TReating Incontinence for Underlying Mental and Physical Health

Официальное название

Cognitive, Urinary, and Functional Trajectories of Older Women Using Pharmacologic Treatment Strategies for Urgency Incontinence

Обзор

The TRIUMPH study is a randomized, double-blinded, 3-arm, parallel-group trial designed to compare the effects of anticholinergic bladder therapy versus a) beta-3-adrenergic agonist bladder therapy and b) no bladder pharmacotherapy on cognitive, urinary, and other aging-related functional outcomes in ambulatory older women with urgency-predominant urinary incontinence and either normal or mildly impaired cognitive function at baseline.

Вмешательства

• Препарат Tolterodine Tartrate ER
  Anticholinergic
• Препарат Mirabegron
  Beta-3-adrenergic agonist
• Препарат Placebo
  matching placebo pill

Первичные конечные точки

• Change in composite cognitive function over 6 months (24 weeks) of treatment, using a composite cognitive score that incorporates normalized data from all domain-specific cognitive tests. [Срок оценки: Baseline to 6 months]

Вторичные конечные точки (12)

• Change in composite cognitive function over 9 months (36 weeks), using a composite cognitive score that incorporates normalized data from all domain-specific cognitive tests. [Срок оценки: Baseline to 9 months (3 months after end of treatment)]
• Change in Auditory Verbal Learning Test total learning score assessed over 6 months (24 weeks) of treatment [Срок оценки: Baseline to 6 months (end of treatment)]
• Change in Auditory Verbal Learning Test total learning score assessed over 9 months (36 weeks). [Срок оценки: Baseline to 9 months (3 months after end of treatment)]
• Change Auditory Verbal Learning Test delayed free recall score over 6 months (24 weeks) of treatment. [Срок оценки: Baseline to 6 months (end of treatment)]
• Change Auditory Verbal Learning Test delayed free recall score over 9 months (36 weeks). [Срок оценки: Baseline to 9 months (3 months after end of treatment)]
• Change in Oral Trail Making A score over 6 months (24 weeks) of treatment. [Срок оценки: Baseline to 6 months (end of treatment)]
• Change in Oral Trail Making A score over 9 months (36 weeks). [Срок оценки: Baseline to 9 months (3 months after end of treatment)]
• Change in Oral Trail Making B score over 6 months (24 weeks) of treatment. [Срок оценки: Baseline to 6 months (end of treatment)]
• Change in Oral Trail Making B score over 9 months (36 weeks). [Срок оценки: Baseline to 9 months (3 months after end of treatment)]
• Change in Digit Span reverse component (total correct trials) over 6 months (24 weeks) of treatment. [Срок оценки: Baseline to 6 months (end of treatment)]
• Change in Digit Span reverse component (total correct trials) over 9 months (36 weeks). [Срок оценки: Baseline to 9 months (3 months after end of treatment)]
• Change in Digit Symbol Substitution Test score over 6 months (24 weeks) of treatment. [Срок оценки: Baseline to 6 months (end of treatment)]

Критерии участия

Критерии включения

• Aged 60 years or older at the time of enrollment
• Female sex at birth, without surgical or hormonal gender re-assignment therapy
• Able to walk to the bathroom and use the toilet without assistance
• Report urinary incontinence starting at least 3 months prior to screening
• Report that at least half of incontinence episodes occur with a sudden or strong sensation of urgency
• Report 2 or more urgency incontinence episodes over a 7-day period
• Willing to provide informed consent and adhere to study procedures throughout the length of the study

Критерии исключения

• Prior clinician diagnosis of dementia, or a Montreal Cognitive Assessment (MOCA) score of 17 or lower on screening cognitive evaluation
• Current use of anticholinergic, beta-3-adrenergic agonist, or other medication designed to improve urgency incontinence symptoms, or use in the past 1 month
• Initiation, discontinuation, or dose change of dementia medications (such as donepezil, galantamine, memantine, rivastigmine) in the past 1 month (but candidates on stable doses are eligible)
• Initiation, discontinuation, or dose change of other drugs with strong anticholinergic effects (based on the Beers List) in the past 1 month (but candidates on stable doses are eligible)
• Initiation, discontinuation, or dose change of other drugs that can affect urinary frequency, including diuretics, in the past 1 month (but candidates on stable doses are eligible)
• Current urinary tract infection (UTI) based on screening urinalysis and culture (but candidates can re-present for re-screening after undergoing treatment for UTI)
• History of allergy or sensitivity to either of the study medications or an ingredient in the placebo or study medication capsule
• Severe hepatic impairment (Child-Pugh score B or greater) or renal impairment (creatinine clearance <30 mL/min) as a contraindication to both study medications
• Current bladder obstruction or urinary retention (defined by symptoms suggesting difficulty emptying the bladder in addition to postvoid residual urine volume greater than 150 cc by portable bladder ultrasound)
• Uncontrolled hypertension (based on measured systolic blood pressure greater than 180 or diastolic blood pressure greater than 110 mmHg) as a contraindication to beta-3-adrenergic therapy
• Self-reported history of gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe ulcerative colitis, or toxic megacolon as contraindications for anticholinergic bladder therapy
• Use of drugs with adverse interactions with one of the study medications in the past 1 month, including potent CYP3A4 inhibitors, hepatic enzyme metabolism inducers, narrow therapeutic index drugs metabolized by CYP2D6, or intention to start taking one of these medications during the study treatment period
• History of bladder surgery, invasive intra-vesical therapy, or bulk bladder injections in the past 3 months (more remote surgery will not be exclusionary), or intention to undergo one of these procedures in the study treatment period
• Use of other specialized incontinence therapy (electrostimulation, pelvic physiotherapy, formal behavioral therapy overseen by certified practitioners) in the past 3 months (more remote therapy will not be exclusionary), or intention to undergo one of these procedures in the study treatment period
• Inability to sign informed consent or complete questionnaires, interviews, or study testing in English
• Other condition that would prevent the participant from completing study procedures, in the opinion of the investigators (e.g., uncontrolled psychosis)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Stanford University — Palo Alto
• University of California San Francisco — San Francisco

Публикации

• Huang AJ, Walter LC, Yaffe K, Vittinghoff E, Kornblith E, Schembri M, Chang A, Subak LL. TReating Incontinence for Underlying Mental and Physical Health (TRIUMPH): a study protocol for a multicenter, double-blinded, randomized, 3-arm trial to evaluate the multisystem effects of pharmacologic treatment strategies for urgency-predominant urinary incontinence in ambulatory older women. Trials. 2023 A PMID 37085880

Идентификаторы

NCT: NCT05362292 · 21-35858 · 1R01AG075471-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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