Treatment of Incontinence Without Memory Problems
TRIUMPH
Sponsor study identifier
interventional
23
1 country
1
Study Start
February 2016
Actual (reported)Primary Completion
December 2017
Actual (reported)Study Completion
July 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 30, 2015
Actual (reported)May 7, 2015
Actual (reported)February 2016
Actual (reported)December 2017
Actual (reported)July 2018
Actual (reported)April 16, 2019
Actual (reported)The Number of Participants Who Completed and Discontinued the Study
Feasibility - Assessment of retention rates.
Baseline to Week 8
Change From Baseline in California Verbal Learning Test (CVLT) Score at 8 Weeks
Baseline to Week 8
Change From Baseline in Trail Making Test, Trail A Score at 8 Weeks
Baseline and 8 weeks
Change From Baseline in Short Physical Performance Battery (SPPB) Score at 8 Weeks
Baseline to Week 8
Change From Baseline in Total Urinary Incontinence Frequency Measured by a Voiding Diary at 8 Weeks
Baseline to Week 8
Change From Baseline in Urge Incontinence Episodes Per Day on a Voiding Diary at 8 Weeks.
Baseline and 8 weeks
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).
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.
University of California, San Francisco
San Francisco, California, 94115, United States
Leslee Subak, MD
University of California, San Francisco
23 participants (actual enrollment reported by the registry).
First Submitted
April 30, 2015
First Posted
May 7, 2015
Study Start
February 2016
Actual (reported)Slow Paced-Respiration Intervention to Reduce Incontinence Trial (SPIRIT)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 2017
Actual (reported)Study Completion
July 2018
Actual (reported)Last Updated
April 16, 2019
Results First Posted
April 16, 2019
Record last verified: 2019-03
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Source: ClinicalTrials.gov.
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