Trial · NCT00910845
Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
NCT00910845, Phase 3, Completed, Allergan; results first posted 2013-03-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence. Trials, record NCT00910845. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00910845
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
- NCT number
- NCT00910845
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 557 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Overactive Bladder
- Interventions
- onabotulinumtoxinA, normal saline
- First posted
- 2009-06-01
- Last updated
- 2013-03-05
- Results first posted
- 2013-03-05
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Number of Daily Episodes of Urinary Incontinence | Baseline, Week 12 | A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement). |
| Secondary | Change From Baseline in Number of Daily Micturition Episodes | Baseline, Week 12 | The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement). |
| Secondary | Change From Baseline in Volume Voided Per Micturition | Baseline, Week 12 | The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Number of Daily Episodes of Urinary Incontinence | Baseline, Week 12 | Intent-to-treat population included all randomized patients. | Incontinence episodes | MEAN |
| SECONDARY | Change From Baseline in Number of Daily Micturition Episodes | Baseline, Week 12 | Intent-to-treat population included all randomized patients. | micturition episodes | MEAN |
| SECONDARY | Change From Baseline in Volume Voided Per Micturition | Baseline, Week 12 | Intent-to-treat population included all randomized patients. | milliliters | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Number of Daily Episodes of Urinary Incontinence | onabotulinumtoxinA | Baseline | 5.47 | Standard Deviation 3.621 | Incontinence episodes |
| Change From Baseline in Number of Daily Episodes of Urinary Incontinence | Placebo/onabotulinumtoxinA | Baseline | 5.09 | Standard Deviation 3.204 | Incontinence episodes |
| Change From Baseline in Number of Daily Episodes of Urinary Incontinence | onabotulinumtoxinA | Change from Baseline at Week 12 | -2.65 | Standard Deviation 3.333 | Incontinence episodes |
| Change From Baseline in Number of Daily Episodes of Urinary Incontinence | Placebo/onabotulinumtoxinA | Change from Baseline at Week 12 | -0.87 | Standard Deviation 2.833 | Incontinence episodes |
| Change From Baseline in Number of Daily Micturition Episodes | onabotulinumtoxinA | Baseline | 11.98 | Standard Deviation 4.259 | micturition episodes |
| Change From Baseline in Number of Daily Micturition Episodes | Placebo/onabotulinumtoxinA | Baseline | 11.20 | Standard Deviation 3.070 | micturition episodes |
| Change From Baseline in Number of Daily Micturition Episodes | onabotulinumtoxinA | Change from Baseline at Week 12 | -2.15 | Standard Deviation 2.933 | micturition episodes |
| Change From Baseline in Number of Daily Micturition Episodes | Placebo/onabotulinumtoxinA | Change from Baseline at Week 12 | -0.91 | Standard Deviation 2.577 | micturition episodes |
| Change From Baseline in Volume Voided Per Micturition | onabotulinumtoxinA | Baseline | 156.4 | Standard Deviation 63.21 | milliliters |
| Change From Baseline in Volume Voided Per Micturition | Placebo/onabotulinumtoxinA | Baseline | 161.1 | Standard Deviation 68.65 | milliliters |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Cycle 1 | STARTED | onabotulinumtoxinA | 280 | |
| Treatment Cycle 1 | STARTED | Placebo/onabotulinumtoxinA | 277 | |
| Treatment Cycle 1 | COMPLETED | onabotulinumtoxinA | 249 | |
| Treatment Cycle 1 | COMPLETED | Placebo/onabotulinumtoxinA | 243 | |
| Treatment Cycle 1 | NOT COMPLETED | onabotulinumtoxinA | 31 | |
| Treatment Cycle 1 | NOT COMPLETED | Placebo/onabotulinumtoxinA | 34 | |
| Treatment Cycle 2 | STARTED | onabotulinumtoxinA | 141 | |
| Treatment Cycle 2 | STARTED | Placebo/onabotulinumtoxinA | 212 | |
| Treatment Cycle 2 | COMPLETED | onabotulinumtoxinA | 136 | |
| Treatment Cycle 2 | COMPLETED | Placebo/onabotulinumtoxinA | 203 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events74
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 | Urinary tract infection | Infections and infestations | onabotulinumtoxinA | 68 | 278 | |
| other | Urinary tract infection | Infections and infestations | Placebo/onabotulinumtoxinA | 25 | 272 | |
| other | Bacteriuria | Infections and infestations | onabotulinumtoxinA | 23 | 278 | |
| other | Bacteriuria | Infections and infestations | Placebo/onabotulinumtoxinA | 10 | 272 | |
| other | Dysuria | Renal and urinary disorders | onabotulinumtoxinA | 40 | 278 | |
| other | Dysuria | Renal and urinary disorders | Placebo/onabotulinumtoxinA | 27 | 272 | |
| other | Urinary retention | Renal and urinary disorders | onabotulinumtoxinA | 16 | 278 | |
| other | Urinary retention | Renal and urinary disorders | Placebo/onabotulinumtoxinA | 1 | 272 | |
| other | Haematuria | Renal and urinary disorders | onabotulinumtoxinA | 8 | 278 | |
| other | Haematuria | Renal and urinary disorders | Placebo/onabotulinumtoxinA | 16 | 272 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | onabotulinumtoxinA | ||
| Total, all-cause mortality | Placebo/onabotulinumtoxinA | ||
| Total, other adverse events | onabotulinumtoxinA | 155 | 278 |
| Total, other adverse events | Placebo/onabotulinumtoxinA | 79 | 272 |
| Total, serious adverse events | onabotulinumtoxinA | 18 | 278 |
| Total, serious adverse events | Placebo/onabotulinumtoxinA | 16 | 272 |
Source ClinicalTrials.gov
Papers3
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| onabotulinumtoxinA vs Placebo/onabotulinumtoxinA: 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.
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/NCT00910845
GET https://conductscience.org/api/trials/v1/NCT00910845/events?page=2