![]() The secondary objective of the trial is to compare the effects of anticholinergic bladder therapy versus beta-3 adrenergic agonist therapy and versus no bladder pharmacotherapy on domain-specific cognitive function frequency, severity, and impact of participants’ urgency incontinence and other urgency-associated urinary symptoms perceived sleep quality and daytime sleepiness perceived and objectively assessed physical function and balance psychological function including depression and anxiety symptoms and bowel symptoms including constipation and bowel incontinence in this population.The list of esteemed guests lining up to duet with Frankie Miller on this album speaks volumes of the high regard in which he’s held by fellow musicians – Rod Stewart, Elton John, Willie Nelson, and Steve Cropper among them. ![]() ![]() The primary objective of the TRIUMPH trial is to compare the effect of anticholinergic bladder pharmacotherapy versus (a) beta-3 adrenergic agonist bladder pharmacotherapy and (b) no overactive bladder pharmacotherapy on overall (composite) cognitive function in older ambulatory women with urgency-predominant incontinence. Name and contact information for the trial sponsor Subak, MD 3Īffiliations: 1University of California San Francisco 2San Francisco Veterans Affairs 3Stanford University Walter, MD 1 Kristine Yaffe, MD 1 Eric Vittinghoff, PhD 1 Erica Kornblith, PhD 1,2 Michael Schembri, BS 1 Arunee Ann Chang, BS 1 Leslee L. National Institute on Aging grants R01AG075471 and K24AG068601 (no other financial, material, or other support)Īuthors: Alison J. Protocol version 1.5, as of December 8, 2022 All items from the WHO Trial Registration Dataset can be found in this protocol or in the trial’s listing TReating Incontinence for Underlying Mental and Physical Health (TRIUMPH): a study protocol for a multicenter, three-arm, double-blinded randomized trial to evaluate the multisystem effects of pharmacologic treatment strategies for urgency-predominant urinary incontinence in ambulatory older womenĬ Identifier: NCT05362292. The TRIUMPH trial addresses the need for rigorous evidence to guide counseling and decision-making for older women who are weighing the potential multisystem benefits and risks of pharmacologic treatments for urgency incontinence in order to preserve their day-to-day functioning, quality of life, and independence in older age. Secondary outcomes include changes over 24 and 36 weeks in domain-specific cognitive function frequency, severity, and impact of urgency-associated urinary symptoms physical function and balance sleep quality and daytime sleepiness psychological function and bowel function. The primary outcome is change in composite cognitive function over 24 weeks assessed by a comprehensive battery of cognitive tests, with a secondary exploration of the persistence of change at 36 weeks. Participants also receive patient-oriented information and instructions about practicing first-line behavioral management strategies for incontinence. Participants are randomized in equal ratios to take identically encapsulated oral anticholinergic bladder therapy (in the form of tolterodine 2 mg extended release ), oral beta-3 adrenergic agonist bladder therapy (mirabegron 25 mg ER), or placebo daily for 24 weeks, with the option of participant-directed dose titration (to tolterodine 4 mg ER, mirabegron 50 mg ER, or matching placebo daily). Women aged 60 years and older (target N = 270) who have chronic urgency-predominant urinary incontinence and either normal or mildly impaired cognition at baseline are recruited from the community by investigators based in northern California, USA. The TRIUMPH study is a randomized, double-blinded, 3-arm, parallel-group trial comparing the multisystem effects of anticholinergic versus beta-3-adrenergic agonist bladder therapy and versus no active bladder anti-spasmodic pharmacotherapy in older women with urgency incontinence. Observational studies have raised concern about potentially higher rates of delirium and dementia in older adults taking anticholinergic bladder medications, but few prospective data are available to evaluate the effects of these and other pharmacologic treatments for urgency incontinence on cognition and other multisystem functional domains important to older women. Urgency-type urinary incontinence affects one in four older community-dwelling women and overlaps with other common aging-associated health syndromes such as cognitive impairment, physical mobility impairment, and depression.
0 Comments
Leave a Reply. |