Trial · NCT00876447
A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis
NCT00876447, Phase 3, Completed, Allergan; results first posted 2014-06-13
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ConductScience Library. A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis. Trials, record NCT00876447. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00876447
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis
- NCT number
- NCT00876447
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 397 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Overactive Bladder
- Interventions
- Botulinum Toxin Type A 300U, Botulinum Toxin Type A 200U
- First posted
- 2009-04-06
- Last updated
- 2019-05-01
- Results first posted
- 2014-06-13
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline, Week 6 Treatment Cycle 1 | Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement). |
| Primary | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline, Week 6 Treatment Cycle 2 | Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement). |
| Primary | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline, Week 6 Treatment Cycle 3 | Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement). |
| Primary | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline, Week 6 Treatment Cycle 4 | Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement). |
| Primary | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline, Week 6 Treatment Cycle 5 | Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement). |
| Secondary | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Study Baseline, Week 6 Treatment Cycle 1 | The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL. |
| Secondary | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Study Baseline, Week 6 Treatment Cycle 2 | The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL. |
| Secondary | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Study Baseline, Week 6 Treatment Cycle 3 | The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL. |
| Secondary | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Study Baseline, Week 6 Treatment Cycle 4 | The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL. |
| Secondary | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Study Baseline, Week 6 Treatment Cycle 5 | The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
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 the Daily Average Number of Urinary Incontinence Episodes | Study Baseline, Week 6 Treatment Cycle 1 | BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received | Incontinence Episodes | MEAN |
| PRIMARY | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline, Week 6 Treatment Cycle 2 | BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received | Incontinence Episodes | MEAN |
| PRIMARY | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline, Week 6 Treatment Cycle 3 | BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received | Incontinence Episodes | MEAN |
| PRIMARY | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline, Week 6 Treatment Cycle 4 | BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received | Incontinence Episodes | MEAN |
| PRIMARY | Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Study Baseline, Week 6 Treatment Cycle 5 | BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received | Incontinence Episodes | MEAN |
| SECONDARY | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Study Baseline, Week 6 Treatment Cycle 1 | BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received | Scores on a Scale | MEAN |
| SECONDARY | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Study Baseline, Week 6 Treatment Cycle 2 | BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received | Scores on a Scale | MEAN |
| SECONDARY | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Study Baseline, Week 6 Treatment Cycle 3 | BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received | Scores on a Scale | MEAN |
| SECONDARY | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Study Baseline, Week 6 Treatment Cycle 4 | BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received | Scores on a Scale | MEAN |
| SECONDARY | Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score | Study Baseline, Week 6 Treatment Cycle 5 | BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received | Scores on a Scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group60
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 the Daily Average Number of Urinary Incontinence Episodes | Botulinum Toxin Type A 300U | Study Baseline (BL) | 4.4 | Standard Deviation 2.54 | Incontinence Episodes |
| Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Botulinum Toxin Type A 200U | Study Baseline (BL) | 4.5 | Standard Deviation 2.64 | Incontinence Episodes |
| Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Botulinum Toxin Type A 300U | Chg from Study BL at Wk 6 Tmt Cycle1 (N=176, 195) | -3.4 | Standard Deviation 3.16 | Incontinence Episodes |
| Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Botulinum Toxin Type A 200U | Chg from Study BL at Wk 6 Tmt Cycle1 (N=176, 195) | -3.2 | Standard Deviation 2.69 | Incontinence Episodes |
| Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Botulinum Toxin Type A 300U | Study Baseline | 4.5 | Standard Deviation 2.62 | Incontinence Episodes |
| Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Botulinum Toxin Type A 200U | Study Baseline | 4.6 | Standard Deviation 2.71 | Incontinence Episodes |
| Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Botulinum Toxin Type A 300U | Chg from Study BL at Wk 6 Tmt Cycle2 (N=153, 175) | -3.5 | Standard Deviation 3.13 | Incontinence Episodes |
| Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Botulinum Toxin Type A 200U | Chg from Study BL at Wk 6 Tmt Cycle2 (N=153, 175) | -3.3 | Standard Deviation 2.85 | Incontinence Episodes |
| Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Botulinum Toxin Type A 300U | Study Baseline | 4.4 | Standard Deviation 2.33 | Incontinence Episodes |
| Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes | Botulinum Toxin Type A 200U | Study Baseline | 4.6 | Standard Deviation 2.65 | Incontinence Episodes |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Botulinum Toxin Type A 300U | 185 | |
| Overall Study | STARTED | Botulinum Toxin Type A 200U | 203 | |
| Overall Study | COMPLETED | Botulinum Toxin Type A 300U | 105 | |
| Overall Study | COMPLETED | Botulinum Toxin Type A 200U | 122 | |
| Overall Study | NOT COMPLETED | Botulinum Toxin Type A 300U | 80 | |
| Overall Study | NOT COMPLETED | Botulinum Toxin Type A 200U | 81 |
Source ClinicalTrials.gov
Adverse events5,070
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 | Diarrhoea | Gastrointestinal disorders | Botulinum Toxin Type A 300U Treatment Cycle 1 | 7 | 185 | |
| other | Diarrhoea | Gastrointestinal disorders | Botulinum Toxin Type A 200U Treatment Cycle 1 | 10 | 203 | |
| other | Diarrhoea | Gastrointestinal disorders | Botulinum Toxin Type A 300U Treatment Cycle 2 | 7 | 163 | |
| other | Diarrhoea | Gastrointestinal disorders | Botulinum Toxin Type A 200U Treatment Cycle 2 | 6 | 187 | |
| other | Diarrhoea | Gastrointestinal disorders | Botulinum Toxin Type A 300U Treatment Cycle 3 | 3 | 119 | |
| other | Diarrhoea | Gastrointestinal disorders | Botulinum Toxin Type A 200U Treatment Cycle 3 | 0 | 175 | |
| other | Diarrhoea | Gastrointestinal disorders | Botulinum Toxin Type A 300U Treatment Cycle 4 | 3 | 69 | |
| other | Diarrhoea | Gastrointestinal disorders | Botulinum Toxin Type A 200U Treatment Cycle 4 | 4 | 153 | |
| other | Diarrhoea | Gastrointestinal disorders | Botulinum Toxin Type A 300U Treatment Cycle 5 | 2 | 34 | |
| other | Diarrhoea | Gastrointestinal disorders | Botulinum Toxin Type A 200U Treatment Cycle 5 | 4 | 110 |
1 to 10 of 5,070Source ClinicalTrials.gov
See all 5,070 adverse eventsAdverse event totals78
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Botulinum Toxin Type A 300U Treatment Cycle 1 | ||
| Total, all-cause mortality | Botulinum Toxin Type A 200U Treatment Cycle 1 | ||
| Total, all-cause mortality | Botulinum Toxin Type A 300U Treatment Cycle 2 | ||
| Total, all-cause mortality | Botulinum Toxin Type A 200U Treatment Cycle 2 | ||
| Total, all-cause mortality | Botulinum Toxin Type A 300U Treatment Cycle 3 | ||
| Total, all-cause mortality | Botulinum Toxin Type A 200U Treatment Cycle 3 | ||
| Total, all-cause mortality | Botulinum Toxin Type A 300U Treatment Cycle 4 | ||
| Total, all-cause mortality | Botulinum Toxin Type A 200U Treatment Cycle 4 | ||
| Total, all-cause mortality | Botulinum Toxin Type A 300U Treatment Cycle 5 | ||
| Total, all-cause mortality | Botulinum Toxin Type A 200U Treatment Cycle 5 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26607743 | BACKGROUND |
Source PubMed
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.
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