Urge IncontinencePhase 4TRIUMPHNCT02436889
Treatment of Incontinence Without Memory Problems
A Phase 4 study testing Mirabegron and Tolterodine Tartrate in people with Urge Incontinence and Urinary Incontinence, Urge, run by University of California, San Francisco at 1 site in United States.
Trial summary
An 8-week randomized, controlled, pilot clinical trial of Mirabegron compared to a standard anticholinergic therapy (Detrol LA) in elderly women with urgency urinary incontinence. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urge Incontinence, Urinary Incontinence, Urge
- What is being tested?
- Mirabegron and Tolterodine Tartrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Jul 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Community-dwelling, ambulatory females ≥ 65 years old
- Urgency or Mixed Urgency Predominate Urinary Incontinence (subject-reported) for ≥ 3 months prior to Screening (Visit 1)
- On a 3-day voiding diary, documentation of at least 3 urgency incontinence episodes with the number of urgency incontinence episodes greater than number of stress incontinence episodes
- Capability of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risk and benefits
- Ability to perform all procedures and tests required by the protocol
- Report having a primary health care provider
- Willingness to remain on stable medication regime for duration of the randomized controlled trial. Participants will be asked to not add new medications during the randomized controlled trial, such as diuretics and other medications which may affect their voiding pattern.
Who cannot join
- Seated blood pressure >180/110 at Screening or Baseline
- Physician diagnosis of dementia
- Current use of dementia medications, debilitating or recent neurologic disease
- Mini Mental State Examination (MMSE) score <20
- History of urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe ulcerative colitis, toxic megacolon, fistula or a hole in your bladder or rectum, birth defect leading to urine leakage, and urine leakage starting in childhood
- Clinically significant hepatic (Child Pugh B or greater) or renal (creatinin clearance <30 mL/min or eGFR <30 mL/min/1.73 m2)
Show all 28Show fewer
- Neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson's disease.
- Major cardiovascular even in the past 6 months (i.e., MI, unstable angina, hospitalization for chest pain)
- Symptomatic pelvic organ prolapse defined as participant report of feeling or seeing a bulge outside the vagina within the past 3 months.
- History of surgery for incontinence in the past 5 years, pelvic surgery the past 6 months (i.e., for prolapse or hysterectomy), intra-vesical therapy (botox), and/or bulk injections within the past 6 months.
- A known history of interstitial cystitis or a significant pain component associated with OAB symptoms, uninvestigated hematuria, urogenital cancer, radiation to the pelvis or external genitalia.
- Urinary tract infection (UTI) as shown by the results of the urinalysis at screening or recurrent urinary tract infection (RUTIs) defined as treatment for UTI >3 times in the last year.
- Urinary retention (post-void residual urine volume >150 cc measured by Bladder scan at screening.
- Use of any electrostimulation, bladder training, or pelvic floor exercises (with certified incontinence practitioners) within 4 weeks of Screening.
- Received study medication in any previous mirabegron clinical trial.
- Prior failure for either efficacy or tolerability of ≥ 2 OAB medications in the last year. (Failure: inadequate symptom control after two medications for a minimum of one month each.)
- Has been treated within 2 weeks prior to Screening and/or is currently being treated with:
- Any drug treatment for OAB
- Any drugs with significant anticholinergic and antispasmodic effects (see exception for tricyclic antidepressants below)
- Has started treatment with tricyclic antidepressants or estrogens within 4 weeks prior to Screening and/or is not on a stable dose.
- Intermittent use or unstable dose of diuretics. Treatment with diuretics initiated within 2 weeks prior to baseline and/or is not on a stable dose is not permitted.
- Treatment with potent CYP3A4 inhibitors, such as clarithromycin, ketoconazole, and itraconazole within 2 weeks prior to Screening.
- Administration of medications capable of inducing hepatic enzyme metabolism or transport (e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John's Wort) in the past 30 days.
- Administration of narrow therapeutic index drugs metabolized by CYP2D6, such as thioridazine, flecainide, and propafenone.
- Previously received any investigational drug within 30 days prior to trial entry.
- Alcohol and/or any other drug abuse in the opinion of the investigator.
- Participants who have any medical (including known history of major hematological, renal, cardiovascular, or hepatic abnormalities) or psychological condition or social circumstances that would impair their ability to participate reliably in the trial, or those who may increase the risk to themselves or others by participating.
- Participants who, in the opinion of the investigator, are not likely to complete the trial for whatever reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94115
About this study
An 8-week randomized, controlled, pilot clinical trial of Mirabegron compared to a standard anticholinergic therapy (Detrol LA) in elderly women with urgency urinary incontinence.
- Conditions
- Urge Incontinence, Urinary Incontinence, Urge
- Being tested
- Mirabegron, Tolterodine Tartrate
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirabegronDrug
Also called Myrbetriq
Tolterodine TartrateDrug
Also called Detrol LA
| Study group | Role | What they receive |
|---|---|---|
| Mirabegron | Experimental | Participants will be instructed to take one tablet and 1 capsule (total of 2) of blinded study medication once a day, orally, for 8 weeks. They will start with Mirabegron (25mg) dose of study medication and will have the option of dose escalation to 2 tablets and 2 capsules (total of 4) per day (Mirabegron 50mg). Receives: Drug: Mirabegron |
| Tolterodine Tartrate | Active comparator | Participants will be instructed to take one tablet and 1 capsule (total of 2) of blinded study medication once a day, orally, for 8 weeks. They will start with tolterodine tartrate (4 mg) dose of study medication and will have the option of dose escalation to 2 tablets and 2 capsules (total of 4) per day tolterodine tartrate 4 mg + identical placebo. Receives: Drug: Tolterodine Tartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Who Completed and Discontinued the Study
Feasibility - Assessment of retention rates.
Measured: Baseline to Week 8
Secondary outcomes (5)
Change From Baseline in California Verbal Learning Test (CVLT) Score at 8 Weeks
Range of 0-80, with the higher the score the better.
Measured: Baseline to Week 8
Change From Baseline in Trail Making Test, Trail A Score at 8 Weeks
Trail Making Test, Trail A Time, Range 0-150 seconds, Lower score indicates better functioning
Measured: Baseline and 8 weeks
Change From Baseline in Short Physical Performance Battery (SPPB) Score at 8 Weeks
Physical function/mobility, Range 0-12, the higher the score the better.
Measured: Baseline to Week 8
Change From Baseline in Total Urinary Incontinence Frequency Measured by a Voiding Diary at 8 Weeks
Study participants record number of urinary incontinence episodes in a voiding diary. The total urinary incontinence frequency is the sum of urinary incontinence episodes per day.
Measured: Baseline to Week 8
Change From Baseline in Urge Incontinence Episodes Per Day on a Voiding Diary at 8 Weeks.
The sum of urge type incontinence episodes reported by participants on a voiding diary per day.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startFeb 2016
- Primary completionDec 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urge IncontinenceStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison Huang, MD, University of California, San Francisco
- Investigators
- Leslee Subak, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436889
- Sponsor's protocol ID
- 14-15553
- Acronym
- TRIUMPH
- Status last verified
- Mar 2019
- First submitted
- 30 Apr 2015
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Incontinence Without Memory Problems
- ClinicalTrials.gov ID
- NCT02436889
- Acronym / sponsor ID
- TRIUMPH / 14-15553
- Conditions
- Urge Incontinence, Urinary Incontinence, Urge
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 7 May 2015 (estimated)
- Results
- Posted 16 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An 8-week randomized, controlled, pilot clinical trial of Mirabegron compared to a standard anticholinergic therapy (Detrol LA) in elderly women with urgency urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirabegron | Experimental | Drug: MirabegronParticipants will be instructed to take one tablet and 1 capsule (total of 2) of blinded study medication once a day, orally, for 8 weeks. They will start with Mirabegron (25mg) dose of study medication and will have the option of dose escalation to 2 tablets and 2 capsules (total of 4) per day (Mirabegron 50mg). |
| Tolterodine Tartrate | Active comparator | Drug: Tolterodine TartrateParticipants will be instructed to take one tablet and 1 capsule (total of 2) of blinded study medication once a day, orally, for 8 weeks. They will start with tolterodine tartrate (4 mg) dose of study medication and will have the option of dose escalation to 2 tablets and 2 capsules (total of 4) per day tolterodine tartrate 4 mg + identical placebo. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Community-dwelling, ambulatory females ≥ 65 years old
- Urgency or Mixed Urgency Predominate Urinary Incontinence (subject-reported) for ≥ 3 months prior to Screening (Visit 1)
- On a 3-day voiding diary, documentation of at least 3 urgency incontinence episodes with the number of urgency incontinence episodes greater than number of stress incontinence episodes
- Capability of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risk and benefits
- Ability to perform all procedures and tests required by the protocol
Key exclusion criteria (28 listed)
- Seated blood pressure >180/110 at Screening or Baseline
- Physician diagnosis of dementia
- Current use of dementia medications, debilitating or recent neurologic disease
- Mini Mental State Examination (MMSE) score <20
- History of urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe ulcerative colitis, toxic megacolon, fistula or a hole in your bladder or rectum, birth defect leading to urine leakage, and urine leakage starting in childhood
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 |
|---|---|---|
| MirabegronAlso: Myrbetriq | Drug | Mirabegron |
| Tolterodine TartrateAlso: Detrol LA | Drug | Tolterodine Tartrate |
Primary outcome
The Number of Participants Who Completed and Discontinued the Study
Time frame: Baseline to Week 8
Feasibility - Assessment of retention rates.
5 secondary outcomes
Change From Baseline in California Verbal Learning Test (CVLT) Score at 8 Weeks
Time frame: Baseline to Week 8
Change From Baseline in Trail Making Test, Trail A Score at 8 Weeks
Time frame: Baseline and 8 weeks
Change From Baseline in Short Physical Performance Battery (SPPB) Score at 8 Weeks
Time frame: Baseline to Week 8
Change From Baseline in Total Urinary Incontinence Frequency Measured by a Voiding Diary at 8 Weeks
Time frame: Baseline to Week 8
Change From Baseline in Urge Incontinence Episodes Per Day on a Voiding Diary at 8 Weeks.
Time frame: Baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Leslee Subak, 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 Mirabegron and Tolterodine Tartrate in people with Urge Incontinence and Urinary Incontinence, Urge, 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 28 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: finished, as of the sponsor's last update on 16 Apr 2019. 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. 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?
Yes. Results are posted in the registry (first posted 16 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants Who Completed and Discontinued the Study (time frame: Baseline to Week 8). 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 16 Apr 2019.