Treatment Of Overactive Bladder Research Articles

Outcomes of para-sacral transcutaneous electric nerve stimulation in treatment of primary and refractory overactive bladder among children.

Overactive bladder (OAB) is the most prevalent lower urinary tract dysfunction among children. Refractory OAB lacks response to the first line treatments, including anticholinergic, and it is a major clinical challenge. This study aims to compare the efficacy of para-sacral transcutaneous electric nerve stimulation (PS-TENS) in the treatment of primary and refractory OAB among children. A prospective, randomized clinical study included 64 children aged 5-12 years with OAB divided equally into two groups: group (1) included 32 children with treatment-naive OAB, while group (2) included 32 children with refractory OAB who failed complete course of anticholinergics. Both groups received PS-TENS three times weekly for 12weeks. Detailed medical history, voiding diary, ultrasound, and uroflowmetry with EMG were performed at baseline and after 12 weeks of treatment. Filling cystometry was performed for children with refractory OAB before and after PS-TENS. After the end of treatment the number of children with urge incontinence decreased significantly among the two groups: from 25 to 13 and 27 to 15 for the primary and refractory groups, respectively. Micturition frequency per 24h decreased significantly among children with primary OAB. Bladder capacity increased significantly and the resting detrusor pressure decreased significantly among children with refractory OAB. PS-TENS is an effective and safe treatment option for children with OAB. The magnitude of improvement is higher among children with primary as compared to refractory OAB.

Comparative analysis of real-world adherence and persistence patterns with vibegron, mirabegron, and anticholinergics in patients with overactive bladder: A retrospective claims study.

Vibegron is a selective β3-adrenergic receptor agonist that was approved by the US Food and Drug Administration in December 2020 for the treatment of overactive bladder in adults. This retrospective study assessed US pharmacy claims data to evaluate the real-world adherence and persistence of vibegron compared with mirabegron and with anticholinergics. This analysis used the Optum Research Database to identify adults with ≥1 pharmacy claim for vibegron, mirabegron, or an anticholinergic from April 1, 2021, to August 31, 2022. Patients had ≥ 90 days of continuous commercial or Medicare medical and pharmacy coverage preindex and ≥ 60 days of continuous pharmacy coverage postindex. Two independent propensity-score models matched patients treated with (1) vibegron versus mirabegron and (2) vibegron versus anticholinergics on key variables such as demographics and clinical characteristics, index copay, days' supply, and time of entry into analysis (index quarter). Adherence was measured by proportion of days covered (PDC) from index to the end of follow-up and was defined as PDC ≥ 80%. Persistence was defined as days to discontinuation of index medication (first 30-day gap) or end of follow-up. The matched vibegron and mirabegron cohorts included 4921 and 9842 patients, respectively, and the matched vibegron and anticholinergic cohorts included 4676 and 9352 patients, respectively. Patients receiving vibegron had greater mean PDC versus patients receiving mirabegron (0.67 vs. 0.64, respectively; p < 0.001) or anticholinergics (0.67 vs. 0.58; p < 0.001). A greater percentage of patients receiving vibegron were adherent versus those receiving mirabegron (49.0% vs. 45.1%, respectively; p < 0.001) or anticholinergics (49.1% vs. 38.5%; p < 0.001). Persistence was longer with vibegron compared with both mirabegron (median [95% CI], 171 [159-182] vs. 128 [122-137] days, respectively; p < 0.001) and anticholinergics (172 [159-183] vs. 91 [91] days; p < 0.001). In this retrospective analysis of pharmacy claims data, patients receiving vibegron exhibited significantly higher adherence and demonstrated longer persistence in comparison to matched patient cohorts receiving either mirabegron or anticholinergics.

ANALYTICAL TECHNIQUES FOR DETERMINATION OF MIRABEGRON FROM BULK, PHARMACEUTICAL FORMULATION, AND BIOLOGICAL MATRICES: A CRITICAL REVIEW

Mirabegron is a beta-3 adrenergic receptor agonist and is specified for the treatment of overactive Bladder. This review covers analytical methods aimed at the identification and quantification of mirabegron in bulk, commercial dosage forms, and Biological fluids. Using various techniques such as UV-spectroscopy, spectro-fluorimetry, planer chromatography, High Performance-Thin Layer Chromatography (HPTLC), HPLC, High-Performance Liquid Chromatography-MS/MS (HPLC-MS/MS), Ultra-Pressure Liquid Chromatography-MS/MS (UPLC-MS/MS), and capillary electrophoresis. HPLC is the most used analytical technique for the identification and quantification of mirabegron in bulk and commercial dosage forms.

The effect of pelvic floor muscle training in men with benign prostatic hyperplasia and overactive bladder

BackgroundMen with overactive bladder (OAB) and benign prostatic hyperplasia (BPH), will have deterioration in the quality of life.ObjectiveThe aim of this study was to evaluate the effect of combining pelvic floor muscle training with the urgency suppression technique (PFMT-st) and silodosin in comparison with silodosin in men with benign prostatic hyperplasia (BPH) and overactive bladder (OAB) after 12 weeks of treatment.Patients and methodsA total of 158 patients were randomized into two groups. The control group received oral silodosin at a daily dose of 8 mg. The experimental group was administered PFMT-st and silodosin. The evaluation methods included the number of voids and intensity of urgencies over 24 h using a micturition diary, the International Prostate Symptom Score (IPSS), the Overactive Bladder Questionnaire (OAB-q), and the patient global impression of improvement (PGI-I).Results142 of 172 (86.6%) men were assessed (70 in the control group, 72 in the experimental group). The significant changes were in favor of the experimental group (p < 0.001) in the number of voids per 24 h (− 1.95 ± 1.94 vs. − 0.90 ± 1.44), the OAB-q symptom score (− 14.25 ± 10.05 vs. − 9.28 ± 10.60), the intensity of urgencies (− 0.97 ± 0.53 vs. 0.24 ± 0.57), the IPSS (− 4.59 ± 3.00 vs. − 2.30 ± 3.63), and in the PGI-I (2.24 ± 0.79 vs. 3.60 ± 0.92).ConclusionsThe addition of PFMT-st to silodosin treatment significantly improved OAB in men with BPH. This is the first study to confirm that PFMT-st should be the first-choice treatment for OAB in BPH.

Lessons learned from a multi-data source research collaboration: The mirabegron post-authorization safety study program.

Many factors contribute to developing and conducting a successful multi-data source, non-interventional, post-authorization safety study (NI-PASS) for submission to multiple health authorities. Such studies are often large undertakings; evaluating and sharing lessons learned can provide useful insights to others considering similar studies. We discuss challenges and key methodological and organizational factors that led to the delivery of a successful post-marketing requirement (PMR)/PASS program investigating the risk of cardiovascular and cancer events among users of mirabegron, an oral medication for the treatment of overactive bladder. We provide context and share learnings, including sections on research program collaboration, scientific transparency, organizational approach, mitigation of uncertainty around potential delays, validity of study outcomes, selection of data sources and optimizing patient numbers, choice of comparator groups and enhancing precision of estimates of associations, potential confounding and generalizability of study findings, and interpretation of results. This large PMR/PASS program was a long-term commitment from all parties and benefited from an effective coordinating center and extensive scientific interactions across research partners, scientific advisory board, study sponsor, and health authorities, and delivered useful learnings related to the design and organization of multi-data source NI-PASS.

The AUA/SUFU Guideline on the Diagnosis and Treatment of Idiopathic Overactive Bladder.

The purpose of this guideline is to provide evidence-based guidance to clinicians of all specialties on the evaluation, management, and treatment of idiopathic overactive bladder (OAB). The guideline informs the reader on valid diagnostic processes and provides an approach to selecting treatment options for patients with OAB through the shared decision-making process, which will maximize symptom control and quality of life, while minimizing adverse events and burden of disease. An electronic search employing OVID was used to systematically search the MEDLINE and EMBASE databases, as well as the Cochrane Library, for systematic reviews and primary studies evaluating diagnosis and treatment of OAB from January 2013 to November 2023. Criteria for inclusion and exclusion of studies were based on the Key Questions and the populations, interventions, comparators, outcomes, timing, types of studies and settings (PICOTS) of interest. Following the study selection process, 159 studies were included and were used to inform evidence-based recommendation statements. This guideline produced 33 statements that cover the evaluation and diagnosis of the patient with symptoms suggestive of OAB; the treatment options for patients with OAB, including non-invasive therapies, pharmacotherapy, minimally invasive therapies, invasive therapies, and indwelling catheters; and the management of patients with BPH and OAB. Once the diagnosis of OAB is made, the clinician and the patient with OAB have a variety of treatment options to choose from and should, through shared decision-making, formulate a personalized treatment approach taking into account evidence-based recommendations as well as patient values and preferences.

Percutaneous tibial nerve stimulation for the overactive bladder: A single-arm trial.

We hypothesise that PTNS is a safe and effective treatment for OAB. Overactive bladder (OAB) is estimated to affect 11.8% of women worldwide, causing diminished quality of life. Lifestyle modifications, muscarinic receptor antagonist and beta-adrenoreceptor agonist remain the mainstay of treatment but are limited by their efficacy and adverse effects. Access to third-line therapies of intravesical botulinum toxin type A or sacral neuromodulation is limited by their invasive nature. Percutaneous tibial nerve stimulation (PTNS) has emerged as a non-invasive treatment option for OAB. This study was a single-arm trial of women requesting third-line treatment for OAB. The primary treatment outcome was patient-reported visual analogue score (VAS) improvement of at least 50%. Secondary outcome measures were Urinary Distress Inventory Short Form (UDI-6) score and two-day bladder diary. Patients also provided feedback on adverse effects encountered. In the 84 women recruited, initial treatment protocol showed a success rate of 77.2% among those who completed treatment based on VAS, with a statistically significant improvement in mean UDI-6 score of 20.13 (P < 0.01, standard deviation: 12.52). Continued success following tapering protocol of 60.8% and a mean maintenance protocol of 14.2 months was achieved. No adverse effects were reported. The results from this study are in concordance with previously published literature on the effectiveness and safety of PTNS as a treatment modality for OAB. Further randomised controlled trials to evaluate the optimal treatment protocol are warranted to establish a standardised regime.

Examining the safety of mirabegron: an analysis of real-world pharmacovigilance data from the US FDA adverse event reporting system (FAERS) database.

Background: Mirabegron, the first β-3 adrenergic receptor agonist, received approval from the Food and Drug Administration (FDA) in 2012 for the treatment of overactive bladder (OAB). This pharmacovigilance study investigated the safety profile of mirabegron treatment using the US FDA Adverse Event Reporting System (FAERS) database. Methods: This study employed disproportionality analyses, including the reporting odds ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) algorithm, to quantify signals of adverse events associated with mirabegron. Results: From the first quarter of 2012 to the third quarter of 2023, a comprehensive total of 14,356,234 adverse event (AE) reports were submitted to the FDA Adverse Event Reporting System database. Within this dataset, encompassing 18,763 reports specifically associated with mirabegron, healthcare professionals notably contributed 2,902 of these reports. A total of 80 preferred terms (PTs) of interest were identified using both the ROR and information component algorithms. The most common AEs included blood pressure increased, urinary retention, atrial fibrillation, dry mouth, and tachycardia, which were consistent with the product instructions. Unexpected significant AEs, such as arrhythmia, palpitations, dementia, transient ischemic attack, Parkinson's disease, anti-neutrophil cytoplasmic antibody positive vasculitis, lip swelling, and swollen tongue, were also identified. The study findings indicated that the majority of onset time occurred within 30days (n = 358, 55.68%). However, AEs were still possible after 1year of mirabegron treatment. Conclusion: This study provided valuable evidence for the real-world safety of mirabegron, helping clinical professionals enhance their understanding of mirabegron's safety in clinical practice. It also contributed valuable evidence for further safety studies on mirabegron.

Development and characterization of 3D printed ethylene vinyl acetate (EVA) as drug delivery device for the treatment of overactive bladder

The overactive bladder is a condition characterized by a sudden urge to urinate, even with small volumes of urine present in the bladder. The current treatments available for this pathology consist on conservative approaches and the continuous administration of drugs, which when made by conventional methods has limitations related to the first pass metabolism, bioavailability, severe side effects, and low patient adherence to treatments, ultimately leading to low effectiveness. Within this context, the present work proposes the design, manufacture, and characterization of an intravesical implant for the treatment of overactive bladder pathology, using EVA copolymer as a matrix and oxybutynin as a drug. The fabrication of devices through two manufacturing techniques (extrusion and additive manufacturing by fused filament fabrication, FFF) and the evaluation of the implants through characterization tests was proposed. The usability and functionality were evaluated through simulated insertion of the device/prototype in a bladder model through catheter insertion tests. The safety and effectiveness of the devices was investigated from mechanical testing as well as drug release assays. Drug release assays presented a burst release in the first 24 h, followed by a release of 1.8 and 2.8 mg/d, totalizing 32 d. Mechanical tests demonstrated an increase in the stiffness of the specimens due to the addition of the drug, showing a change in maximum stress and strain at break. The released dose was higher than that usually presented when considering the oral administration route, showing the optimization of the development of this implant has the potential to improve the quality of life of patients with overactive bladder.

Multicomponent Intervention for Overactive Bladder in Women

Although the cognitive components of behavioral therapy for overactive bladder (OAB) are widely recognized, there is a lack of studies evaluating the effectiveness of multicomponent interventions that include cognitive components as a treatment for OAB. To examine the efficacy of a multicomponent intervention in improving health-related quality of life (HRQOL) for women with moderate to severe OAB. This multicenter, open-label, randomized clinical trial was conducted in Japan among women aged 20 to 80 years who had moderate to severe OAB. Participants were recruited from 4 institutions between January 16, 2020, and December 31, 2022, through self-referral via advertisement or referral from the participating institutions. Participants were randomized 1:1 by minimization algorithm using an internet-based central cloud system to four 30-minute weekly sessions of a multicomponent intervention or waiting list. Both groups continued to receive baseline treatment throughout the study period. The primary outcome was the least-squares mean changes from baseline through week 13 in HRQOL total scores of the OAB questionnaire between 2 groups. Secondary outcomes included OAB symptom score and frequency volume chart. A total of 79 women were randomized to either the intervention group (39 participants; mean [SD] age, 63.5 [14.6] years) or the waiting list control group (40 participants; mean [SD] age, 63.5 [12.9] years). One participant from each group dropped out from the allocated intervention, while 5 participants in the intervention group and 2 in the control group dropped out from the primary outcome assessment at week 13. Thirty-six participants (92.3%) in the intervention group and 35 (87.5%) in the control group had moderate OAB. The change in HRQOL total score from baseline to week 13 was 23.9 points (95% CI, 18.4-29.5 points) in the intervention group and 11.3 points (95% CI, 6.2-16.4 points) in the waiting list group, a significant difference of 12.6 points (95% CI, 6.6-18.6 points; P < .001). Similar superiority of the intervention was confirmed for frequency of micturition and urgency but not for OAB symptom score. These findings demonstrate that a multicomponent intervention improves HRQOL for women with moderate to severe OAB and suggest that the cognitive component may be an effective treatment option for women with OAB. UMIN Clinical Trials Registry Identifier: UMIN000038513.

Green LC-MS/MS method for in-vivo pharmacokinetics of mirabegron-encapsulated nanostructured lipid carriers in rat plasma: Integrating white analytical chemistry and analytical quality by design approach

Mirabegron (MBG) stands as the top choice for managing overactive bladder, yet its limited aqueous solubility and low bioavailability pose significant challenges. To overcome these hurdles, the objective was to develop and characterize nanostructured lipid carriers (NLCs) for mirabegron, facilitating its controlled release for overactive bladder treatment through the Quality by Design (QbD) approach. The literature showcases several analytical techniques for mirabegron quantification in pharmaceutical formulations and biological fluids, yet most employ toxic organic solvents in their mobile phases, posing environmental risks and threats to aquatic life. To address this concern, a green liquid chromatographic-tandem mass spectrometry method was developed for in-vivo pharmacokinetic assessment of mirabegron-loaded NLCs in rat plasma, utilizing safe organic solvents. The method's development embraced the principles of analytical QbD, aiming to curtail organic waste generation during sample analysis. Rigorous validation was conducted in accordance with the International Council for Harmonization (ICH) Q2 (R1) and M10 guidelines. The developed method found application in both in-vitro drug release kinetics and in-vivo pharmacokinetic investigations of mirabegron-loaded NLCs. Its performance was assessed using the principles of green and white analytical chemistry through a comparative study with existing analytical techniques. The proposed method's exceptional sensitivity, robustness, and eco-friendliness in mirabegron estimation were highlighted by the results. In conclusion, this proposed green analytical approach not only provides a reliable means of mirabegron analysis but also aligns with sustainable practices by minimizing environmental impact and promoting the principles of green and white analytical chemistry and analytical quality by design.

Pilot Study of a Digital Behavioral Therapy for Overactive Bladder in Women.

The burden and high prevalence of overactive bladder (OAB) underline the urgent need for effective treatment. This study provides an initial look at an alternative approach to behavioral therapy for overactive bladder (OAB) that is delivered as an app on a smartphone. This study aimed to investigate feasibility, acceptability, and preliminary efficacy of a digital therapeutic for OAB. This was a multicentered prospective pilot study. We used a convenience sample (N = 30) from waiting lists of women referred for incontinence, excluding urinary tract infections, urinary retention, bladder pain syndrome, pelvic cancer, current pregnancy, kidney disease, dementia, stroke, and prior neuromodulation. The intervention, a smartphone app, provided an 8-week program with weekly modules combining evidence-based knowledge videos and skill-building exercises that incorporated behavioral therapy, cognitive behavioral therapy, pelvic muscle training, and general health information. Combined scores on the International Consultation on Incontinence Questionnaire was the primary outcome measure. Secondary outcomes included improvement in quality of life, based on International Consultation on Incontinence Questionnaire, a 72-hour urinary diary, and Patient Global Impression of Improvement. We evaluated usability with the Mobile Application Rating Scale. Statistical tests included Shapiro-Wilk tests and paired-sample t tests. Overall, 100% of participants reported a reduction in their OAB symptoms and 82% reported an improvement in quality of life. There was a significant improvement in diary parameters, including frequency (10.19-6.71 a day: SD, 1.25; P = 0.017) and incontinence (10-3.57: SD, 4.58). Participants rated the app highly on functionality, and 70% would recommend it. Patient Global Impression of Improvement improved for 72% of participants. This study supports the application of a digital platform to over-come the real-world barriers for first-line treatment for OAB and offers information to inform further evaluation of the safety and efficacy of the NUIG OAB App.

Variation in Defining Retention After Onabotulinum Toxin A for Overactive Bladder: A Systematic Review.

Urinary retention is a common adverse effect after intravesical injection of onabotulinum toxin A (BTX) for overactive bladder (OAB). Reported retention rates range from 1.6% to more than 40%. This variation may be due to varying definitions of retention in the literature. We aimed to assess the variation in definitions of urinary retention across studies of BTX for the treatment of OAB. We performed a systematic review of studies of BTX for OAB by querying MEDLINE and EMBASE according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We included original research studies on adults with overactive bladder treated with BTX and urinary retention reported as an outcome from January 2000 to December 2020. From 954 results, we identified 53 articles that met inclusion criteria. There were 6 definitions for urinary retention. The majority of studies (60.4%) reported initiating clean intermittent catheterization (CIC) as the metric for retention. Five (9.5%) studies provided no definition despite reporting retention as an adverse event. Twenty studies (37.7%) specified a postvoid residual volume (PVR) threshold for initiating CIC in asymptomatic patients; 19 (35.8%) specified a PVR threshold for CIC in symptomatic patients. The PVR thresholds ranged from 100 to 400 mL. Twenty-three studies (43.4%) did not address asymptomatic elevation of PVR, and 22 (41.5%) did not address how symptomatic patients were managed. Urinary retention after BTX injection is inconsistently defined in the literature. Lack of standardization in reporting retention after intravesical BTX prevents accurate assessment of the risk of urinary retention and comparison of outcomes between studies.

Challenging electroanalytical method for the determination of mirabegron in biological samples and pharmaceutical formulations

A simple, economic, sensitive, and time-saving differential pulse voltammetric (DPV) procedure using nanostructured zinc oxide modified carbon paste electrode (nano ZnO-CPE) in conjunction with an anionic surfactant sodium dodecyl sulfate (SDS) was developed for ultra- sensitive detection of mirabegron (MIR), the most prescribed pharmaceutical drug in treatment of overactive bladder (OAB). The use of nanostructured zinc oxide CPE modifier increased the electrode active surface area as well as improved the process of electron transfer, also it was found that at optimal conditions MIR electrochemical process was both irreversible and diffusion-regulated. The morphological characterization of the fabricated electrode was performed using field emission scanning electron microscopy (FESEM) and energy-dispersive X-ray spectroscopy (EDX). MIR voltammetric behavior was investigated using Nano ZnO-CPE in different content and electrode compositions. Therefore, ultra-sensitive results were attained with a linearity range of (0.55 to 100.20 ng ml−1) and a low limit of detection (LOD) of 0.51 ng ml−1 and limit of quantification (LOQ) of 1.54 ng ml−1 in a 0.04 M Britton-Robinson (BR) buffer at an adjusted pH of 6.0 with scan rate 100 mV s−1. Furthermore, the proposed approach was successful in measuring MIR with acceptable percentage recoveries (99.81–100.11 %) in pharmaceutical dosage form and varying concentration ranges in biological samples (99.74–100.35 %). The proposed method has been validated using ICH criteria and proven to be accurate and repeatable.

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.

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.

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.

Comparing Impact of Overactive Bladder Therapies on Nocturia.

Nocturia is a significant symptom in overactive bladder with little data regarding the impact of overactive bladder treatments on nocturia. Compare the effect of anticholinergic (AC) medication, onabotulinum toxin A (BTX), and sacral neuromodulation (SNM) on nocturia. Secondary analysis of the ABC and ROSETTA trials using data from the National Institutes of Health Data and Specimen Hub database. Patients reporting mean ≥2 voids/night on 3-day diary were included and divided into cohorts by treatment: the ABC trial: (1) AC and (2) BTX 100 units, and the ROSETTA trial: (3) BTX 200 units and (4) SNM. Primary outcome was change in mean voids/night on 3-day diary from baseline to 6 months assessed by mixed-effects models for repeated-measures data with interaction between treatment cohort and time included in model. A total of 197 patients were included: 43 (22%) AC, 37 (19%) BTX 100 U, 63 (32%) BTX 200 U, and 54 (27%) SNM. There were no significant differences in baseline voids/night, demographics, or urodynamic values except for younger age in AC and BTX 100 U cohorts (P = 0.04). At 6 months, all cohorts demonstrated a mean 41% decrease in mean voids/night (2.7 ± 0.4 at baseline to 1.6 ± 0.5 at 6 months; P < 0.001), with no significant difference in change in mean voids/night between treatment cohorts (decrease of 44% in AC, 46% in 100 U BTX, 32% 200 in U BTX, and 33% in SNM; P > 0.05). For women with nocturia ≥2/night, treatment with AC, BTX 100 or 200 units, or SNM led to a significant decrease in voids/night at 6 months.

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

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

Patient and physician decision-making dynamics in overactive bladder care: A mixed methods study.

Overactive bladder management includes multiple therapeutic options with comparable efficacy but a range of administration modalities and side effects, creating an ideal setting for shared decision-making. This study investigates patient and physician health beliefs surrounding decision-making and expectations for overactive bladder with the aim of better understanding and ultimately improving decision-making in overactive bladder care. Patient and physician participants completed a questionnaire followed by a semi-structured interview to assess health beliefs surrounding decision making and expectations for overactive bladder treatment. The semi-structured interview guide, developed in an iterative fashion by the authors, probed qualities of overactive bladder therapies patients and physicians valued, their process of treatment selection, and their experiences with therapies. Patients (n = 20) frequently cited treatment invasiveness, efficacy, and safety as the most important qualities that influenced their decision when selecting overactive bladder therapy. Physicians (n = 12) frequently cited safety/contraindications, convenience, cost/insurance, and patient preference as the most important qualities. In our integration analysis, we identified four key themes associated with decision making in overactive bladder care: frustration with inaccessibility of overactive bladder treatments, discordant perception of patient education, diverging acceptability of expected outcomes, and lack of insight into other parties' decisional priorities and control preferences. While both patients and physicians desire to engage in a shared decision-making process when selecting therapies for overactive bladder, this process is challenged by significant divergence between patient and physician viewpoint across key domains.