Trial Outcomes & Findings for Mirabegron and Urinary Urgency Incontinence (NCT NCT02495389)
NCT ID: NCT02495389
Last Updated: 2020-11-13
Results Overview
Response to therapy was measured using the Patient Perception of Bladder Control (PPBC) questionnaire which measures patients' perceived bladder condition on a 6-point ordinal scale ranging from 1 (no problems at all) to 6 (many severe problems). Women reporting a PPBC score of 4 or 5 by week 12 responded to therapy. Women reporting a PPBC score of 1, 2, or 3 by week 12 did not respond to therapy.
COMPLETED
PHASE4
84 participants
12 weeks
2020-11-13
Participant Flow
Patients were recruited from January 2015 through October 2018 (46 months) from a tertiary care female pelvic medicine and reconstructive surgery practice.
Participant milestones
| Measure |
Mirabegron
This arm comprises women who received mirabegron
|
|---|---|
|
Overall Study
STARTED
|
84
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
40
|
Reasons for withdrawal
| Measure |
Mirabegron
This arm comprises women who received mirabegron
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
40
|
Baseline Characteristics
One participant did not report her age
Baseline characteristics by cohort
| Measure |
Mirabegron
n=84 Participants
This arm comprises women who received mirabegron
|
|---|---|
|
Age, Continuous
|
66.67 years
STANDARD_DEVIATION 12.46 • n=83 Participants • One participant did not report her age
|
|
Sex: Female, Male
Female
|
84 Participants
n=84 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=84 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian or White
|
65 Participants
n=84 Participants
|
|
Race/Ethnicity, Customized
Race · African American or Black
|
11 Participants
n=84 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=84 Participants
|
|
Race/Ethnicity, Customized
Race · Multiracial
|
1 Participants
n=84 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
4 Participants
n=84 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
2 Participants
n=84 Participants
|
|
Region of Enrollment
United States
|
84 Participants
n=84 Participants
|
|
Hormone Replacement Therapy
Taking hormone replacement therapy
|
7 Participants
n=84 Participants
|
|
Hormone Replacement Therapy
Not taking hormone replacement therapy
|
75 Participants
n=84 Participants
|
|
Hormone Replacement Therapy
Unknown
|
2 Participants
n=84 Participants
|
|
Type II Diabetes Status
Diabetic
|
16 Participants
n=84 Participants
|
|
Type II Diabetes Status
Non-Diabetic
|
67 Participants
n=84 Participants
|
|
Type II Diabetes Status
Not reported
|
1 Participants
n=84 Participants
|
|
Smoker Status
Smoker
|
8 Participants
n=84 Participants
|
|
Smoker Status
Non-smoker
|
74 Participants
n=84 Participants
|
|
Smoker Status
Not reported
|
2 Participants
n=84 Participants
|
|
Hypertension Status
Hypertensive
|
43 Participants
n=84 Participants
|
|
Hypertension Status
Non-hypertensive
|
40 Participants
n=84 Participants
|
|
Hypertension Status
Not reported
|
1 Participants
n=84 Participants
|
|
Cardiovascular Status
Heart disease
|
12 Participants
n=84 Participants
|
|
Cardiovascular Status
No heart disease
|
71 Participants
n=84 Participants
|
|
Cardiovascular Status
Not reported
|
1 Participants
n=84 Participants
|
|
Chronic Obstructive Pulmonary Disease (COPD)
Positive
|
4 Participants
n=84 Participants
|
|
Chronic Obstructive Pulmonary Disease (COPD)
Negative
|
78 Participants
n=84 Participants
|
|
Chronic Obstructive Pulmonary Disease (COPD)
Not reported
|
2 Participants
n=84 Participants
|
|
Asthma Status
Positive
|
13 Participants
n=84 Participants
|
|
Asthma Status
Negative
|
69 Participants
n=84 Participants
|
|
Asthma Status
Not reported
|
2 Participants
n=84 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: This analysis comprises women who received mirabegron and completed 12 weeks of therapy
Response to therapy was measured using the Patient Perception of Bladder Control (PPBC) questionnaire which measures patients' perceived bladder condition on a 6-point ordinal scale ranging from 1 (no problems at all) to 6 (many severe problems). Women reporting a PPBC score of 4 or 5 by week 12 responded to therapy. Women reporting a PPBC score of 1, 2, or 3 by week 12 did not respond to therapy.
Outcome measures
| Measure |
Mirabegron
n=44 Participants
This arm comprises women who received mirabegron
|
|---|---|
|
Response to Therapy
Responded to therapy
|
15 Participants
|
|
Response to Therapy
Did not respond to therapy
|
29 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: This analysis comprises women who received mirabegron for 12 weeks and completed the Overactive Bladder Questionnaire at baseline and after 12 weeks of therapy
The Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL) score is a measure of patients' bladder symptom severity. It ranges from 25 to 150 where higher scores indicate greater quality of life.
Outcome measures
| Measure |
Mirabegron
n=40 Participants
This arm comprises women who received mirabegron
|
|---|---|
|
Change in Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL)
Baseline
|
50.92 score on a scale
Standard Deviation 26.14
|
|
Change in Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL)
After 12 weeks of therapy
|
74.88 score on a scale
Standard Deviation 25.35
|
|
Change in Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL)
Change Score
|
23.96 score on a scale
Standard Deviation 17.54
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: This analysis comprises women who received mirabegron for 12 weeks and completed the Urinary Distress Inventory at baseline and after 12 weeks of therapy
The Urinary Distress Inventory is a 29-item questionnaire that asks patients to report how bothered they are by symptoms of urinary urgency on a scale from 1 (not at all) to 4 (quite a bit). The total score ranges from 0 to 300 where higher scores indicate worsening symptom severity.
Outcome measures
| Measure |
Mirabegron
n=44 Participants
This arm comprises women who received mirabegron
|
|---|---|
|
Change in Urinary Distress Inventory (UDI)
Baseline
|
121.25 score on a scale
Standard Deviation 51.19
|
|
Change in Urinary Distress Inventory (UDI)
After 12 weeks of therapy
|
69.62 score on a scale
Standard Deviation 46.75
|
|
Change in Urinary Distress Inventory (UDI)
Change Score
|
-51.62 score on a scale
Standard Deviation 40.85
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: This analysis comprises women who received mirabegron for 12 weeks and completed the Prolapse Distress Inventory at baseline and after 12 weeks of therapy
The Pelvic Organ Prolapse Distress Inventory (POPDI) is a 16-item questionnaire that asks patients to report how bothered they are by symptoms of urinary urgency on a scale from 1 (not at all) to 4 (quite a bit). The total score ranges from 0 to 300 where higher scores indicate worsening symptom severity.
Outcome measures
| Measure |
Mirabegron
n=44 Participants
This arm comprises women who received mirabegron
|
|---|---|
|
Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score
Change Score
|
-29.30 score on a scale
Standard Deviation 36.28
|
|
Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score
Baseline
|
77.85 score on a scale
Standard Deviation 64.80
|
|
Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score
After 12 weeks of therapy
|
48.55 score on a scale
Standard Deviation 50.91
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: This analysis comprises women who received mirabegron for 12 weeks and completed the Colo-Rectal-Anal Distress Inventory at baseline and after 12 weeks of therapy
The Colo-Rectal-Anal Distress Inventory (CRADI) is a 17-item questionnaire that asks patients to report how bothered they are by symptoms of urinary urgency on a scale from 1 (not at all) to 4 (quite a bit). The total score ranges from 0 to 400 where higher scores indicate worsening symptom severity.
Outcome measures
| Measure |
Mirabegron
n=44 Participants
This arm comprises women who received mirabegron
|
|---|---|
|
Change in Colo-Rectal-Anal Distress Inventory (CRADI)
Baseline
|
94.50 score on a scale
Standard Deviation 82.18
|
|
Change in Colo-Rectal-Anal Distress Inventory (CRADI)
After 12 weeks of therapy
|
62.50 score on a scale
Standard Deviation 68.17
|
|
Change in Colo-Rectal-Anal Distress Inventory (CRADI)
Change Score
|
-32.00 score on a scale
Standard Deviation 40.61
|
Adverse Events
Mirabegron
Serious adverse events
| Measure |
Mirabegron
n=84 participants at risk
This arm comprises women who received mirabegron
|
|---|---|
|
Nervous system disorders
Stroke
|
1.2%
1/84 • Number of events 1 • Adverse event data were collected for 26 weeks
|
|
Immune system disorders
Breast Cancer
|
1.2%
1/84 • Number of events 1 • Adverse event data were collected for 26 weeks
|
Other adverse events
| Measure |
Mirabegron
n=84 participants at risk
This arm comprises women who received mirabegron
|
|---|---|
|
Infections and infestations
Bacterial Infection
|
1.2%
1/84 • Number of events 1 • Adverse event data were collected for 26 weeks
|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/84 • Number of events 1 • Adverse event data were collected for 26 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
3/84 • Number of events 3 • Adverse event data were collected for 26 weeks
|
|
General disorders
Somnolence
|
1.2%
1/84 • Number of events 1 • Adverse event data were collected for 26 weeks
|
|
General disorders
Leg pain
|
1.2%
1/84 • Number of events 1 • Adverse event data were collected for 26 weeks
|
|
Vascular disorders
Elevated Systolic Blood Pressure
|
2.4%
2/84 • Number of events 2 • Adverse event data were collected for 26 weeks
|
|
Gastrointestinal disorders
Abdominal Cramping
|
1.2%
1/84 • Number of events 1 • Adverse event data were collected for 26 weeks
|
|
General disorders
Nausea
|
1.2%
1/84 • Number of events 1 • Adverse event data were collected for 26 weeks
|
|
Product Issues
Allergic Reaction to mirabegron
|
1.2%
1/84 • Number of events 1 • Adverse event data were collected for 26 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place