Trial · NCT02495389
Mirabegron and Urinary Urgency Incontinence
NCT02495389, Phase 4, Completed, Loyola University; results first posted 2020-11-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mirabegron and Urinary Urgency Incontinence. Trials, record NCT02495389. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02495389
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mirabegron and Urinary Urgency Incontinence
- NCT number
- NCT02495389
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 84 participants, actual
- Lead sponsor
- Loyola University
- Conditions
- Overactive Bladder
- Interventions
- Mirabegron
- First posted
- 2015-07-13
- Last updated
- 2020-11-13
- Results first posted
- 2020-11-13
- Limitations and caveats
- There are no limitations or caveats to report
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response to Therapy | 12 weeks | This analysis comprises women who received mirabegron and completed 12 weeks of therapy | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL) | 12 weeks | This analysis comprises women who received mirabegron for 12 weeks and completed the Overactive Bladder Questionnaire at baseline and after 12 weeks of therapy | score on a scale | MEAN |
| SECONDARY | Change in Urinary Distress Inventory (UDI) | 12 weeks | This analysis comprises women who received mirabegron for 12 weeks and completed the Urinary Distress Inventory at baseline and after 12 weeks of therapy | score on a scale | MEAN |
| SECONDARY | Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score | 12 weeks | This analysis comprises women who received mirabegron for 12 weeks and completed the Prolapse Distress Inventory at baseline and after 12 weeks of therapy | score on a scale | MEAN |
| SECONDARY | Change in Colo-Rectal-Anal Distress Inventory (CRADI) | 12 weeks | 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 | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response to Therapy | Mirabegron | Responded to therapy | 15 | Participants | |
| Response to Therapy | Mirabegron | Did not respond to therapy | 29 | Participants | |
| Change in Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL) | Mirabegron | Baseline | 50.92 | Standard Deviation 26.14 | score on a scale |
| Change in Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL) | Mirabegron | After 12 weeks of therapy | 74.88 | Standard Deviation 25.35 | score on a scale |
| Change in Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL) | Mirabegron | Change Score | 23.96 | Standard Deviation 17.54 | score on a scale |
| Change in Urinary Distress Inventory (UDI) | Mirabegron | Baseline | 121.25 | Standard Deviation 51.19 | score on a scale |
| Change in Urinary Distress Inventory (UDI) | Mirabegron | After 12 weeks of therapy | 69.62 | Standard Deviation 46.75 | score on a scale |
| Change in Urinary Distress Inventory (UDI) | Mirabegron | Change Score | -51.62 | Standard Deviation 40.85 | score on a scale |
| Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score | Mirabegron | Baseline | 77.85 | Standard Deviation 64.80 | score on a scale |
| Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score | Mirabegron | After 12 weeks of therapy | 48.55 | Standard Deviation 50.91 | score on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mirabegron | 84 | |
| Overall Study | COMPLETED | Mirabegron | 44 | |
| Overall Study | NOT COMPLETED | Mirabegron | 40 |
Source ClinicalTrials.gov
Adverse events11
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bacterial Infection | Infections and infestations | Mirabegron | 1 | 84 | 1 |
| other | Constipation | Gastrointestinal disorders | Mirabegron | 1 | 84 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Mirabegron | 3 | 84 | 3 |
| other | Somnolence | General disorders | Mirabegron | 1 | 84 | 1 |
| other | Leg pain | General disorders | Mirabegron | 1 | 84 | 1 |
| other | Elevated Systolic Blood Pressure | Vascular disorders | Mirabegron | 2 | 84 | 2 |
| other | Abdominal Cramping | Gastrointestinal disorders | Mirabegron | 1 | 84 | 1 |
| other | Nausea | General disorders | Mirabegron | 1 | 84 | 1 |
| other | Allergic Reaction to mirabegron | Product Issues | Mirabegron | 1 | 84 | 1 |
| serious | Stroke | Nervous system disorders | Mirabegron | 1 | 84 | 1 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mirabegron | 0 | 84 |
| Total, other adverse events | Mirabegron | 12 | 84 |
| Total, serious adverse events | Mirabegron | 2 | 84 |
Source ClinicalTrials.gov
Papers24
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02495389
GET https://conductscience.org/api/trials/v1/NCT02495389/papers?page=2