Trial Outcomes & Findings for Study of Behavioral Modification Program and Mirabegron to Improve Urinary Urgency in Multiple Sclerosis (NCT NCT02086188)
NCT ID: NCT02086188
Last Updated: 2023-10-18
Results Overview
Primary outcome: Overactive Bladder Symptom Composite Score (OAB-SCS) total score, average daily, Baseline vs. Final Visit The OAB-SCS measures symptoms of overactive bladder, urgency, frequency, incontinence. This is an ordinal scale is 1-5, 1 (minimum) = no urgency, 5 (maximum) = urgency incontinence. Higher values represent a worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
28 participants
Primary outcome timeframe
10 weeks
Results posted on
2023-10-18
Participant Flow
Participant milestones
| Measure |
Mirabegron
Mirabegron - 25mg (one tablet) taken by mouth daily with option to up-titrate to 50mg daily (two tablets) taken by mouth daily
Mirabegron: see detailed information in associated Arm Description
|
Placebo
Placebo - one tablet taken by mouth daily and two tablets taken by mouth daily if subject chooses up-titration
Placebo: Sugar pill manufactured to mimic Mirabegron 25mg tablet.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Behavioral Modification Program and Mirabegron to Improve Urinary Urgency in Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Mirabegron
n=14 Participants
Mirabegron - 25mg (one tablet) taken by mouth daily with option to up-titrate to 50mg daily (two tablets) taken by mouth daily
Mirabegron: see detailed information in associated Arm Description
|
Placebo
n=14 Participants
Placebo - one tablet taken by mouth daily and two tablets taken by mouth daily if subject chooses up-titration
Placebo: Sugar pill manufactured to mimic Mirabegron 25mg tablet.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
50 years
n=7 Participants
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPrimary outcome: Overactive Bladder Symptom Composite Score (OAB-SCS) total score, average daily, Baseline vs. Final Visit The OAB-SCS measures symptoms of overactive bladder, urgency, frequency, incontinence. This is an ordinal scale is 1-5, 1 (minimum) = no urgency, 5 (maximum) = urgency incontinence. Higher values represent a worse outcome.
Outcome measures
| Measure |
Mirabegron
n=14 Participants
Mirabegron - 25mg (one tablet) taken by mouth daily with option to up-titrate to 50mg daily (two tablets) taken by mouth daily
Mirabegron: see detailed information in associated Arm Description
|
Placebo
n=14 Participants
Placebo - one tablet taken by mouth daily and two tablets taken by mouth daily if subject chooses up-titration
Placebo: Sugar pill manufactured to mimic Mirabegron 25mg tablet. egron group had a worse outcome on this measure.
|
|---|---|---|
|
Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Final Visit
|
3.01 score on a scale
Standard Deviation 0.48
|
2.56 score on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: 5 weeksPopulation: MS patients with overactive bladder
Secondary Outcome Measure based on voiding diary: Average daily Overactive Bladder Symptom Composite Score (OAB-SCS) Baseline compared to Titration Visit The OAB-SCS measures symptoms of overactive bladder, urgency, frequency, incontinence. This is an ordinal scale is 1-5, 1 (minimum) = no urgency, 5 (maximum) = urgency incontinence. Higher values represent a worse outcome.
Outcome measures
| Measure |
Mirabegron
n=14 Participants
Mirabegron - 25mg (one tablet) taken by mouth daily with option to up-titrate to 50mg daily (two tablets) taken by mouth daily
Mirabegron: see detailed information in associated Arm Description
|
Placebo
n=14 Participants
Placebo - one tablet taken by mouth daily and two tablets taken by mouth daily if subject chooses up-titration
Placebo: Sugar pill manufactured to mimic Mirabegron 25mg tablet. egron group had a worse outcome on this measure.
|
|---|---|---|
|
Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Titration Visit
|
2.8 score on a scale
Standard Deviation 0.64
|
2.23 score on a scale
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: 10 weeksSecondary Outcome Measure based on voiding diary: Baseline vs Final Visit: mean # of micturitions/day
Outcome measures
| Measure |
Mirabegron
n=14 Participants
Mirabegron - 25mg (one tablet) taken by mouth daily with option to up-titrate to 50mg daily (two tablets) taken by mouth daily
Mirabegron: see detailed information in associated Arm Description
|
Placebo
n=14 Participants
Placebo - one tablet taken by mouth daily and two tablets taken by mouth daily if subject chooses up-titration
Placebo: Sugar pill manufactured to mimic Mirabegron 25mg tablet. egron group had a worse outcome on this measure.
|
|---|---|---|
|
Mean # of Micturitions/Day Based on Voiding Diaries
|
6.82 micturitions/day
Standard Deviation 2.2
|
8.72 micturitions/day
Standard Deviation 3.14
|
SECONDARY outcome
Timeframe: 10 weeksSecondary Outcome Measure based on voiding diary: Baseline vs. Final Visit: Mean # of incontinence episodes/day
Outcome measures
| Measure |
Mirabegron
n=14 Participants
Mirabegron - 25mg (one tablet) taken by mouth daily with option to up-titrate to 50mg daily (two tablets) taken by mouth daily
Mirabegron: see detailed information in associated Arm Description
|
Placebo
n=14 Participants
Placebo - one tablet taken by mouth daily and two tablets taken by mouth daily if subject chooses up-titration
Placebo: Sugar pill manufactured to mimic Mirabegron 25mg tablet. egron group had a worse outcome on this measure.
|
|---|---|---|
|
Mean # of Incontinence Episodes/Day
|
0.7 Incontinence Episodes/Day
Standard Deviation 1.09
|
1.05 Incontinence Episodes/Day
Standard Deviation 2.82
|
SECONDARY outcome
Timeframe: 10 weeksSecondary Outcome Measure based on voiding diary: Baseline vs. Final Visit: Mean volume voided/micturition
Outcome measures
| Measure |
Mirabegron
n=14 Participants
Mirabegron - 25mg (one tablet) taken by mouth daily with option to up-titrate to 50mg daily (two tablets) taken by mouth daily
Mirabegron: see detailed information in associated Arm Description
|
Placebo
n=14 Participants
Placebo - one tablet taken by mouth daily and two tablets taken by mouth daily if subject chooses up-titration
Placebo: Sugar pill manufactured to mimic Mirabegron 25mg tablet. egron group had a worse outcome on this measure.
|
|---|---|---|
|
Mean Volume Voided/Micturition
|
356 ml/micturition
Standard Deviation 153
|
282 ml/micturition
Standard Deviation 174
|
SECONDARY outcome
Timeframe: 10 weeksSecondary Outcome Measures based on the Qualiveen Questionnaire at Final Visit compared to Baseline Qualiveen questionaire is used, including 8 questions about aspects of bladder problems. Each question is rated 0 (not at all)- 4 (extremely). Overall score is averaged (average score per question)
Outcome measures
| Measure |
Mirabegron
n=14 Participants
Mirabegron - 25mg (one tablet) taken by mouth daily with option to up-titrate to 50mg daily (two tablets) taken by mouth daily
Mirabegron: see detailed information in associated Arm Description
|
Placebo
n=14 Participants
Placebo - one tablet taken by mouth daily and two tablets taken by mouth daily if subject chooses up-titration
Placebo: Sugar pill manufactured to mimic Mirabegron 25mg tablet. egron group had a worse outcome on this measure.
|
|---|---|---|
|
Qualiveen Questionnaire
|
0.96 score on a scale
Standard Deviation 0.84
|
0.71 score on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: 10 weeksSecondary Outcome Measures based on the Subject Global Impression (single question) at Final Visit compared to Baseline This is a single question: "How would you rate your level of bladder control during the past week?" 1-7 analog scale, 1 = "terrible'" 7 = "delighted."
Outcome measures
| Measure |
Mirabegron
n=14 Participants
Mirabegron - 25mg (one tablet) taken by mouth daily with option to up-titrate to 50mg daily (two tablets) taken by mouth daily
Mirabegron: see detailed information in associated Arm Description
|
Placebo
n=14 Participants
Placebo - one tablet taken by mouth daily and two tablets taken by mouth daily if subject chooses up-titration
Placebo: Sugar pill manufactured to mimic Mirabegron 25mg tablet. egron group had a worse outcome on this measure.
|
|---|---|---|
|
Subject Global Impression (Single Question)
|
5.71 score on a scale
Standard Deviation 1.14
|
4.86 score on a scale
Standard Deviation 1.29
|
Adverse Events
Mirabegron
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mirabegron
n=14 participants at risk
Mirabegron - 25mg (one tablet) taken by mouth daily with option to up-titrate to 50mg daily (two tablets) taken by mouth daily
Mirabegron: see detailed information in associated Arm Description
|
Placebo
n=14 participants at risk
Placebo - one tablet taken by mouth daily and two tablets taken by mouth daily if subject chooses up-titration
Placebo: Sugar pill manufactured to mimic Mirabegron 25mg tablet.
|
|---|---|---|
|
Nervous system disorders
headache
|
7.1%
1/14 • Number of events 1 • 10 weeks
|
14.3%
2/14 • Number of events 2 • 10 weeks
|
|
Cardiac disorders
hypertension
|
0.00%
0/14 • 10 weeks
|
7.1%
1/14 • Number of events 1 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
7.1%
1/14 • Number of events 1 • 10 weeks
|
0.00%
0/14 • 10 weeks
|
|
Gastrointestinal disorders
gastritis
|
7.1%
1/14 • Number of events 1 • 10 weeks
|
0.00%
0/14 • 10 weeks
|
|
Nervous system disorders
fatigue
|
7.1%
1/14 • Number of events 1 • 10 weeks
|
0.00%
0/14 • 10 weeks
|
|
Infections and infestations
urinary tract infection
|
7.1%
1/14 • Number of events 1 • 10 weeks
|
0.00%
0/14 • 10 weeks
|
|
Gastrointestinal disorders
diarrhea
|
7.1%
1/14 • Number of events 1 • 10 weeks
|
0.00%
0/14 • 10 weeks
|
|
Nervous system disorders
dizziness
|
0.00%
0/14 • 10 weeks
|
7.1%
1/14 • Number of events 1 • 10 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place