NCT05362292 TReating Incontinence for Underlying Mental and Physical Health
| NCT ID | NCT05362292 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of California, San Francisco |
| Condition | Urinary Incontinence, Urge |
| Study Type | INTERVENTIONAL |
| Enrollment | 270 participants |
| Start Date | 2022-10-04 |
| Primary Completion | 2027-05-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 270 participants in total. It began in 2022-10-04 with a primary completion date of 2027-05-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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)
Contact & Investigator
Alison Huang, MD, MAS, MPhil
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT05362292 clinical trial?
This trial is open to female participants only, aged 60 Years or older, studying Urinary Incontinence, Urge. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05362292 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05362292 currently recruiting?
Yes, NCT05362292 is actively recruiting participants. Contact the research team at alison.huang@ucsf.edu for enrollment information.
Where is the NCT05362292 trial being conducted?
This trial is being conducted at Palo Alto, United States, San Francisco, United States.
Who is sponsoring the NCT05362292 clinical trial?
NCT05362292 is sponsored by University of California, San Francisco. The principal investigator is Alison Huang, MD, MAS, MPhil at University of California, San Francisco. The trial plans to enroll 270 participants.