NocturiaPhase 4NCT07829029
Ancillary Nocturnal Urinary Symptoms Analyses for TRIUMPH
A Phase 4 study testing TolterodineTartrate ER and Mirabegron in people with Nocturia, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nocturia
- What is being tested?
- TolterodineTartrate ER and Mirabegron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2022to 2 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ann Chang contact
United States1 site, 1 recruiting
- Recruiting
University of California San Francisco
San Francisco, California, 94115
Claudia Vila Manes, 415-885-7547, claudia.vilamanes@ucsf.edu
Amy Zhang, (415) 885-7547, amy.zhang4@ucsf.edu
About this study
Official title: Ancillary Nocturnal Urinary Symptom Investigation in the TRIUMPH 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.
- Conditions
- Nocturia
- Being tested
- TolterodineTartrate ER, Mirabegron, Placebo
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolterodineTartrate ERDrug
Anticholinergic
MirabegronDrug
Beta-3-adrenergic agonist
PlaceboDrug
matching placebo pill
| Study group | Role | What they receive |
|---|---|---|
| Anticholinergic bladder medication plusbehavioral self-management education | Active comparator | Tolterodine tartrate is a muscarinic receptor antagonist designed to treat urgency incontinence, urgency, and frequency associated with overactive bladder. Behavioral self-management education includes written education about timed urge suppression Receives: Drug: TolterodineTartrate ER |
| Beta-3-adrenergic agonist medication plusbehavioral self-management education | Active comparator | Mirabegron, currently sold under the brand name Mybetriq by Astellas Pharma, is a selective beta-3-adrenergic receptor agonist approved for treatment of urgency urinary incontinence, urgency, and frequency associated with overactive bladder. Behavioral self-management education includes written education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression. Receives: Drug: Mirabegron |
| Placebo medication plus behavioral self-management education | Placebo comparator | Microcrystalline cellulose placebo encapsulated to appear identical to tolterodine and mirabegron medication will be prepared by a compounding pharmacy. Behavioral self-management education includes written education about time duration, lifestyle changes, pelvic floor muscle exercises, and urge suppression. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months
Secondary outcomes (7)
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.
Measured: Baseline to 6 months
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.
Measured: Baseline to 6 months
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.
Measured: Baseline to 6 months
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.
Measured: Baseline to 6 months
Change in depression symptoms over 6 months (24 weeks) of treatment.
Depression symptoms will be assessed using the 15-item short form of the GeriatricDepression Scale-15 (GDS-15), which assesses symptoms of depression over a 1-week period. Score range: 0-24, with higher scores indicating a worse outcome. Score range: 0-15, with higher scores indicating a worse outcome.
Measured: Baseline to 6 months
Change in anxiety symptoms over 6 months (24 weeks) of treatment.
Anxiety symptoms will be assessing using the Generalized Anxiety Disorder-7 (GAD7),7-item short form, questionnaire to assess severity of anxiety symptoms over a 2-week period. Score range: 0-21, with higher scores indicating a worse outcome.
Measured: Baseline to 6 months
Change in composite cognitive function over 6 months (24 weeks) of treatment, using a composite cognitive score that incorporates normalized data from all domain-specific cognitive tests.
The composite cognitive score will be calculated as the average of Z-scores from the following individual cognitive tests: a) Auditory Verbal Learning Test (AVLT); b) Oral Trail Making Test (OTMT) part A; c) OTMT part B; d) Digit Span Test; and e) Digit Symbol Substitution Test (DSST). The normative mean of each cognitive test will be subtracted from each participant's component test score, and this difference will be divided by the standard deviation for the appropriate normative sample. After scores from individual tests are transformed to Z scores as a common metric based on normative data, the average Z score from all available tests will be calculated to provide a composite Z score.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start4 Oct 2022
- Primary completion2 May 2027 (estimated)
- Study completion2 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Alison Huang, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829029
- Sponsor's protocol ID
- 2K24AG068601
- Other IDs
- 2K24AG068601
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ancillary Nocturnal Urinary Symptom Investigation in the TRIUMPH Trial
- ClinicalTrials.gov ID
- NCT07829029
- Acronym / sponsor ID
- 2K24AG068601
- Conditions
- Nocturia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 2 May 2027 (estimated)
- Study completion
- 2 May 2027 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anticholinergic bladder medication plusbehavioral self-management education | Active comparator | Drug: TolterodineTartrate ERTolterodine tartrate is a muscarinic receptor antagonist designed to treat urgency incontinence, urgency, and frequency associated with overactive bladder. Behavioral self-management education includes written education about timed urge suppression |
| Beta-3-adrenergic agonist medication plusbehavioral self-management education | Active comparator | Drug: MirabegronMirabegron, currently sold under the brand name Mybetriq by Astellas Pharma, is a selective beta-3-adrenergic receptor agonist approved for treatment of urgency urinary incontinence, urgency, and frequency associated with overactive bladder. Behavioral self-management education includes written education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression. |
| Placebo medication plus behavioral self-management education | Placebo comparator | Drug: PlaceboMicrocrystalline cellulose placebo encapsulated to appear identical to tolterodine and mirabegron medication will be prepared by a compounding pharmacy. Behavioral self-management education includes written education about time duration, lifestyle changes, pelvic floor muscle exercises, and urge suppression. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TolterodineTartrate ERAnticholinergic | Drug | Anticholinergic bladder medication plusbehavioral self-management education |
| MirabegronBeta-3-adrenergic agonist | Drug | Beta-3-adrenergic agonist medication plusbehavioral self-management education |
| Placebomatching placebo pill | Drug | Placebo medication plus behavioral self-management education |
Primary outcome
Change in nocturnal urination frequency over 6 months (24 weeks) of treatment, based on a validated voiding diary.
Time frame: Baseline to 6 months
Frequency of nocturnal urination will be assessed using a standardized, 7-day voiding diary.
7 secondary outcomes
Change in nocturnal urinary incontinence frequency over 6 months (24 weeks) of treatment, based on a validated voiding diary.
Time frame: Baseline to 6 months
Change in global sleep quality score over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months
Change in daytime sleepiness score over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months
Change in sleep efficiency over 6 months (24 weeks) of treatment, based on the PSQI sleep efficiency score.
Time frame: Baseline to 6 months
Change in depression symptoms over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months
Change in anxiety symptoms over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months
Change in composite cognitive function over 6 months (24 weeks) of treatment, using a composite cognitive score that incorporates normalized data from all domain-specific cognitive tests.
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann Chang contact
Alison Huang, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TolterodineTartrate ER and Mirabegron in people with Nocturia, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alison Huang, MD, MAS, MPhil ((415) 514-8697, alison.huang@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nocturnal urination frequency over 6 months (24 weeks) of treatment, based on a validated voiding diary. (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.