Neutrophil-to-lymphocyte ratio as a promising non-invasive biomarker for symptom assessment and diagnosis of interstitial cystitis/bladder pain syndrome.

BACKGROUND: Our study aims to investigate the association between the serum neutrophil-to-lymphocyte ratio (NLR) and interstitial cystitis (IC), as well as to explore whether NLR can serve as a diagnostic marker to distinguish IC from overactive bladder (OAB). We postulate that elevated NLR levels are intricately linked to the onset and clinical presentation of IC, and that the NLR profiles in OAB patients exhibit discernible disparities from those of IC patients. METHODS: In a retrospective analysis, we scrutinized the medical records of 70 women diagnosed with IC/BPS, 20 women diagnosed with OAB, and a randomly selected cohort of 150 healthy women who underwent physical examinations during the same temporal frame. A comprehensive panel of blood tests was administered to all participants, and NLR was determined through the calculation of the neutrophil-to-lymphocyte proportion. Additionally, symptom assessment questionnaires and urination diaries were collected from IC/BPS patients. RESULTS: NLR levels exhibited significant distinctions among the IC/BPS, Normal, and OAB groups (P < 0.001). Within the IC/BPS group, Hunner type interstitial cystitis (HIC) demonstrated notably divergent NLR levels in comparison to non-Hunner type interstitial cystitis (NHIC) (p = 0.001). Additionally, we observed positive correlations between NLR and Nighttime voids (r = 0.268, p = 0.029), ICPI (r = 0.327, p = 0.007), ICSI (r = 0.369, p = 0.002), PUF Symptom Scale (r = 0.263, p = 0.032), and PUF (r = 0.297, p = 0.015). The receiver operating characteristic (ROC) analysis yielded an area under the curve (AUC) of 0.765 for NLR in distinguishing IC/BPS from the Normal group, and an AUC of 0.707 in discerning IC from OAB. Furthermore, the AUC of NLR was 0.723 for identifying HIC and NHIC patients. CONCLUSIONS: Our study unveils the prospective utility of serum NLR as a promising biomarker for both diagnostic and symptom evaluation purposes in IC/BPS patients. It effectively demarcates this condition from OAB, which presents with similar clinical features. Consequently, NLR demonstrates potential as a non-invasive diagnostic instrument to distinguish between the subtypes of IC, particularly HIC and NHIC, which manifest similar symptoms within the IC/BPS spectrum.

Comparative safety of antimuscarinics versus mirabegron for overactive bladder in Parkinson disease.

BACKGROUND: Overactive bladder (OAB) is a common non-motor symptom of Parkinson disease (PD), often treated with antimuscarinics or beta-3 agonists. There is lack of evidence to guide OAB management in PD. OBJECTIVES: To assess the comparative safety of antimuscarinics versus beta-3 agonists for OAB treatment in PD. METHODS: We employed a new-user, active-comparator cohort study design. We included Medicare beneficiaries age ≥65 years with PD who were new users of either antimuscarinic or beta-3 agonist. The primary outcome was any acute care encounter (i.e., non-elective hospitalization or emergency department visit) within 90 days of OAB drug initiation. The main secondary outcome was a composite measure of acute care encounters for anticholinergic related adverse events (AEs). Matching on high-dimensional propensity score (hdPS) was used to address potential confounding. We used Cox proportional hazards models to examine the association between OAB drug category and outcomes. We repeated analyses for 30- and 180-day follow-up periods. RESULTS: We identified 27,091 individuals meeting inclusion criteria (mean age: 77.8 years). After hdPS matching, antimuscarinic users had increased risks for any acute care encounter (hazard ratio [HR] 1.23, 95% confidence interval [CI] 1.12-1.37) and encounters for anticholinergic related AEs (HR 1.18, 95% CI 1.04-1.34) compared to beta-3 agonist users. Similar associations were observed for sensitivity analyses. CONCLUSIONS: Among persons with PD, anticholinergic initiation was associated with a higher risk of acute care encounters compared with beta-3 agonist initiation. The long-term safety of anticholinergic vs. beta-3 agonist therapy in the PD population should be evaluated in a prospective study.

Assessment of bladder pressure and discomfort symptoms: How do overactive bladder differ from interstitial cystitis/bladder pain syndrome patients?

BACKGROUND: To better understand the sensation of bladder "pressure" and "discomfort", and how they are similar or distinct from the "pain" and "urgency" symptoms in IC/BPS and OAB. METHODS: IC/BPS and OAB patients rated their bladder pain, pressure, discomfort, and urinary urgency on separate 0-10 numeric rating scales (NRS). Their NRS ratings were compared between IC/BPS and OAB, and Pearson correlations were performed. RESULTS: Among IC/BPS patients (n = 27), their mean numeric ratings of pain, pressure, discomfort, and urinary urgency were almost identical (6.6 ± 2.1, 6.0 ± 2.5, 6.5 ± 2.2, and 6.0 ± 2.8 respectively). The three-way correlations between pain, pressure, or discomfort were very strong (all > 0.77). Among OAB patients (n = 51), their mean numeric ratings of pain, pressure, and discomfort (2.0 ± 2.6, 3.4 ± 2.9, 3.4 ± 2.9) were significantly lower than urgency (6.1 ± 2.6, p < 0.001). The correlations between urgency and pain, and between urgency and pressure were weak in OAB (0.21 and 0.26). The correlation between urgency and discomfort was moderate in OAB (0.45). The most bothersome symptom of IC/BPS was bladder/pubic pain, while the most bothersome symptom of OAB was urinary urgency and daytime frequency. CONCLUSIONS: IC/BPS patients interpreted bladder pain, pressure, or discomfort as the similar concepts and rated their intensity similarly. It is unclear whether pressure or discomfort provide additional information beyond pain in IC/BPS. Discomfort may also be confused with urgency in OAB. We should re-examine the descriptors pressure or discomfort in the IC/BPS case definition.

Physiotherapeutic assessment and management of overactive bladder syndrome: a case report.

INTRODUCTION: Overactive Bladder Syndrome (OAB) has multiple treatment methods including pharmacotherapy, pelvic floor muscle training, electrostimulation, or surgery. One of the nonpharmacological treatment options is physiotherapy including pelvic floor muscle training. CASE DESCRIPTION: The patient was a 25 year-old woman who attended the urogynecological physiotherapy consulting room due to frequent sensations of bladder pressure. Manual inspection and ultrasound imaging was used by the physiotherapist in order to assess the function of pelvic and abominal structures. The patient reported pain symptoms during examination of several pelvic floor and abdominal muscles. The patient was judged eligible for urogynecological physiotherapeutic treatment. Manual therapy of the lumbopelvic hip complex, manual therapy per vaginum, manual therapy of the musculus piriformis, and therapy of the superficial back line myofascial meridian and the lateral line myofascial meridian were used. During the final session, the patient reported an improvement in relation to the symptoms presented, most notably no frequent feeling of bladder pressure. CONCLUSIONS: Treatment of OAB is often a multistage process involving application of different therapies by a multidisciplinary team. For this patient, physiotherapy assessment and intervention were an integral part of the conservative management of OAB.

Pathophysiology, assessment, and treatment of overactive bladder symptoms in patients with interstitial cystitis/bladder pain syndrome.

INTRODUCTION: Interstitial cystitis/bladder pain syndrome (IC/BPS) is prevalent, difficult to treat, and has close symptom overlap with overactive bladder (OAB). A review of the pathophysiology, assessment, and treatment of IC/BPS patients with overlapping OAB symptoms has not been summarized recently in the published literature. METHODS: A review of the published literature on the overlap of IC/BPS and OAB was conducted using MeSH terminology (1992-2022). RESULTS: The pathophysiology of IC/BPS is not fully understood. Animal research has found the bladder trigone and base are richly populated by afferent fibers, including many small unmyelinated C-fibers that may be upregulated in IC/BPS. Successful therapies with multimodal effects on OAB symptoms in patients with IC/BPS are likely to exert beneficial effects on both pain and lower urinary tract symptoms. Potentially efficacious therapies for the treatment of OAB in IC/BPS include pelvic floor physical therapy, oral pharmacotherapy (antimuscarinics and beta-3 agonists), sacral neuromodulation, percutaneous tibial nerve stimulation, and botulinum toxin A (BTA). Antimuscarinics and beta-3 agonists have yielded partial efficacy in IC/BPS, although may help differentiate symptoms of OAB from those associated with IC/BPS. The transvaginal trigone treatment (T3) intradetrusor injection approach allows for delivery of therapeutics to the bladder without the need for a cystoscope and appears to be feasible. CONCLUSIONS: Further research is needed to understand the pathophysiology of IC/BPS and symptom overlap with OAB, which in turn should enable the development of more personalized therapeutics.

Why Patients Fall Through the Cracks: Assessment of Patients' Overactive Bladder Treatment.

Objective: Despite an established treatment algorithm for overactive bladder (OAB), it is unclear how many patients proceed through each step. Our objective was to evaluate the percentage of patients receiving each step of care and identify reasons why patients did not receive certain treatments. Methods: This was a retrospective cohort study with cross-sectional survey of new OAB patients. The medical record was queried for relevant patient characteristics and documentation of conservative, medical, and third-line therapies. In the survey, patients were asked about current bladder symptoms and reasons why they did not use certain treatments. Descriptive statistics were used for analysis. Results: One hundred eleven patients met the inclusion criteria; the most common diagnosis was mixed incontinence (40%, n = 45). The median number of visits for OAB was 2 (range 1-8). On retrospective analysis, 64% (71) of patients had documented attempts at conservative therapy. Seventy-six percent (84) of patients attempted medical therapy, and only 11% (12) progressed to any third-line therapy. Fifty-nine percent (64) of eligible patients responded to the survey. Fifty-three percent (34) of respondents reported persistent moderate to very severe bother due to bladder symptoms. Thirty percent to fifty percent of patients who did not attempt one or more of the three levels of OAB therapy reported that they were never offered that treatment option. Conclusions: Many patients do not progress to the next steps in OAB therapy despite failure of more conservative treatments. Barriers to care included limited follow-up and education about other therapy options. A formalized institutional care pathway may lead to improved OAB treatment.

Female Urgency, Trial of Urodynamics as Routine Evaluation (FUTURE study): a superiority randomised clinical trial to evaluate the effectiveness and cost-effectiveness of invasive urodynamic investigations in management of women with refractory overactive bladder symptoms.

BACKGROUND: Overactive bladder (OAB) syndrome is a symptom complex affecting 12-14% of the UK adult female population. Symptoms include urinary urgency, with or without urgency incontinence, increased daytime urinary frequency and nocturia. OAB has a negative impact on women's social, physical, and psychological wellbeing. Initial treatment includes lifestyle modifications, bladder retraining, pelvic floor exercises and pharmacological therapy. However, these measures are unsuccessful in 25-40% of women (refractory OAB). Before considering invasive treatments, such as Botulinum toxin injection or sacral neuromodulation, most guidelines recommend urodynamics to confirm diagnosis of detrusor overactivity (DO). However, urodynamics may fail to show evidence of DO in up to 45% of cases, hence the need to evaluate its effectiveness and cost-effectiveness. FUTURE (Female Urgency, Trial of Urodynamics as Routine Evaluation) aims to test the hypothesis that, in women with refractory OAB, urodynamics and comprehensive clinical assessment is associated with superior patient-reported outcomes following treatment and is more cost-effective, compared to comprehensive clinical assessment only. METHODS: FUTURE is a pragmatic, multi-centre, superiority randomised controlled trial. Women aged ≥ 18 years with refractory OAB or urgency predominant mixed urinary incontinence, and who have failed/not tolerated conservative and medical treatment, are considered for trial entry. We aim to recruit 1096 women from approximately 60 secondary/tertiary care hospitals across the UK. All consenting women will complete questionnaires at baseline, 3 months, 6 months and 15 months post-randomisation. The primary outcome is participant-reported success at 15 months post-randomisation measured using the Patient Global Impression of Improvement. The primary economic outcome is incremental cost per quality-adjusted life year gained at 15 months. The secondary outcomes include adverse events, impact on other urinary symptoms and health-related quality of life. Qualitative interviews with participants and clinicians and a health economic evaluation will also be conducted. The statistical analysis of the primary outcome will be by intention-to-treat. Results will be presented as estimates and 95% CIs. DISCUSSION: The FUTURE study will inform patients, clinicians and policy makers whether routine urodynamics improves treatment outcomes in women with refractory OAB and whether it is cost-effective. TRIAL REGISTRATION: ISRCTN63268739 . Registered on 14 September 2017.

Patient Perceptions Impact Progression to Third-Line Therapy for Treatment of Overactive Bladder.

PURPOSE: We aimed to understand the reasons patients choose to pursue third-line overactive bladder (OAB) therapy. MATERIALS AND METHODS: We conducted a mixed methods study that included patient interviews and survey data. Eligible patients were diagnosed by symptoms, had tried behavioral modifications, and OAB medications enrolled from October 2018 to August 2019. In addition to interviews, patients completed 4 surveys: the Pelvic Floor Distress Inventory, Overactive Bladder Questionnaire Short Form, Life Orientation Test-Revised, and a patient confidence in the health care system survey. Qualitative interview data were analyzed thematically. Logistic regression and chi-square analysis was used to analyze survey data. RESULTS: A total of 69 patients were consented, 4 withdrew, and 51 completed both interview and survey data. Overall 55% of patients were Caucasian, 45% were African American, and their average age was 71 (SD=10.4); 75% intended to pursue third-line OAB therapy and 31 (61%) expressed interest in a specific third-line therapy. Major interview themes included a desire for a better quality of life, embarrassment with accidents, and problems with medication. Themes leading patients away from third-line OAB treatment included concern about invasiveness and side effects of treatments, and restrictions to accessing care. CONCLUSIONS: Most patients desired to progress to third-line OAB therapy, were motivated by embarrassment, but were concerned about treatment side effects. We found that economic burden of OAB treatment is associated with patient interest in and decision to receive third-line therapies to include onabotulinumtoxinA and percutaneous tibial nerve stimulation. Improved quality of life, medication frustration, and concerns about side effects of further therapy are themes patients identified when patients considered third-line overactive bladder therapy.

An Exploratory Analysis of Tamsulosin for Overactive Bladder (OAB) in Men With Varying Voiding Symptom Burden.

OBJECTIVE: To evaluate tamsulosin (α-blocker therapy) for male overactive bladder (OAB) and to examine if indicators of concomitant benign prostatic hyperplasia are associated with OAB symptom improvement. MATERIALS AND METHODS: This was a planned, exploratory analysis of a 4-week, α-blocker (tamsulosin 0.4 mg) run-in phase of the Male Overactive Bladder Trial in Veterans (MOTIVE). Participants with urinary urgency and urinary frequency (> 8 voids/24 hours) completed bladder diaries, answered symptom questionnaires (AUA-7 SI), and had post-void residual and noninvasive uroflowmetry measurement. RESULTS: A total of 116 male Veterans aged 42-88 years with OAB participated. There were statistically significant reductions in voiding frequency (11.3 > 10.0 voids/24 hours, P < .0001), urgency scores (mean 2.5-2.2 points, P < .0001), and nightly nocturia (2.1 > 1.8, P < .001). Only baseline AUA-7 SI total and voiding subscale categories (mild, moderate, severe) were associated with significant reduction in AUA-7 SI total score. For continuous variables, only AUA-7 SI baseline total score was associated with AUA-7 SI storage symptom changes. No other baseline measures were associated with changes in urgency, frequency, or nocturia. CONCLUSION: Initiation of short course tamsulosin therapy in men was associated with statistical reduction in OAB symptoms. Baseline post-void residual, uroflow rate, and the voiding symptom subscore of the AUA-7 SI were not predictive of OAB symptom improvement with tamsulosin. These findings merits further exploration.

Validation of the Overactive Bladder-Bladder Assessment Tool (OAB-BAT): A Potential Alternative to the Standard Bladder Diary for Monitoring OAB Outcomes.

BACKGROUND: An advisory board concluded that a new, comprehensive overactive bladder (OAB) patient-reported outcome (PRO) measure should be developed in accordance with regulatory guidelines. The OAB-Bladder Assessment Tool (OAB-BAT) was developed with qualitative input from OAB patients and experts to measure symptoms, bother, impacts, and satisfaction with treatment. OBJECTIVE: Psychometric evaluation of the OAB-BAT assessing PRO OAB symptoms, bother, and impacts during a 7-d recall period. DESIGN, SETTING, AND PARTICIPANTS: Psychometric testing was conducted for a 28-d observational study of 170 OAB patients. Eligibility criteria included clinician-confirmed OAB diagnosis with at least eight micturitions per day. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Assessments included the OAB-BAT, a 7-d bladder diary, and co-validating OAB PROs. Analysis included classical and modern test theories. A scoring algorithm was developed and psychometric properties were assessed. RESULTS AND LIMITATIONS: The majority of participants were women (72.4%) with moderate OAB symptom severity (53.5%). More than one-third of participants (34.1%) were incontinent. Responses were well balanced across bother and impact items, while symptom frequency items showed sparse responses. Analysis supported an eight-item unidimensional model based on bother and impacts. No items performed differently by gender or continence status. The OAB-BAT showed internal consistency (ω=0.918), retest reliability (two-way random intraclass correlation coefficient=0.81), and convergent validity with the OAB-q (r>0.4). Known groups showed the expected trend. Comparisons between OAB-BAT scores and components of the bladder diary showed a moderate effect size (r>0.4). CONCLUSIONS: The eight-item OAB-BAT with 7-d recall is valid and reliable as an OAB PRO measure. Structural modeling, balanced with content validity considerations, produced robust scores. The OAB-BAT is a useful addition to the clinical assessment of patients, designed to complement the use of bladder diaries for monitoring OAB outcomes, in clinical trial and clinical practice environments. Future studies will need to assess the treatment satisfaction items in a larger sample of patients receiving OAB treatment. PATIENT SUMMARY: We tested a questionnaire designed to assess overactive bladder (OAB) symptoms, bother, satisfaction, and impacts by asking patients to complete it on a weekly basis. We found that the questionnaire accurately captures the symptoms and impacts that are most important to patients with OAB. We conclude that the questionnaire could be a useful instrument and, after further assessment in clinical practice and research, a possible alternative to a bladder diary in measuring OAB outcomes.

Evaluating the Quality of Overactive Bladder Patient Education Material on YouTube: A Pilot Study Using the Patient Education Materials Assessment Tool.

OBJECTIVES: To assess the characteristics and quality of patient education content for overactive bladder (OAB) on YouTube. METHODS: We searched YouTube on September 10, 2019 and reviewed the top 25 search results for "overactive bladder." For comparison, we reviewed 3 Urology Care Foundation (UCF) OAB education videos on YouTube. Videos were scored using the Agency for Healthcare Research and Quality's Patient Education Materials Assessment Tool (PEMAT) for Audiovisual materials, which is subdivided into understandability and actionability domains, each with a maximum score of 100%. RESULTS: The mean length was 9.5 (0.9-34) minutes and the mean number of views was 151,382 (127-2,032,441). Of the top 25 search results, the mean PEMAT understandability score was 74% ± 16% (range 41%-100%). The mean PEMAT actionability score was 57% ± 39% (range 0%-100%). Seventy-two percent of the reviewed videos featured a physician. In comparison, the 3 UCF videos had an average of 5840 views, 3 minutes length, and PEMAT understandability and actionability scores of 93% and 100%. All UCF OAB videos featured urologists. CONCLUSION: The quality of OAB patient education materials on YouTube varies significantly in understandability and actionability. Although the UCF videos scored much higher on the PEMAT than our reviewed videos, they did not appear within the top 25 search results for OAB. There is great opportunity for the American Urological Association (AUA)/UCF and Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) to increase its outreach to patients on platforms like YouTube.

Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019.

PURPOSE: The purpose of this guideline is to provide a clinical framework for the diagnosis and treatment of non-neurogenic overactive bladder (OAB). MATERIALS & METHODS: The primary source of evidence for the original version of this guideline was the systematic review and data extraction conducted as part of the Agency for Healthcare Research and Quality (AHRQ) Evidence Report/Technology Assessment Number 187 titled Treatment of Overactive Bladder in Women (2009). That report was supplemented with additional searches capturing literature published through December 2011. Following initial publication, this guideline underwent amendment in 2014 and 2018. The current document reflects relevant literature published through October 2018. RESULTS: When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high), B (moderate), or C (low). Such statements are provided as Standards, Recommendations, or Options. In instances of insufficient evidence, additional guidance information is provided as Clinical Principles and Expert Opinions. CONCLUSIONS: The evidence-based statements are provided for diagnosis and overall management of OAB, as well as for the various treatments. Diagnosis and treatment methodologies can be expected to change as the evidence base grows and as new treatment strategies become obtainable.

Need for urodynamic evaluation as a regular follow-up tool in assessment of long-term urological outcomes in patients with sacrococcygeal teratoma.

AIM: To assess the long-term urologic outcomes in follow-up of patients of sacrococcygeal teratoma (SCT) using urodynamic study (UDS) in addition to clinical and radiologic evaluation. METHODS: A prospective study of clinical, radiological and urodynamic evaluation in patients with SCT who underwent resection between January 2002-June 2015 and were followed up till January 2016 was conducted. RESULTS: Total 57 patients, 42 (73.7%) females and 15 (26.3%) males with 35 (62.4%) following treatment for benign and 22 (38.5%) for malignant disease were included. Twenty-eight of 57 (49.12%) had urological problems. Clinical complaints in 21 (36.8%) patients included stress urinary incontinence-14 (66.7%), enuresis-9 (42.9%), and poor stream or dribbling of urine-6 (28.6%). Eight of 51 patients (15.7%) had abnormal ultrasound findings, which included contracted, trabeculated thick walled bladder (3), bilateral hydronephrosis (3) and significant post void residue (PVR) (6). Seven of 57 underwent micturating cystourethrogram (MCU), 5 had an abnormal report[significant PVR (4), small trabeculated bladder (3), reflux (2) and large capacity bladder (1)]. Urodynamic study was done in 27 patients, 18/27 (66.7%) had abnormalities. Six patients without any clinical or ultrasonographic abnormalities had abnormal UDS. Total 28 (49.12%) had urological comorbidities. Three patients had overactive bladder, five dysfunctional voiding, one underactive bladder and one had giggle incontinence. Children were managed by behaviour therapy and pharmacotherapy. CONCLUSION: Urodynamic evaluation could detect abnormalities in patients who had no urinary complaints or abnormality on ultrasound. The abnormalities have a potential for progressive upper tract damage. Urodynamics should be an integral part of urological surveillance in patients operated for SCT. TYPE OF STUDY: Prognostic study. LEVEL OF EVIDENCE: Level II (Prospective cohort study).

Socioeconomic status and health-related quality of life among adults and older with overactive bladder.

OBJECTIVE: To study the effect of socioeconomic status (SES) on health-related quality of life (HRQoL) among persons with overactive bladder (OAB). DESIGN: A randomized HRQoL study was conducted from the year 2014 until the year 2016 based on the OAB pathology department of the regional clinical diagnostics center. SETTING: The medical institutions where the study was conducted had outpatient care. PARTICIPANTS: The simple response frequency was 81%. A total of 1893 men and women with OAB aged 35-85 (average 58.3 years) were selected by blind random sampling. Included into the group of examined individuals were persons who diagnosis provided after the examination was OAB. INTERVENTION: Evaluation of HRQoL was conducted using the SF-6D questionnaire. The OAB diagnosis was confirmed using the OAB-questionnaire and uroflowmetry. MAIN OUTCOME MEASURE(S): We hypothesized that the impact of SES on the HRQoL of patients with OAB has significant features. RESULTS: Described for the first time were HRQoL measures in various SES levels within different ages of people suffering from OAB. The strongest relationship was identified between education level, professional activity and HRQoL measures; meanwhile the weakest relationship was between income and HRQoL measures. We also confirmed the efficiency of evaluating HRQoL while using SF-6D and SRH as an external standard. CONCLUSION: The improvement of HRQoL in persons with OAB is contingent upon increment in their level of awareness about the methods of OAB treatment and the effectiveness of treatment for severe symptoms of LUT pathology, increased social support and, possibly, physical activity.

Mirabegron or tolterodine for the treatment of overactive bladder in Japan: Which drug is more cost-effective as the first-line treatment?

OBJECTIVES: To assess the cost-effectiveness of mirabegron 50 mg relative to tolterodine extended release 4 mg for the treatment of overactive bladder if used as the first-line treatment in Japan. METHODS: A Markov model was developed to simulate the cost-effectiveness of the mirabegron first-line treatment (and tolterodine second-line) versus tolterodine first-line treatment (and mirabegron second-line) taken for 5 years from the randomized European-Australian study (SCORPIO trial) and single technology appraisal assessment report by the National Institute for Health and Care Excellence. The incremental cost-effectiveness ratio was calculated with utility value by quality-adjusted life year with cost using the medical fee and the drug price tariff in 2016. For the study of transition of treatment status, our analytical model was established. The transition probabilities of severity states were calculated based on the probabilities for the mean numbers of incontinence episodes/day and micturition episodes/day in mirabegron-treated and tolterodine-treated patients in the single technology appraisal assessment report. RESULTS: The 5-year expected effect per patient was 3.860 quality-adjusted life years for first-line mirabegron and 3.839 quality-adjusted life years for first-line tolterodine. The 5-year expected cost per patient was ¥526 191 for first-line mirabegron, and ¥472 390 for first-line tolterodine. The incremental cost-effectiveness ratio was ¥2 565 927/quality-adjusted life year. This value was below the willingness-to-pay threshold of ¥5 million/quality-adjusted life year. In more severe states, the incremental cost-effectiveness ratio exceeded ¥5 million. CONCLUSIONS: First-line mirabegron appears to be more cost-effective than first-line tolterodine. In patients with severe symptoms, first-line mirabegron is not economically preferable.

Does industry-sponsored education foster overdiagnosis and overtreatment of depression, osteoporosis and over-active bladder syndrome? An Australian cohort study.

OBJECTIVES: To investigate patterns of industry-sponsored educational events that focus on specific health conditions for which there are concerns about overdiagnosis and overtreatment. DESIGN AND SETTING: This retrospective cohort study examines publicly reported industry-sponsored events in Australia from October 2011 to September 2015 for three conditions potentially subject to overdiagnosis and overtreatment: depression, osteoporosis and overactive bladder. We used a database of transparency reports to identify events with a focus on depression, osteoporosis and overactive bladder and compared these with other sponsored events. We hypothesised that companies marketing treatments for each condition would sponsor related events and that target audiences would mainly work in primary care, reflecting a broad patient population. MAIN OUTCOME MEASURES: Event and attendee characteristics, sponsoring companies, related marketed treatments, cost-effectiveness ratings and dispensing rates. RESULTS: Over the study period, we identified 1567 events focusing on depression, 1375 on osteoporosis and 190 on overactive bladder (total n=3132, with 96 660 attendees). These events were attended by primary care doctors more often than sponsored events without a focus on these three conditions: relative risk (RR)=3.06 (95% CI 2.81 to 3.32) for depression, RR=1.48 (95% CI 1.41 to 1.55) for osteoporosis and RR=2.59 (95% CI 2.09 to 3.21) for overactive bladder. Servier, which markets agomelatine and AstraZeneca (quetiapine) sponsored 51.2% and 23.0% of depression events, respectively. Amgen and GlaxoSmithKline, which co-market denosumab, sponsored 49.5% of osteoporosis events and Astellas and Commonwealth Serum Laboratories (CSL) (mirabegron and solifenacin) sponsored 80.5% of overactive bladder events. CONCLUSIONS: This 4-year overview of industry-sponsored events on three overdiagnosed and overtreated conditions found that primary care clinicians were often targeted, dinner was often provided and that a few companies sponsored most events. In most cases, sponsors' products are not cost-effective choices for the specified condition. This pattern highlights the need for professional education to be free of commercial sponsorship.

Extraordinary daytime only urinary frequency in childhood: Prevalence, diagnosis, and management.

INTRODUCTION: Since standardization of the ICCS terminology, only two small case series of children with extraordinary daytime only urinary frequency (EDOUF) have been published. The aims of the present study were i) to describe a large cohort of children affected by EDOUF, to evaluate its rate among the main micturition pediatric disturbances, and to determine if there is different EDOUF onset among seasons; ii) to investigate possible associations with urodynamic abnormalities by non-invasive techniques; iii) to evaluate whether postponing micturition exercise (PME) can objectively verify the anamnestic data hinting at the EDOUF diagnosis; and iv) to determine the effect of postponing micturition at home. MATERIAL AND METHODS: We reviewed the records of all patients with EDOUF, nocturnal enuresis, and/or overactive bladder firstly examined from March 2012 to February 2016. We evaluated post-void residual and bladder wall thickness by urinary ultrasound and uroflowmetry and recorded the season in which the EDOUF started. Through the PME, the EDOUF diagnosis was confirmed if patients were able to postpone micturition reaching at least 80% of the expected bladder capacity without showing urinary incontinence. At home, we recommended postponing micturition for a maximum of 3 h if EDOUF affected the normal daily activities of both children and parents. We set a telephone interview for 3 months later. RESULTS: The clinical characteristics of the EDOUF population are shown in the Table. The EDOUF rate was 12.1%. The rate of EDOUF onset was significantly lower during the summer than in other seasons (p = 0.02) and the OR for onset of EDOUF in the summer - compared with the other seasons - was 0.37 (95% CI 0.18-0.74; p = 0.005). Eighty-five (80.2%) patients reported an intermittent trend of the EDOUF with variable periods of improvement and worsening. All the EDOUF patients had normal uroflowmetry, 1/106 had post-micturition bladder wall thickness >5 mm and one post-void residual. At the PME, 106 out of 106 (100%) patients with EDOUF were able to reach at least 80% of the EBC without showing urinary incontinence or urgency incontinence. After 3 months, in 98.1% of the patients the symptoms had disappeared or improved. DISCUSSION AND CONCLUSIONS: Childhood EDOUF is rather common and is generally associated with normal non-invasive urodynamic patterns. The PME allows verification of anamnestic data of EDOUF. The sole recommendation to postpone micturition for a maximum of 3 h or until the micturition postponement became stressful could be considered as a possible approach.

Development of an overactive bladder assessment tool (BAT): A potential improvement to the standard bladder diary.

AIMS: To develop a comprehensive patient-reported bladder assessment tool (BAT) for assessing overactive bladder (OAB) symptoms, bother, impacts, and satisfaction with treatment. METHODS: Subjects were consented and eligibility was confirmed by a recruiting physician; subjects were then scheduled for in-person interviews. For concept elicitation and cognitive interviews, 30 and 20 subjects, respectively, were targeted for recruitment from US sites. All interviews were conducted face-to-face, audio-recorded, transcribed verbatim, anonymized, and analyzed using a qualitative data analysis software program. A draft BAT was created based on the results of the concept elicitation interviews and further revised based on cognitive interviews as well as feedback from an advisory board of clinical and patient-reported outcome (PRO) experts. RESULTS: Nocturia, daytime frequency, and urgency were reported by all subjects (n = 30, 100.0%), and incontinence was reported by most subjects (n = 25, 83.3%). The most frequently reported impacts were waking up to urinate (n = 30, 100.0%), embarrassment/shame (n = 24, 80.0%), stress/anxiety (n = 23, 76.7%), and lack of control (n = 23, 76.7%). Following analysis, item generation, cognitive interviews, and advisory board feedback, the resulting BAT contains four hypothesized domains (symptom frequency, symptom bother, impacts, and satisfaction with treatment) and 17 items with a 7-day recall period. CONCLUSIONS: The BAT has been developed in multiple stages with input from both OAB patients and clinical experts following the recommended processes included in the FDA PRO Guidance for Industry. Once fully validated, we believe it will offer a superior alternative to use of the bladder diary and other PROs for monitoring OAB patients in clinical trials and clinical practice.

Development and feasibility assessment of a 3 day electronic bladder diary as an app for smart-phone.

AIMS: To develop a 3 day bladder diary (BD) as an easy-to-use application for smart-phone (eDM3d). To test its feasibility and acceptance in a reduced number of patients. METHODS: An external agency developed the eDM3d following the structure of the Spanish validated 3 day BD (DM3d©), which includes a frequency-volume chart, the assessment of the grade of urgency, the incontinence events and fluid intake. The eDM3d consisted in a main interface of four buttons ("wake up," "go to bed," "urinate," "drink") which had to be clicked to create an event. Results were automatically transferred to an internet server to obtain an electronic report. We recruited 25 patients with overactive bladder syndrome or nocturia and previous experience on paper BD. They were asked to complete the eDM3d. Finally, a direct question about satisfaction was answered: "If you had to complete a BD again, would you choose the paper or the app version?" RESULTS: Three patients (12%) did not complete the eDM3d, 1 patient (4%) completed 2 days of the eDM3d and did not register volumes of micturition nor fluid intake, 1 patient (4%) completed all 2 days variables and 20 patients (80%) completed all 3 day variables. Regarding satisfaction, 19 patients (86.4%) would choose the app version, 2 patients (9.1%) would choose a paper version and 1 patient (4.5%) would choose either indistinctly. CONCLUSIONS: The eDM3d is a useful tool easily filled in by patients with a high satisfaction rate. Adequate validation of the eDM3d is required.

Predictors for detrusor overactivity following extensive vaginal pelvic reconstructive surgery.

AIM: This study aims to identify the predictors for detrusor overactivity (DO) in women following extensive vaginal pelvic reconstructive surgery (PRS) for advanced pelvic organ prolapse (POP). METHODS: We enrolled 1503 women who had prolapse POP-Q stage ≥ 3 and underwent vaginal PRS with or without MUS from January 2006 to December 2015. All subjects completed a 72-h voiding diary, IIQ-7, UDI-6, POPDI-6, and PISQ-12. Urodynamics (UDS) was performed pre- and post-operatively. RESULTS: Among 1503 women, 56 patients were excluded due to incomplete data. Women who had trans-vaginal mesh were 1083 of 1447 (74.8%) and concomitant MUS were 353 (24.4%). Pre-operative DO were 245 (16.9%) and 24.5% (60/245) of them continued to have persistent DO post-operatively. Women who had normal pre-operative stable detrusor were 1202 (83.1%) and 3.5% (30/1202) developed de novo DO post-operatively. The overall incidence of post-operative DO was 6.2% (90/1447). Patients with age ≥66 year, neurological factors like Cerebrovascular accident and Parkinsonian disease, pre-operative bladder outlet obstruction (BOO) maximum urethral closure pressure (MUCP) ≥60 cmH2 O, Maximum flow rate (MFR) <15 mL/s and detrusor at maximum flow (Dmax) ≥20 cmH2 O) and post-void residue (PVR) ≥200 mL hold a significant higher risk of developing DO either persistent or de novo following PRS. CONCLUSION: Age ≥66 year, neurological factors like CVA and Parkinsonian disease, pre-operative MUCP ≥60 cmH2 O, MFR < 15 mL, Dmax ≥ 20 cmH2 O, and PVR ≥ 200 mL are independent risk factors for developing post-operative DO following vaginal PRS for advanced POP.