Trial · NCT01908829
A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)
NCT01908829, Phase 3, Completed, Astellas Pharma Europe Ltd.; results first posted 2017-10-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin). Trials, record NCT01908829. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01908829
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)
- NCT number
- NCT01908829
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,174 participants, actual
- Lead sponsor
- Astellas Pharma Europe Ltd.
- Conditions
- Urinary Bladder Diseases, Urinary Bladder Overactive, Urologic Diseases
- Interventions
mirabegron 25 mg, mirabegron 50 mg, solifenacin 5 mg, solifenacin 10 mg, mirabegron 25 mg matching placebo, mirabegron 50 mg matching placebo, solifenacin 5 mg matching placebo, solifenacin 10 mg matching placebo
- First posted
- 2013-07-26
- Last updated
- 2024-10-31
- Other registries' IDs
- eudract:2012-005401-41
- Results first posted
- 2017-10-09
- Limitations and caveats
- One participant was randomized to the Combination arm, but actually received Solifenacin 10 mg. In terms of actual treatment received, the participant was allocated to the solifenacin 10 mg arm.
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and end of treatment (up to 12 weeks) | The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. The analysis population consisted of the Full Analysis Set (FAS) which comprised of all the Randomized Analysis Set's (RAS) participants who met the following criteria: took at least 1 dose of double-blind study drug after randomization, reported at least 1 micturition in the baseline diary \& at least 1 micturition postbaseline \& reported at least 1 incontinence episode in the baseline diary. For participants who withdrew before EoT (week 12) and have no measurement available for that diary period, the Last Observation Carried Forward (LOCF) value during the double-blind study period was used as EoT value to derive the primary variable. |
| Secondary | Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and weeks 4, 8 & 12 | The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. |
| Secondary | Change From Baseline in Mean Number of Micturitions Per 24 Hours | Baseline and weeks 4, 8 & 12 | The average number of micturitions (voluntary urinations (excluding incontinence only episodes)) per 24 hours was derived from number of micturitions recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period (excluding incontinence only episodes). |
| Secondary | Number of Incontinence Episodes Reported During the 3-Day Diary | Weeks 4, 8 and 12 | The number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from total number of incontinence episodes on valid diary days recorded during the 3-day micturition diary period. |
| Secondary | Change From Baseline in Mean Volume Voided (MVV) Per Micturition | Baseline and weeks 4, 8 & 12 | MVV per micturition was defined as MVV (mL) per micturition during last 3 days of the 3-day micturition diary period. MVV per micturition was calculated as the sum of each volume voided for each record with volume voided \> 0 on valid diary days divided by the total number of records with a volume voided \> 0 on valid diary days during the 3-day micturition diary period. |
| Secondary | Change From Baseline to EoT in Corrected Micturition Frequency (CMF) | Baseline and EoT (up to 12 weeks) | CMF was defined as the mean number of micturitions per 24 hours that participants would have at EoT if their fluid intake had remained unchanged since baseline. This was calculated by the MVV per Micturition at baseline multiplied by the mean number of micturitions per 24 hours at baseline divided by the MVV per micturition at EoT. |
| Secondary | Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours | Baseline and weeks 4, 8 & 12 | UI was defined as the complaint of involuntary urine leakage accompanied by or immediately preceded by urgency. UI was measured using the Patient Perception of Intensity of Urgency Scale (PPIUS), a patient reported outcome validated 5-point categorical scale rating the degree of associated urinary urgency severity (0=No urgency, I felt no need to empty my bladder, but did so for other reasons. 1=Mild, I could postpone voiding as long as necessary, without fear of wetting myself. 2= Moderate, I could postpone voiding for a short while, without fear of wetting myself. 3=Severe, I could not postpone voiding, but had to rush to the toilet in order not to wet myself. 4=Urgency incontinence, I leaked before arriving to the toilet). One urgency incontinence episode was counted for each record of the diary in which the following occurred: incontinence episode or 'both' was recorded \& severity of urinary urgency recorded was 3 or 4. |
| Secondary | Number of UI Episodes Reported During the 3-Day Diary | Weeks 4, 8 and 12 | Number of UI episodes was calculated using the number of UI episodes recorded on valid diary days during the 3-day micturition diary period. NOTE: Only urgency incontinence episodes recorded on a valid diary day were counted. |
| Secondary | Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Baseline and weeks 4, 8 & 12 | An urgency episode was defined as the complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes (severity of 3 or 4) per 24 hours was defined as the average number of times a participant recorded an urgency episode (severity of 3 or 4) with or without incontinence per day during the 3-day micturition diary period. Measured using the PPIUS scale. This was calculated using the sum of each record with an urgency episode (severity of 3 or 4) recorded on a valid diary day divided by the number of valid diary days during the 3-day micturition diary period. |
| Secondary | Change From Baseline in Mean Number of Pads Per 24 Hours | Baseline and weeks 4, 8 & 12 | The mean number of pads per 24 hours was defined as the average number of times a participant recorded a new pad used per day during the 3-day micturition diary period. This was calculated using the number of new pads used during valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes36
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and end of treatment (up to 12 weeks) | The analysis population consisted of the FAS. LOCF was used for EoT. | incontinence episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and weeks 4, 8 & 12 | The analysis population consisted of the FAS with data available at each time point. | incontinence episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Number of Micturitions Per 24 Hours | Baseline and weeks 4, 8 & 12 | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | micturitions | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Incontinence Episodes Reported During the 3-Day Diary | Weeks 4, 8 and 12 | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | incontinence episodes | MEAN |
| SECONDARY | Change From Baseline in Mean Volume Voided (MVV) Per Micturition | Baseline and weeks 4, 8 & 12 | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to EoT in Corrected Micturition Frequency (CMF) | Baseline and EoT (up to 12 weeks) | LOCF was used. The analysis population consisted of the FAS. | micturitions | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours | Baseline and weeks 4, 8 & 12 | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one UI episode reported in baseline diary were included. | UI episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Number of UI Episodes Reported During the 3-Day Diary | Weeks 4, 8 and 12 | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one UI episode reported in baseline diary were included. | UI episodes | MEAN |
| SECONDARY | Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Baseline and weeks 4, 8 & 12 | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one urgency episode reported in baseline diary were included. | urgency episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Number of Pads Per 24 Hours | Baseline and weeks 4, 8 & 12 | LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with reported use of at least one pad reported in baseline diary were included. | pads | LEAST_SQUARES_MEAN |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 outcomesResults by group951
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours | Combination (Solifenacin + Mirabegron) | -1.8 | Standard Error 0.08 | incontinence episodes | |
| Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours | Solifenacin 5 mg | -1.53 | Standard Error 0.08 | incontinence episodes | |
| Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours | Solifenacin 10 mg | -1.67 | Standard Error 0.08 | incontinence episodes | |
| Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours | Combination (Solifenacin + Mirabegron) | Week 4 | -1.24 | Standard Error 0.07 | incontinence episodes |
| Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours | Solifenacin 5 mg | Week 4 | -0.91 | Standard Error 0.07 | incontinence episodes |
| Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours | Solifenacin 10 mg | Week 4 | -1.12 | Standard Error 0.07 | incontinence episodes |
| Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours | Combination (Solifenacin + Mirabegron) | Week 8 | -1.68 | Standard Error 0.07 | incontinence episodes |
| Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours | Solifenacin 5 mg | Week 8 | -1.29 | Standard Error 0.07 | incontinence episodes |
| Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours | Solifenacin 10 mg | Week 8 | -1.49 | Standard Error 0.07 | incontinence episodes |
| Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours | Combination (Solifenacin + Mirabegron) | Week 12 | -1.81 | Standard Error 0.08 | incontinence episodes |
1 to 10 of 951Source ClinicalTrials.gov
See all 951 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Combination (Solifenacin + Mirabegron) | 727 | |
| Overall Study | STARTED | Solifenacin 5 mg | 728 | |
| Overall Study | STARTED | Solifenacin 10 mg | 719 | |
| Overall Study | Treated With Double-blind Drug | Combination (Solifenacin + Mirabegron) | 725 | |
| Overall Study | Treated With Double-blind Drug | Solifenacin 5 mg | 728 | |
| Overall Study | Treated With Double-blind Drug | Solifenacin 10 mg | 719 | |
| Overall Study | COMPLETED | Combination (Solifenacin + Mirabegron) | 678 | |
| Overall Study | COMPLETED | Solifenacin 5 mg | 679 | |
| Overall Study | COMPLETED | Solifenacin 10 mg | 680 | |
| Overall Study | NOT COMPLETED | Combination (Solifenacin + Mirabegron) | 49 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events126
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 | Combination (Solifenacin + Mirabegron) | 43 | 725 | 44 |
| other | Dry mouth | Gastrointestinal disorders | Solifenacin 5 mg | 41 | 728 | 44 |
| other | Dry mouth | Gastrointestinal disorders | Solifenacin 10 mg | 68 | 719 | 70 |
| serious | Acute myocardial infarction | Cardiac disorders | Combination (Solifenacin + Mirabegron) | 0 | 725 | 0 |
| serious | Acute myocardial infarction | Cardiac disorders | Solifenacin 5 mg | 0 | 728 | 0 |
| serious | Acute myocardial infarction | Cardiac disorders | Solifenacin 10 mg | 1 | 719 | 1 |
| serious | Atrial fibrillation | Cardiac disorders | Combination (Solifenacin + Mirabegron) | 0 | 725 | 0 |
| serious | Atrial fibrillation | Cardiac disorders | Solifenacin 5 mg | 1 | 728 | 1 |
| serious | Atrial fibrillation | Cardiac disorders | Solifenacin 10 mg | 0 | 719 | 0 |
| serious | Atrioventricular block complete | Cardiac disorders | Combination (Solifenacin + Mirabegron) | 1 | 725 | 1 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combination (Solifenacin + Mirabegron) | ||
| Total, all-cause mortality | Solifenacin 5 mg | ||
| Total, all-cause mortality | Solifenacin 10 mg | ||
| Total, other adverse events | Combination (Solifenacin + Mirabegron) | 43 | 725 |
| Total, other adverse events | Solifenacin 5 mg | 41 | 728 |
| Total, other adverse events | Solifenacin 10 mg | 68 | 719 |
| Total, serious adverse events | Combination (Solifenacin + Mirabegron) | 13 | 725 |
| Total, serious adverse events | Solifenacin 5 mg | 10 | 728 |
| Total, serious adverse events | Solifenacin 10 mg | 15 | 719 |
Source ClinicalTrials.gov
Papers2
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
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