Anticholinergic bladder medication for Urinary Incontinence

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Stanford University, Palo Alto, CA
Urinary Incontinence+7 More
Tolterodine Tartrate ER - Drug
Eligibility
18+
Female
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Study 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 women with urgency-predominant urinary incontinence and either normal or mildly impaired cognitive function at baseline.

Eligible Conditions

  • Urinary Incontinence
  • Overactive Bladder Syndrome (OABS)
  • Urinary Incontinence (UI)
  • Incontinence
  • Urinary Incontinence, Urge
  • Urinary Urge Incontinence

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

2 Primary · 65 Secondary · Reporting Duration: Baseline to 6 months (end of treatment) and 9 months (3 months after end of treatment)

Month 9
Change in Digit Symbol Substitution Test score over 9 months (36 weeks).
Baseline to 6 months
Change in attention score from baseline to 6 months (24 weeks) of treatment.
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.
Change in composite cognitive function over 6 months of treatment, using a composite cognitive score that incorporates normalized data from all domain-specific cognitive tests.
Change in executive function score from baseline to 6 months (24 weeks) of treatment.
Change in incidental memory, visual scanning, and processing speed from baseline to 6 months (24 weeks) of treatment.
Change in score on verbal learning assessed from baseline to 6 months (24 weeks) of treatment.
Change in short-term verbal memory score from baseline to 6 months (24 weeks) of treatment.
Month 6
Change Auditory Verbal Learning Test delayed free recall score over 6 months (24 weeks) of treatment.
Change in Auditory Verbal Learning Test total learning score assessed over 6 months (24 weeks) of treatment
Change in Digit Span reverse component (total correct trials) over 6 months (24 weeks) of treatment.
Change in Digit Symbol Substitution Test score over 6 months (24 weeks) of treatment.
Change in Oral Trail Making A score over 6 months (24 weeks) of treatment.
Change in Oral Trail Making B score over 6 months (24 weeks) 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.
Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Symptom Bother domain score over 6 months (24 weeks) of treatment.
Change in anxiety symptoms over 6 months (24 weeks) of treatment.
Change in bowel incontinence symptoms over 6 months (24 weeks) of treatment.
Change in confidence in maintaining balance over 6 months (24 weeks) of treatment.
Change in constipation symptoms over 6 months (24 weeks) of treatment.
Change in daytime sleepiness score over 6 months (24 weeks) of treatment.
Change in depression symptoms over 6 months (24 weeks) of treatment.
Change in frequency of any-type incontinence (episodes/week) over 6 months (24 weeks) of treatment.
Change in frequency of urgency-type incontinence (episodes/week) over 6 months (24 weeks) of treatment.
Change in global sleep quality score over 6 months (24 weeks) of treatment.
Change in lower extremity strength measured by chair stand testing over 6 months (24 weeks) of treatment.
Change in overall physical performance over 6 months (24 weeks) of treatment.
Change in perceived physical function over 6 months (24 weeks) of treatment.
Change in static balance over 6 months (24 weeks) of treatment.
Resolution of urinary incontinence from baseline to 6 months (24 weeks).
Month 9
Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Health-Related Quality of Life domain score from baseline to 6 months (24 weeks).
Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Symptom Bother domain score from baseline to 6 months (24 weeks).
Change in anxiety symptoms from baseline to 6 months (24 weeks).
Change in bowel incontinence from baseline to 6 months (24 weeks).
Change in confidence in maintaining balance from baseline to 6 months (24 weeks).
Change in constipation symptoms from baseline to 6 months (24 weeks).
Change in daytime sleepiness score from baseline to 6 months (24 weeks).
Change in depression symptoms from baseline to 6 months (24 weeks).
Change in frequency of any-type incontinence (episodes/week) from baseline to 6 months (24 weeks).
Change in frequency of urgency-type incontinence (episodes/week) from baseline to 6 months (24 weeks).
Change in global sleep quality score from baseline to 6 months (24 weeks).
Change in lower extremity strength from baseline to 6 months (24 weeks).
Change in perceived physical function from baseline to 6 months (24 weeks).
Change in physical function from baseline to 6 months (24 weeks).
Change in static balance from baseline to 6 months (24 weeks).
Month 9
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 9 months (36 weeks).
Change in Digit Span reverse component (total correct trials) over 9 months (36 weeks).
Change in Oral Trail Making A score over 9 months (36 weeks).
Change in Oral Trail Making B score over 9 months (36 weeks).
Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Health-Related Quality of Life domain score over 9 months (36 weeks).
Change in Overactive Bladder Questionnaire Short-Form (OAB-Q SF) Symptom Bother domain score over 9 months (36 weeks).
Change in anxiety symptoms over 9 months (36 weeks).
Change in bowel incontinence symptoms over 9 months (36 weeks).
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.
Change in confidence in maintaining balance over 9 months (36 weeks).
Change in constipation symptoms over 9 months (36 weeks).
Change in daytime sleepiness score over 9 months (36 weeks).
Change in depression symptoms over 9 months (36 weeks).
Change in frequency of any-type incontinence (episodes/week) over 9 months (36 weeks).
Change in frequency of urgency-type incontinence (episodes/week) over 9 months (36 weeks).
Change in global sleep quality score over 9 months (36 weeks).
Change in lower extremity strength measured by chair stand testing over 9 months (36 weeks).
Change in overall physical performance over 9 months (36 weeks).
Change in perceived physical function over 9 months (36 weeks).
Change in static balance from over 9 months (36 weeks).
Resolution of urinary incontinence from baseline to 9 months (36 weeks).

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

6 Treatment Groups

Anticholinergic bladder medication
1 of 6
Beta-3-adrenergic agonist medication
1 of 6
Anticholinergic bladder medication plus behavioral self-management education
1 of 6
Beta-3-adrenergic agonist medication plus behavioral self-management education
1 of 6
Placebo medication
1 of 6
Placebo medication plus behavioral self-management education
1 of 6
Active Control
Non-Treatment Group

270 Total Participants · 6 Treatment Groups

Primary Treatment: Anticholinergic bladder medication · Has Placebo Group · Phase 4

Placebo medication
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Anticholinergic bladder medication
Drug
ActiveComparator Group · 1 Intervention: Tolterodine Tartrate ER · Intervention Types: Drug
Beta-3-adrenergic agonist medication
Drug
ActiveComparator Group · 1 Intervention: Mirabegron · Intervention Types: Drug
Anticholinergic bladder medication plus behavioral self-management education
Drug
ActiveComparator Group · 1 Intervention: Tolterodine Tartrate ER · Intervention Types: Drug
Placebo medication plus behavioral self-management education
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Beta-3-adrenergic agonist medication plus behavioral self-management education
Drug
ActiveComparator Group · 1 Intervention: Mirabegron · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 6 months (end of treatment) and 9 months (3 months after end of treatment)
Closest Location: Stanford University · Palo Alto, CA
Photo of Stanford University  1Photo of Stanford University  2Photo of Stanford University  3
1992First Recorded Clinical Trial
4 TrialsResearching Urinary Incontinence
768 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Female Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to provide informed consent and abide by study procedures throughout the length of the study.
You have urinary incontinence starting at least 3 months prior to screening.
You have a sudden or strong sensation of urgency when you have to go to the toilet.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.