Trial Outcomes & Findings for Treatment of Incontinence Without Memory Problems (NCT NCT02436889)
NCT ID: NCT02436889
Last Updated: 2019-04-16
Results Overview
Feasibility - Assessment of retention rates.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
23 participants
Primary outcome timeframe
Baseline to Week 8
Results posted on
2019-04-16
Participant Flow
Participant milestones
| Measure |
Mirabegron
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).
Mirabegron
|
Tolterodine Tartrate
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.
Tolterodine Tartrate
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Mirabegron
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).
Mirabegron
|
Tolterodine Tartrate
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.
Tolterodine Tartrate
|
|---|---|---|
|
Overall Study
No improvement in symptoms
|
1
|
0
|
|
Overall Study
Does not like/could not tolerate medicat
|
0
|
1
|
Baseline Characteristics
Treatment of Incontinence Without Memory Problems
Baseline characteristics by cohort
| Measure |
Mirabegron
n=12 Participants
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).
Mirabegron
|
Tolterodine Tartrate
n=11 Participants
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.
Tolterodine Tartrate
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
65-69 years
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Asian American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latina
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latina
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Incontinence Frequency
Total Urge Incontinence
|
3.87 Episodes per day
STANDARD_DEVIATION 2.33 • n=5 Participants
|
4.48 Episodes per day
STANDARD_DEVIATION 1.92 • n=7 Participants
|
4.16 Episodes per day
STANDARD_DEVIATION 2.11 • n=5 Participants
|
|
Incontinence Frequency
Total Urinary Incontinence
|
4.43 Episodes per day
STANDARD_DEVIATION 3.20 • n=5 Participants
|
4.96 Episodes per day
STANDARD_DEVIATION 1.98 • n=7 Participants
|
4.68 Episodes per day
STANDARD_DEVIATION 2.64 • n=5 Participants
|
|
California Verbal Learning Test
|
51.36 Trials 1-5 Free Recall Total
STANDARD_DEVIATION 12.29 • n=5 Participants
|
49.50 Trials 1-5 Free Recall Total
STANDARD_DEVIATION 10.98 • n=7 Participants
|
50.48 Trials 1-5 Free Recall Total
STANDARD_DEVIATION 11.43 • n=5 Participants
|
|
Short Physical Performance Battery
|
10.67 Score on Scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
11.00 Score on Scale
STANDARD_DEVIATION 2.2 • n=7 Participants
|
10.83 Score on Scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Trail Making Test
Trail A Time (0-150 sec)
|
40.33 seconds
STANDARD_DEVIATION 26.3 • n=5 Participants
|
35.06 seconds
STANDARD_DEVIATION 9.5 • n=7 Participants
|
37.81 seconds
STANDARD_DEVIATION 19.9 • n=5 Participants
|
|
Trail Making Test
Trail B Time (0-300 sec)
|
93.03 seconds
STANDARD_DEVIATION 61.5 • n=5 Participants
|
85.39 seconds
STANDARD_DEVIATION 29.4 • n=7 Participants
|
89.38 seconds
STANDARD_DEVIATION 47.9 • n=5 Participants
|
|
Instrumental Activities of Daily Living
|
7.83 score on scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
7.91 score on scale
STANDARD_DEVIATION 0.3 • n=7 Participants
|
7.87 score on scale
STANDARD_DEVIATION 0.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8Feasibility - Assessment of retention rates.
Outcome measures
| Measure |
Mirabegron
n=12 Participants
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).
Mirabegron
|
Tolterodine Tartrate
n=11 Participants
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.
Tolterodine Tartrate
|
|---|---|---|
|
The Number of Participants Who Completed and Discontinued the Study
Completed study
|
11 Participants
|
10 Participants
|
|
The Number of Participants Who Completed and Discontinued the Study
Discontinued Early
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Although 21 participants completed week 8 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.
Range of 0-80, with the higher the score the better.
Outcome measures
| Measure |
Mirabegron
n=9 Participants
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).
Mirabegron
|
Tolterodine Tartrate
n=8 Participants
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.
Tolterodine Tartrate
|
|---|---|---|
|
Change From Baseline in California Verbal Learning Test (CVLT) Score at 8 Weeks
|
4.70 Score on a Scale
Interval 1.13 to 8.27
|
1.59 Score on a Scale
Interval -2.2 to 5.37
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: Although 21 participants completed week 8 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.
Trail Making Test, Trail A Time, Range 0-150 seconds, Lower score indicates better functioning
Outcome measures
| Measure |
Mirabegron
n=10 Participants
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).
Mirabegron
|
Tolterodine Tartrate
n=9 Participants
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.
Tolterodine Tartrate
|
|---|---|---|
|
Change From Baseline in Trail Making Test, Trail A Score at 8 Weeks
|
-11.34 seconds
Interval -15.57 to -7.11
|
0.67 seconds
Interval -3.79 to 5.13
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Although 21 participants completed week 8 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.
Physical function/mobility, Range 0-12, the higher the score the better.
Outcome measures
| Measure |
Mirabegron
n=10 Participants
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).
Mirabegron
|
Tolterodine Tartrate
n=8 Participants
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.
Tolterodine Tartrate
|
|---|---|---|
|
Change From Baseline in Short Physical Performance Battery (SPPB) Score at 8 Weeks
|
-0.39 score on a scale
Interval -1.03 to 0.25
|
0.24 score on a scale
Interval -0.47 to 0.96
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Although 21 participants completed week 8 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.
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.
Outcome measures
| Measure |
Mirabegron
n=10 Participants
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).
Mirabegron
|
Tolterodine Tartrate
n=9 Participants
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.
Tolterodine Tartrate
|
|---|---|---|
|
Change From Baseline in Total Urinary Incontinence Frequency Measured by a Voiding Diary at 8 Weeks
|
-2.04 episodes per day
Interval -3.1 to -0.99
|
-3.91 episodes per day
Interval -5.02 to -2.8
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: Although 21 participants completed week 8 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.
The sum of urge type incontinence episodes reported by participants on a voiding diary per day.
Outcome measures
| Measure |
Mirabegron
n=10 Participants
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).
Mirabegron
|
Tolterodine Tartrate
n=9 Participants
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.
Tolterodine Tartrate
|
|---|---|---|
|
Change From Baseline in Urge Incontinence Episodes Per Day on a Voiding Diary at 8 Weeks.
|
-1.64 episodes per day
Interval -2.73 to -0.54
|
-3.74 episodes per day
Interval -4.9 to -2.58
|
Adverse Events
Mirabegron
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Tolterodine Tartrate
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mirabegron
n=12 participants at risk
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).
Mirabegron
|
Tolterodine Tartrate
n=11 participants at risk
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.
Tolterodine Tartrate
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • Baseline to Week 8
|
18.2%
2/11 • Number of events 2 • Baseline to Week 8
|
|
General disorders
Cold/flu
|
0.00%
0/12 • Baseline to Week 8
|
9.1%
1/11 • Number of events 1 • Baseline to Week 8
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Baseline to Week 8
|
27.3%
3/11 • Number of events 3 • Baseline to Week 8
|
|
General disorders
Dry mouth
|
0.00%
0/12 • Baseline to Week 8
|
27.3%
3/11 • Number of events 3 • Baseline to Week 8
|
|
Nervous system disorders
Memory problems/confusion
|
0.00%
0/12 • Baseline to Week 8
|
9.1%
1/11 • Number of events 1 • Baseline to Week 8
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/12 • Baseline to Week 8
|
18.2%
2/11 • Number of events 2 • Baseline to Week 8
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • Baseline to Week 8
|
0.00%
0/11 • Baseline to Week 8
|
|
Eye disorders
Stye
|
8.3%
1/12 • Number of events 1 • Baseline to Week 8
|
9.1%
1/11 • Number of events 1 • Baseline to Week 8
|
|
Eye disorders
Blurry vision
|
0.00%
0/12 • Baseline to Week 8
|
9.1%
1/11 • Number of events 1 • Baseline to Week 8
|
|
Gastrointestinal disorders
Reflux
|
8.3%
1/12 • Number of events 1 • Baseline to Week 8
|
0.00%
0/11 • Baseline to Week 8
|
|
General disorders
Dizziness
|
8.3%
1/12 • Number of events 1 • Baseline to Week 8
|
0.00%
0/11 • Baseline to Week 8
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
8.3%
1/12 • Number of events 1 • Baseline to Week 8
|
0.00%
0/11 • Baseline to Week 8
|
|
Renal and urinary disorders
Bladder Infection
|
8.3%
1/12 • Number of events 1 • Baseline to Week 8
|
0.00%
0/11 • Baseline to Week 8
|
|
Renal and urinary disorders
Frequent urination
|
8.3%
1/12 • Number of events 1 • Baseline to Week 8
|
0.00%
0/11 • Baseline to Week 8
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12 • Baseline to Week 8
|
18.2%
2/11 • Number of events 2 • Baseline to Week 8
|
|
Nervous system disorders
Drowsy
|
0.00%
0/12 • Baseline to Week 8
|
9.1%
1/11 • Number of events 1 • Baseline to Week 8
|
Additional Information
Alison Huang, MD
University of California, San Francisco
Phone: 415-514-8697
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place