Trial · NCT01767519
A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence
NCT01767519, Phase 3, Completed, Allergan; results first posted 2016-01-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence. Trials, record NCT01767519. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01767519
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence
- NCT number
- NCT01767519
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 356 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Overactive Bladder, Urinary Incontinence
- Interventions
- BOTOX®, solifenacin, Botox placebo (normal saline), solifenacin placebo
- First posted
- 2013-01-14
- Last updated
- 2019-04-23
- Results first posted
- 2016-01-12
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 | Study Baseline, Week 12 | Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. |
| Primary | Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1 | Study Baseline, Week 12 | Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period and compared to baseline to determine 100% reduction in episodes. |
| Secondary | Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1 | Week 12 | A positive treatment response on the Treatment Benefit Scale is a score of either 1 or 2, representing 'greatly improved' or 'improved.' |
| Secondary | Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1 | Study Baseline, Week 12 | The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. |
| Secondary | Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1 | Study Baseline, Week 12 | Nocturia episodes are measured over a 3 day diary prior to each visit in Treatment Cycle 1. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. |
| Secondary | Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1 | Study Baseline, Week 12 | The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the role limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. |
| Secondary | Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1 | Study Baseline, Week 12 | The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the social limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 | Study Baseline, Week 12 | Intent-to-Treat: includes all patients according to the group to which they are randomized | Incontinence Episodes | MEAN |
| PRIMARY | Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1 | Study Baseline, Week 12 | Intent-to-Treat: includes all patients according to the group to which they are randomized | Percentage of Patients | NUMBER |
| SECONDARY | Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1 | Week 12 | Intent-to-Treat: includes all patients according to the group to which they are randomized | Percentage of Patients | NUMBER |
| SECONDARY | Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1 | Study Baseline, Week 12 | Intent-to-Treat: includes all patients according to the group to which they are randomized | Micturition Episodes | MEAN |
| SECONDARY | Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1 | Study Baseline, Week 12 | Intent-to-Treat: includes all patients according to the group to which they are randomized | Nocturia Episodes | MEAN |
| SECONDARY | Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1 | Study Baseline, Week 12 | Intent-to-Treat: includes all patients according to the group to which they are randomized | Scores on a Scale | MEAN |
| SECONDARY | Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1 | Study Baseline, Week 12 | Intent-to-Treat: includes all patients according to the group to which they are randomized | Scores on a Scale | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 | BOTOX® | Study Baseline | 4.86 | Standard Deviation 3.206 | Incontinence Episodes |
| Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 | Solifenacin | Study Baseline | 5.23 | Standard Deviation 3.333 | Incontinence Episodes |
| Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 | Placebo | Study Baseline | 4.38 | Standard Deviation 2.485 | Incontinence Episodes |
| Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 | BOTOX® | Change from Study Baseline at Week 12 | -3.10 | Standard Deviation 2.799 | Incontinence Episodes |
| Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 | Solifenacin | Change from Study Baseline at Week 12 | -2.66 | Standard Deviation 3.059 | Incontinence Episodes |
| Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 | Placebo | Change from Study Baseline at Week 12 | -0.98 | Standard Deviation 2.417 | Incontinence Episodes |
| Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1 | BOTOX® | 33.8 | Percentage of Patients | ||
| Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1 | Solifenacin | 24.5 | Percentage of Patients | ||
| Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1 | Placebo | 11.7 | Percentage of Patients | ||
| Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1 | BOTOX® | 71.3 | 95% Confidence Interval 62.9 to 78.7 | Percentage of Patients |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BOTOX® | 145 | |
| Overall Study | STARTED | Solifenacin | 151 | |
| Overall Study | STARTED | Placebo | 60 | |
| Overall Study | COMPLETED | BOTOX® | 131 | |
| Overall Study | COMPLETED | Solifenacin | 138 | |
| Overall Study | COMPLETED | Placebo | 55 | |
| Overall Study | NOT COMPLETED | BOTOX® | 14 | |
| Overall Study | NOT COMPLETED | Solifenacin | 13 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events60
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 | BOTOX® | 4 | 145 | |
| other | Dry mouth | Gastrointestinal disorders | Solifenacin | 12 | 147 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 0 | 60 | |
| other | Urinary tract infection | Infections and infestations | BOTOX® | 37 | 145 | |
| other | Urinary tract infection | Infections and infestations | Solifenacin | 15 | 147 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 6 | 60 | |
| other | Bacteriuria | Infections and infestations | BOTOX® | 11 | 145 | |
| other | Bacteriuria | Infections and infestations | Solifenacin | 14 | 147 | |
| other | Bacteriuria | Infections and infestations | Placebo | 3 | 60 | |
| other | Residual urine volume | Investigations | BOTOX® | 10 | 145 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BOTOX® | ||
| Total, all-cause mortality | Solifenacin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | BOTOX® | 57 | 145 |
| Total, other adverse events | Solifenacin | 40 | 147 |
| Total, other adverse events | Placebo | 13 | 60 |
| Total, serious adverse events | BOTOX® | 6 | 145 |
| Total, serious adverse events | Solifenacin | 6 | 147 |
| Total, serious adverse events | Placebo | 2 | 60 |
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
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/NCT01767519
GET https://conductscience.org/api/trials/v1/NCT01767519/results?page=2