Trial · NCT02138747
A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB)
NCT02138747, Phase 4, Completed, Astellas Pharma Global Development, Inc.; results first posted 2017-02-14
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ConductScience Library. A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB). Trials, record NCT02138747. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02138747
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB)
- NCT number
- NCT02138747
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 376 participants, actual
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Conditions
- Overactive Bladder (OAB)
- Interventions
- Mirabegron, Tolterodine ER
- First posted
- 2014-05-15
- Last updated
- 2020-02-26
- Results first posted
- 2017-02-14
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT) | Week 8 (End of Period 1) and Week 18 (End of Period 2) | The medication tolerability scale measured the level of bothersomeness related to the occurrence of a side effect that was known to be related to the approved OAB medication (i.e., constipation, dry mouth, drowsiness, headache, nausea and blurred vision). The OAB medication tolerability score was calculated as a sum of the responses and converted to a scale from 0 to 100, where higher score indicates better perceived OAB medication tolerability (less bother from side-effects). |
| Secondary | Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods. | Week 18 (End of Period 2) | Participants were asked to choose which treatment period they preferred and the degree of preference. Preference was assessed on a 5-point scale assessed at the end of period 2 ("strong preference for period 1," "mild preference for period 1," "no preference," "mild preference for period 2," "strong preference for period 2"). Participants who selected either a "mild preference" or "strong preference" were considered as having a preference for a specific study drug and participants who selected "no preference" were considered as having no preference for one study drug over the other study drug." |
| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB. | Week 8 (End of Period 1) and Week 18 (End of Period 2) | Impact on daily living with the OAB was scored from 0 to 100, with higher scores indicating greater satisfaction with ability to perform daily activities. |
| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control | Week 8 (End of Period 1) and Week 18 (End of Period 2) | OAB control was scored from 0 to 100, with higher scores indicating better OAB control. |
| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control | Week 8 (End of Period 1) and Week 18 (End of Period 2) | Satisfaction with OAB control was scored from 0 to 100 with higher scores indicating greater satisfaction with OAB control. |
| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant's Fulfillment of OAB Medication Expectations | Week 8 (End of Period 1) and Week 18 (End of Period 2) | The final item score for overall assessment of patient's fulfillment of OAB medication expectations ranged from 1 to 5, with higher scores indicating better fulfillment of OAB medication expectations. |
| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Interruption of Day-to-Day Life Due to OAB | Week 8 (End of Period 1) and Week 18 (End of Period 2) | Overall assessment of interruption of day-to-day life due to OAB was assessed on a scale from 1 to 5, with higher scores indicating less interruption of day-to-day life due to OAB symptoms. |
| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication | Week 8 (End of Period 1) and Week 18 (End of Period 2) | Overall satisfaction with OAB medication was assessed on a scale of 1 to 5, with higher scores indicating greater satisfaction with current OAB medication. |
| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication | Week 8 (End of Period 1) and Week 18 (End of Period 2) | Overall assessment of willingness to continue OAB medication, was assessed on a scale from 1 to 5, with higher scores indicating greater desire to continue with current OAB medication. |
| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Improvement in Day-to-Day Life Due to OAB Medication | Week 8 (End of Period 1) and Week 18 (End of Period 2) | Overall assessment of improvement in day-to-day life due to OAB medication was assessed on a scale from 1 to 5, with higher scores indicating greater improvement in day-to-day life due to current OAB medication. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT) | Week 8 (End of Period 1) and Week 18 (End of Period 2) | The Full Analysis Set (FAS) comprised of all randomized participants who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods. | Week 18 (End of Period 2) | Full Analysis Set (FAS-PNP \[Preference/No Preference\]) consisted of all randomized participant who took at least 14 days of double-blind study drug in each treatment period and had filled out the patient preference form. | Percentage of participants | NUMBER |
| SECONDARY | Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB. | Week 8 (End of Period 1) and Week 18 (End of Period 2) | Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a post baseline visit. Last observation carried forward imputation (LOCF) was utilized. | Units on a Scale | MEAN |
| SECONDARY | Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control | Week 8 (End of Period 1) and Week 18 (End of Period 2) | Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized. | Units on a Scale | MEAN |
| SECONDARY | Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control | Week 8 (End of Period 1) and Week 18 (End of Period 2) | Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized. | Units on a Scale | MEAN |
| SECONDARY | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant's Fulfillment of OAB Medication Expectations | Week 8 (End of Period 1) and Week 18 (End of Period 2) | Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized. | Units on a Scale | MEAN |
| SECONDARY | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Interruption of Day-to-Day Life Due to OAB | Week 8 (End of Period 1) and Week 18 (End of Period 2) | Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized. | Unit on a Scale | MEAN |
| SECONDARY | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication | Week 8 (End of Period 1) and Week 18 (End of Period 2) | Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized. | Units on a Scale | MEAN |
| SECONDARY | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication | Week 8 (End of Period 1) and Week 18 (End of Period 2) | Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized. | Units on a Scale | MEAN |
| SECONDARY | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Improvement in Day-to-Day Life Due to OAB Medication | Week 8 (End of Period 1) and Week 18 (End of Period 2) | Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized. | Units on a Scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT) | Mirabegron | 86.29 | Standard Error 1.418 | Units on a Scale | |
| Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT) | Tolterodine ER | 83.40 | Standard Error 1.423 | Units on a Scale | |
| Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods. | AB: Mirabegron/Tolterodine ER | Preference for Period 1 | 29.9 | Percentage of participants | |
| Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods. | BA: Tolterodine ER /Mirabegron | Preference for Period 1 | 34.4 | Percentage of participants | |
| Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods. | AA: Mirabegron/Mirabegron | Preference for Period 1 | 36.0 | Percentage of participants | |
| Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods. | BB: Tolterodine ER /Tolterodine ER | Preference for Period 1 | 23.1 | Percentage of participants | |
| Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods. | AB: Mirabegron/Tolterodine ER | Preference for Period 2 | 37.8 | Percentage of participants | |
| Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods. | BA: Tolterodine ER /Mirabegron | Preference for Period 2 | 37.6 | Percentage of participants | |
| Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods. | AA: Mirabegron/Mirabegron | Preference for Period 2 | 36.0 | Percentage of participants | |
| Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods. | BB: Tolterodine ER /Tolterodine ER | Preference for Period 2 | 50.0 | Percentage of participants |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 | STARTED | AB: Mirabegron/Tolterodine ER | 156 | |
| Treatment Period 1 | STARTED | BA: Tolterodine ER /Mirabegron | 157 | |
| Treatment Period 1 | STARTED | AA: Mirabegron/Mirabegron | 31 | |
| Treatment Period 1 | STARTED | BB: Tolterodine ER /Tolterodine ER | 32 | |
| Treatment Period 1 | COMPLETED | AB: Mirabegron/Tolterodine ER | 136 | |
| Treatment Period 1 | COMPLETED | BA: Tolterodine ER /Mirabegron | 132 | |
| Treatment Period 1 | COMPLETED | AA: Mirabegron/Mirabegron | 27 | |
| Treatment Period 1 | COMPLETED | BB: Tolterodine ER /Tolterodine ER | 28 | |
| Treatment Period 1 | NOT COMPLETED | AB: Mirabegron/Tolterodine ER | 20 | |
| Treatment Period 1 | NOT COMPLETED | BA: Tolterodine ER /Mirabegron | 25 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events24
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 | Dry mouth | Gastrointestinal disorders | Mirabegron | 29 | 319 | |
| other | Dry mouth | Gastrointestinal disorders | Tolterodine ER | 53 | 325 | |
| other | Constipation | Gastrointestinal disorders | Mirabegron | 18 | 319 | |
| other | Constipation | Gastrointestinal disorders | Tolterodine ER | 20 | 325 | |
| other | Headache | Nervous system disorders | Mirabegron | 18 | 319 | |
| other | Headache | Nervous system disorders | Tolterodine ER | 19 | 325 | |
| serious | Atrial fibrillation | Cardiac disorders | Mirabegron | 2 | 319 | |
| serious | Atrial fibrillation | Cardiac disorders | Tolterodine ER | 1 | 325 | |
| serious | Small intestinal obstruction | Gastrointestinal disorders | Mirabegron | 0 | 319 | |
| serious | Small intestinal obstruction | Gastrointestinal disorders | Tolterodine ER | 2 | 325 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mirabegron | ||
| Total, all-cause mortality | Tolterodine ER | ||
| Total, other adverse events | Mirabegron | 55 | 319 |
| Total, other adverse events | Tolterodine ER | 79 | 325 |
| Total, serious adverse events | Mirabegron | 3 | 319 |
| Total, serious adverse events | Tolterodine ER | 8 | 325 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Mirabegron vs Tolterodine ER: serious adverse events |
Source Trial comparisons
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.
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Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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