Overactive Bladder Medications Research Articles

Assessing the Impact of Overactive Bladder Medications on Cognition.

Emerging literature has associated the use of anticholinergic medications to cognitive decline. The aim of this study was to evaluate the association of overactive bladder medications on cognitive function with prospective longitudinal cognitive assessments. A population-based cohort of individuals 50 years and older who had serial validated cognitive assessment, in accordance with the Mayo Clinic Study of Aging, was evaluated from October 2004 through December 2021. Anticholinergic overactive bladder medications were grouped by traditional anticholinergic medications and central nervous system (CNS)- sparing anticholinergic medications and compared to no medication exposure. A linear mixed effects model with time-dependent exposures evaluated the association between overactive bladder anticholinergic medication exposure and subsequent trajectories of cognitive z-scores. We included 5,872 participants with a median follow-up of 6.4 years. Four hundred forty-three were exposed to traditional anticholinergic medications, 60 to CNS-sparing medications, and 5,369 had no exposure. On multivariable analyses, exposure to any anticholinergic overactive bladder medication was significantly associated with deterioration in longitudinal cognitive scores in the language and attention assessments compared to the control cohort. Traditional anticholinergic medication exposure was associated with worse attention scores than nonexposed participants. Exposure to CNS-sparing anticholinergic medications was associated with a deterioration in the language domain compared to those unexposed. Among women, traditional anticholinergic medication exposure was associated with worse global and visuospatial scores than nonexposed participants, but this association was not identified in the CNS-sparing group. Exposure to anticholinergic overactive bladder medications was associated with small but significantly worse decline in cognitive scoring in the language and attention domains when compared to nonexposed individuals.

Fragility of overactive bladder medication clinical trials: A systematic review.

Overactive bladder (OAB) syndrome significantly impairs quality of life, often necessitating pharmacological interventions with associated risks. The fragility of OAB trial outcomes, as measured by the fragility index (FI: smallest number of event changes to reverse statistical significance) and quotient (FQ: FI divided by total sample size expressed as a percentage), is critical yet unstudied. We conducted a systematic search for randomized controlled trials on OAB medications published between January 2000 and August 2023. Inclusion criteria were trials with two parallel arms reporting binary outcomes related to OAB medications. We extracted trial details, outcomes, and statistical tests employed. We calculated FI and FQ, analyzing associations with trial characteristics through linear regression. We included 57 trials with a median sample size of 211 participants and a 12% median lost to follow-up. Most studies investigated anticholinergics (37/57, 65%). The median FI/FQ was 5/3.5%. Larger trials were less fragile (median FI 8; FQ 1.0%) compared to medium (FI: 4; FQ 2.5%) and small trials (FI: 4; FQ 8.3%). Double-blinded studies exhibited higher FQs (median 2.9%) than unblinded trials (6.7%). Primary and secondary outcomes had higher FIs (median 5 and 6, respectively) than adverse events (FI: 4). Each increase in 10 participants was associated with a +0.19 increase in FI (p < 0.001). A change in outcome for a median of five participants, or 3.5% of the total sample size, could reverse the direction of statistical significance in OAB trials. Studies with larger sample sizes and efficacy outcomes from blinded trials were less fragile.

The impact of anticholinergics on cognitive function in patients with neurogenic lower urinary tract dysfunction: A narrative review.

This narrative review discusses the relationship between anticholinergic medications and cognitive change specifically in patients with neurogenic lower urinary tract dysfunction (NLUTD). NLUTD is prevalent in various conditions, including spinal cord injury (SCI), spina bifida (SB), multiple sclerosis (MS), Parkinson's, stroke, and dementia and often requires anticholinergic overactive bladder (OAB) medications. In the general population, and among those with OAB, several studies have found a significant association between this class of medications and cognitive side effects, mostly when used for > 90 days. These cognitive side effects may be particularly relevant to people with NLUTD due to their higher baseline risk of cognitive impairment. Two studies (one in people with SCI and another in MS) found evidence of cognitive impairment with the use of OAB anticholinergics (specifically oxybutynin and tolterodine). People with dementia commonly use OAB anticholinergics, and there is evidence that oxybutynin and tolterodine may impair cognition in this population. Two recent studies in children with SB studied 12 months of solifenacin and 6 months of fesoterodine/oxybutynin and found there was no significant change in neuropsychological testing. Clinical studies in people with Parkinson's disease and prior stroke have not shown that trospium, darifenacin, or fesoterodine have a significant impact on cognitive measures. In summary, oxybutynin and tolterodine may pose a higher risk of cognitive impairment than newer OAB anticholinergics in people with NLUTD; there is no evidence that children with SB experience cognitive impairment with OAB anticholinergics. Further study is necessary to confirm cognitive safety, particularly as the NLUTD population may have a high exposure to OAB anticholinergics. Advocating for potentially safer OAB medications is necessary if there is concern about cognitive risks.

Treatment Patterns with Mirabegron and Antimuscarinics for Overactive Bladder: A Prospective, Registry Study in Taiwan and South Korea (FAITH).

This study aimed to assess overactive bladder (OAB) treatment patterns and factors associated with effectiveness and persistence. A prospective, longitudinal, observational registry study of adults starting OAB therapy with mirabegron or antimuscarinics was undertaken. Primary endpoints were time from treatment initiation to discontinuation/switching; proportion who discontinued/switched; and reasons for discontinuation/switching. Secondary endpoints included OAB Symptom Score (OABSS), OAB Questionnaire: Short Form, and OAB Bladder Assessment Tool scores; factors associated with effectiveness and persistence; and safety. In total, 556 patients initiating mirabegron and 250 initiating antimuscarinics were enrolled. There was no treatment switch, change, or discontinuation in 68.5% of the mirabegron initiator group and median time to treatment change was not reached. Mean initial treatment duration was 130.8days. In multivariable models, baseline OABSS was the only variable significantly associated with change from baseline in OABSS, and patients with mild and moderate OAB had significantly better persistence with mirabegron than those with severe OAB. Urinary tract infection was the most common adverse event with mirabegron. There was no treatment switch, change, or discontinuation in 60.4% of the antimuscarinics initiator group and median time to treatment change was not reached. Solifenacin was the most frequent initial treatment (66.0%). Mean treatment duration was 122.2days. In multivariable models, baseline OABSS was the only variable significantly associated with change from baseline in OABSS, while patients with OAB medication in the 12months before enrollment had significantly better persistence with antimuscarinics than those with no previous OAB medication. Dry mouth was the most common adverse event with antimuscarinics. Mirabegron and solifenacin were commonly prescribed as first-line OAB medications. There was no treatment switch, change, or discontinuation in more than 60% of the mirabegron initiator and antimuscarinics initiator groups. Mean initial treatment duration was 130.8days and 122.2days for mirabegron and antimuscarinics, respectively. Graphical Abstract available for this article. ClinicalTrials.gov NCT03572231.

Overactive Bladder Medication Access.

The price range, insurance coverage, and side effect burden of overactive bladder medications is broad and varied. An internal quality improvement project was undertaken to improve patient ability to access and ultimately adhere to preferred medication therapy for treatment of overactive bladder. Our objective was to increase the percentage of patients per month at an academic Urogynecology practice who receive their preferred overactive bladder medication from baseline 39.5% to 45%. Data were extracted via Epic report. Manual chart review and calls to patients and/or pharmacy were completed to obtain status of medication access and reasons why medications were not taken. A targeted intervention was implemented with creation of a written document to help guide patients with options to decrease prescription costs. After this document was embedded into Epic after visit summary documentation, a repeat analysis was performed. The most common barrier to medication access was cost; specifically, the medication was not covered and a prior authorization was not initiated. Before the intervention, more than 60% of patients did not persist with their initially prescribed overactive bladder medication at a 6-month follow-up interval from office visit. Following implementation of a cost-navigation guide, persistence increased to 45.5% at a 3-month follow-up interval. A targeted intervention on cost navigation of prescriptions can have a positive effect on patient access and persistence of using overactive bladder medications. Our practice continues to use our prescription navigation handout.

A Comparison of U.S. Individual and Family Plan Medication Coverage for Overactive Bladder.

There is strong evidence for long-term cognitive effects with anticholinergic use. Differences in insurance coverage of anticholinergics and beta-3 agonists hinder individualization of overactive bladder (OAB) treatment. The aims of the study were to assess individual and family health insurance plan coverage for select OAB medications and to compare coverage of preferred medications to those with a greater risk of cognitive dysfunction. This cross-sectional study analyzed formularies for the top 7 U.S. medical insurers. Coverage tiers were assessed for the following 7 OAB medications: (1) oxybutynin instant-release 5 mg, (2) oxybutynin extended-release 5 mg, (3) solifenacin 5 mg, (4) trospium instant-release 20 mg, (5) trospium extended-release 60 mg, (6) mirabegron 25 mg, and (7) vibegron 75 mg. Coverage was compared between nonpreferred (oxybutynin, solifenacin) and preferred medications (trospium, mirabegron, vibegron). Coverage scores, representing a weighted average based on coverage tier frequency relative to the number of plans investigated for each state or insurer, were generated with a lower coverage score indicating better coverage (range, 0.2-1.0). A total of 2,780 insurance plans from 41 states representing a 47% market share for the individual and family marketplace were evaluated. Oxybutynin IR had the best coverage score across insurers (0.2) while vibegron had the worst (0.92). Preferred medications were more often designated to higher tiers with worse coverage compared with nonpreferred medications (P < 0.001). Less concordance in coverage between insurers was noted for anticholinergics with greater bladder specificity and for extended-release formulations. Despite risks with anticholinergics, beta-3 agonists were more expensive across all insurers highlighting the need for expanded coverage of preferred medications to avoid cognitive dysfunction when undergoing treatment for OAB.

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.

Who Progresses to Third-Line Therapies for Overactive Bladder? Trends From the AQUA Registry.

Overactive bladder (OAB) patients who do not achieve satisfactory results with second-line OAB medications should be offered third-line therapies (percutaneous tibial nerve stimulation, sacral neuromodulation, onabotulinumtoxinA bladder injection [BTX-A]). We aimed to determine which clinical factors affect progression from second- to third-line OAB therapy. Between 2014 and 2020, the AUA Quality Registry was queried for adult patients with idiopathic OAB. For the primary outcome, patient and provider factors associated with increased odds of progression from second- to third-line therapy were assessed. Secondary outcomes included median time for progression to third-line therapy and third-line therapy utilization across subgroups. A total of 641,122 patients met inclusion criteria and were included in analysis. Of these, only 7487 (1.2%) received third-line therapy after receiving second-line therapy. On multivariate analysis, patients aged 65 to 79, women, White race, history of dual anticholinergic and β3 agonist therapy, metropolitan area, government insurance, and single specialty practice had the greatest odds of progressing to third-line therapy. Black and Asian race, male gender, and rural setting had lower odds of progressing to third-line therapy. BTX-A was the most common therapy overall (40% BTX-A, 32% sacral neuromodulation, 28% percutaneous tibial nerve stimulation). The median time of progression from second- to third-line therapy was 15.4 months (IQR 5.9, 32.4). Patients < 50 years old and women progressed fastest to third-line therapy. Very few patients received third-line therapies, and the time to progression from second- to third-line therapies is > 1 year. The study findings highlight a potential need to improve third-line therapy implementation.

Evaluation of dementia risk in patients taking medication for overactive bladder using medication history in Japan

Evaluation of dementia risk in patients taking medication for overactive bladder using medication history in Japan

Importance of Regular Examination and Follow-up in Pediatric Patients with Neurogenic Bladder: 24-Month Follow-up Study Using a Japanese Health Insurance Database.

Data on the long-term management of neurogenic bladder (NGB) are scarce. We evaluated the current status of NGB management in Japanese children over 24-month follow-up using the JMDC database. In this descriptive, observational, retrospective cohort study, patients (≤ 17years) with NGB were included. Patient characteristics and their management status were investigated. A multivariate analysis evaluating the potential risk factors for the development of urinary tract infection (UTI) was performed. The diagnosis of spina bifida, demographics, baseline comorbidities, and early use of clean intermittent catheterization (CIC) and/or overactive bladder (OAB) drugs were used as independent variables. Of 883 eligible children, 39.3% had spina bifida. Over 12/24-month post-index periods, renal urinary tract ultrasound and urinalysis were performed at least once in > 35%/> 45% patients, respectively, while specific tests (urodynamics, cystourethrography, scintigraphy) were performed in substantially fewer (< 11%/< 13%) patients. Over 24months, 21.5% patients used OAB medications (mostly anticholinergics) and 10.8% underwent CIC, alone or with medications; 1.2% patients underwent surgery. Lower UTI (23.3%), urinary incontinence (9.7%), and hydronephrosis (7.0%) were the most common incident complications. Multivariate analysis evaluating risk factors for UTI showed significantly higher odds ratios with point estimates of ≥ 2 for CIC (5.70), presence of spina bifida (2.86), and constipation (2.07). Overall, urodynamic assessments were inadequately performed. Patients with use of CIC and/or having spina bifida and constipation had a higher risk of UTI, suggesting the need for careful follow-up. More guideline-compliant and diligent patient management is necessary in Japanese children with NGB.

The Use of Metformin in Overactive Bladder: A Retrospective Nested Case-control, Population-based Analysis

To determine if metformin use is associated with a lower rate of overactive bladder (OAB) medication use. Metformin facilitates the proliferation and migration of stem cells, which have been shown to improve bladder overactivity in animal models. We conducted a retrospective nested case-control cohort study using population-based health-care administrative databases. Our cohort included patients with diabetes mellitus type 2 (DM2) ≥69years. Cases received a prescription for an OAB medication, matched with up to 4 controls based on age, sex, and DM2 diagnosis date. Exposure was a new prescription for metformin prior to receiving an OAB medication. Adjusted odds ratios were estimated using conditional logistic regression. Sensitivity analysis was done to assess the relationship between cumulative days' supply of metformin and use of OAB medications. Within our cohort of 2,233,084 patients with DM2, there were 16,549 case subjects who received a prescription for an OAB medication, and 64,171 matched controls. We found a positive association between OAB medication use and metformin use (adjusted odds ratios=1.07, 95% CI=1.03-1.12). Summed days' supply of metformin was also associated with OAB medication use, except when summed metformin days was >2220. Older patients with DM2 exposed to metformin had a slightly higher rate of OAB medication use, until 2220+ days' metformin supply, whereafter no association was found. This suggests no protective role for metformin in the prevention of OAB in this patient population.

Mixed Urinary Incontinence: Diagnosis and Management

The evaluation and treatment of mixed urinary incontinence receives relatively little attention as compared to other forms of incontinence. Mixed incontinence, however, defined as the combination of stress and urgency incontinence, accounts for the largest proportion of incontinence, with an increased incidence in older women. The condition can be very challenging to manage due to the coexistence of multiple pathologies. Treating either component can worsen the other, which means careful discussion of the risks and benefits, in addition to considerations of multimodal treatment approaches are required. In the older adult population, where this condition confers a significant impact on quality of life, there are many special considerations when evaluating and treating patients. Evaluation requires a careful assessment of the impact on QOL and goals of care and may need to involve caregivers and/or family members in the discussion, in addition to considerations of more advance evaluation on an individual basis prior to invasive treatments. Conservative treatments including behavioral and lifestyle modifications and pelvic floor physical therapy should be the mainstay of first-line treatment for older women with MUI, while taking into careful consideration how cognitive and/or physical limitations may impact treatment. Pharmacologic therapy should include a consideration of vaginal estrogen replacement, however oral medications for urgency and overactive bladder have increased risks in older women, which means more advanced treatments may want to be introduced sooner. There is really limited data on the use of third-line overactive bladder treatments in older women with mixed incontinence, however there may be some demonstrated benefits. Finally, when considering surgical interventions in this population, although the data demonstrate some benefit in mixed incontinence, providers may want to utilize a formalized assessment of frailty due to the increased morbidity associated with frailty in surgeries for incontinence.

Comparative assessment of efficacy and safety of approved oral therapies for overactive bladder: a systematic review and network meta-analysis.

Pubmed, Embase, Web of Science, and the Cochrane Register of Clinical Trials databases were systematically searched. The search time frame was from database creation to June 2, 2022. Randomized controlled double-blind trials of oral medication for overactive bladder were screened against the protocol's entry criteria. Trials were evaluated for quality using the Cochrane Risk of Bias Assessment Tool, and data were statistically analyzed using Stata 16.0 software. A total of 60 randomized controlled double-blind clinical trials were included involving 50,333 subjects. Solifenacin 10mg was the most effective in mean daily micturitions and incontinence episodes, solifenacin 5/10mg in mean daily urinary urgency episodes and nocturia episodes, fesoterodine 8mg in urgency incontinence episodes/d and oxybutynin 5mg in voided volume/micturition. In terms of safety, solifenacin 5mg, ER-tolterodine 4mg, mirabegron, vibegron and ER-oxybutynin 10mg all showed a better incidence of dry mouth, fesoterodine 4mg, ER-oxybutynin 10mg, tolterodine 2mg, and vibegron in the incidence of constipation. Compared to placebo, imidafenacin 0.1mg showed a significantly increased incidence in hypertension, solifenacin 10mg in urinary tract infection, fesoterodine 4/8mg and darifenacin 15mg in headache. Solifenacin showed better efficacy. For safety, most anticholinergic drugs were more likely to cause dry mouth and constipation, lower doses were better tolerated. The choice of drugs should be tailored to the patient's specific situation to find the best balance between efficacy and safety.

Analyzing Access and Costs of Oral Medications for Overactive Bladder: Uncovering Disparities

To report out-of-pocket costs associated with overactive bladder (OAB) medications among Medicare beneficiaries and the uninsured. We performed a cross-sectional analysis of the Centers for Medicare & Medicaid Services Prescription Drug Plan Formulary Data (Q1-2022). FDA-approved medications for OAB were identified. We calculated out-of-pocket costs for Medicare beneficiaries in each Part D prescription benefit phase, average retail price, total yearly costs and discounted prices through cash-pay discount coupons (GoodRx) or online pharmacies like Mark Cuban Cost Plus Drug Company (MCCPDC). We also report plan utilization management requirements. We analyzed 5721 plan formularies for 18 medications. Mirabegron was the only beta-3 agonist (B3). Only Vesicare oral solution (14.3% of plans) and Mirabegron (0.1%) required prior authorization. Many plans required step therapy for selective generic anticholinergics (ACH) (12.4%-43.3%), while the B3 rarely required step therapy (0.6%). Monthly costs varied by coverage phase and averaged $59 for ACHs in the initial coverage phase ($14 in catastrophic; $72 in coverage gap). The monthly cost for the B3 averaged $47 in the initial coverage phase ($26 in catastrophic; $129 in coverage gap). The total yearly cost for generic ACHs ranged from $494 (oxybutynin IR) to $1452 (darifenacin) and the yearly cost for brand-name ACHs ranged from $1175 (Toviaz ER) to $2198 (Oxytrol). The total yearly cost for the B3 was $1283. We evaluated coverage, out-of-pocket costs, total yearly costs, and utilization management for OAB medications to make pricing more transparent. While selective medications may be "covered," coverage does not translate into affordable drug prices.

Patient and Clinician Challenges with Anticholinergic Step Therapy in the Treatment of Overactive Bladder: A Narrative Review.

Anticholinergics have been used in the treatment of overactive bladder (OAB), but their use is limited by poor tolerability and anticholinergic-related side effects. Increasingly, providers are discontinuing anticholinergic prescribing because of growing evidence of the association of anticholinergic use with increased risk of cognitive decline and other adverse effects. Newer medications for OAB, the β3-adrenergic receptor agonists mirabegron and vibegron, do not have anticholinergic properties and are typically well tolerated; however, many insurance plans have limited patient access to these newer OAB medications by requiring step therapy, meaning less expensive anticholinergic medications must be trialed and/or failed before a β3-agonist will be covered and dispensed. Thus, many patients are unable to easily access these medications. Step therapy and other drug utilization strategies (e.g., prior authorization) are often used to manage the growing costs of pharmaceuticals, but these policies do not always follow treatment guidelines and may harm patients as a result of treatment delays, discontinuations, or related increases in adverse events. Medical professionals have called for reform of drug utilization strategies through partnerships that include clinicians and policymakers. This narrative review discusses prescribing patterns for OAB treatment and the effect of switching between drugs, as well as the costs of step therapy and prior authorization on patients and prescribers.

Overactive Bladder Medication Prescribing Trends in the Era of Known Cognitive Effects from Anticholinergic Drugs

Overactive Bladder Medication Prescribing Trends in the Era of Known Cognitive Effects from Anticholinergic Drugs

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

To characterize first therapeutic change and healthcare resource utilization in older men initiating an overactive bladder (OAB) or benign prostatic obstruction (BPO) medication. 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 (β3 agonist, antimuscarinic) or BPO (α-blocker, 5-α-reductase inhibitor) prescription and ≥1-year postindex data (index=first observed dispensation). 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. 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%). 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.

Ninjin'yoeito Improves Genitourinary Symptoms in Patients With Frailty.

Introduction In geriatric medicine, there is currently significant attention on frailty, a condition commonly associated with aging and characterized by muscle weakness and other age-related changes. Within the fields of urology and gynecology, conditions such as overactive bladder (OAB) and genitourinary syndrome of menopause (GSM) have been identified as crucial concerns due to their negative impact on the quality of life of elderly individuals. In this study, we investigated the potential of Ninjin'yoeito (NYT), a traditional Chinese herbal medicine, as a viable treatment option for frailty. Additionally, we hypothesized that NYT may also contribute to the improvement of symptoms associated with OAB and GSM, and potentially help in reducing the dosage of OAB medications. Methods In this retrospective cohort study conducted from November 2016 to November 2022, we created a website describing the relationship between frailty and genitourinary symptoms in frail patients aged ≥ 65 years with GSM who underwent pelvic floor muscle training. The patients were divided into two propensity score-matched groups: NYT group (received NYT for one year) and no-NYT group (did not receive NYT), based on their wishes. The fatigue, resistance, ambulation, illnesses, and loss of weight (FRAIL) scale was used to assess frailty status. Urinary symptoms were evaluated using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and Overactive Bladder Symptom Score (OABSS). Genital symptoms were investigated using the vaginal health index score and vulvodynia swab test. The value of each score was obtained before (T0) and 12 months after (T12) treatment, and the difference (ΔT0/T12) was calculated. Results During the study period, 985 outpatients visited our clinic, of whom 725 were considered frail/pre-frail; 402 women with frailty/pre-frailty (mean age 77.5 ± 6.49 years) were included, with a median follow-up of 14.5 months. The NYT and no-NYT groups had 220 and 182 patients, respectively. After propensity score matching, each group had 159 patients. ΔT0/T12FRAIL scale score was significantly higher in the NYT group (0.13 ± 0.37) than in the no-NYT (0.01 ± 0.10) group (p=0.001.) However, urinary symptoms improved in the NYT group more than in the no-NYT in terms of the following parameters: ΔT0/T12OABSS (NYT: 0.89 ± 1.65; no-NYTl: 0.36 ± 1.14, p=0.001) and ΔT0/T12ICIQ-SF score (NYT: 1.51 ± 1.75; no-NYT: 0.42 ± 1.18, p<0.001). Genital symptoms were better in the NYT group in terms of ΔT0/T12VHIS (NYT: 0.58 ±1.08; no-NYT: 0.21 ±0.65, p<0.001). The vulvodynia swab test showed improvements in left para-hymen evoked pain in both groups. In the NYT group, 5% of the patients underwent antimuscarinic drug dose reduction for overactive bladder treatment. NYT use was not associated with significant side effects, and only 0.6% of patients reported drug allergies. Conclusion NYT improved activity levels in frail/pre-frail patients. Moreover, NYT use improved various genitourinary symptoms experienced by patients with frailty/pre-frailty. Treatment with NYT may reduce the dose of overactive bladder medications. The anticholinergic load-reducing effect of NYT may help solve the problem of polypharmacy.

Is there an increased risk of dementia with use of medications for overactive bladder?

East Pierce Family Medicine Residency Program, Puyallup, WA The corresponding author is Chelsi Goodman; [email protected] The authors declare no conflicts of interest.

One treatment with onabotulinumtoxinA relieves symptoms of overactive bladder in patients refractory to one or more oral medications.

Patients with overactive bladder (OAB) often undergo prolonged treatment with one or more oral OAB medications. OnabotulinumtoxinA (onabotA), a type A botulinum toxin, may provide an appropriate alternative to oral treatments in patients intolerant of or refractory to one or more oral OAB medications. The GRACE study demonstrated real-world benefits of onabotA treatment for OAB in patients refractory to oral medications. This exploratory post hoc analysis of data from the GRACE study aims to determine if treatment history impacts benefit from treatment with onabotA. This is a subanalysis of the GRACE study, a prospective observational study (NCT02161159) that enrolled patients with symptomatic OAB inadequately managed by at least one oral OAB medication. Patients had a treatment history of one or more anticholinergics (AC) and/or β-3 adrenoreceptor agonists (β-3) for relief of OAB; results were stratified according to treatment history. Patients in this analysis elected to discontinue oral medications upon treatment with onabotA. Safety was followed for 12 months in all patients that received at least 1 dose of onabotA; efficacy was determined over a 12-week period. Compared to baseline levels, significant reductions in urinary incontinence(UI), urgency, micturition, and nocturia were noted as early as 1week and were sustained at 12 weeks, regardless of the type and number of oral medications taken before treatment with onabotA. At 12 weeks post-onabotA, the mean change from baseline UI episodes/day for those with a treatment history of only one AC was -2.4 (n = 43, p ≤ 0.001); more than one AC, -2.4 (n = 52, p ≤ 0.001); one β-3, -3.3 (n = 12, p < 0.05); at least one AC and at least one β-3, -3.2 (n = 56, p ≤ 0.001). Pad and liner use was significantly decreased at 12 weeks post-onabotA across all treatment history groups. Reductions in diaper pant use varied, with less of a reduction in patients with a treatment history of more than one AC compared to patients with a history of at least one AC and one β-3 (p < 0.05) or those with a history of only one AC (p < 0.05). Overall, a total of 253/288 of patients (88%) reported improvements on the treatment benefit scale 12 weeks after treatment with onabotA, regardless of type and number of prior oral medications. In the population of patients that received at least one dose of onabotA (N = 504), 57 adverse events were reported in 38 patients (7.5%); 9 were serious (1.8%). Urinary retention was reported in 5 patients (1.0%); 1 was severe (0.2%). Symptomatic urinary tract infection was reported in 2 patients (0.4%). In this exploratory post hoc analysis of real-world data from the GRACE study, there were few significant differences in outcomes based on the type and number of prior oral medications. Thus, patients who are refractory to one or more oral OAB medications may benefit from earlier treatment with onabotA.