NCT05362292招募中4 期
Cognitive, Urinary, and Functional Trajectories of Older Women Using Pharmacologic Treatment Strategies for Urgency Incontinence
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Anticholinergic bladder medication plus behavioral self-management education
Active Comparator
Tolterodine tartrate is a muscarinic receptor antagonist designed to treat urgency incontinence, urgency, and frequency associated with overactive bladder. Behavioral self-management education includes written education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression.
干预措施: Tolterodine Tartrate ER (Drug)
Beta-3-adrenergic agonist medication plus behavioral self-management education
Active Comparator
Mirabegron, currently sold under the brand name Mybetriq by Astellas Pharma, is a selective beta-3-adrenergic receptor agonist approved for treatment of urgency urinary incontinence, urgency, and frequency associated with overactive bladder. Behavioral self-management education includes written education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression.
干预措施: Mirabegron (Drug)
Placebo medication plus behavioral self-management education
Placebo Comparator
Microcrystalline cellulose placebo encapsulated to appear identical to tolterodine and mirabegron medication will be prepared by a compounding pharmacy. Behavioral self-management education includes written education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression.
干预措施: Placebo (Drug)
结局指标
主要结局
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.
时间窗: Baseline to 6 months
The composite cognitive score will be calculated as the average of Z-scores from the following individual cognitive tests: a) Auditory Verbal Learning Test (AVLT); b) Oral Trail Making Test (OTMT) part A; c) OTMT part B; d) Digit Span Test; and e) Digit Symbol Substitution Test (DSST). The normative mean of each cognitive test will be subtracted from each participant's component test score, and this difference will be divided by the standard deviation for the appropriate normative sample. After scores from individual tests are transformed to Z scores as a common metric based on normative data, the average Z score from all available tests will be calculated to provide a composite Z score.
次要结局
- Change in Digit Span reverse component (total correct trials) over 6 months (24 weeks) of treatment.(Baseline to 6 months (end of treatment))
- Change in Digit Span reverse component (total correct trials) over 9 months (36 weeks).(Baseline to 9 months (3 months after end of treatment))
- Change in Digit Symbol Substitution Test score over 6 months (24 weeks) of treatment.(Baseline to 6 months (end of treatment))
- Change in Digit Symbol Substitution Test score over 9 months (36 weeks).(Baseline 9 months (3 months after end of treatment))
- Change in frequency of urgency-type incontinence (episodes/week) over 6 months (24 weeks) of treatment.(Baseline to 6 months (end of treatment))
- Change in frequency of urgency-type incontinence (episodes/week) over 9 months (36 weeks).(Baseline to 9 months (3 months after end of treatment))
- Change in frequency of any-type incontinence (episodes/week) over 6 months (24 weeks) of treatment.(Baseline to 6 months (end of treatment))
- Change in frequency of any-type incontinence (episodes/week) over 9 months (36 weeks).(Baseline to 9 months (3 months after end of treatment))
- Resolution of urinary incontinence from baseline to 6 months (24 weeks).(Baseline to 6 months (end of treatment))
- Resolution of urinary incontinence from baseline to 9 months (36 weeks).(Baseline to 9 months (3 months after end of treatment))
- Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Symptom Bother domain score over 6 months (24 weeks) of treatment.(Baseline to 6 months (end of treatment))
- Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Symptom Bother domain score over 9 months (36 weeks).(Baseline to 9 months (3 months after end of treatment))
- Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Health-Related Quality of Life domain score over 6 months (24 weeks) of treatment.(Baseline to 6 months (end of treatment))
- 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.(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(Baseline to 6 months (end of treatment))
- Change in Auditory Verbal Learning Test total learning score assessed over 9 months (36 weeks).(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.(Baseline to 6 months (end of treatment))
- Change Auditory Verbal Learning Test delayed free recall score over 9 months (36 weeks).(Baseline to 9 months (3 months after end of treatment))
- Change in Oral Trail Making A score over 6 months (24 weeks) of treatment.(Baseline to 6 months (end of treatment))
- Change in Oral Trail Making A score over 9 months (36 weeks).(Baseline to 9 months (3 months after end of treatment))
- Change in Oral Trail Making B score over 6 months (24 weeks) of treatment.(Baseline to 6 months (end of treatment))
- Change in Oral Trail Making B score over 9 months (36 weeks).(Baseline to 9 months (3 months after end of treatment))
- Change in overall physical performance over 9 months (36 weeks).(Baseline to 9 months (3 months after end of treatment))
- Change in static balance over 6 months (24 weeks) of treatment.(Baseline to 6 months (end of treatment))
- Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Health-Related Quality of Life domain score over 9 months (36 weeks).(Baseline to 9 months (3 months after end of treatment))
- Change in global sleep quality score over 6 months (24 weeks) of treatment.(Baseline to 6 months (end of treatment))
- Change in global sleep quality score over 9 months (36 weeks).(Baseline to 9 months (3 months after end of treatment))
- Change in daytime sleepiness score over 6 months (24 weeks) of treatment.(Baseline to 6 months (end of treatment))
- Change in daytime sleepiness score over 9 months (36 weeks).(Baseline to 9 months (3 months after end of treatment))
- Change in perceived physical function over 6 months (24 weeks) of treatment.(Baseline to 6 months (end of treatment))
- Change in perceived physical function over 9 months (36 weeks).(Baseline to 9 months (3 months after end of treatment))
- Change in confidence in maintaining balance over 6 months (24 weeks) of treatment.(Baseline to 6 months (end of treatment))
- Change in overall physical performance over 6 months (24 weeks) of treatment.(Baseline to 6 months (end of treatment))
- Change in constipation symptoms over 6 months (24 weeks) of treatment.(Baseline to 6 months (end of treatment))
- Change in confidence in maintaining balance over 9 months (36 weeks).(Baseline to 9 months (3 months after end of treatment))
- Change in static balance from over 9 months (36 weeks).(Baseline to 9 months (3 months after end of treatment))
- Change in lower extremity strength measured by chair stand testing over 6 months (24 weeks) of treatment.(Baseline to 6 months (end of treatment))
- Change in lower extremity strength measured by chair stand testing over 9 months (36 weeks).(Baseline to 9 months (3 months after end of treatment))
- Change in depression symptoms over 6 months (24 weeks) of treatment.(Baseline to 6 months (end of treatment))
- Change in depression symptoms over 9 months (36 weeks).(Baseline to 9 months (3 months after end of treatment))
- Change in anxiety symptoms over 6 months (24 weeks) of treatment.(Baseline to 6 months (end of treatment))
- Change in anxiety symptoms over 9 months (36 weeks).(Baseline to 9 months (3 months after end of treatment))
- Change in constipation symptoms over 9 months (36 weeks).(Baseline to 9 months (3 months after end of treatment))
- Change in bowel incontinence symptoms over 9 months (36 weeks).(Baseline to 9 months (3 months after end of treatment))
- Change in bowel incontinence symptoms over 6 months (24 weeks) of treatment.(Baseline to 6 months (end of treatment))
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