Trial · NCT00439140
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
NCT00439140, Phase 3, Terminated, Allergan; results first posted 2014-01-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder. Trials, record NCT00439140. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00439140
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
- NCT number
- NCT00439140
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 41 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Overactive Bladder
- Interventions
- botulinum toxin Type A, Normal Saline (Placebo)
- First posted
- 2007-02-23
- Last updated
- 2014-01-24
- Results first posted
- 2014-01-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Forced Vital Capacity (FVC) | Baseline, Week 6 | Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible, at Baseline and Week 6. A positive change from Baseline indicated improvement. |
| Primary | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Baseline, Week 6 | Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FEV1, the maximum amount of air exhaled in one second, at Baseline and Week 6. The highest value at each time-point was recorded. A positive change from Baseline indicated improvement. |
| Primary | Change From Baseline in FEV1/FVC Ratio | Baseline, Week 6 | The FEV1/FVC ratio was calculated by dividing the FEV1 value by the FVC value representing the portion (or ratio) of FVC exhaled in one second. A positive change from Baseline indicated improvement. |
| Secondary | Change From Baseline in the Number of Urinary Incontinence Episodes | Baseline, Week 6 | The number of urinary incontinence episodes or leakage occurring over the previous 3 days was recorded in the patient bladder diary at Baseline and prior to Week 6. A negative change from Baseline indicated improvement (less incontinence/leakage). |
| Secondary | Change From Baseline in the Maximum (Amplitude) Detrusor Pressure (MDP) | Baseline, Week 6 | MDP was measured at the first involuntary detrusor contraction using urodynamic testing. A catheter was inserted into the bladder at Baseline and Week 6 and the pressure \[measured in centimeters water (cm H20)\] was determined as the bladder filled. A negative change from Baseline indicated improvement (less Detrusor pressure). |
| Secondary | Change From Baseline in Maximum Cystometric Capacity (MCC) | Baseline, Week 6 | MCC (the maximum amount of urine the bladder could hold) was measured using urodynamic testing. The amount of urine collected was subtracted from the total volume infused measured as milliliters (mL) of urine. A positive change from Baseline indicated improvement (fuller bladder/ less incontinence). |
| Other | Number of Participants With at Least a 15% Decrease From Baseline in FVC | Baseline, Weeks 2, 6 and 12 | Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible at Baseline, Weeks 2, 6 and 12. |
| Other | Number of Participants With at Least a 20% Decrease From Baseline in FVC | Baseline, Weeks 2, 6 and 12 | Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible at Baseline, Weeks 2, 6 and 12. |
Source ClinicalTrials.gov
Outcomes8
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 Forced Vital Capacity (FVC) | Baseline, Week 6 | Safety Population included all randomized participants who received treatment. | Liters | MEAN |
| PRIMARY | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Baseline, Week 6 | Safety population included all randomized participants who received treatment. | Liters | MEAN |
| PRIMARY | Change From Baseline in FEV1/FVC Ratio | Baseline, Week 6 | Safety population included all randomized participants who received treatment. | Ratio | MEAN |
| SECONDARY | Change From Baseline in the Number of Urinary Incontinence Episodes | Baseline, Week 6 | Participants from the Intent-to-treat population (all randomized participants) using observed data for analysis. | Episodes | MEAN |
| SECONDARY | Change From Baseline in the Maximum (Amplitude) Detrusor Pressure (MDP) | Baseline, Week 6 | Intent-to-treat population included all randomized participants. | cm H2O | MEAN |
| SECONDARY | Change From Baseline in Maximum Cystometric Capacity (MCC) | Baseline, Week 6 | Intent-to-treat population included all randomized participants. | mL | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With at Least a 15% Decrease From Baseline in FVC | Baseline, Weeks 2, 6 and 12 | Safety population included all randomized participants who received treatment. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With at Least a 20% Decrease From Baseline in FVC | Baseline, Weeks 2, 6 and 12 | Safety population included all randomized participants who received treatment. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group54
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 Forced Vital Capacity (FVC) | Botulinum Toxin Type A 200U | Baseline | 2.659 | Standard Deviation 0.5308 | Liters |
| Change From Baseline in Forced Vital Capacity (FVC) | Botulinum Toxin Type A 300U | Baseline | 2.955 | Standard Deviation 0.7733 | Liters |
| Change From Baseline in Forced Vital Capacity (FVC) | Placebo | Baseline | 3.095 | Standard Deviation 0.6868 | Liters |
| Change From Baseline in Forced Vital Capacity (FVC) | Botulinum Toxin Type A 200U | Change from Baseline at Week 6 | -0.124 | Standard Deviation 0.2758 | Liters |
| Change From Baseline in Forced Vital Capacity (FVC) | Botulinum Toxin Type A 300U | Change from Baseline at Week 6 | -0.096 | Standard Deviation 0.2248 | Liters |
| Change From Baseline in Forced Vital Capacity (FVC) | Placebo | Change from Baseline at Week 6 | -0.025 | Standard Deviation 0.2391 | Liters |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Botulinum Toxin Type A 200U | Baseline | 2.290 | Standard Deviation 0.5815 | Liters |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Botulinum Toxin Type A 300U | Baseline | 2.534 | Standard Deviation 0.7227 | Liters |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Placebo | Baseline | 2.535 | Standard Deviation 0.7626 | Liters |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Botulinum Toxin Type A 200U | Change from Baseline at Week 6 | -0.067 | Standard Deviation 0.2525 | Liters |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Cycle 1 | STARTED | Botulinum Toxin Type A 200U | 15 | |
| Treatment Cycle 1 | STARTED | Botulinum Toxin Type A 300U | 14 | |
| Treatment Cycle 1 | STARTED | Placebo | 12 | |
| Treatment Cycle 1 | COMPLETED | Botulinum Toxin Type A 200U | 14 | |
| Treatment Cycle 1 | COMPLETED | Botulinum Toxin Type A 300U | 10 | |
| Treatment Cycle 1 | COMPLETED | Placebo | 11 | |
| Treatment Cycle 1 | NOT COMPLETED | Botulinum Toxin Type A 200U | 1 | |
| Treatment Cycle 1 | NOT COMPLETED | Botulinum Toxin Type A 300U | 4 | |
| Treatment Cycle 1 | NOT COMPLETED | Placebo | 1 | |
| Treatment Cycle 2 | STARTED | Botulinum Toxin Type A 200U | 13 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events372
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 | Anaemia | Blood and lymphatic system disorders | Botulinum Toxin Type A 200U | 0 | 15 | |
| other | Anaemia | Blood and lymphatic system disorders | Botulinum Toxin Type A 300U | 1 | 14 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo/Botulinum Toxin Type A | 0 | 12 | |
| other | Syringomyelia | Congenital, familial and genetic disorders | Botulinum Toxin Type A 200U | 1 | 15 | |
| other | Syringomyelia | Congenital, familial and genetic disorders | Botulinum Toxin Type A 300U | 0 | 14 | |
| other | Syringomyelia | Congenital, familial and genetic disorders | Placebo/Botulinum Toxin Type A | 0 | 12 | |
| other | Thyroid cyst | Endocrine disorders | Botulinum Toxin Type A 200U | 1 | 15 | |
| other | Thyroid cyst | Endocrine disorders | Botulinum Toxin Type A 300U | 0 | 14 | |
| other | Thyroid cyst | Endocrine disorders | Placebo/Botulinum Toxin Type A | 0 | 12 | |
| other | Conjunctivitis | Eye disorders | Botulinum Toxin Type A 200U | 0 | 15 |
1 to 10 of 372Source ClinicalTrials.gov
See all 372 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Botulinum Toxin Type A 200U | ||
| Total, all-cause mortality | Botulinum Toxin Type A 300U | ||
| Total, all-cause mortality | Placebo/Botulinum Toxin Type A | ||
| Total, other adverse events | Botulinum Toxin Type A 200U | 12 | 15 |
| Total, other adverse events | Botulinum Toxin Type A 300U | 12 | 14 |
| Total, other adverse events | Placebo/Botulinum Toxin Type A | 10 | 12 |
| Total, serious adverse events | Botulinum Toxin Type A 200U | 4 | 15 |
| Total, serious adverse events | Botulinum Toxin Type A 300U | 6 | 14 |
| Total, serious adverse events | Placebo/Botulinum Toxin Type A | 1 | 12 |
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 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/NCT00439140
GET https://conductscience.org/api/trials/v1/NCT00439140/results?page=2