Systematic literature review of clinical trials evaluating pharmacotherapy for overactive bladder in elderly patients: An assessment of trial quality

Kistler, Kristin; Xu, Yu; Zou, Kelly H.; Ntanios, Fady; Chapman, Douglass; Luo, Xuemei

doi:10.1002/nau.23309

Cited by 10 publications

(7 citation statements)

References 58 publications

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“…[22, 23] The EPHPP allows for the evaluation of internal (study design, confounding, blinding, withdrawals and dropouts, intervention integrity, analyses) as well as external (data collection methods, selection bias) validity of studies. [24] The quality assessment results are summarised in the S1 Table.…”

Section: Literature Search Strategymentioning

confidence: 99%

Health-related quality of life in paediatric patients with Type 1 diabetes mellitus using insulin infusion systems. A systematic review and meta-analysis

Rosner

Román-Urrestarazu

2019

PLoS ONE

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Background In 2017, more than 1.1 million children were living with type 1 diabetes mellitus (T1DM) globally. The goal in paediatric diabetes therapy is reaching optimal glycaemic control as early as possible in order to avoid complications and early mortality without compromising the quality of life (QoL) of children. Several different insulin regimens are available for T1DM patients to reach this goal. Aims This review set out to analyse whether continuous subcutaneous insulin infusion (CSII) regimens are superior to multiple daily injection (MDI) therapy in T1DM youth regarding QoL. Additionally, it assessed glycaemic control and adverse events as secondary outcomes and discussed potential future public health implications and justifications for using CSII as a first-line therapy in diabetic youth. Methods A systematic review and random effects meta-analysis was performed on studies investigating the association between QoL and diabetes treatment regimen. Differences in adverse event rates between groups were analysed using a Mann-Whitney U test. Lastly, differences in glycaemic control were assessed using a random effects meta-analysis. Results QoL and glycaemic control was significantly better in CSII subjects at baseline and follow-up. No significant differences in adverse events were found between study groups. No significant changes over time could be shown for either QoL or glycaemic control. Conclusion CSII proved to provide similar or slightly better outcomes in all analysed fields. This is consistent with previous research. However, to make credible recommendations, better-designed studies are needed to investigate the impact of CSII in children.

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Section: Literature Search Strategymentioning

confidence: 99%

Health-related quality of life in paediatric patients with Type 1 diabetes mellitus using insulin infusion systems. A systematic review and meta-analysis

Rosner

Román-Urrestarazu

2019

PLoS ONE

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“…The study found a significant research gap for antimuscarinics and mirabegron time-to-effect for OAB through its clinical use had been extensively researched (5)(6)(7)(8)(9)(10)(11)(12)(13)(14). Our research of the available limited data found that for these drugs, the time-toeffect was after seven days, but more investigation is needed to analyze this occurrence, especially in the first week of medication.…”

Section: Discussionmentioning

confidence: 91%

“…After that, the gather publications were reviewed manually, and the most related ones had their references checked to find other correlated publications that would be important for the study. Besides, the study chose to view currently available meta-analyses and systematic reviews that focused on pharmacotherapy of OAB to increase the data availability and validity of the research (5)(6)(7)(8)(9)(10)(11)(12)(13)(14).…”

Section: Methodsmentioning

confidence: 99%

“…Besides, research also specified that other causes of OAB treatment termination were associated with adverse effects and failed prospective medical results. The study found that scholars and other stakeholders have not identified the best efficacy duration for OAB as the available data shows that in most randomized clinical trials it has been assessed to be between 2 weeks and twelve months, which is highly ambiguous (5)(6)(7)(8)(9)(10)(11)(12)(13)(14). As such, it could be hypothesized that some research could underrate the drug effectiveness with short periods of drug administration (26)(27)(28), while the length of medication in other research could be longer than needed (29,30).…”

Section: Pharmacotherapy Durationmentioning

confidence: 99%

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The Pharmacotherapy Time-to-Effect of Overactive Bladder Medications and Treatment Duration

Przydacz¹,

Chłosta²

2020

Acta Poloniae Pharmaceutica - Drug Research

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For Overactive Bladder (OAB) treatment, pharmacotherapy is currently deemed as a second option. However, in the current publications related to OAB, there is a significant research gap concerning the time-toeffect and duration of OAB pharmacotherapy. Such data is vital for effective and successful treatment of OAB, and hence, the study aimed to find information in this gap to assist healthcare providers in their daily activities in treating OAB. The study utilized the Web of Science databases, MEDLINE, Cochrane Library, and PubMed Central to find and collect the highest number of data. The literature review showed limited research concerning the time-to-effect and optimal treatment duration for OAB. However, based on the available data, it can be stated that the time-to-effect of OAB pharmacotherapy would be after seven days of the initial treatment. Besides, patients with OAB can be effectively treated for 6 to 12 months before the medications are stopped but patients need to be carefully educated about a risk of symptom reoccurrence and retreatment. Those who require further medications or have a higher risk of symptom reoccurrence may need lifetime pharmacotherapy or different treatment approaches. Further research is needed to focus on the time-to-effect during the first week of medication to accurately determine when first symptom reduction occurs, and carefully follow up for patients that show a positive response after the treatment has been ceased.

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“…The older patient population with OAB has high levels of concomitant medication use and comorbidity, is more likely to experience falls and fractures, and is at increased risk of impairment of activities of daily living [6][7][8]. However, frail elderly patients with multiple comorbidities are often excluded from clinical trials [9][10][11].…”

Section: Introductionmentioning

confidence: 99%

Effect of mirabegron on cognitive function in elderly patients with overactive bladder: MoCA results from a phase 4 randomized, placebo-controlled study (PILLAR)

et al. 2020

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Background: Antimuscarinics are often used for treatment of overactive bladder (OAB), but exposure to medications such as antimuscarinics that have anticholinergic properties has been linked to adverse cognitive effects. A phase 4 placebocontrolled study (PILLAR; NCT02216214) described the efficacy and safety of mirabegron, a β 3 -adrenoreceptor agonist, for treatment of wet OAB in patients aged ≥65 years. This pre-planned analysis aimed to measure differences in cognitive function between mirabegron and placebo, using a rapid screening instrument for mild cognitive impairment: the Montreal Cognitive Assessment (MoCA).Methods: Outpatients aged ≥65 years with wet OAB were randomized 1:1 to mirabegron or placebo, stratified by age (<75/≥75 years). There were no exclusion criteria regarding cognitive status. Patients randomized to mirabegron initially received 25 mg/day with an optional increase to 50 mg/day after week 4/8 based on patient/investigator discretion. The MoCA was administered at baseline and end of treatment (EoT, week 12). The study protocol was Independent Ethics Committee/Institutional Review Board-approved.Results: Of the 887 randomized patients who received ≥1 dose of study drug, 72.3% were female, 79.5% were white, and 28.1% were aged ≥75 years. All patients had ≥1 comorbidity and 94.3% were receiving ≥1 concomitant medication. One third of patients had a history of psychiatric disorders, the most common being depression (17.2%), insomnia (15.7%), and anxiety (11.4%). Baseline mean (standard error, SE) MoCA total scores were 26.9 (0.1) and 26.8 (0.1) in the mirabegron and placebo groups, respectively. Among patients with MoCA data available at baseline/EoT, 27.1% (115/425) and 25.8% (106/411) of mirabegron and placebo group patients, respectively, had impaired cognitive function at baseline (MoCA total score <26). There was no statistically significant change in adjusted mean (SE) MoCA total score from baseline to EoT in the mirabegron group (−0.2 [0.1]) or the placebo group (−0.1 [0.1]).Conclusions: Treatment with mirabegron for 12 weeks did not contribute to drug-related cognitive side effects in patients aged ≥65 years, as measured by the MoCA. Furthermore, the pattern of change in cognition over time in an older OAB trial population does not appear to differ from that of subjects receiving placebo.

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Systematic literature review of clinical trials evaluating pharmacotherapy for overactive bladder in elderly patients: An assessment of trial quality

Cited by 10 publications

References 58 publications

Health-related quality of life in paediatric patients with Type 1 diabetes mellitus using insulin infusion systems. A systematic review and meta-analysis

Health-related quality of life in paediatric patients with Type 1 diabetes mellitus using insulin infusion systems. A systematic review and meta-analysis

The Pharmacotherapy Time-to-Effect of Overactive Bladder Medications and Treatment Duration

Effect of mirabegron on cognitive function in elderly patients with overactive bladder: MoCA results from a phase 4 randomized, placebo-controlled study (PILLAR)

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