Urinary Incontinence, UrgePhase 4TRIUMPHNCT05362292
TReating Incontinence for Underlying Mental and Physical Health
A Phase 4 study testing Tolterodine Tartrate ER and Mirabegron in people with Urinary Incontinence, Urge and Urinary Incontinence, run by University of California, San Francisco at 2 sites in United States.
Trial 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… 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
- Urinary Incontinence, Urge, Urinary Incontinence, Overactive Bladder
- What is being tested?
- Tolterodine Tartrate 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
- 2 sitesUnited States
- Study dates
- 4 Oct 2022to 2 Aug 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ann Chang contact
United States2 sites, 2 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94305
Leslee Subak, MD, 650-723-5533, lsubak@stanford.edu
- Recruiting
University of California San Francisco
San Francisco, California, 94115
Alison Huang, MD, MAS, MPhil, alison.huang@ucsf.edu
Claudia Vila Manes, 415-885-7547, claudia.vilamanes@ucsf.edu
About this study
Official title: Cognitive, Urinary, and Functional Trajectories of Older Women Using Pharmacologic Treatment Strategies for Urgency Incontinence
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.
- Conditions
- Urinary Incontinence, Urge, Urinary Incontinence, Overactive Bladder, Incontinence, Urge, Incontinence, Urinary, Incontinence
- Being tested
- Tolterodine Tartrate ER, Mirabegron, Placebo
- Medical subject headings
- Urinary Incontinence, Urge, Urinary Incontinence, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tolterodine Tartrate ERDrug
Anticholinergic
MirabegronDrug
Beta-3-adrenergic agonist
PlaceboDrug
matching placebo pill
| Study group | Role | What they receive |
|---|---|---|
| Anticholinergic bladder medication plus behavioral 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 urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression. Receives: Drug: Tolterodine Tartrate ER |
| Beta-3-adrenergic agonist medication plus behavioral 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 timed urination, 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 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
Secondary outcomes (45)
Change in composite cognitive function over 9 months (36 weeks), 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 9 months (3 months after end of treatment)
Change in Auditory Verbal Learning Test total learning score assessed over 6 months (24 weeks) of treatment
The Rey Auditory Verbal Learning Test (AVLT), a widely used test of immediate and delayed verbal learning with established norms in older adults and multiple alternate forms. The total learning score is the sum of words learned from trials 1-5.
Measured: Baseline to 6 months (end of treatment)
Change in Auditory Verbal Learning Test total learning score assessed over 9 months (36 weeks).
The Rey Auditory Verbal Learning Test (AVLT), a widely used test of immediate and delayed verbal learning with established norms in older adults and multiple alternate forms. The total learning score is the sum of words learned from trials 1-5.
Measured: Baseline to 9 months (3 months after end of treatment)
Change Auditory Verbal Learning Test delayed free recall score over 6 months (24 weeks) of treatment.
The Rey Auditory Verbal Learning Test (AVLT), a widely used test of immediate and delayed verbal learning with established norms in older adults and multiple alternate forms. Score range of 0-15.
Measured: Baseline to 6 months (end of treatment)
Change Auditory Verbal Learning Test delayed free recall score over 9 months (36 weeks).
The Rey Auditory Verbal Learning Test (AVLT), a widely used test of immediate and delayed verbal learning with established norms in older adults and multiple alternate forms. Score range of 0-15.
Measured: Baseline to 9 months (3 months after end of treatment)
Change in Oral Trail Making A score over 6 months (24 weeks) of treatment.
The oral version of the Trail Making Test (OTMT), a timed measure of attention (part A) and executive function (part B) adapted from the written TMT, with established norms for participants across a wide range of ages. Range of 1-150 seconds
Measured: Baseline to 6 months (end of treatment)
Change in Oral Trail Making A score over 9 months (36 weeks).
The oral version of the Trail Making Test (OTMT), a timed measure of attention (part A) and executive function (part B) adapted from the written TMT, with established norms for participants across a wide range of ages. Range of 1-150 seconds
Measured: Baseline to 9 months (3 months after end of treatment)
Change in Oral Trail Making B score over 6 months (24 weeks) of treatment.
The oral version of the Trail Making Test (OTMT), a timed measure of attention (part A) and executive function (part B) adapted from the written TMT, with established norms for participants across a wide range of ages. Range of 1-300 seconds.
Measured: Baseline to 6 months (end of treatment)
Change in Oral Trail Making B score over 9 months (36 weeks).
The oral version of the Trail Making Test (OTMT), a timed measure of attention (part A) and executive function (part B) adapted from the written TMT, with established norms for participants across a wide range of ages. Range of 1-300 seconds.
Measured: Baseline to 9 months (3 months after end of treatment)
Change in Digit Span reverse component (total correct trials) over 6 months (24 weeks) of treatment.
The Digit Span Reverse (total correct trials), a subtest of the Wechsler Adult Intelligence and Memory Scales, a test of attention and short-term verbal memory, with reliability across in-person and videoconference platforms. Range of 0-14.
Measured: Baseline to 6 months (end of treatment)
Change in Digit Span reverse component (total correct trials) over 9 months (36 weeks).
The Digit Span Reverse (total correct trials), a subtest of the Wechsler Adult Intelligence and Memory Scales, a test of attention and short-term verbal memory, with reliability across in-person and videoconference platforms. Range of 0-14.
Measured: Baseline to 9 months (3 months after end of treatment)
Change in Digit Symbol Substitution Test score over 6 months (24 weeks) of treatment.
The Digit Symbol Substitution Test (DSST), a timed, written test assessing incidental memory, visual scanning, and processing speed, in which subjects translate numbers into symbols using a key. Range of 1-133.
Measured: Baseline to 6 months (end of treatment)
Change in Digit Symbol Substitution Test score over 9 months (36 weeks).
The Digit Symbol Substitution Test (DSST), a timed, written test assessing incidental memory, visual scanning, and processing speed, in which subjects translate numbers into symbols using a key. Range of 1-133.
Measured: Baseline 9 months (3 months after end of treatment)
Change in frequency of urgency-type incontinence (episodes/week) over 6 months (24 weeks) of treatment.
Frequency and type of incontinence will be assessed using a standardized, 7-day voiding diary.
Measured: Baseline to 6 months (end of treatment)
Change in frequency of urgency-type incontinence (episodes/week) over 9 months (36 weeks).
Frequency and type of incontinence will be assessed using a standardized, 7-day voiding diary.
Measured: Baseline to 9 months (3 months after end of treatment)
Change in frequency of any-type incontinence (episodes/week) over 6 months (24 weeks) of treatment.
Frequency and type of incontinence will be assessed using a standardized, 7-day voiding diary.
Measured: Baseline to 6 months (end of treatment)
Change in frequency of any-type incontinence (episodes/week) over 9 months (36 weeks).
Frequency and type of incontinence will be assessed using a standardized, 7-day voiding diary.
Measured: Baseline to 9 months (3 months after end of treatment)
Resolution of urinary incontinence from baseline to 6 months (24 weeks).
Frequency and type of incontinence will be assessed using a standardized, 7-day voiding diary.
Measured: Baseline to 6 months (end of treatment)
Resolution of urinary incontinence from baseline to 9 months (36 weeks).
Frequency and type of incontinence will be assessed using a standardized, 7-day voiding diary.
Measured: Baseline to 9 months (3 months after end of treatment)
Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Symptom Bother domain score over 6 months (24 weeks) of treatment.
Bothersomeness and impact of overactive bladder symptoms (such as urgency, incontinence, and nocturia) will be assessed using the short-form of the OAB-Q, which generates both a Symptom Bother domain and a Health-Related Quality of Life domain score.
Measured: Baseline to 6 months (end of treatment)
Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Symptom Bother domain score over 9 months (36 weeks).
Bothersomeness and impact of overactive bladder symptoms (such as urgency, incontinence, and nocturia) will be assessed using the short-form of the OAB-Q, which generates both a Symptom Bother domain and a Health-Related Quality of Life domain score.
Measured: Baseline to 9 months (3 months after end of treatment)
Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Health-Related Quality of Life domain score over 6 months (24 weeks) of treatment.
Bothersomeness and impact of overactive bladder symptoms (such as urgency, incontinence, and nocturia) will be assessed using the short-form of the OAB-Q, which generates both a Symptom Bother domain and a Health-Related Quality of Life domain score.
Measured: Baseline to 6 months (end of treatment)
Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Health-Related Quality of Life domain score over 9 months (36 weeks).
Bothersomeness and impact of overactive bladder symptoms (such as urgency, incontinence, and nocturia) will be assessed using the short-form of the OAB-Q, which generates both a Symptom Bother domain and a Health-Related Quality of Life domain score.
Measured: Baseline to 9 months (3 months after end of treatment)
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.
Measured: Baseline to 6 months (end of treatment)
Change in global sleep quality score over 9 months (36 weeks).
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.
Measured: Baseline to 9 months (3 months after end of treatment)
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.
Measured: Baseline to 6 months (end of treatment)
Change in daytime sleepiness score over 9 months (36 weeks).
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.
Measured: Baseline to 9 months (3 months after end of treatment)
Change in perceived physical function over 6 months (24 weeks) of treatment.
Perceived physical function will be assessed using the PROMIS 10B Adult Physical Function Scale, a 10-item measure that assesses the extent to which daily activities are limited by function of the extremities and central regions.
Measured: Baseline to 6 months (end of treatment)
Change in perceived physical function over 9 months (36 weeks).
Perceived physical function will be assessed using the PROMIS 10B Adult Physical Function Scale, a 10-item measure that assesses the extent to which daily activities are limited by function of the extremities and central regions.
Measured: Baseline to 9 months (3 months after end of treatment)
Change in confidence in maintaining balance over 6 months (24 weeks) of treatment.
Confidence in maintaining balance will be assessed using the 15-item Activities Balance Confidence Scale (ABC-S), in which participants self-rate their confidence in keeping balance with performing daily living tasks.
Measured: Baseline to 6 months (end of treatment)
Change in confidence in maintaining balance over 9 months (36 weeks).
Confidence in maintaining balance will be assessed using the 15-item Activities Balance Confidence Scale (ABC-S), in which participants self-rate their confidence in keeping balance with performing daily living tasks.
Measured: Baseline to 9 months (3 months after end of treatment)
Change in overall physical performance over 6 months (24 weeks) of treatment.
Physical function will be directly assessed using the Short Physical Performance Battery (SPPB), involving: 1) side-by-side, semi-tandem, and tandem balance tests; 2) a 4-meter walk test; and 3) 5 chair stands, in which participants will be asked to stand up repeatedly from a standard chair to a full extended standing position.
Measured: Baseline to 6 months (end of treatment)
Change in overall physical performance over 9 months (36 weeks).
Physical function will be directly assessed using the Short Physical Performance Battery (SPPB), involving: 1) side-by-side, semi-tandem, and tandem balance tests; 2) a 4-meter walk test; and 3) 5 chair stands, in which participants will be asked to stand up repeatedly from a standard chair to a full extended standing position.
Measured: Baseline to 9 months (3 months after end of treatment)
Change in static balance over 6 months (24 weeks) of treatment.
Static balance will additionally be assessed by asking participants to attempt to assume a one-legged stand for 30 seconds.
Measured: Baseline to 6 months (end of treatment)
Change in static balance from over 9 months (36 weeks).
Static balance will additionally be assessed by asking participants to attempt to assume a one-legged stand for 30 seconds.
Measured: Baseline to 9 months (3 months after end of treatment)
Change in lower extremity strength measured by chair stand testing over 6 months (24 weeks) of treatment.
Physical strength will be assessed 30-second chair stand, by asking participants to stand up as many times as possible within 30 seconds, with higher number indicating more strength or power.
Measured: Baseline to 6 months (end of treatment)
Change in lower extremity strength measured by chair stand testing over 9 months (36 weeks).
Physical strength will be assessed 30-second chair stand, by asking participants to stand up as many times as possible within 30 seconds, with higher number indicating more strength or power.
Measured: Baseline to 9 months (3 months after end of treatment)
Change in depression symptoms over 6 months (24 weeks) of treatment.
Depression symptoms will be assessed using the 15-item short form of the Geriatric Depression Scale-15 (GDS-15), which assesses symptoms of depression over a 1-week period.
Measured: Baseline to 6 months (end of treatment)
Change in depression symptoms over 9 months (36 weeks).
Depression symptoms will be assessed using the 15-item short form of the Geriatric Depression Scale-15 (GDS-15), which assesses symptoms of depression over a 1-week period.
Measured: Baseline to 9 months (3 months after end of treatment)
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.
Measured: Baseline to 6 months (end of treatment)
Change in anxiety symptoms over 9 months (36 weeks).
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.
Measured: Baseline to 9 months (3 months after end of treatment)
Change in constipation symptoms over 6 months (24 weeks) of treatment.
Symptoms of constipation as a possible side effect of anticholinergic therapy will be assessed by the 9-item PROMIS Constipation scale of the PROMIS Gastrointestinal Symptoms-Constipation Scale.
Measured: Baseline to 6 months (end of treatment)
Change in constipation symptoms over 9 months (36 weeks).
Symptoms of constipation as a possible side effect of anticholinergic therapy will be assessed by the 9-item PROMIS Constipation scale of the PROMIS Gastrointestinal Symptoms-Constipation Scale.
Measured: Baseline to 9 months (3 months after end of treatment)
Change in bowel incontinence symptoms over 6 months (24 weeks) of treatment.
Bowel incontinence as a syndrome that frequently overlaps with urinary incontinence will be assessed using the 4-item PROMIS Bowel Incontinence scale.
Measured: Baseline to 6 months (end of treatment)
Change in bowel incontinence symptoms over 9 months (36 weeks).
Bowel incontinence as a syndrome that frequently overlaps with urinary incontinence will be assessed using the 4-item PROMIS Bowel Incontinence scale.
Measured: Baseline to 9 months (3 months after end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start4 Oct 2022
- Primary completion2 May 2027 (estimated)
- Study completion2 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence, UrgeStudies 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, MAS, MPhil, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362292
- Sponsor's protocol ID
- 21-35858
- Other IDs
- 1R01AG075471-01
- Acronym
- TRIUMPH
- Status last verified
- Mar 2026
- First submitted
- 2 May 2022
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigative team will make publicly available de-identified individual participant data that underlie the results reported in the publication. This will include data about the baseline characteristics of enrolled participants and any primary or secondary trial outcomes presented in the publication. To gain access, data requestors will be asked to sign a data access agreement.
Publications
Huang AJ, Walter LC, Yaffe K, Vittinghoff E, Kornblith E, Schembri M, Chang A, Subak LL. TReating Incontinence for Underlying Mental and Physical Health (TRIUMPH): a study protocol for a multicenter, double-blinded, randomized, 3-arm trial to evaluate the multisystem effects of pharmacologic treatment strategies for urgency-predominant urinary incontinence in ambulatory older women. Trials. 2023 Apr 21;24(1):287. doi: 10.1186/s13063-023-07279-z.
PubMed 37085880
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive, Urinary, and Functional Trajectories of Older Women Using Pharmacologic Treatment Strategies for Urgency Incontinence
- ClinicalTrials.gov ID
- NCT05362292
- Acronym / sponsor ID
- TRIUMPH / 21-35858
- Conditions
- Urinary Incontinence, Urge, Urinary Incontinence, Overactive Bladder, Incontinence, Urge, Incontinence, Urinary, Incontinence
- 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 Aug 2027 (estimated)
- First posted
- 5 May 2022 (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 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.
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 plus behavioral self-management education | Active comparator | Drug: Tolterodine Tartrate 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 urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression. |
| Beta-3-adrenergic agonist medication plus behavioral 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 timed urination, 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 |
|---|---|---|
| Tolterodine Tartrate ERAnticholinergic | Drug | Anticholinergic bladder medication plus behavioral self-management education |
| MirabegronBeta-3-adrenergic agonist | Drug | Beta-3-adrenergic agonist medication plus behavioral self-management education |
| Placebomatching placebo pill | Drug | Placebo medication plus behavioral self-management education |
Primary outcome
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
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.
45 secondary outcomes
Change in composite cognitive function over 9 months (36 weeks), using a composite cognitive score that incorporates normalized data from all domain-specific cognitive tests.
Time frame: Baseline to 9 months (3 months after end of treatment)
Change in Auditory Verbal Learning Test total learning score assessed over 6 months (24 weeks) of treatment
Time frame: Baseline to 6 months (end of treatment)
Change in Auditory Verbal Learning Test total learning score assessed over 9 months (36 weeks).
Time frame: Baseline to 9 months (3 months after end of treatment)
Change Auditory Verbal Learning Test delayed free recall score over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months (end of treatment)
Change Auditory Verbal Learning Test delayed free recall score over 9 months (36 weeks).
Time frame: Baseline to 9 months (3 months after end of treatment)
Change in Oral Trail Making A score over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months (end of treatment)
Change in Oral Trail Making A score over 9 months (36 weeks).
Time frame: Baseline to 9 months (3 months after end of treatment)
Change in Oral Trail Making B score over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months (end of treatment)
Change in Oral Trail Making B score over 9 months (36 weeks).
Time frame: Baseline to 9 months (3 months after end of treatment)
Change in Digit Span reverse component (total correct trials) over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months (end of treatment)
Change in Digit Span reverse component (total correct trials) over 9 months (36 weeks).
Time frame: Baseline to 9 months (3 months after end of treatment)
Change in Digit Symbol Substitution Test score over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months (end of treatment)
Change in Digit Symbol Substitution Test score over 9 months (36 weeks).
Time frame: Baseline 9 months (3 months after end of treatment)
Change in frequency of urgency-type incontinence (episodes/week) over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months (end of treatment)
Change in frequency of urgency-type incontinence (episodes/week) over 9 months (36 weeks).
Time frame: Baseline to 9 months (3 months after end of treatment)
Change in frequency of any-type incontinence (episodes/week) over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months (end of treatment)
Change in frequency of any-type incontinence (episodes/week) over 9 months (36 weeks).
Time frame: Baseline to 9 months (3 months after end of treatment)
Resolution of urinary incontinence from baseline to 6 months (24 weeks).
Time frame: Baseline to 6 months (end of treatment)
Resolution of urinary incontinence from baseline to 9 months (36 weeks).
Time frame: Baseline to 9 months (3 months after end of treatment)
Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Symptom Bother domain score over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months (end of treatment)
Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Symptom Bother domain score over 9 months (36 weeks).
Time frame: Baseline to 9 months (3 months after end of treatment)
Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Health-Related Quality of Life domain score over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months (end of treatment)
Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Health-Related Quality of Life domain score over 9 months (36 weeks).
Time frame: Baseline to 9 months (3 months after end of treatment)
Change in global sleep quality score over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months (end of treatment)
Change in global sleep quality score over 9 months (36 weeks).
Time frame: Baseline to 9 months (3 months after end of treatment)
Change in daytime sleepiness score over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months (end of treatment)
Change in daytime sleepiness score over 9 months (36 weeks).
Time frame: Baseline to 9 months (3 months after end of treatment)
Change in perceived physical function over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months (end of treatment)
Change in perceived physical function over 9 months (36 weeks).
Time frame: Baseline to 9 months (3 months after end of treatment)
Change in confidence in maintaining balance over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months (end of treatment)
Change in confidence in maintaining balance over 9 months (36 weeks).
Time frame: Baseline to 9 months (3 months after end of treatment)
Change in overall physical performance over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months (end of treatment)
Change in overall physical performance over 9 months (36 weeks).
Time frame: Baseline to 9 months (3 months after end of treatment)
Change in static balance over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months (end of treatment)
Change in static balance from over 9 months (36 weeks).
Time frame: Baseline to 9 months (3 months after end of treatment)
Change in lower extremity strength measured by chair stand testing over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months (end of treatment)
Change in lower extremity strength measured by chair stand testing over 9 months (36 weeks).
Time frame: Baseline to 9 months (3 months after end of treatment)
Change in depression symptoms over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months (end of treatment)
Change in depression symptoms over 9 months (36 weeks).
Time frame: Baseline to 9 months (3 months after end of treatment)
Change in anxiety symptoms over 6 months (24 weeks) of treatment.
Time frame: Baseline to 6 months (end of treatment)
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 6 Mar 2026.
- Derived from this study: PubMed 37085880Huang AJ, Walter LC, Yaffe K, Vittinghoff E, Kornblith E, Schembri M, Chang A, Subak LL. TReating Incontinence for Underlying Mental and Physical Health (TRIUMPH): a study protocol for a multicenter, double-blinded, randomized, 3-arm trial to evaluate the multisystem effects of pharmacologic treatment strategies for urgency-predominant urinary incontinence in ambulatory older women. Trials. 2023 Apr 21;24(1):287. doi: 10.1186/s13063-023-07279-z.
- Individual participant dataSharing planned: Yes. The investigative team will make publicly available de-identified individual participant data that underlie the results reported in the publication. This will include data about the baseline characteristics of enrolled participants and any primary or secondary trial outcomes presented in the publication. To gain access, data requestors will be asked to sign a data access agreement.
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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, MAS, MPhil principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tolterodine Tartrate ER and Mirabegron in people with Urinary Incontinence, Urge and Urinary Incontinence, run by University of California, San Francisco at 2 sites 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 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05362292, which also lists 1 linked publication.
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 6 Mar 2026.