Overactive Bladder
Conditions
Keywords
Urinary Urgency Incontinence, Mirabegron, Myrbetriq, Betmiga
Brief summary
This study is for women diagnosed with urinary urgency incontinence (UUI) or overactive bladder (OAB). Some patients continue to have symptoms even while taking medication for OAB. The purpose of this study is to estimate the number of women who respond to a medication called mirabegron and estimate change in symptom severity over 12 weeks of therapy. A secondary goal is to correlate the female urinary microbiome (FUM) with response to treatment and change in symptom severity over 12 weeks of therapy.
Detailed description
Mirabegron is an FDA-approved medication for urgency incontinence. Evaluation of mirabegron's influence on clinical symptoms may need to take into account the effect of the female urinary microbiome (FUM) on a patient's response to treatment. Compared to asymptomatic patients, several bacterial species are more common in patients with overactive bladder. Currently, physicians have limited ability to personalize a patient's urinary urgency incontinence treatment and, consequently, the prescribed medication may provide minimal symptom relief. Since the FUM can be assessed prior to treatment, this study proposes to determine if baseline FUM assessment can provide insight into future symptom relief with mirabegron treatment.
Interventions
DRUGMirabegron
Mirabegron is a medication for the treatment of overactive bladder. It was developed by Astellas Pharma and was approved by the United States Food and Drug Administration (FDA) in July 2012.
Sponsors
Astellas Pharma US, Inc.
Loyola University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
There is no masking scheme
Intervention model description
All patients receive mirabegron daily for 12 weeks
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Bothersome idiopathic (non-neurologic) urgency urinary incontinence (UUI) who recall ≥ 5 urgency predominant urinary incontinence episodes in the prior week (urgency urinary incontinence or mixed urinary incontinence-urgency predominant) * No contraindications to taking mirabegron * Patients on current OAB therapy will undergo a two-week drug washout period prior to baseline assessment
Exclusion criteria
* Neurologic disease known to affect the lower urinary tract * Systemic immunologic deficiency * Current urinary tract infection (UTI) (based on dipstick assessment) or recurrent culture-proven UTIs * History or current pelvic malignancy or radiation * Untreated symptomatic pelvic organ prolapse (POP) \> POP-Q Stage II * A contraindication to receiving mirabegron * Women of childbearing potential who are pregnant or nursing or intend to become pregnant during the study, or who are not practicing a reliable method of contraception * Must not have taken any antibiotics in the 4 weeks prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to Therapy | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL) | 12 weeks | 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. |
| Change in Urinary Distress Inventory (UDI) | 12 weeks | 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. |
| Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score | 12 weeks | 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. |
| Change in Colo-Rectal-Anal Distress Inventory (CRADI) | 12 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from January 2015 through October 2018 (46 months) from a tertiary care female pelvic medicine and reconstructive surgery practice.
Participants by arm
| Arm | Count |
|---|---|
| Mirabegron This arm comprises women who received mirabegron | 84 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 40 |
Baseline characteristics
| Characteristic | Mirabegron |
|---|---|
| Age, Continuous | 66.67 years STANDARD_DEVIATION 12.46 |
| Asthma Status Negative | 69 Participants |
| Asthma Status Not reported | 2 Participants |
| Asthma Status Positive | 13 Participants |
| Cardiovascular Status Heart disease | 12 Participants |
| Cardiovascular Status No heart disease | 71 Participants |
| Cardiovascular Status Not reported | 1 Participants |
| Chronic Obstructive Pulmonary Disease (COPD) Negative | 78 Participants |
| Chronic Obstructive Pulmonary Disease (COPD) Not reported | 2 Participants |
| Chronic Obstructive Pulmonary Disease (COPD) Positive | 4 Participants |
| Hormone Replacement Therapy Not taking hormone replacement therapy | 75 Participants |
| Hormone Replacement Therapy Taking hormone replacement therapy | 7 Participants |
| Hormone Replacement Therapy Unknown | 2 Participants |
| Hypertension Status Hypertensive | 43 Participants |
| Hypertension Status Non-hypertensive | 40 Participants |
| Hypertension Status Not reported | 1 Participants |
| Race/Ethnicity, Customized Race African American or Black | 11 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants |
| Race/Ethnicity, Customized Race Caucasian or White | 65 Participants |
| Race/Ethnicity, Customized Race Multiracial | 1 Participants |
| Race/Ethnicity, Customized Race Not Reported | 2 Participants |
| Race/Ethnicity, Customized Race Other | 4 Participants |
| Region of Enrollment United States | 84 Participants |
| Sex: Female, Male Female | 84 Participants |
| Sex: Female, Male Male | 0 Participants |
| Smoker Status Non-smoker | 74 Participants |
| Smoker Status Not reported | 2 Participants |
| Smoker Status Smoker | 8 Participants |
| Type II Diabetes Status Diabetic | 16 Participants |
| Type II Diabetes Status Non-Diabetic | 67 Participants |
| Type II Diabetes Status Not reported | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 84 |
| other Total, other adverse events | 12 / 84 |
| serious Total, serious adverse events | 2 / 84 |
Outcome results
Primary
Response to 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.
Time frame: 12 weeks
Population: This analysis comprises women who received mirabegron and completed 12 weeks of therapy
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mirabegron | Response to Therapy | Responded to therapy | 15 Participants |
| Mirabegron | Response to Therapy | Did not respond to therapy | 29 Participants |
Secondary
Change in Colo-Rectal-Anal Distress Inventory (CRADI)
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.
Time frame: 12 weeks
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron | Change in Colo-Rectal-Anal Distress Inventory (CRADI) | Baseline | 94.50 score on a scale | Standard Deviation 82.18 |
| Mirabegron | Change in Colo-Rectal-Anal Distress Inventory (CRADI) | After 12 weeks of therapy | 62.50 score on a scale | Standard Deviation 68.17 |
| Mirabegron | Change in Colo-Rectal-Anal Distress Inventory (CRADI) | Change Score | -32.00 score on a scale | Standard Deviation 40.61 |
Comparison: The null hypothesis is that there is no change in patients' baseline Colo-Rectal-Anal Distress Inventory score after 12 weeks of therapy.p-value: <0.000195% CI: [-44.35, -19.65]t-test, 2 sided
Secondary
Change in Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL)
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.
Time frame: 12 weeks
Population: This analysis comprises women who received mirabegron for 12 weeks and completed the Overactive Bladder Questionnaire at baseline and after 12 weeks of therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 |
| Mirabegron | 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 |
| Mirabegron | 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 |
Comparison: The null hypothesis is that there is no change in patients' baseline Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL) score after 12 weeks of therapy.p-value: <0.000195% CI: [18.35, 29.57]t-test, 2 sided
Secondary
Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score
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.
Time frame: 12 weeks
Population: This analysis comprises women who received mirabegron for 12 weeks and completed the Prolapse Distress Inventory at baseline and after 12 weeks of therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron | Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score | Baseline | 77.85 score on a scale | Standard Deviation 64.8 |
| Mirabegron | Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score | After 12 weeks of therapy | 48.55 score on a scale | Standard Deviation 50.91 |
| Mirabegron | Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score | Change Score | -29.30 score on a scale | Standard Deviation 36.28 |
Comparison: The null hypothesis is that there is no change in patients' baseline Pelvic Organ Prolapse Distress Inventory score after 12 weeks of therapy.p-value: <0.000195% CI: [-40.33, -18.27]t-test, 2 sided
Secondary
Change in Urinary Distress Inventory (UDI)
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.
Time frame: 12 weeks
Population: This analysis comprises women who received mirabegron for 12 weeks and completed the Urinary Distress Inventory at baseline and after 12 weeks of therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron | Change in Urinary Distress Inventory (UDI) | Baseline | 121.25 score on a scale | Standard Deviation 51.19 |
| Mirabegron | Change in Urinary Distress Inventory (UDI) | After 12 weeks of therapy | 69.62 score on a scale | Standard Deviation 46.75 |
| Mirabegron | Change in Urinary Distress Inventory (UDI) | Change Score | -51.62 score on a scale | Standard Deviation 40.85 |
Comparison: The null hypothesis is that there is no change in patients' baseline Urinary Distress Inventory score after 12 weeks of therapy.p-value: <0.000195% CI: [-64.04, -39.2]t-test, 2 sided