A Retrospective Database Analysis to Investigate Treatment Patterns and Health Care Resource Utilisation in Patients who CYCLe AntiMuscarinics in ENgland (CYCLAMEN).

BACKGROUND: Patients with overactive bladder may cycle through different antimuscarinic medications even though there is limited evidence to support this approach. OBJECTIVE: To describe treatment patterns and the associated health care resource utilisation (HCRU) according to antimuscarinic cycling groups. DESIGN, SETTING, AND PARTICIPANTS: The CYCLe AntiMuscarinics in ENgland (CYCLAMEN) study was a retrospective observational investigation that used primary care records from the Clinical Practice Research Datalink GOLD database linked to Hospital Episode Statistics secondary care data. Eligible patients (≥18 yr) were prescribed their first antimuscarinic between January 2014 and December 2017. Patients were categorised into groups prescribed one, two, or three or more (groups 1-3) consecutive unique antimuscarinics over 18 mo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The HCRU rate and costs were calculated for the period of continuous antimuscarinic therapy (first antimuscarinic treatment episode) and the 18-mo follow-up period. Treatment sequence patterns were displayed using sunburst plots and Kaplan-Meier analysis was used to assess time on treatment. RESULTS AND LIMITATIONS: Overall, 35 369 patients were included, of whom 31 760 (89.8%) received one antimuscarinic (group 1), 3182 (9.0%) received two (group 2), and 427 (1.2%) received three or more (group 3). The most common initial antimuscarinics were solifenacin (13 628 patients, 42.9%) in group 1, and oxybutynin in group 2 (1267 patients, 39.8%) and group 3 (200 patients, 46.8%). The median duration of the first antimuscarinic treatment episode was 57 d and <20% of patients were receiving any antimuscarinic after 18 mo. The number of primary care visits and mean costs increased across groups. The reasons for cycling could not be identified in this study. CONCLUSIONS: Approximately 10% of patients underwent sequential cycling with two or more antimuscarinics. Furthermore, as the majority discontinued treatment within 18 mo, there is a need to improve the management of these patients in the clinical care setting. PATIENT SUMMARY: We investigated treatment patterns and health care use for patients with overactive bladder who were prescribed at least one antimuscarinic drug (AMD), which are drugs that reduce some of the impulses passing from the bladder to the brain. Around 10% of patients accessing primary health care in England received more than one sequential AMD. Most patients discontinued treatment, which may indicate inadequate management of their condition. Prescription of a higher number of AMDs was associated with higher health care costs.

Treatment Patterns in Men Prescribed Benign Prostatic Obstruction or Overactive Bladder Medications in Canada: A Retrospective Population-based Study.

OBJECTIVE: To characterize first therapeutic change and healthcare resource utilization in older men initiating an overactive bladder (OAB) or benign prostatic obstruction (BPO) medication. METHODS: A retrospective cohort study using health administrative data from ICES in Ontario, Canada (from April 01, 2010 to December 31, 2018) was conducted in men aged ≥66 years with ≥1 OAB (ß3 agonist, antimuscarinic) or BPO (α-blocker, 5-α-reductase inhibitor) prescription and ≥1-year postindex data (index=first observed dispensation). EXCLUSIONS: prescriptions for these drugs ≤1 year preindex, a related procedure ≤5 years. Patients were grouped by condition based on index prescription. Treatment changes in relation to OAB and BPO were characterized by type. Costs and healthcare resource utilization pre- and post-index were compared. RESULTS: Age, geographic region, and income were similar between groups. The most common initial treatments were antimuscarinics (78.1%) in the OAB group and alpha-blockers (86.4%) in the BPO group. The OAB group was more likely to experience a therapeutic change and had a shorter time to first change in therapy (78 [30,231] vs 104 [30,350] days) and higher mean healthcare costs both pre- ($12,354 vs $11,497) and postindex ($14,423 vs $12,852). The most common first therapeutic change in both groups was discontinuing treatment (OAB: 75.6%; BPO: 69.9%). CONCLUSION: Men initiating OAB medications changed therapy sooner than those initiating BPO medications. Most discontinued first-line therapy without initiating further treatment, suggesting unmet need in this population.

The use of mono- and combination drug therapy in men and women with lower urinary tract symptoms (LUTS) in the UK: a retrospective observational study.

BACKGROUND: Combination drug therapy for lower urinary tract symptoms (LUTS) is beneficial to selected patients and recommended by guidelines. Patterns of real-world LUTS drug use, especially combination drug therapy, have not been studied extensively. Moreover, further understanding of the recent landscape is required following the introduction of the beta-3-adrenoceptor agonist mirabegron in the UK in 2013 for overactive bladder (OAB). The objective was to describe mono- and combination drug therapy use for LUTS in patients in UK clinical practice. METHODS: This was a retrospective, descriptive, observational database study using UK Clinical Practice Research Datalink GOLD and linked databases. Men and women ≥ 18 years with a first prescription for any LUTS drug from 2014 to 2016 with ≥ 12 months continuous enrollment pre- and post-index date were included. Primary endpoints were mono- or combination drug therapy use for LUTS in male and female cohorts. Secondary endpoints were description of treatment prescribed, treatment persistence and patient demographics. Data were analyzed descriptively. Sub-cohorts were defined by drugs prescribed at index date. RESULTS: 79,472 patients (61.3% male) were included, based on index treatments. Of all men, 82.5% received any benign prostatic obstruction (BPO) drug, 25.4% any OAB drug, and 7.9% any BPO drug plus any OAB drug. As either mono- or combination drug therapy, 77.1% received an alpha-blocker, 18.9% a 5-alpha reductase inhibitor, 23.9% an antimuscarinic agent, and 2.1% mirabegron. Of all women, 94.5% received any OAB drug, 6.0% duloxetine, and 0.5% any OAB drug plus duloxetine. As either mono- or combination drug therapy, 87.7% received an antimuscarinic, and 9.7% mirabegron. In men or women receiving OAB treatment, approximately 2.5% received combination drug therapy with an antimuscarinic agent and mirabegron. For OAB drug monotherapies, mirabegron had the highest persistence in both male and female cohorts. CONCLUSIONS: This study provides a better understanding of the recent landscape of LUTS drug use in UK clinical practice. It highlights potential undertreatment of storage symptoms in men with LUTS and the low use of combination OAB treatments.

Anticholinergic Burden and Associated Healthcare Resource Utilization in Older Adults with Overactive Bladder.

BACKGROUND: Bladder anticholinergics are the most widely used drugs to treat overactive bladder (OAB) but can contribute to cumulative anticholinergic burden, which may be associated with adverse outcomes. OBJECTIVE: This study aimed to evaluate the association between cumulative anticholinergic burden and healthcare resource utilization (HRU) and costs in older adults with OAB. MATERIALS AND METHODS: This was a retrospective, observational study that used data from the UK Clinical Practice Research Datalink (CPRD) GOLD database. Participants were aged ≥ 65 years with ≥ 3 years of continuous enrolment before and ≥ 2 years after the index date (date of OAB diagnosis or first prescription for any OAB drug between 1 April 2007 and 31 December 2015). The primary endpoint was the association between cumulative anticholinergic burden (assessed using the Anticholinergic Cognitive Burden [ACB] scale during the 3-year pre-index period) and HRU (GP consultations, specialist referrals, urological tests, hospital admissions) over the 2-year post-index period. RESULTS: Data from 23,561 adults were included in the analysis. Mean (SD) ACB scores in the pre- and post-index periods were 1.0 (1.1) and 2.4 (1.7), respectively; urological drugs contributed most (58.8%) to the latter. For the primary endpoint, higher pre-index ACB scores were associated with higher post-index HRU and costs. Mean (SD) ACB scores in the post-index period were 1.2 (1.3) and 2.5 (1.7) in those treated with mirabegron (beta-3 agonist) or bladder anticholinergics, respectively. LIMITATIONS: The generalizability of the results outside the UK is unclear. CONCLUSIONS: In older adults with OAB, higher anticholinergic burden before initiating OAB drugs is associated with higher HRU and costs. When making treatment decisions in older adults, consideration should be given to assessing the existing anticholinergic burden and using OAB treatments that do not add to this burden.

A retrospective analysis comparing persistence and adherence to treatment with free- vs fixed-dose combination of an alpha blocker and an antimuscarinic agent in men with LUTS in Spain.

INTRODUCTION: Combination therapy with an alpha blocker (AB) plus an antimuscarinic (AM) is recommended for men with moderate-to-severe mixed lower urinary tract symptoms (LUTS) when monotherapy is not effective in relieving storage symptoms. This study compared treatment persistence and adherence with an AB plus AM fixed-dose combination (FDC) vs an AB plus AM free-dose combination in men with LUTS in Spain. METHODS: Retrospective study using the Spanish IQVIA Cegedim Electronic Medical Records database. Men prescribed AB plus AM combination therapy were included in an FDC or free-dose combination cohort based on their index treatment. Treatment persistence was the time from index date to first discontinuation of ≥1 of the two index drugs over 12 months. Adherence was measured using the fixed medication possession ratio (MPR). RESULTS: Of 3114 patients identified, 999 were included (FDC, n = 790; free-dose combination, n = 209). Median (95% CI) persistence was longer in the FDC (125 [109-151] days) than in the free-dose combination (31 [31-36] days) cohort (hazard ratio [HR], 2.9; 95% CI, 2.4-3.4; P < .0001). The 12-month persistence rates were 31.1% (FDC cohort) and 8.9% (free-dose cohort). The mean (SD) fixed MPR was higher in the FDC cohort (48.8 [37.2]) compared with the free-dose cohort (23.1 [28.4]); more patients in the FDC cohort (34.2%) than in the free-dose cohort (10.0%) were adherent (MPR ≥ 80%). The probability of treatment persistence and adherence increased with age (>80 vs <65 years, persistence HR, 0.7 [95% CI, 0.5-0.9]; MPR difference, 12.5), polypharmacy (persistence HR, 0.7 [95% CI, 0.6-0.9]; MPR difference, 10.7) and previous use of AB (persistence HR, 0.8 [95% CI, 0.7-1.0]; MPR difference, 5.7) or AB/AM combinations (persistence HR, 0.7 [95% CI, 0.5-0.9]; MPR difference, 11.1). CONCLUSIONS: Treatment with an AB/AM FDC is associated with better persistence and adherence vs a free-dose combination in men with LUTS in Spain.

Cough stress tests to diagnose stress urinary incontinence in women with pelvic organ prolapse with indication for surgical treatment.

AIMS: To evaluate the diagnostic ability of different cough stress tests (CSTs) in women with pelvic organ prolapse (POP), performed during outpatient urogynaecological exams. METHODS: Prospective, multicentre observational study involving women on waiting lists for POP surgery. With a subjectively full bladder, patients were asked to perform five different CSTs: without prolapse reduction ([a] standing, followed by [b] semilithotomy position); keeping semilithotomy position with prolapse reduced (by [c] posterior speculum, followed by [d] pessary); [e] standing again with the pessary in place. Primary outcome was positive CST in at least one of the five CSTs. Bladder volume was measured and symptoms of stress urinary incontinence (SUI) were detected by two validated questionnaires. RESULTS: A total of 297 women completed all CSTs and were included in the analyses. Mean (SD) age, parity, and body mass index were 64.8 (9.9) years, 2.7 (1.3) deliveries, and 26.6 (3.4) kg/m2 , respectively. In total, 99 women (33.3%) reported SUI symptoms. At least one positive CST was recorded in 152 patients (51.1%), and in 90 (59.2%) of these 152, a positive CST was observed only when POP was reduced (occult SUI). The CST was positive in 92 (92.9%) of the 99 patients with coexisting SUI symptoms and in 60 (30.3%) of the 205 asymptomatic patients. The percentage of patients with a positive CST was significantly lower when bladder volume was <200 mL vs ≥200 mL (P = .046). CONCLUSIONS: The identification of urinary leakage cases with CSTs is best achieved using multiple different patient positions, different prolapse reduction methods, and bladder volumes ≥200 mL.

Qualitative Analysis of Factors Influencing Patient Persistence and Adherence to Prescribed Overactive Bladder Medication in UK Primary Care.

INTRODUCTION: Pharmacotherapy for overactive bladder (OAB) is generally associated with low rates of persistence and adherence. This study was conducted to explore the patient journey in a UK primary care setting (experiences, perceptions, attitudes, and levels of engagement and expectations) and identify self-reported reasons for patient non-adherence and/or non-persistence to medications for OAB. METHODS: This was a qualitative, non-interventional study involving one-to-one semi-structured, face-to-face or phone interviews with individuals aged 40-80 years, diagnosed with OAB, and currently taking, or having taken, either antimuscarinic or ß3-adrenoceptor agonist medications within the last 12 months. Thematic analyses of interview transcripts identified themes surrounding the participants' experiences with OAB. RESULTS: A total of 20 interviews were conducted (face-to-face, n = 13; telephone, n = 7). Interviews from five men and 13 women (mean age 70 years) were included in the final analysis. The most common OAB symptoms reported included urgency, frequency, incontinence and nocturia. Several key themes of factors influencing persistence and/or adherence to prescribed OAB medication were identified: patients' attitude and condition adaptation behaviour; support with treatment; unmet efficacy/tolerability expectations; drug/condition hierarchy. Non-adherence and/or non-persistence to OAB medication was largely intentional, with patients balancing side effects against perceived clinical benefits. Perceived lack of efficacy was the primary reason for discontinuing treatment. Other factors cited included side effects of medication (either experienced or a fear of future effects), a general aversion to long-term medication taking, drug/condition hierarchy relative to other comorbidities, and limited healthcare professional (HCP) support/engagement. Patients expressed condition adaptation behaviours to help self-manage their condition. CONCLUSION: Persistence and adherence to OAB medication may be suboptimal. HCPs might be able to improve persistence and adherence by fostering realistic treatment expectations and scheduling regular medication reviews. These measures may help optimise patient care and support more adherent behaviours, thus minimising the impact of undertreated OAB on patient quality of life. FUNDING: Innovate UK and Astellas Pharma Europe Ltd (APEL).