A Phase 4 interventional study of Tolterodine Tartrate ER and Mirabegron in Urinary Incontinence, Urge, Urinary Incontinence and Overactive Bladder, sponsored by University of California, San Francisco. Recruiting at 2 sites in United States. Open to female participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
Among 135 studies in Urinary Incontinence, Urge with a site in United States — 20 open to participants now, 27 under way, none of them phase 3. Urinary Incontinence, Urge · United States.
Among the 135 studies in Urinary Incontinence, Urge with a site in United States, this one is the 22nd largest by planned enrollment of the 119 interventional ones, is one of 9 that started in 2022, is one of 19 in phase 4, reaches primary completion later than 20 of the 26 other live ones, and was the 105th registered.
242 studies on the registry are indexed under Urinary Incontinence, Urge; 39 are open to participants now.
This study's planned enrollment of 270 is above the median of 86 across 190 interventional studies indexed under Urinary Incontinence, Urge.
Browse Urinary Incontinence, Urge studies →20 of the 135 studies in Urinary Incontinence, Urge with a site in United States are open now, in 3 countries. Each count lists the studies.
Of the 26 Urinary Incontinence, Urge studies recruiting now, 19 (73%) set no upper age limit and 2 (8%) stop at 75 or younger; 1 take children under 18; 2 take healthy volunteers.
This study: 60 Years and older · female · healthy volunteers too.
The full table on the hub →135 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 9 started in 2022.
Median enrollment 75 across the 119 interventional studies, 47 across the 15 observational. Of the 96 that completed or were terminated, 51 (53%) have results posted.
53 of 135 have an industry lead sponsor. The 10 most frequent:
University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
University of California, San Francisco has 6 studies filed under Urinary Incontinence, Urge — fewer than ten, so there is no comparison to draw.
11 of the studies in Urinary Incontinence, Urge with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06797245Medstar Health Research InstituteAPPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women | 2026-11 |
| NCT07387315TriHealth Inc.A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections | 2026-11 |
| NCT07335484Axonics, Inc.Aquarius Pilot Study to Evaluate the New Axonics Trial System | 2026-11 |
| NCT07247136Neuspera Medical, Inc.Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System | 2026-11 |
| NCT06186765Axonics, Inc.F15 Recharge Free Axonics SNM System Clinical Study | 2026-12 |
Among the 135 studies in Urinary Incontinence, Urge with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Tolterodine Tartrate ER
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.
Drug: Mirabegron
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.
Drug: Placebo
Anticholinergic
Beta-3-adrenergic agonist
matching placebo pill
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.
Time frame: Baseline to 6 months
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.
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
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.
Time frame: 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.
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.
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.
Time frame: 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.
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.
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
Time frame: 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
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.
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.
Time frame: 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.
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.
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.
Time frame: 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.
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.
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.
Time frame: 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.
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.
Frequency and type of incontinence will be assessed using a standardized, 7-day voiding diary.
Time frame: 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.
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.
Frequency and type of incontinence will be assessed using a standardized, 7-day voiding diary.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
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.
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).
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.
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.
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.
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).
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 9 months (3 months after end of treatment)
Plan to share: 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.
Supporting information: Informed consent form
Time frame: Starting no later than 6 months following publication of the main trial results (including on-line publication), 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 the study participants and any primary or secondary trial outcomes presented in the publication.
Started Oct 2022 (actual). Primary completion is estimated for May 2027, 54 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Tolterodine · Mirabegron
University of California, San Francisco →