosis and Embase) and congress abstracts. Preclinical studies and randomised controlled trials in adults were reviewed.Results:Five randomised, double-blind, multiple-dose studies of cognitive function were identified. Oxybutynin was consistently associated with cognitive deficit (four studies), whereas darifenacin did not impair cognition (three studies). These findings were supported by data from sleep/attention and EEG studies. Tolterodine data were limited to one small study with each formulation. For solifenacin and trospium, there were no human studies evaluating memory, the cognitive function most vulnerable to CNS anticholinergics.Conclusions:There is compelling evidence of cognitive impairment with oxybutynin, whereas darifenacin stands out by demonstrating no impairment of memory or other cognitive functions in three randomised, controlled trials. This may be attributed to the differences in physicochemical properties, efflux mechanisms and relative M1 muscarinic receptor sparing. The risk of CNS impairment is of particular concern for vulnerable populations such as the elderly (a substantial proportion of the OAB population), and CNS-compromised neurogenic bladder patients such as those with multiple sclerosis or Parkinson’s disease.

Understanding the elements of overactive bladder: questions raised by the EPIC study

To compare the prevalence of frequency and nocturia and the bother they impose in a population-based sample of men and women using current International Continence Society (ICS) definitions of lower urinary tract symptoms (LUTS) and commonly used alternative definitions of these LUTS to emphasize the importance of standardizing the definitions when evaluating overactive bladder (OAB) syndrome; we also describe the spectrum of LUTS and bother they impose in this population with OAB. Several validated disease-specific measures were used in a population-based, cross-sectional telephone survey of adults aged >or=18 years in five countries. The population with OAB was defined as those participants who answered 'yes' to questions about urgency or urgency urinary incontinence according to ICS standards. The prevalence of daytime frequency and nocturia within the OAB population was examined using two different criteria for each symptom. Frequency was defined using the current ICS definition (i.e. subject's perception of whether they urinated too often during the day) or more than eight daytime voids. Nocturia was defined according to the ICS definition of having to wake once or more per night to void and using the threshold of waking twice or more per night to urinate. Urinary symptom bother within the OAB population was compared using the different criteria for frequency and nocturia. In all, 1434 participants (502 men and 932 women) were classified as having OAB; 31% of men and 25% of women with OAB had daytime frequency consistent with the ICS definition. The ICS-defined frequency identified a population with a varied distribution of reported daytime voiding frequencies; most respondents reported frequencies below the threshold of nine daytime voids. The ICS-defined daytime frequency was reported as bothersome by more than half of the OAB population (46% of men, 66% of women). Of the OAB population, approximately 75% reported one or more nocturia episodes per night, and approximately 40% reported two or more per night. The proportion of the OAB population that was bothered by nocturia increased markedly as the number of nocturia episodes increased. Among those with OAB, the most prevalent combination of OAB symptoms was urgency and nocturia. More than half of those with OAB reported urgency combined with three or more other LUTS (including voiding and postmicturition symptoms), and the number of LUTS reported increased with age. The proportion of the population reporting symptom bother increased as the number of reported LUTS in that population increased. The ICS definitions for daytime frequency as 'the subject's perception of urinating too often' and for nocturia as 'one or more episodes per night' adequately described bladder symptoms within the OAB population when assessed by the level of symptom bother. Urgency was uncommon in isolation and did not alone impose as high a level of bother as when combined with other LUTS. In this population, the most predominant manifestation of OAB was a combination of urgency with one or more other OAB symptoms. Symptom bother became more common as the number of symptoms reported increased. LUTS other than the defining symptoms of OAB were also highly prevalent within the OAB population.

過活動膀胱の医療経済

Overactive bladder (OAB) is characterized by involuntary contractions of the detrusor muscles of the bladder. The primary symptoms of OAB include urinary urgency and frequency, with or without urge incontinence. Despite the growing awareness of OAB as a chronic medical condition, little is known about the disease's economic burden. Therefore, in the present study, the costs associated with the management of OAB symptoms in Japan were estimated, and the potential cost saving by increasing the rate of physician visits in OAB population was analyzed. To estimate the costs of OAB symptoms in Japan, we collected a variety of epidemiologic and economic literatures about OAB or urinary incontinence published by June, 2007. Three types of costs were considered in this estimation: 1. OAB treatment cost (pharmacological treatment cost, diagnostic cost and cost for physician visits), 2. direct cost (OAB-related cost [urinary tract infections, skin infections and fractures] and incontinence care cost [costs of pads, diapers and cleaning]), and 3. indirect cost (work loss due to absence from work and decrease in productivity). The analysis was conducted on community dwelling Japanese persons aged > or = 40 years, and assumed that OAB patients visited a hospital or a clinic once every four weeks. For the estimation of pharmacological treatment cost, four anticholinergic drugs (immediate-release oxybutynin (Pollakisu), propiverine (BUP-4), extended-release tolterodine (Detrusitol) and solifenacin (Vesicare)) were referred. Potential cost saving was estimated on the assumption that the hospital visit rate would increase from the current 22.7% to 35% and 50%, respectively. The number of persons with OAB symptoms and OAB patients was estimated at 8.6 million (4.6 million men, 4.0 million women) and 2.0 million (1.7 million men, 0.3 million women), respectively. The annual cost for OAB was estimated to be 956.2 billion yen (112,000 yen per one person with OAB symptoms). This cost included 180.9 billion yen (19%) for OAB treatment cost (including medication of 159.1 billion yen), 62 billion yen (6%) for OAB-related cost, 28.7 billion yen (3%) for incontinence care cost and 684.6 billion yen (72%) for work loss. Therefore, the cost for work loss accounted for the majority of OAB cost. The potential annual cost saving was estimated at 92.7 billion yen and 205.8 billion yen for the assumed hospital visit rate of 35% and 50%, respectively, and 88,000 yen per newly visiting OAB patient. It was revealed that the economic impact imposed by OAB was enormous. It might be possible to reduce the cost for OAB by appropriate treatment for OAB population.