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Ancillary Nocturnal Urinary Symptoms Analyses for TRIUMPH

ConditionNocturia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age60+
SponsorUniversity of California, San Francisco

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • TolterodineTartrate ER

    Drug

    Anticholinergic

  • Mirabegron

    Drug

    Beta-3-adrenergic agonist

  • Placebo

    Drug

    matching placebo pill

Treatment groups

270 Participants
are divided into 3 treatment groups
Group A: Anticholinergic bladder medication plusbehavioral self-management educationActive comparator 1 intervention
Group B: Beta-3-adrenergic agonist medication plusbehavioral self-management educationActive comparator 1 intervention
Group C: Placebo medication plus behavioral self-management educationPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in nocturnal urination frequency over 6 months (24 weeks) of treatment, based on a validated voiding diary.

Frequency of nocturnal urination will be assessed using a standardized, 7-day voiding diary.

Time frame
Baseline to 6 months

Secondary outcomes

1

Change in nocturnal urinary incontinence frequency over 6 months (24 weeks) of treatment, based on a validated voiding diary.

Frequency of nocturnal urination will be assessed using a standardized, 7-day voiding diary.

Time frame
Baseline to 6 months
2

Change in global sleep quality score over 6 months (24 weeks) of treatment.

Perceived sleep quality will be assessed using the Pittsburgh Sleep Quality Index(PSQI), an 18-item validated questionnaire designed to assess sleep quality, latency, efficiency, and problems over a one-week period. Score range: 0-21, with higher scores indicating a worse outcome.

Time frame
Baseline to 6 months
3

Change in daytime sleepiness score over 6 months (24 weeks) of treatment.

Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS), an 8-item questionnaire assessing the level of general sleepiness during real-life situations in order to distinguish excessive daytime sleepiness from normal daytime sleepiness. Score range: 0-24, with higher scores indicating a worse outcome.

Time frame
Baseline to 6 months
4

Change in sleep efficiency over 6 months (24 weeks) of treatment, based on the PSQI sleep efficiency score.

Sleep efficiency will be assessed based on questions 1, 3, and 4 of the Pittsburgh Sleep Quality Index (PSQI). Score range: 0-3, with higher scores indicating a worse sleep efficiency.

Time frame
Baseline to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov
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