Your session is about to expire
← Back to Search
Beta-3 Adrenergic Agonist
Bladder Therapy for Urinary Incontinence (TRIUMPH Trial)
Phase 4
Recruiting
Led By Alison Huang, MD, MAS, MPhil
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Report 2 or more urgency incontinence episodes over a 7-day period
Female sex at birth, without surgical or hormonal gender re-assignment therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 9 months (3 months after end of treatment)
Awards & highlights
TRIUMPH Trial Summary
This trial is comparing the effects of two types of bladder therapy versus no therapy on cognitive, urinary, and other functional outcomes in older women with urinary incontinence.
Who is the study for?
The TRIUMPH study is for ambulatory older women aged 60 or above with urgency-predominant urinary incontinence and normal to mildly impaired cognitive function. Participants must have experienced urinary incontinence for at least 3 months, with episodes of sudden urgency, and be able to use the toilet without help. Exclusions include dementia diagnosis, recent medication changes affecting cognition or urination, severe liver/renal impairment, UTI, certain medical conditions like uncontrolled glaucoma or myasthenia gravis.Check my eligibility
What is being tested?
This trial compares two medications—Tolterodine Tartrate ER (an anticholinergic) and Mirabegron (a beta-3-adrenergic agonist)—against a placebo to see their effects on cognitive and urinary functions in older women with overactive bladders. It's a randomized double-blind study where participants won't know which treatment they're getting.See study design
What are the potential side effects?
Potential side effects may include dry mouth, constipation (from Tolterodine), increased blood pressure, headaches (from Mirabegron), and general discomfort from taking the medications. The exact side effects will vary by individual.
TRIUMPH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least 2 sudden urges to urinate that I couldn't control in the last week.
Select...
I was born female and have not undergone gender re-assignment.
Select...
I can walk to the bathroom and use it by myself.
Select...
I am 60 years old or older.
TRIUMPH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 9 months (3 months after end of treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 9 months (3 months after end of treatment)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Secondary outcome measures
Change Auditory Verbal Learning Test delayed free recall score over 6 months (24 weeks) of treatment.
Change Auditory Verbal Learning Test delayed free recall score over 9 months (36 weeks).
Change in Auditory Verbal Learning Test total learning score assessed over 6 months (24 weeks) of treatment
+42 moreTRIUMPH Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Anticholinergic bladder medication plus behavioral self-management educationActive Control1 Intervention
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.
Group II: Beta-3-adrenergic agonist medication plus behavioral self-management educationActive Control1 Intervention
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.
Group III: Placebo medication plus behavioral self-management educationPlacebo Group1 Intervention
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.
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,285 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,655 Total Patients Enrolled
Alison Huang, MD, MAS, MPhilPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't changed any medications that affect how often I urinate in the last month.I currently have a urinary tract infection.I have had urinary incontinence for at least 3 months.I do not have gastric retention, uncontrolled glaucoma, myasthenia gravis, severe ulcerative colitis, or toxic megacolon.I haven't taken any medication in the last month that could badly interact with the study drugs.I have not had bladder surgery or specific bladder treatments in the last 3 months.You have a condition that would make it difficult for you to complete the study, according to the doctors. For example, if you have uncontrolled psychosis.I do not have severe liver or kidney problems.I have had at least 2 sudden urges to urinate that I couldn't control in the last week.I haven't started, stopped, or changed the dose of any strong anticholinergic drugs in the last month.My blood pressure is not higher than 180/110 mmHg.I am currently using or have used medication for urgency incontinence in the last month.Most of my incontinence episodes happen with a sudden need to urinate.I was born female and have not undergone gender re-assignment.I am experiencing difficulty emptying my bladder fully.I haven't changed my dementia medication in the last month.I can walk to the bathroom and use it by myself.I am 60 years old or older.I have not used specialized incontinence therapy in the last 3 months and do not plan to during the study.You have been diagnosed with dementia by a doctor, or you scored 17 or lower on a test that checks your memory and thinking skills.
Research Study Groups:
This trial has the following groups:- Group 1: Anticholinergic bladder medication plus behavioral self-management education
- Group 2: Beta-3-adrenergic agonist medication plus behavioral self-management education
- Group 3: Placebo medication plus behavioral self-management education
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum capacity of individuals that may enroll in this trial?
"Confirmed. Clinicaltrials.gov's records demonstrate that this medical research is presently enrolling participants, with the trial first being posted on September 19th 2022 and updated just two days later. The study needs to recruit 270 individuals at 2 different sites."
Answered by AI
Is this research endeavor presently admitting participants?
"Affirmative. The information accessible on clinicaltrials.gov demonstrates that the trial, which was originally posted on September 19th 2022, is actively seeking participants. 270 individuals need to be recruited from two distinct medical centres."
Answered by AI
What aims are medical researchers hoping to achieve with this experiment?
"This trial will track composite cognitive function, anxiety symptoms, balance confidence and physical function across a six-month interval. To assess these metrics the study team plans to utilise Generalized Anxiety Disorder-7 (GAD7), Activities Balance Confidence Scale (ABC-S) and Short Physical Performance Battery tests respectively."
Answered by AI
Is Anticholinergic therapy for bladder issues associated with any risks?
"The Anticholinergic bladder medication was assigned a score of 3 due to its Phase 4 trial status, which indicates that it has been approved for use by the public."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger