TReating Incontinence for Underlying Mental and Physical Health
a study on Urinary Incontinence Overactive Bladder Urge Incontinence Incontinence
Summary
- Eligibility
- for females ages 60 years and up (full criteria)
- Healthy Volunteers
- healthy people welcome
- Location
- at San Francisco, California and other locations
- Dates
- study startedcompletion around
- Principal Investigator
- by Alison Huang
Description
Summary
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.
Official Title
Cognitive, Urinary, and Functional Trajectories of Older Women Using Pharmacologic Treatment Strategies for Urgency Incontinence
Keywords
Urinary Incontinence, Urge, Urinary Incontinence, Overactive Bladder, Incontinence, Urge, Incontinence, Urinary, Incontinence, Enuresis, Overactive Urinary Bladder, Urge Urinary Incontinence, Mirabegron, Tolterodine Tartrate, Tolterodine Tartrate ER
Eligibility
You can join if…
Open to females ages 60 years and up
- 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
You CAN'T join if...
- 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)
Locations
- UCSF
accepting new patients
San Francisco California 94115 United States - Stanford University
accepting new patients
Palo Alto California 94305 United States
Lead Scientist at UCSF
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- University of California, San Francisco
- ID
- NCT05362292
- Phase
- Phase 4 research study
- Study Type
- Interventional
- Participants
- Expecting 270 study participants
- Last Updated
Frequently Asked Questions
Please contact me about this study
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT05362292.