The safety and efficacy of tolterodine extended release in the treatment of overactive bladder in the elderly

After lifestyle and behavioral measures to control overactive bladder, the mainstay of pharmacological treatment is the use of antimuscarinic therapy. Overactive bladder predominantly affects older people, who experience the most severe disease, and are also at a greater risk of side effects from antimuscarinic therapy. Thus it is imperative that data are available on the efficacy and tolerability of this group of drugs when used in older people. This article reviews the pathophysiology of the condition, its effect on the elderly and the evidence for the use of extended release tolterodine in the elderly using data from placebo and active drug controlled studies

Continence Across Continents To Upend Stigma and Dependency (CACTUS-D): study protocol for a cluster randomized controlled trial

Background: Urinary incontinence occurs in 40 % of women aged 65 years and over; however, only 15 % seek care and many delay healthcare seeking for years. Incontinence is associated with depression, social isolation, reduced quality of life, falls and other comorbidities. It is accompanied by an enormous cost to the individual and society. Despite the substantial implications of urinary incontinence on social, psychological and physical well-being of older women, the impact of continence promotion on urinary symptom improvement and subsequent effects on falls, quality of life, stigma, social participation and the cost of care remains unknown. Methods: This study is a mixed methods multi-national open-label 2-arm parallel cluster randomized controlled trial aiming to recruit 1000 community-dwelling incontinent women aged 65 years and older across Quebec, Western Canada, France and United Kingdom. Participants will be recruited through community organizations. Data will be collected at 6 time points: baseline and 1 week, 3 months, 6 months, 9 months and 12 months after baseline. One of the primary objectives is to evaluate whether the continence promotion intervention improves incontinence symptoms (measured with the Patient Global Impression of Improvement questionnaire, PGI-I) at 12 months post intervention compared to the control group. Other co-primary outcomes include changes in incontinence-related stigma, fall reduction, and incremental cost-effectiveness ratio and quality-adjusted life years. Data analysis will account for correlation of outcomes (clustering) within community organizations. A qualitative sub-study will explore stigma reduction. Discussion: Community-based continence promotion programs may be a cost-effective strategy to reduce urinary incontinence, stigma and falls among older women with untreated incontinence, and simultaneously improve quality of life and healthy active life expectancy.European Research Area on Ageing2 (ERA-AGE2) progra

Mobility of Vulnerable Elders (MOVE): study protocol to evaluate the implementation and outcomes of a mobility intervention in long-term care facilities

<p>Abstract</p> <p>Background</p> <p>Almost 90% of residents living in long-term care facilities have limited mobility which is associated with a loss of ability in activities of daily living, falls, increased risk of serious medical problems such as pressure ulcers, incontinence and a significant decline in health-related quality of life. For health workers caring for residents it may also increase the risk of injury. The effectiveness of rehabilitation to facilitate mobility has been studied with dedicated research assistants or extensively trained staff caregivers; however, few investigators have examined the effectiveness of techniques to encourage mobility by <it>usual caregivers </it>in long-term care facilities.</p> <p>Methods/Design</p> <p>This longitudinal, quasi-experimental study is designed to demonstrate the effect of the sit-to-stand activity carried out by residents in the context of daily care with health care aides. In three intervention facilities health care aides will prompt residents to repeat the sit-to-stand action on two separate occasions during each day and each evening shift as part of daily care routines. In three control facilities residents will receive usual care. Intervention and control facilities are matched on the ownership model (public, private for-profit, voluntary not-for-profit) and facility size. The dose of the mobility intervention is assessed through the use of daily documentation flowsheets in the health record. Resident outcome measures include: 1) the 30-second sit-to-stand test; 2) the <it>Functional Independence Measure</it>; 3) the <it>Health Utilities Index Mark 2 and 3; </it>and, 4) the <it>Quality of Life - Alzheimer's Disease</it>.</p> <p>Discussion</p> <p>There are several compelling reasons for this study: the widespread prevalence of limited mobility in this population; the rapid decline in mobility after admission to a long-term care facility; the importance of mobility to quality of life; the increased time (and therefore cost) required to care for residents with limited mobility; and, the increased risk of injury for health workers caring for residents who are unable to stand. The importance of these issues is magnified when considering the increasing number of people living in long-term care facilities and an aging population.</p> <p>Trial Registration</p> <p>This clinical trial is registered with ClinicalTrials.gov (trial registration number: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01474616">NCT01474616</a>).</p

Cardiovascular Safety of β3-adrenoceptor Agonists for the Treatment of Patients with Overactive Bladder Syndrome

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Privacy and Dignity in Continence Care Project Phase 2.

This report provides an account of the methods and findings of Phase 2 of the Privacy and Dignity in Continence Care for Older People study funded by the Royal College of Physicians and the British Geriatrics Society. The overall objectives of this two year project were to: • Identify and validate person-centred attributes of dignity in relation to continence; • Develop reflective guidelines for dignified care; • Produce recommendations for best practice

Persistence and Adherence with Mirabegron versus Antimuscarinic Agents in Patients with Overactive Bladder: A Retrospective Observational Study in UK Clinical Practice

Background: Persistence with antimuscarinic therapy in overactive bladder (OAB) is poor, but may be different for mirabegron, a β3-adrenoceptor agonist with a different adverse event profile. Objective: To compare persistence and adherence with mirabegron versus tolterodine extended release (ER) and other antimuscarinics in routine clinical practice over a 12-mo period. Design, setting, and participants: Retrospective, longitudinal, observational study of anonymised data from the UK Clinical Practice Research Datalink GOLD database. Eligibility: age ≥18 yr, ≥1 prescription for target OAB drug (between May 1, 2013 and June 29, 2014), and 12-mo continuous enrolment before and after the index prescription date. Interventions: Mirabegron, darifenacin, fesoterodine, flavoxate, oxybutynin ER or immediate-release (IR), propiverine, solifenacin, tolterodine ER or IR, and trospium chloride. Outcome measurements and statistical analysis: The primary endpoint was persistence (time to discontinuation). Secondary endpoints included 12-mo persistence rates and adherence (assessed using medication possession ratio, MPR). Cox proportional-hazards regression models and logistic regression models adjusted for potential confounding factors were used to compare cohorts. Analyses were repeated after 1:1 matching. Results and limitations: The study population included 21. 996 eligible patients. In the unmatched analysis, the median time-to-discontinuation was significantly longer for mirabegron (169 d, interquartile range [IQR] 41-not reached) compared to tolterodine ER (56 d, IQR 28-254; adjusted hazard ratio [HR] 1.55, 95% confidence interval 1.41-1.71; p <. 0.0001) and other antimuscarinics (range 30-78 d; adjusted HR range 1.24-2.26, p <. 0.0001 for all comparisons). The 12-mo persistence rates and MPR were also significantly greater with mirabegron than with all the antimuscarinics. Limitations include the retrospective design, use of prescription records to estimate outcomes, and inability to capture reasons for discontinuation. Conclusions: Persistence and adherence were statistically significantly greater with mirabegron than with tolterodine ER and other antimuscarinics prescribed for OAB in the UK. Patient summary: This study assessed persistence and adherence (or compliance) with medications prescribed for OAB in a large UK population. We found that patients prescribed mirabegron remained on treatment for longer and showed greater adherence than those prescribed traditional antimuscarinics. For chronic conditions such as overactive bladder, long-term adherence is important to maintain treatment benefit. Persistence with antimuscarinics is a recognised challenge. This analysis of a UK primary care database demonstrates that persistence and adherence are significantly greater with mirabegron versus antimuscarinics

Prioritizing supports and services to help older adults age in place: A Delphi study comparing the perspectives of family/friend care partners and healthcare stakeholders

Aging in place (AIP) is a policy strategy designed to help older adults remain in their community. While planners internationally have modified aspects of the older adult care continuum (e.g., home care, assisted living, nursing homes) to facilitate AIP, further improvements to community-based supports and services are also required. This study compared and constrasted the community-based factors (e.g., supports, services and personal strategies or characteristics) that family/friend care partners and healthcare stakeholders (i.e., planners/providers) view as most important to help older adults successfully AIP.; An initial list of factors shown to influence AIP was created from the academic literature. These factors were used to develop a Delphi survey implemented separately on care partners and healthcare stakeholders. Respondents rated the importance of each factor using a 10-point Likert Scale (1 = not important; 10 = absolutely critical). Consensus in each group was defined when at least 80% of participants scored a factor ≥8 ("very important"), with an interquartile range ≤2. Respondents suggested additional factors during Delphi round one.; Care partners (N = 25) and healthcare stakeholders (N = 36) completed two and three Delphi rounds, respectively. These groups independently agreed that the following 3 (out of 27) factors were very important to help older adults age in place: keeping one's home safe, maintaining strong inter-personal relationships, and coordinating care across formal providers. While healthcare stakeholders did not reach consensus on other factors, care partners agreed that 7 additional factors (e.g., access to affordable housing, having mental health programs) were important for AIP.; Compared to healthcare stakeholders, care partners felt that more and diverse community-based factors are important to support older adults to successfully AIP. Future research should replicate these findings in other jurisdictions, examine the availability and accessibility of the priority factors, and develop sustainable solutions to enhance their effectiveness

EFFICACY, SAFETY, AND TOLERABILITY OF MIRABEGRON IN PATIENTS AGED ≥65 YR WITH OVERACTIVE BLADDER WET: A PHASE IV, DOUBLE-BLIND, RANDOMISED, PLACEBOCONTROLLED STUDY (PILLAR)

Pozadina: Većina bolesnika s prekomjerno aktivnim mokraćnim mjehurom (PAMM) starija je od 65 godina. Dosad nije bilo prospektivnih ispitivanja kojima bi se ocijenila djelotvornost liječenja agonistom β3-adrenoreceptora mirabegronom u ovoj specifi čnoj dobnoj skupini. Cilj: Ispitivanje faze IV u kojem se uspoređuju mirabegron u fl eksibilnoj dozi i placebo u starijih bolesnika s PAMM om i urgentnom inkontinencijom. Dizajn, uvjeti i sudionici: Bolesnici iz lokalne zajednice koji imaju ≥ 65 godina i PAMM u trajanju od ≥ 3 mjeseca. Intervencija: Nakon 2 tjednog uvodnog razdoblja tijekom kojeg se primjenjivao placebo bolesnici s jednom ili više epizoda inkontinencije, tri ili više epizoda urgencije i prosječno osam ili više mokrenja tijekom 24 h bili su randomizirani u omjeru 1:1 za dvostruko zaslijepljenu primjenu 25 mg mirabegrona ili odgovarajuće formulacije placeba na dan tijekom 12 tjedana. Nakon 4. ili 8. tjedna doza se prema odluci bolesnika i ispitivača mogla povećati na 50 mg mirabegrona/odgovarajuće formulacije placeba na dan. Mjere ishoda i statistička analiza: Primarne mjere ishoda: promjena srednjeg broja mokrenja tijekom 24 h i srednjeg broja epizoda inkontinencije tijekom 24 h od početka ispitivanja do završetka liječenja. Sekundarne mjere ishoda: promjena srednjeg izmokrenog volumena nakon mokrenja, srednjeg broja epizoda urgencije tijekom 24 h i srednjeg broja epizoda urgentne inkontinencije tijekom 24 h od početka ispitivanja do završetka liječenja. Za ocjenu srednjeg broja mokrenja tijekom 24 h, srednjeg izmokrenog volumena nakon mokrenju i srednjeg broja epizoda urgencije tijekom 24 h koristila se analiza kovarijance (ANCOVA). Za ocjenu srednjeg broja epizoda inkontinencije tijekom 24 h i srednjeg broja epizoda urgentne inkontinencije tijekom 24 h koristila se stratifi cirana rang ANCOVA. Rezultati i ograničenja: Uz mirabegron su opažena statistički značajna poboljšanja u odnosu na placebo s obzirom na promjenu srednjeg broja mokrenja tijekom 24 h, srednjeg broja epizoda inkontinencije tijekom 24 h, srednjeg izmokrenog volumena nakon mokrenja, srednjeg broja epizoda urgencije tijekom 24 h i srednjeg broja epizoda urgentne inkontinencije tijekom 24 h od početka ispitivanja do završetka liječenja. Sigurnost i podnošljivost odgovarale su poznatom sigurnosnom profi lu mirabegrona. Zaključci: Potvrđene su djelotvornost, sigurnost i podnošljivost mirabegrona tijekom 12 tjedana u bolesnika s PAMM om i inkontinencijom u dobi od ≥ 65 godina. Sažetak za bolesnike: Ispitivali smo učinak mirabegrona u usporedbi s placebom u osoba u dobi od 65 ili više godina s prekomjerno aktivnim mokraćnim mjehurom i inkontinencijom. Mirabegron je ublažio simptome prekomjerno aktivnog mokraćnog mjehura u usporedbi s placebom. Opažene nuspojave bile su slične poznatim nuspojavama mirabegrona.Background: The majority of patients with overactive bladder (OAB) are aged >65 yr. There has been no prospectively designed study assessing treatment effi cacy with the b3-adrenoreceptor agonist, mirabegron, specifi cally in this age group. Objective: A phase IV study comparing fl exibly dosed mirabegron versus placebo in elderly patients with OAB and urgency incontinence. Design, setting, and participants: Community-dwelling patients aged ≥65 yr with OAB for ≥3 mo. Intervention: Following a 2-wk placebo run in, patients with one or more incontinence episodes, three or more urgency episodes, and an average of eight or more micturitions/ 24 h were randomised 1:1 to double-blind 25 mg/d mirabegron or matched placebo, for 12 wk. After week 4 or 8, the dose could be increased to 50 mg/d mirabegron/matched placebo based on patient and investigator discretion. Outcome measurements and statistical analysis: Coprimary endpoints: change from baseline to end of treatment (EOT) in the mean numbers of micturitions/24 h and incontinence episodes/24 h. Secondary endpoints: change from baseline to EOT in the mean volume voided/micturition, mean number of urgency episodes/24 h, and mean number of urgency incontinence episodes/24 h. Analysis of covariance (ANCOVA) was used for the mean number of micturitions/24 h, mean volume voided/micturition, and mean number of urgency episodes/24 h. Stratifi ed rank ANCOVA was used for the mean numbers of incontinence episodes/24 h and urgency incontinence episodes/24 h. Results and limitations: Statistically signifi cant improvements were observed for mirabegron versus placebo in change from baseline to EOT in the mean number of micturitions/24 h, mean number of incontinence episodes/24 h, mean volume voided/micturition, mean number of urgency episodes/24 h, and mean number of urgency incontinence episodes/24 h. Safety and tolerability were consistent with the known mirabegron safety profi le. Conclusions: Mirabegron effi cacy, safety, and tolerability over 12 wk were confi rmed in patients aged ≥65 yr with OAB and incontinence

EFFICACY, SAFETY, AND TOLERABILITY OF MIRABEGRON IN PATIENTS AGED ≥65 YR WITH OVERACTIVE BLADDER WET: A PHASE IV, DOUBLE-BLIND, RANDOMISED, PLACEBOCONTROLLED STUDY (PILLAR)

Pozadina: Većina bolesnika s prekomjerno aktivnim mokraćnim mjehurom (PAMM) starija je od 65 godina. Dosad nije bilo prospektivnih ispitivanja kojima bi se ocijenila djelotvornost liječenja agonistom β3-adrenoreceptora mirabegronom u ovoj specifi čnoj dobnoj skupini. Cilj: Ispitivanje faze IV u kojem se uspoređuju mirabegron u fl eksibilnoj dozi i placebo u starijih bolesnika s PAMM om i urgentnom inkontinencijom. Dizajn, uvjeti i sudionici: Bolesnici iz lokalne zajednice koji imaju ≥ 65 godina i PAMM u trajanju od ≥ 3 mjeseca. Intervencija: Nakon 2 tjednog uvodnog razdoblja tijekom kojeg se primjenjivao placebo bolesnici s jednom ili više epizoda inkontinencije, tri ili više epizoda urgencije i prosječno osam ili više mokrenja tijekom 24 h bili su randomizirani u omjeru 1:1 za dvostruko zaslijepljenu primjenu 25 mg mirabegrona ili odgovarajuće formulacije placeba na dan tijekom 12 tjedana. Nakon 4. ili 8. tjedna doza se prema odluci bolesnika i ispitivača mogla povećati na 50 mg mirabegrona/odgovarajuće formulacije placeba na dan. Mjere ishoda i statistička analiza: Primarne mjere ishoda: promjena srednjeg broja mokrenja tijekom 24 h i srednjeg broja epizoda inkontinencije tijekom 24 h od početka ispitivanja do završetka liječenja. Sekundarne mjere ishoda: promjena srednjeg izmokrenog volumena nakon mokrenja, srednjeg broja epizoda urgencije tijekom 24 h i srednjeg broja epizoda urgentne inkontinencije tijekom 24 h od početka ispitivanja do završetka liječenja. Za ocjenu srednjeg broja mokrenja tijekom 24 h, srednjeg izmokrenog volumena nakon mokrenju i srednjeg broja epizoda urgencije tijekom 24 h koristila se analiza kovarijance (ANCOVA). Za ocjenu srednjeg broja epizoda inkontinencije tijekom 24 h i srednjeg broja epizoda urgentne inkontinencije tijekom 24 h koristila se stratifi cirana rang ANCOVA. Rezultati i ograničenja: Uz mirabegron su opažena statistički značajna poboljšanja u odnosu na placebo s obzirom na promjenu srednjeg broja mokrenja tijekom 24 h, srednjeg broja epizoda inkontinencije tijekom 24 h, srednjeg izmokrenog volumena nakon mokrenja, srednjeg broja epizoda urgencije tijekom 24 h i srednjeg broja epizoda urgentne inkontinencije tijekom 24 h od početka ispitivanja do završetka liječenja. Sigurnost i podnošljivost odgovarale su poznatom sigurnosnom profi lu mirabegrona. Zaključci: Potvrđene su djelotvornost, sigurnost i podnošljivost mirabegrona tijekom 12 tjedana u bolesnika s PAMM om i inkontinencijom u dobi od ≥ 65 godina. Sažetak za bolesnike: Ispitivali smo učinak mirabegrona u usporedbi s placebom u osoba u dobi od 65 ili više godina s prekomjerno aktivnim mokraćnim mjehurom i inkontinencijom. Mirabegron je ublažio simptome prekomjerno aktivnog mokraćnog mjehura u usporedbi s placebom. Opažene nuspojave bile su slične poznatim nuspojavama mirabegrona.Background: The majority of patients with overactive bladder (OAB) are aged >65 yr. There has been no prospectively designed study assessing treatment effi cacy with the b3-adrenoreceptor agonist, mirabegron, specifi cally in this age group. Objective: A phase IV study comparing fl exibly dosed mirabegron versus placebo in elderly patients with OAB and urgency incontinence. Design, setting, and participants: Community-dwelling patients aged ≥65 yr with OAB for ≥3 mo. Intervention: Following a 2-wk placebo run in, patients with one or more incontinence episodes, three or more urgency episodes, and an average of eight or more micturitions/ 24 h were randomised 1:1 to double-blind 25 mg/d mirabegron or matched placebo, for 12 wk. After week 4 or 8, the dose could be increased to 50 mg/d mirabegron/matched placebo based on patient and investigator discretion. Outcome measurements and statistical analysis: Coprimary endpoints: change from baseline to end of treatment (EOT) in the mean numbers of micturitions/24 h and incontinence episodes/24 h. Secondary endpoints: change from baseline to EOT in the mean volume voided/micturition, mean number of urgency episodes/24 h, and mean number of urgency incontinence episodes/24 h. Analysis of covariance (ANCOVA) was used for the mean number of micturitions/24 h, mean volume voided/micturition, and mean number of urgency episodes/24 h. Stratifi ed rank ANCOVA was used for the mean numbers of incontinence episodes/24 h and urgency incontinence episodes/24 h. Results and limitations: Statistically signifi cant improvements were observed for mirabegron versus placebo in change from baseline to EOT in the mean number of micturitions/24 h, mean number of incontinence episodes/24 h, mean volume voided/micturition, mean number of urgency episodes/24 h, and mean number of urgency incontinence episodes/24 h. Safety and tolerability were consistent with the known mirabegron safety profi le. Conclusions: Mirabegron effi cacy, safety, and tolerability over 12 wk were confi rmed in patients aged ≥65 yr with OAB and incontinence

Ceci n’est pas une ville

Treballs Finals de Grau de Belles Arts. Facultat de Belles Arts. Universitat de Barcelona, Curs: 2015-16, Tutor: Bibiana Crespo[cat] El títol de l’obra d’aquest Treball Final de Grau, Ceci n’est pas une ville, fa al·lusió a la paradoxa proposada per René Magritte al quadre La Trahison des images (La traïció de les imatges), atès que la incapacitat de distingir realitat i ficció ha sobrepassat el territori de la mera representació, convertint-se en un dels dilemes més presents a la nostra contemporaneïtat, fent-se evident tant en les imatges i la informació que ens envolta com en els paisatges que habitem.La peça és un dibuix en el que es representa un paisatge de gran format, introduint l’espectador dins la vivència d’un lloc fictici, simulat. En el dibuix es presenta el carrer principal de La Roca Village, un centre comercial construït imitant l’arquitectura catalana del segle XIX i dedicat a la venda de grans marques de roba i altres complements. Amb més de 4 milions de visitants a l’any aquest “no-poble” ja és el més visitat de Catalunya. Mitjançant el suport d’un material transparent, pintura blanca i una il·luminació dirigida, es crea una projecció d’ombra del grafisme del dibuix a la paret que domina la visió, fet que suscita una confusió a l’espectador, ja que no sap si està veient el dibuix mateix o l’ombra que genera aquest. L’ obra constitueix una crítica al capitalisme cultural i convida a l’espectador a reflexionar sobre el paisatge que habita, tot considerant que els carrers de La Roca Village, habitats per marques i transitats per consumidors, podrien ser un model per una societat en potència, que amaga les seves diferències sota un espectacle dedicat exclusivament a vendre productes lluents i experiències fictícies.[eng] The work’s title of this Final Degree Dissertation project, Ceci n’est pas une ville, refers to René Magritte’s paradox proposed in his painting La Trahison des images (The image betrayal), since the inability to distinguish reality and fiction has exceeded the territory of the mere representation, becoming one of our most noticeable contemporary dilemmas, making itself evident both in images and information that surround us, as in the landscapes that we inhabit. This piece is a drawing representing a large landscape, aiming to introduce the viewer into the experience of a fictitious and simulated place. The drawing shows the main street of La Roca Village, a shopping center built imitating the Catalan architecture of the 19th Century, devoted to selling big clothing brands. With more than 4 million of visitors per year, this “no-village” is already the most visited one in Catalonia. Through a transparent material support, white painting and a directed light, the shadow of the graphism is projected onto the wall and dominates the vision, this fact causes a confusion to the viewer as he/she doesn’t know if is watching the drawing itself or the shadow that it generates. The work constitutes a critic to cultural capitalism and invites the viewers to think about the landscapes they inhabit. Considering that La Roca Village streets, inhabited by brands and crowded by consumers, could be a potential model for a society that hides its differences under a performance exclusively dedicated to sell shiny products and fictitious experiences