Status:
RECRUITING
TReating Incontinence for Underlying Mental and Physical Health
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Urinary Incontinence, Urge
Urinary Incontinence
Eligibility:
FEMALE
60+ years
Phase:
PHASE4
Brief 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 an...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
October 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 2 2027
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT05362292
Start Date
October 4 2022
End Date
August 2 2027
Last Update
December 16 2025
Active Locations (2)
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1
Stanford University
Palo Alto, California, United States, 94305
2
University of California San Francisco
San Francisco, California, United States, 94115