Trial · NCT00345332
A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence
NCT00345332, Not applicable, Completed, University of Rochester; results first posted 2017-07-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence. Trials, record NCT00345332. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00345332
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence
- NCT number
- NCT00345332
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 31 participants, actual
- Lead sponsor
- University of Rochester
- Conditions
- Urinary Incontinence
- Interventions
- Botox, Placebo
- First posted
- 2006-06-28
- Last updated
- 2017-07-11
- Results first posted
- 2017-07-11
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incontinent Episodes Per Day | week 13 | The number of incontinence episodes per day was recorded by each participant in a diary. All incontinence episodes were counted when calculating episodes per day at each time point. |
| Secondary | Number of Incontinence Pads Used Per Day | week 13 | The number of incontinence pads used per day per day was recorded by each participant in a diary. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incontinent Episodes Per Day | week 13 | incontinence episodes per day | GEOMETRIC_LEAST_SQUARES_MEAN | |
| SECONDARY | Number of Incontinence Pads Used Per Day | week 13 | pads per day | GEOMETRIC_LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incontinent Episodes Per Day | Placebo Group | 7.34 | Standard Error 1.07 | incontinence episodes per day | |
| Incontinent Episodes Per Day | Botox Group | 3.90 | Standard Error 0.75 | incontinence episodes per day | |
| Number of Incontinence Pads Used Per Day | Placebo Group | 5.18 | Standard Error 0.92 | pads per day | |
| Number of Incontinence Pads Used Per Day | Botox Group | 3.13 | Standard Error 0.66 | pads per day |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Group | 11 | |
| Overall Study | STARTED | Botox Group | 20 | |
| Overall Study | COMPLETED | Placebo Group | 11 | |
| Overall Study | COMPLETED | Botox Group | 20 | |
| Overall Study | NOT COMPLETED | Placebo Group | 0 | |
| Overall Study | NOT COMPLETED | Botox Group | 0 |
Source ClinicalTrials.gov
Adverse events4
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 | Placebo Group | 3 | 11 | |
| other | urinary tract infection | Infections and infestations | Botox Group | 11 | 20 | |
| other | post void retention volumes > 200cc | Renal and urinary disorders | Placebo Group | 0 | 11 | |
| other | post void retention volumes > 200cc | Renal and urinary disorders | Botox Group | 5 | 20 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Group | ||
| Total, all-cause mortality | Botox Group | ||
| Total, other adverse events | Placebo Group | 3 | 11 |
| Total, other adverse events | Botox Group | 11 | 20 |
| Total, serious adverse events | Placebo Group | 0 | 11 |
| Total, serious adverse events | Botox Group | 0 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 15538257 | RESULT |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Botox Group vs Placebo Group: 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/NCT00345332
GET https://conductscience.org/api/trials/v1/NCT00345332/registered