Trial · NCT03320850
BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
NCT03320850, Phase 2, Completed, Allergan; results first posted 2021-08-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence. Trials, record NCT03320850. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03320850
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
- NCT number
- NCT03320850
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 383 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Urinary Incontinence, Overactive Bladder With Urinary Incontinence
- Interventions
- OnabotulinumtoxinA and Hydrogel admixture, Placebo and Hydrogel admixture
- First posted
- 2017-10-25
- Last updated
- 2021-08-13
- Results first posted
- 2021-08-13
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day | Baseline (3 consecutive days during Day -14 to Day -1) to 3 consecutive days in the Week prior to Week 12 | The participant recorded urinary incontinence (lack of voluntary control over urination) in a 3-day bladder diary. The average number of UIEs per day is the average of the 3-day diary entries. A negative change from Baseline indicates improvement. Baseline is defined as the last non-missing assessment before the first dose of study treatment. An analysis of covariance (ANCOVA) model was used for analyses. |
| Primary | Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAEs) in the Treatment Period | Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) | An adverse event (AE) is any untoward medical occurrence in a participants or clinical study investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receiving study drug. |
| Secondary | Stage 2: Change From Baseline in the Average Number of Micturition Episodes Per Day | Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12 | The participant recorded the number of micturition (urination in toilet or catherization) episodes per day in a 3-day bladder diary. The average number of micturition episodes per day is the average of the 3-day diary entries. A negative change from Baseline indicates improvement. Baseline is defined as the last non-missing assessment before the first dose of study treatment. ANCOVA model was used for analyses. |
| Secondary | Stage 2: Change From Baseline in the Average Volume Voided Per Micturition | Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12 | Volume voided per micturition was recorded over one 24-hour period during the 3-day bladder diary. The volume voided during each 24-hour period was divided by the number of micturitions during the period. The average volume voided per micturition is the average of the 3-day diary entries. A negative change from Baseline indicates improvement. Baseline is defined as the last non-missing assessment before the first dose of study treatment. ANCOVA model was used for analyses. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day | Baseline (3 consecutive days during Day -14 to Day -1) to 3 consecutive days in the Week prior to Week 12 | Participants from the Intent-to-treat (ITT) Analysis Set, all randomized participants in Stage 2, with data available for analysis at Baseline and Week 12. As per protocol, this endpoint is only applicable to the Stage 2 arms. | episodes per day | LEAST_SQUARES_MEAN |
| PRIMARY | Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAEs) in the Treatment Period | Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks) | Safety Analysis Set included all randomized and treated participants in Stages 1 and 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Stage 2: Change From Baseline in the Average Number of Micturition Episodes Per Day | Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12 | Participants from the ITT Analysis Set, all randomized participants in Stage 2, with data available for analysis at Baseline and Week 12. As per protocol, this endpoint is only applicable to the Stage 2 arms. | episodes per day | LEAST_SQUARES_MEAN |
| SECONDARY | Stage 2: Change From Baseline in the Average Volume Voided Per Micturition | Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12 | Participants from the ITT Analysis Set, all randomized participants in Stage 2, with data available for analysis at Baseline and Week 12. As per protocol, this endpoint is only applicable to the Stage 2 arms. | mL | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day | Stage 2: Placebo + Hydrogel Admixture | -2.72 | Standard Error 0.534 | episodes per day | |
| Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day | Stage 2: BOTOX® 100U + Hydrogel Admixture | -1.62 | Standard Error 0.539 | episodes per day | |
| Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day | Stage 2: BOTOX® 300U + Hydrogel Admixture | -0.89 | Standard Error 0.521 | episodes per day | |
| Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day | Stage 2: BOTOX® 400U + Hydrogel Admixture | -1.52 | Standard Error 0.520 | episodes per day | |
| Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day | Stage 2: BOTOX® 500U + Hydrogel Admixture | -1.85 | Standard Error 0.530 | episodes per day | |
| Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAEs) in the Treatment Period | Stage 1: Placebo + Hydrogel Admixture | 6 | Participants | ||
| Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAEs) in the Treatment Period | Stage 1: BOTOX® 100U + Hydrogel Admixture | 4 | Participants | ||
| Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAEs) in the Treatment Period | Stage 1: BOTOX® 300U + Hydrogel Admixture | 4 | Participants | ||
| Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAEs) in the Treatment Period | Stage 1: BOTOX® 400U + Hydrogel Admixture | 10 | Participants | ||
| Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAEs) in the Treatment Period | Stage 1: BOTOX® 500U + Hydrogel Admixture | 6 | Participants |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow40
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stage 1: Placebo + Hydrogel Admixture | 18 | |
| Overall Study | STARTED | Stage 1: BOTOX® 100U + Hydrogel Admixture | 12 | |
| Overall Study | STARTED | Stage 1: BOTOX® 300U + Hydrogel Admixture | 18 | |
| Overall Study | STARTED | Stage 1: BOTOX® 400U + Hydrogel Admixture | 22 | |
| Overall Study | STARTED | Stage 1: BOTOX® 500U + Hydrogel Admixture | 19 | |
| Overall Study | STARTED | Stage 2: Placebo + Hydrogel Admixture | 58 | |
| Overall Study | STARTED | Stage 2: BOTOX® 100U + Hydrogel Admixture | 57 | |
| Overall Study | STARTED | Stage 2: BOTOX® 300U + Hydrogel Admixture | 60 | |
| Overall Study | STARTED | Stage 2: BOTOX® 400U + Hydrogel Admixture | 60 | |
| Overall Study | STARTED | Stage 2: BOTOX® 500U + Hydrogel Admixture | 59 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 participant flowAdverse events420
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 | Abdominal pain | Gastrointestinal disorders | Stage 1: Placebo + Hydrogel Admixture | 0 | 18 | |
| other | Abdominal pain | Gastrointestinal disorders | Stage 1: BOTOX® 100U + Hydrogel Admixture | 1 | 12 | |
| other | Abdominal pain | Gastrointestinal disorders | Stage 1: BOTOX® 300U + Hydrogel Admixture | 0 | 18 | |
| other | Abdominal pain | Gastrointestinal disorders | Stage 1: BOTOX® 400U + Hydrogel Admixture | 0 | 22 | |
| other | Abdominal pain | Gastrointestinal disorders | Stage 1: BOTOX® 500U + Hydrogel Admixture | 0 | 19 | |
| other | Abdominal pain | Gastrointestinal disorders | Stage 2: Placebo + Hydrogel Admixture | 0 | 57 | |
| other | Abdominal pain | Gastrointestinal disorders | Stage 2: BOTOX® 100U + Hydrogel Admixture | 0 | 57 | |
| other | Abdominal pain | Gastrointestinal disorders | Stage 2: BOTOX® 300U + Hydrogel Admixture | 0 | 60 | |
| other | Abdominal pain | Gastrointestinal disorders | Stage 2: BOTOX® 400U + Hydrogel Admixture | 0 | 60 | |
| other | Abdominal pain | Gastrointestinal disorders | Stage 2: BOTOX® 500U + Hydrogel Admixture | 0 | 58 |
1 to 10 of 420Source ClinicalTrials.gov
See all 420 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stage 1: Placebo + Hydrogel Admixture | 0 | 18 |
| Total, all-cause mortality | Stage 1: BOTOX® 100U + Hydrogel Admixture | 0 | 12 |
| Total, all-cause mortality | Stage 1: BOTOX® 300U + Hydrogel Admixture | 0 | 18 |
| Total, all-cause mortality | Stage 1: BOTOX® 400U + Hydrogel Admixture | 0 | 22 |
| Total, all-cause mortality | Stage 1: BOTOX® 500U + Hydrogel Admixture | 0 | 19 |
| Total, all-cause mortality | Stage 2: Placebo + Hydrogel Admixture | 0 | 58 |
| Total, all-cause mortality | Stage 2: BOTOX® 100U + Hydrogel Admixture | 0 | 57 |
| Total, all-cause mortality | Stage 2: BOTOX® 300U + Hydrogel Admixture | 0 | 60 |
| Total, all-cause mortality | Stage 2: BOTOX® 400U + Hydrogel Admixture | 0 | 60 |
| Total, all-cause mortality | Stage 2: BOTOX® 500U + Hydrogel Admixture | 0 | 59 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers0
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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03320850
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