Ancillary Nocturnal Urinary Symptom Investigation in the TRIUMPH Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Change in nocturnal urination frequency over 6 months (24 weeks) of treatment, based on a validated voiding diary.
研究概览
简要总结
The TRIUMPH study is a randomized, double-blinded, 3-arm, parallel-group trial designed tocompare the effects of anticholinergic bladder therapy versus a) beta-3-adrenergic agonistbladder therapy and b) no bladder pharmacotherapy on cognitive, urinary, and other aging-related functional outcomes in ambulatory older women with urgency-predominant urinaryincontinence 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 plusbehavioral self-management education
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 urge suppression
干预措施: TolterodineTartrate ER (Drug)
Placebo medication plus behavioral self-management education
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 time duration, lifestyle changes, pelvic floor muscle exercises, and urge suppression.
干预措施: Placebo (Drug)
Beta-3-adrenergic agonist medication plusbehavioral self-management education
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)
结局指标
主要结局
Change in nocturnal urination frequency over 6 months (24 weeks) of treatment, based on a validated voiding diary.
时间窗: Baseline to 6 months
Frequency of nocturnal urination will be assessed using a standardized, 7-day voiding diary.
次要结局
- Change in nocturnal urinary incontinence frequency over 6 months (24 weeks) of treatment, based on a validated voiding diary.(Baseline to 6 months)
- Change in global sleep quality score over 6 months (24 weeks) of treatment.(Baseline to 6 months)
- Change in daytime sleepiness score over 6 months (24 weeks) of treatment.(Baseline to 6 months)
- Change in sleep efficiency over 6 months (24 weeks) of treatment, based on the PSQI sleep efficiency score.(Baseline to 6 months)
- Change in depression symptoms over 6 months (24 weeks) of treatment.(Baseline to 6 months)
- Change in anxiety symptoms over 6 months (24 weeks) of treatment.(Baseline to 6 months)
- 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.(Baseline to 6 months)