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Recruiting NCT07829029

Ancillary Nocturnal Urinary Symptoms Analyses for TRIUMPH

Conditions: Nocturia, Nocturnal Urinary Incontinence

Sex: Female
Ages: 60 Years – N/A
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 270
Sponsor: University of California, San Francisco

Location: University of California San Francisco San Francisco California

Summary

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.

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 \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07829029). StuddyBuddy aggregates publicly available trial information.