Maestro: A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease (MAESTRO)
Study Details
Study Description
Brief Summary
The purpose of this study is to see if the study drug, Mirabegron, is safe and effective in treating symptoms of Overactive Bladder in people with Parkinson's Disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
This study is a randomized 1:1 placebo-controlled 10-week study of Mirabegron as add-on therapy to an educational intervention of behavioral modification including pelvic floor exercise (PFE) in a cohort of 40 Parkinson's subjects over the age of 30 with overactive bladder (OAB). Active drug will be Mirabegron 25 mg daily with up-titration to 50 mg daily after 5 weeks. Subjects will be enrolled based on response to an overactive bladder questionnaire at visit 2.
Enrolled subjects will have 4 study visits to the clinic as well as 2 phone visits.
Enrolled subjects will be asked to record urinary symptoms and pelvic floor exercises in a diary at 3 separate time points for a 72 hour period.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Mirabegron 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 mg daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or, for those in the placebo arm, two placebo tablets. |
Drug: Mirabegron
25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Other Names:
|
| Placebo Comparator: Placebo 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. |
Drug: Placebo
Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in the Mean Daily Overactive Bladder-Symptom Composite Score. [7-82 days. From visit 2 (baseline) to visit 4]
The primary outcome measure will be the change in the mean daily Overactive Bladder-Symptom Composite Score (OAB-SCS) from baseline (visit 2) to visit 4. The Over active Bladder- Symptom Composite Score requires subjects to record the severity of urgency of each micturition over a 72 hour period. Subject ratings ranges from 1 to 6 for each micturition as follows: 1. Not at all, 2.A little bit, 3.Somewhat 4.Quite a bit, 5. A great deal, 6. A very great deal. Maximum score depends on number of micturition episodes in the 72 hour period, as the rating of each episode is summed to get the total score. Higher scores indicate worse symptoms of overactive bladder.
Secondary Outcome Measures
- Overactive Bladder Questionnaire Symptom Severity Scale( OAB-q) [baseline (7-14 days post visit 1), visit 3( 32-40 days post visit 2) and visit 4(74-82 days post visit 2)]
Overactive Bladder questionnaire symptom severity scale (OAB-q), Visit 3 and Visit 4 vs. baseline Scale ranges from 8 to 48 the higher score indicating worse symptoms.
- Non- Motor Symptoms Scale (NMSS) [baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)]
Non-Motor Symptoms Scale (NMSS), which includes questions about 9 different categories of non-motor symptoms in PD, including urinary symptoms; Visit 3 and Visit 4 vs. baseline. Symptoms assessed over the last month. The scale ranges from 0 to 360, with higher scores indicating worse symptoms.
- Patient Perception of Bladder Condition [baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)]
Patient Perception of Bladder Condition at Visit 3 and Visit 4 vs. baseline. the scale ranges from 1 to 6 with higher score indicating worse outcome
- Subjects Global Impression of Change [baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)]
Subject's Global Impression of Change at Visit 3 and Visit 4 vs. baseline the scale ranges from 0 to 7 with higher score indicating worse out come .
Other Outcome Measures
- Change in Mean Daily OAB-SCS Visit 3 vs Baseline [baseline (7-14 days post visit 1) and visit 3 (32-40 days post visit 2)]
The primary outcome measure will be the change in the mean daily Overactive Bladder-Symptom Composite Score (OAB-SCS) from baseline (visit 2) to visit 4. The Over active Bladder- Symptom Composite Score requires subjects to record the severity of urgency of each micturition over a 72 hour period. Subject ratings ranges from 1 to 6 for each micturition as follows: 1. Not at all, 2.A little bit, 3.Somewhat 4.Quite a bit, 5. A great deal, 6. A very great deal. Maximum score depends on number of micturition episodes in the 72 hour period, as the rating of each episode is summed to get the total score. Higher scores indicate worse symptoms of overactive bladder.
- Change in Mean Number of Incontinence Episodes Per 24 Hours [baseline vs visit 3 (32-40 days post baseline) and baseline vs. visit 4 ((74-82 days post visit 2)]
Subjects recorded in a 72-hour micturition diary the number of episodes of urinary incontinence, and this is averaged per 24 hours. Higher scores indicate more episodes of incontinence and thus worse outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:-
-
Diagnosis of Parkinsons by United Kingdom brain bank criteria
-
Age > 30 years old
-
No change in Parkinsons medications during the 4 weeks preceding screening, with no dose changes during the study, except that PRN (as needed) doses of carbidopa/levodopa will be allowed to address periodic worsening of parkinsonian symptoms.
-
Patient willing and able to complete micturition diary
-
Urinary urgency (≥ 8 entries of bladder urgency score > 2) in 72hr voiding diary during screening period
-
Micturition frequency ≥ 8 / 24hr or incontinence ≥ 2 episodes in 72hr voiding diary during screening period
-
Use of other medication that could influence bladder function, other than those specifically prohibited (see below), will be permitted as long as the dose is stable for 4 weeks preceding screening, with no dose changes during the study.
-
Patient expects to have valid health insurance for the duration of the study period
Exclusion Criteria:
-
Women who are breast-feeding, pregnant or have potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures).
-
Cognitive deficits that in the opinion of the investigator would interfere with the subject's ability to give informed consent or perform study testing.
-
Screening blood pressure > 165 systolic or 100 diastolic
-
Heart rate > 100
-
History of allergy to Mirabegron.
-
Screening post-void residual > 200ml
-
Evidence of urinary tract infection at screening
-
History of chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs
-
Intravesical botulinum toxin treatment within the previous six months of screening.
-
Presence of Interstim device
-
Use of indwelling catheter or self-catheterization
-
Concurrent use of thioridazine, flecainide, propafenone, or Digoxin
-
Concurrent use of warfarin (Coumadin)
-
Use of one of the anti-cholinergic bladder medications specified below within 14 days of the screening visit. Subjects who have used one of these medications in the past but discontinued it at least 14 days prior to the screening visit can be enrolled.
-
Screening estimated glomerular filtration rate (eGFR) < 60, AST ( aspartate aminotransferase ) or ALT ( alanine aminotransferase ) > 2x upper limit of normal
-
Any other serious and/or unstable medical condition
-
Participation in other drug studies or use of other investigational drugs within 30 days prior to Screening Visit.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Evergreenhealth Booth Gardner Parkinsons Care Center | Kirkland | Washington | United States | 98034 |
Sponsors and Collaborators
- Daniel Burdick, MD
- Astellas Pharma US, Inc.
Investigators
- Principal Investigator: Daniel J Burdick, MD, Evergreen Health
- Principal Investigator: Pinky Agarwal, MD, Evergreen Health
Study Documents (Full-Text)
More Information
Publications
None provided.- DBPA-2013-01
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Subjects who have met exclusion criteria. |
| Arm/Group Title | Mirabegron | Placebo |
|---|---|---|
| Arm/Group Description | 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. | 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. |
| Period Title: Overall Study | ||
| STARTED | 15 | 15 |
| COMPLETED | 12 | 14 |
| NOT COMPLETED | 3 | 1 |
Baseline Characteristics
| Arm/Group Title | Mirabegron | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. | 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. | Total of all reporting groups |
| Overall Participants | 15 | 15 | 30 |
| Age, Customized (years) [Mean (Full Range) ] | |||
| Age,mean |
66
|
67
|
67
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
3
20%
|
5
33.3%
|
8
26.7%
|
| Male |
12
80%
|
10
66.7%
|
22
73.3%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Caucasian |
15
100%
|
15
100%
|
30
100%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
15
100%
|
15
100%
|
30
100%
|
Outcome Measures
| Title | Change in the Mean Daily Overactive Bladder-Symptom Composite Score. |
|---|---|
| Description | The primary outcome measure will be the change in the mean daily Overactive Bladder-Symptom Composite Score (OAB-SCS) from baseline (visit 2) to visit 4. The Over active Bladder- Symptom Composite Score requires subjects to record the severity of urgency of each micturition over a 72 hour period. Subject ratings ranges from 1 to 6 for each micturition as follows: 1. Not at all, 2.A little bit, 3.Somewhat 4.Quite a bit, 5. A great deal, 6. A very great deal. Maximum score depends on number of micturition episodes in the 72 hour period, as the rating of each episode is summed to get the total score. Higher scores indicate worse symptoms of overactive bladder. |
| Time Frame | 7-82 days. From visit 2 (baseline) to visit 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Mirabegron | Placebo |
|---|---|---|
| Arm/Group Description | 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. | 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. |
| Measure Participants | 15 | 15 |
| Mean (Standard Deviation) [units on a scale] |
-3.2
(8.4)
|
-8.9
(7.9)
|
| Title | Overactive Bladder Questionnaire Symptom Severity Scale( OAB-q) |
|---|---|
| Description | Overactive Bladder questionnaire symptom severity scale (OAB-q), Visit 3 and Visit 4 vs. baseline Scale ranges from 8 to 48 the higher score indicating worse symptoms. |
| Time Frame | baseline (7-14 days post visit 1), visit 3( 32-40 days post visit 2) and visit 4(74-82 days post visit 2) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Mirabegron | Placebo |
|---|---|---|
| Arm/Group Description | 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. | 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. |
| Measure Participants | 15 | 15 |
| Week 3/baseline |
-4.14
(5.2)
|
-3.2
(4.8)
|
| Week4/baseline |
-2.6
(7.9)
|
-8.6
(11.3)
|
| Title | Non- Motor Symptoms Scale (NMSS) |
|---|---|
| Description | Non-Motor Symptoms Scale (NMSS), which includes questions about 9 different categories of non-motor symptoms in PD, including urinary symptoms; Visit 3 and Visit 4 vs. baseline. Symptoms assessed over the last month. The scale ranges from 0 to 360, with higher scores indicating worse symptoms. |
| Time Frame | baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Mirabegron | Placebo |
|---|---|---|
| Arm/Group Description | 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. | 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. |
| Measure Participants | 15 | 15 |
| visit 3/baseline |
-7.5
(15.4)
|
-19.6
(18.9)
|
| visit 4/baseline |
-10.5
(18.5)
|
-17.9
(23)
|
| Title | Patient Perception of Bladder Condition |
|---|---|
| Description | Patient Perception of Bladder Condition at Visit 3 and Visit 4 vs. baseline. the scale ranges from 1 to 6 with higher score indicating worse outcome |
| Time Frame | baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Mirabegron | Placebo |
|---|---|---|
| Arm/Group Description | 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. | 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. |
| Measure Participants | 15 | 15 |
| V3/baseline |
-0.35
(2.09)
|
-0.7
(0.5)
|
| V4/baseline |
-0.38
(1.9)
|
-1.2
(2.18)
|
| Title | Subjects Global Impression of Change |
|---|---|
| Description | Subject's Global Impression of Change at Visit 3 and Visit 4 vs. baseline the scale ranges from 0 to 7 with higher score indicating worse out come . |
| Time Frame | baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Mirabegron | Placebo |
|---|---|---|
| Arm/Group Description | 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. | 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. |
| Measure Participants | 15 | 15 |
| visit 3/baseline |
3.5
(1.8)
|
3.0
(1.3)
|
| visit 4/baseline |
3.5
(2.2)
|
2.6
(1.1)
|
| Title | Change in Mean Daily OAB-SCS Visit 3 vs Baseline |
|---|---|
| Description | The primary outcome measure will be the change in the mean daily Overactive Bladder-Symptom Composite Score (OAB-SCS) from baseline (visit 2) to visit 4. The Over active Bladder- Symptom Composite Score requires subjects to record the severity of urgency of each micturition over a 72 hour period. Subject ratings ranges from 1 to 6 for each micturition as follows: 1. Not at all, 2.A little bit, 3.Somewhat 4.Quite a bit, 5. A great deal, 6. A very great deal. Maximum score depends on number of micturition episodes in the 72 hour period, as the rating of each episode is summed to get the total score. Higher scores indicate worse symptoms of overactive bladder. |
| Time Frame | baseline (7-14 days post visit 1) and visit 3 (32-40 days post visit 2) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Mirabegron | Placebo |
|---|---|---|
| Arm/Group Description | 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. | 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. |
| Measure Participants | 15 | 15 |
| visit 3 (32-40 days post visit 2 |
3.5
(1.8)
|
3.07
(1.3)
|
| baseline (7-14 days post visit 1) |
3.5
(2.2)
|
2.6
(1.2)
|
| Title | Change in Mean Number of Incontinence Episodes Per 24 Hours |
|---|---|
| Description | Subjects recorded in a 72-hour micturition diary the number of episodes of urinary incontinence, and this is averaged per 24 hours. Higher scores indicate more episodes of incontinence and thus worse outcome. |
| Time Frame | baseline vs visit 3 (32-40 days post baseline) and baseline vs. visit 4 ((74-82 days post visit 2) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Mirabegron | Placebo |
|---|---|---|
| Arm/Group Description | 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. | 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. |
| Measure Participants | 15 | 15 |
| V3 vs baseline |
-0.06
(0.82)
|
-0.11
(1.0)
|
| V4/baseline |
0.12
(1.24)
|
-0.61
(1.9)
|
Adverse Events
| Time Frame | Three months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Mirabegron | Placebo | ||
| Arm/Group Description | 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. | 1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets. Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose. | ||
All Cause Mortality |
||||
| Mirabegron | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/15 (0%) | 0/15 (0%) | ||
Serious Adverse Events |
||||
| Mirabegron | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/15 (0%) | 1/15 (6.7%) | ||
| Psychiatric disorders | ||||
| Psychosis | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Pneumonia | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Cellulitis | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Mirabegron | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/15 (60%) | 6/15 (40%) | ||
| Cardiac disorders | ||||
| Hypertension | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Heart palpitations | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| sinus infection | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Sore throat | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Diarrhea | 1/15 (6.7%) | 1 | 1/15 (6.7%) | 1 |
| loose stools | 2/15 (13.3%) | 2 | 0/15 (0%) | 0 |
| Constipation | 3/15 (20%) | 3 | 0/15 (0%) | 0 |
| abdominal cramps | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Dysphagia | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Heartbun | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
| General disorders | ||||
| Fatigue | 2/15 (13.3%) | 2 | 0/15 (0%) | 0 |
| Infections and infestations | ||||
| Cold symptons | 0/15 (0%) | 0 | 2/15 (13.3%) | 2 |
| Musculoskeletal and connective tissue disorders | ||||
| Falls | 0/15 (0%) | 0 | 2/15 (13.3%) | 2 |
| foot or knee pain | 1/15 (6.7%) | 1 | 1/15 (6.7%) | 1 |
| Nervous system disorders | ||||
| Extreme Dyskinesia | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
| Hallucinations | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Dizziness | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| headache | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Renal and urinary disorders | ||||
| urinary incontinence | 2/15 (13.3%) | 2 | 0/15 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| itchy/swollenhands | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
| edema | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Vascular disorders | ||||
| Erectile dysfunction | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Gowri Rajendran |
|---|---|
| Organization | Evergreenhealth |
| Phone | 425-899-5370 |
| grajendran@evergreenhealth.com |
- DBPA-2013-01