Drug Delivery Approaches for Managing Overactive Bladder (OAB): A Systematic Review.
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SUBMITTER: Khizer Z
PROVIDER: S-EPMC8146593 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:PurposeTo evaluate persistence and adherence of oral pharmacotherapy used in the treatment of overactive bladder (OAB) in a real-world setting.Materials and methodsSystematic literature searches of six electronic publication databases were performed to identify observational studies of patients with OAB treated with antimuscarinics and/or mirabegron. Studies obtaining persistence and adherence data from sources other than electronic prescription claims were excluded. Reference lists of identified studies and relevant systematic reviews were assessed to identify additional relevant studies.ResultsThe search identified 3897 studies, of which 30 were included. Overall, persistence ranged from 5% to 47%. In studies reporting data for antimuscarinics and mirabegron (n=3), 1-year persistence was 12%-25% and 32%-38%, respectively. Median time to discontinuation was <5 months for antimuscarinics (except one study (6.5 months)) and 5.6-7.4 months for mirabegron. The proportion of patients adherent at 1 year varied between 15% and 44%. In studies reporting adherence for antimuscarinics and mirabegron, adherence was higher with mirabegron (mean medication possession ratio (MPR): 0.59 vs 0.41-0.53; mean proportion of days covered: 0.66 vs 0.55; and median MPR: 0.65 vs 0.19-0.49). Reported determinants of persistence and adherence included female (sex), older age group, use of extended-release formulation and treatment experience.ConclusionMost patients with OAB discontinued oral OAB pharmacotherapy and were non-adherent 1 year after treatment initiation. In general, mirabegron was associated with greater persistence and adherence compared with antimuscarinics. Combined with existing clinical trial evidence, this real-world review merits consideration of mirabegron for first-line pharmacological treatment among patients with OAB.Prospero registration numberCRD42017059894.
| S-EPMC6252764 | biostudies-literature
Project description:Limited utility data on patients suffering from overactive bladder (OAB) are available in the literature. The objectives of this study were to estimate utility values in patients with OAB using the generic EQ-5D questionnaire and the OAB-5D disease specific questionnaire, to investigate the relationship between utilities and symptoms, and to evaluate the sensitivity of the two instruments to changes in symptom severity.Analyses were based on pooled data from three large multicenter randomized 12-week placebo-controlled trials (SCORPIO, ARIES, CAPRICORN). Patients completed a micturition diary, EQ-5D and OAB-q (a quality of life questionnaire from which OAB-5D is derived) at baseline and at weeks 4, 8 and 12. Time trade-off tariffs elicited from UK population were applied to obtain utilities from both instruments. Repeated measures regressions were used to estimate EQ-5D and OAB-5D utilities by micturition frequency and incontinence severity level. As a test of sensitivity of the instruments, utility changes from baseline to week 12 were estimated by symptomatic response (improvement, stable or worsening).The sample included 4427 patients. Mean utilities (± standard deviation) across all visits were 0.82 (± 0.21) for EQ-5D and 0.86 (±0.09) for OAB-5D. Correlation between EQ-5D and OAB-5D was 0.34 (p < 0.0001). Both OAB-5D and EQ-5D utilities increased as OAB symptoms improved. Utility values were similar for severe levels of symptoms, but higher with OAB-5D than with EQ-5D for mild cases. Micturitions and incontinence had similar impact on EQ-5D utilities, but micturitions had greater impact on OAB-5D utilities than incontinence. Changes from baseline in OAB-5D utilities differed significantly according to symptomatic response. Changes in EQ-5D utilities were not significantly associated with changes in micturition frequency and weakly associated with changes in incontinence severity among patients with mild symptoms at baseline.This study showed that both EQ-5D and OAB-5D can detect changes in severity of OAB, especially in severe cases. However, OAB-5D is more sensitive than EQ-5D in measuring differences between treatments in milder cases. Both OAB-5D and EQ-5D-although leading to different results-may be useful to derive utilities from clinical trial data and perform cost-effectiveness analyses.Clinical Trials NCT00689104, NCT00662909, NCT00912964.
| S-EPMC3842710 | biostudies-literature
Project description:BackgroundOveractive bladder (OAB) syndrome has a diverse etiology that disrupts quality of life domains in affected patients. OAB is significantly under-recognised and undertreated, especially in the primary care setting. In order to educate primary care providers about OAB recognition, evaluation and management, we created a virtual live-streamed and enduring education program.MethodsWe evaluated the impact of education on provider knowledge and self-efficacy via qualitative interviews with a sample of education participants. We analysed participant responses via constant comparative method, an iterative approach that allows for exploration of a priori issues and identification of emergent themes.ResultsWe identified four key themes: (a) taking OAB seriously; (b) variations in therapy; (c) patient motivation; and (d) education value. Participants were proactive about screening for and managing OAB and recognised urgency as a key symptom; some participants used diagnostic tests that are not are not considered necessary in the workup of uncomplicated OAB patients. Participants varied in their descriptions of initial approaches to treatment and most participants described a longer-than-recommended follow-up window to monitor patients. Some participants characterised patients as looking for a "quick fix" in ways that could lead to provider inaction in relation to behavioural/lifestyle interventions. Overall, participants felt that the education validated their current practice and provided new knowledge about evaluation, initiating behavioural treatment, and combination therapy.ConclusionsParticipant responses were congruent with education messages, which likely reflect their "readiness to learn". The rationale for diagnostic tests and evidence on the effectiveness of behavioural regimens represent ongoing areas of unmet educational need.
| S-EPMC7685143 | biostudies-literature
Project description:IntroductionOveractive bladder (OAB) is a symptom syndrome defined by the International Continence Society (ICS) as 'the presence of urinary urgency (both daytime and nighttime), usually accompanied by increased frequency and nocturia with or without urge urinary incontinence in the absence of a urinary tract infection or other obvious pathology'. Clinical studies indicate that acupuncture could reduce micturition over 24 h, urgency episodes over 24 h, and improve quality of life among people with OAB. This systematic review protocol details the proposed methods for evaluating the effectiveness and safety of acupuncture for OAB.Methods and analysisThe following databases will be searched for relevant studies: the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Incontinence Group Trials Register, MEDLINE, EMBASE, Chinese Biomedical Literature Database (CBM), Chinese Medical Current Content (CMCC), Chinese Scientific Journal Database (VIP database), Wan-Fang Data, and China National Knowledge Infrastructure (CNKI) and will hand search a list of medical journals as a supplement. Any randomised controlled trials in English or Chinese without restriction of publication status will be included with treatment of OAB. Outcomes will mainly include number of micturition episodes over 24 h, number of urgency episodes over 24 h and number of incontinence episodes over 24 h. Two reviewers will independently screen the titles, abstracts or even full texts, and extract data. Two other reviewers will assess study quality. Revman 5.1 software will be used to conduct meta-analysis and calculate the risk ratio for dichotomous data. Weighted mean difference or standard mean difference will be calculated for continuous data. The Cochrane collaboration's tool will be used to assess the risk of bias.DisseminationThis systematic review protocol will provide information on acupuncture therapy for OAB. The results will be disseminated through peer-reviewed publication or conference presentations.Protocol registrationPROSPERO CRD42014010181.
| S-EPMC4289716 | biostudies-literature
Project description:IntroductionOveractive bladder (OAB) is a common condition, increasing with age and affecting quality of life. While numerous OAB drugs are available, persistence is low. We evaluated evidence published since 2012 to determine if newer drugs provided better efficacy and harm profiles.MethodsWe searched MEDLINE and the Cochrane Library from 2012 to September 2018 using terms for included drugs and requested information from manufacturers of included drugs. We performed dual review of all systematic review processes, evaluated study quality, and conducted meta-analyses using random effects models.ResultsIn addition to 31 older studies, we included 20 trials published since 2012 (N?=?16,478; 4 good, 11 fair, and 5 poor quality). Where statistical differences were found, they were clinically small (reductions of < 0.5 episodes/day). Solifenacin plus mirabegron improved efficacy outcomes over monotherapy with either drug, but significantly increased constipation compared with solifenacin and dry mouth compared with mirabegron. Solifenacin reduced incontinence over mirabegron and tolterodine and urgency episodes over tolterodine. Mirabegron did not differ from tolterodine in efficacy but had significantly lower incidence of dry mouth than solifenacin or tolterodine. Fesoterodine showed significant improvements but also anticholinergic effects vs. tolterodine. Oxybutynin, solifenacin, and tolterodine had similar efficacy, but dry mouth led to greater discontinuation with oxybutynin. Blurred vision, cardiac arrhythmia, and dizziness were uncommon.ConclusionNew evidence confirms small, but clinically uncertain, differences among monotherapies and also between combination and monotherapy, regardless of statistical significance. While drugs mainly differed in incidence of dry mouth or constipation, none provided improved efficacy without increased harms.
| S-EPMC6795617 | biostudies-literature
Project description:IntroductionUrinary symptoms are associated with an increased risk of falls, but few studies have focused on patients with overactive bladder (OAB). This study aimed to synthesize estimates of the risk of falls and fractures in patients with OAB.MethodsMedline, EMBASE, the Cumulative Index to Nursing and Allied Health Literature, and Scopus were systematically searched for observational studies that focused on patients with OAB. When available, data from a non-OAB comparison sample were included. Double independent review and data extraction were performed. Falls and fractures data were summarized by unadjusted and adjusted risks, and percent attributable risk (PAR) of falls and fractures associated with OAB.ResultsFifteen studies were included in the analyses. The proportion of patients with OAB experiencing at least one fall over a year ranged from 18.9% to 50.0%, and the proportion of patients with OAB experiencing recurrent or serious falls ranged from 10.2% to 56.0%. In studies that included a non-OAB comparison sample, a higher risk of falls was observed in patients with OAB compared to those without. A significantly increased (1.3- to 2.3-fold) adjusted OAB-associated risk of falls was reported, while unadjusted PARs for OAB associated falls ranged from 3.7% to 15.5%. Risk was higher among women and those 65 years of age or older. While analysis of fractures showed elevated point estimates, most studies were underpowered to detect a statistically significant difference between groups.ConclusionsEvidence from the published literature clearly demonstrates the importance of OAB and its symptoms as risk factors for falls and fractures.FundingAstellas.
| S-EPMC6223978 | biostudies-literature
Project description:The objective of pharmaceutics is the development of drugs with increased efficacy and reduced side effects. Prolonged exposure of the diseased tissue to the drug is of crucial importance. Drug-delivery systems (DDSs) have been introduced to control rate, time, and place of release. Drugs can easily reach the bladder through a catheter, while systemically administered agents may undergo extensive metabolism. Continuous urine filling and subsequent washout hinder intravesical drug delivery (IDD). Moreover, the low permeability of the urothelium, also described as the bladder permeability barrier, poses a major challenge in the development of the IDD. DDSs increase bioavailability of drugs, therefore improving therapeutic effect and patient compliance. This review focuses on novel DDSs to treat bladder conditions such as overactive bladder, interstitial cystitis, bladder cancer, and recurrent urinary tract infections. The rationale and strategies for both systemic and local delivery methods are discussed, with emphasis on new formulations of well-known drugs (oxybutynin), nanocarriers, polymeric hydrogels, intravesical devices, encapsulated DDSs, and gene therapy. We give an overview of current and future prospects of DDSs for bladder disorders, including nanotechnology and gene therapy.
| S-EPMC4664547 | biostudies-other
Project description:Overactive bladder (OAB) is a chronic condition affecting both men and women, with prevalence increasing with age. Antimuscarinics form the cornerstone of treatment of OAB. Fesoterodine, a nonselective muscarinic-receptor antagonist, was approved by the US Food and Drug Administration in late 2008 for once daily, oral administration in the treatment of OAB to relieve the symptoms of urinary urge incontinence, urgency, and frequency.The aim of this review was to provide an overview of the mechanism of action of and clinical trial data for fesoterodine, and to discuss the present status of fesoterodine in the management of OAB.The MEDLINE and Google Scholar databases were searched (June 1, 1999-December 1, 2009) using the terms fesoterodine, overactive bladder, and muscarinic antagonists. Full-text articles in English were selected for reference, and articles presenting the mechanism of action, pharmacokinetics, and data from clinical trials were included. The parameters measured were tolerability, efficacy, and health-related quality of life (HRQoL). Trials involving animals and Phase I studies were excluded.The initial literature search yielded 48 papers. A total of 20 articles fulfilled the inclusion criteria. In two 12-week, randomized, multicenter, Phase III clinical trials involving patients with increased micturition frequency and urgency and/or urinary urge incontinence (n = 836 and 1132 in each trial), both fesoterodine 4 and 8 mg were associated with significantly improved symptoms of OAB (frequency of micturition, urgency, and urge incontinence) compared with placebo (P < 0.05). In a post hoc analysis of pooled data of the Phase III trials, HRQoL improved significantly with both doses. In a 12-week, Phase Illb trial, fesoterodine 4 and 8 mg led to treatment satisfaction in ?80% of patients (of 516 enrolled) who were initially unsatisfied with their previous treatment.A review of the literature suggests that fesoterodine is an efficacious and well-tolerated treatment option for patients with OAB.
| S-EPMC3969610 | biostudies-other
Project description:BackgroundIn 2019, a new coronavirus emerged in China, and the disease caused by the virus (COVID-19) was rapidly classified as a pandemic. Pregnant women with gestational diabetes mellitus (GDM) are considered to be at risk for severe COVID-19. In the context of the pandemic, there are serious concerns regarding adverse effects on maternal and neonatal outcomes for women with GDM. Effective treatments for patients with GDM are therefore particularly important. Due to contact restrictions and infection risks, digital approaches such as telemedicine are suitable alternatives.ObjectiveThis systematic review aims to summarize currently available evidence on maternal and offspring outcomes of pregnant women with GDM and COVID-19 and to examine telemedical interventions to improve maternal glycemic control during the COVID-19 pandemic.MethodsPublications were systematically identified by searching the Cochrane Library, MEDLINE via PubMed, Web of Science Core Collection, Embase, and CINAHL databases for studies published up to March 2021. We sorted the COVID-19 studies by outcome and divided the telemedical intervention studies into web-based and app-based groups. We analyzed case reports (COVID-19) and both randomized and nonrandomized controlled clinical trials (telemedicine). To determine the change in glycated hemoglobin A1c (HbA1c), we pooled appropriate studies and calculated the differences in means, with 95% CIs, for the intervention and control groups at the end of the interventions.ResultsRegarding COVID-19 studies, we identified 11 case reports, 3 letters, 1 case series, and 1 retrospective single-center study. In total, 41 patients with GDM and COVID-19 were analyzed. The maternal and neonatal outcomes were extremely heterogeneous. We identified adverse outcomes for mother and child through the interaction of GDM and COVID-19, such as cesarean deliveries and low Apgar scores. Furthermore, we selected 9 telemedicine-related articles: 6 were randomized controlled trials, 2 were clinical controlled trials, and 1 was a quasi-experimental design. In total, we analyzed 480 patients with GDM in the intervention groups and 494 in the control groups. Regarding the quality of the 9 telemedical studies, 4 were rated as strong, 4 as moderate, and 1 as weak. Telemedical interventions can contribute to favorable impacts on HbA1c and fasting blood glucose values in the context of the COVID-19 pandemic. Meta-analysis revealed a mean difference in HbA1c of -0.19% (95% CI 0.34% to 0.03%) for all telemedical interventions, -0.138% (95% CI -0.24% to -0.04%) for the web-based interventions, and -0.305% (96% CI -0.88% to 0.27%) for the app-based interventions.ConclusionsTelemedicine is an effective approach in the context of COVID-19 and GDM because it enables social distancing and represents optimal care of patients with GDM, especially with regard to glycemic control, which is very important in view of the identified adverse maternal and neonatal outcomes. Further research is needed.
| S-EPMC8345174 | biostudies-literature
Project description:BackgroundOveractive bladder (OAB) is common and morbid. Medication and diagnosis claims may be specific, but lack sensitivity to identify patients with overactive bladder. We used an "electronic health record (EHR) phenotype" to identify cases and describe treatment choices and anticholinergic burden for OAB.MethodsWe conducted a retrospective cohort study in a large, integrated health delivery system between July 2011 and June 2012 (2-year follow-up). We examined care from primary care and specialty clinics, medication and procedure use, and anticholinergic burden for each patient.ResultsThere were 7362 patients with an EHR OAB phenotype; 50% of patients were?>?65?years old, 74% were female, and 83% were white. The distribution of care included primary care physician (PCP)/specialty co-management (25% of patients); PCP care only (18%); urology only (13%); or some other combination of specialty care (33%). Only 40% of patients were prescribed at least 1 OAB medication during the study. The mean duration of prescribed medication was 1.5?months (95% confidence interval [CI], 1.4 to 1.6?months; range, <?1?month to 24?months). Independent predictors of receipt of an OAB medication included increasing age (odds ratio [OR], 1.4 for every 10?years; 95% CI, 1.4 to 1.5), women (OR, 1.6 compared with men; 95% CI, 1.4 to 1.8), diabetes (OR, 1.3; 95% CI, 1.1 to 1.5), and certain sources of care compared with PCP-only care: PCP/specialty co-management (OR, 1.8; 95% CI, 1.5 to 2.0), urology (OR, 2.2; 95% CI, 1.8 to 2.6), and multiple specialists (OR, 1.4; 95% CI, 1.2 to 1.8). Very few patients received other treatments: biofeedback (<?1%), onabotulinumtoxinA (2%), or sacral nerve stimulation (1%). Patients who received OAB medications had significantly higher anticholinergic burden than patients who did not (anticholinergic total standardized daily dose, 125 versus 46; P?<?.001).ConclusionsAlthough OAB is common and morbid, in a longitudinal study using an EHR OAB phenotype 40% of patients were treated with OAB medication and only briefly.
| S-EPMC7238545 | biostudies-literature