Trial · NCT00451191
Botulinum Toxin Injection for the Management of BPH
NCT00451191, Phase 2, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2013-06-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Botulinum Toxin Injection for the Management of BPH. Trials, record NCT00451191. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00451191
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Botulinum Toxin Injection for the Management of BPH
- NCT number
- NCT00451191
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 134 participants, actual
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- botulinum toxin type A (BoNT/A)
- First posted
- 2007-03-23
- Last updated
- 2020-04-21
- Results first posted
- 2013-06-24
- Limitations and caveats
First, this study was not designed to compare the effect of onabotulinum toxin A to placebo. Second, we assessed our primary outcome, treatment efficacy, at 3 months post-injection. The long-term safety of this product should also be evaluated.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Improvement in the AUA Symptom Score Index by 30% From Baseline Within the First 12 Weeks After Injection. | 12 weeks | The primary outcome was treatment success at 3 months post-treatment, defined as (1) improvement in the AUASI by at least 30% and/or (2) Qmax improvement of more than 30%, each determined from baseline to 3 months after injection. In addition, two safety criteria also had to be met; a dose failed if (1) any reported event was determined to be related to the onabotulinum toxin A injection and was considered life threatening, disabling, or fatal or (2) \>=40% of the participants reported a moderate or severe side effect related to the botulinum toxin injection. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Improvement in the AUA Symptom Score Index by 30% From Baseline Within the First 12 Weeks After Injection. | 12 weeks | By the last 12-month follow-up visit, 15 men (22%) in the 100 U dose arm and 11 (17%) in the 300 U dose arm had withdrawn due to dissatisfaction with treatment results or continued to attend study follow-up but received additional alternate treatment prior to 12 months. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Improvement in the AUA Symptom Score Index by 30% From Baseline Within the First 12 Weeks After Injection. | 100 Units Botulinum Toxin Type A | 46 | participants | ||
| Improvement in the AUA Symptom Score Index by 30% From Baseline Within the First 12 Weeks After Injection. | 300 Units Botulinum Toxin Type A | 50 | participants |
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 | 100 Units Botulinum Toxin Type A | 68 | |
| Overall Study | STARTED | 300 Units Botulinum Toxin Type A | 66 | |
| Overall Study | COMPLETED | 100 Units Botulinum Toxin Type A | 53 | |
| Overall Study | COMPLETED | 300 Units Botulinum Toxin Type A | 55 | |
| Overall Study | NOT COMPLETED | 100 Units Botulinum Toxin Type A | 15 | |
| Overall Study | NOT COMPLETED | 300 Units Botulinum Toxin Type A | 11 |
Source ClinicalTrials.gov
Adverse events6
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 | Grade 1-3 Adverse Event | General disorders | 100 Units Botulinum Toxin Type A | 46 | 68 | 116 |
| other | Grade 1-3 Adverse Event | General disorders | 300 Units Botulinum Toxin Type A | 41 | 66 | 109 |
| serious | Grade 2 - 4 Serious Adverse Event | General disorders | 100 Units Botulinum Toxin Type A | 6 | 68 | 6 |
| serious | Grade 2 - 4 Serious Adverse Event | General disorders | 300 Units Botulinum Toxin Type A | 5 | 66 | 6 |
| serious | Grade 5 Serious Adverse Event (Death) | General disorders | 100 Units Botulinum Toxin Type A | 1 | 68 | 1 |
| serious | Grade 5 Serious Adverse Event (Death) | General disorders | 300 Units Botulinum Toxin Type A | 0 | 66 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 100 Units Botulinum Toxin Type A | ||
| Total, all-cause mortality | 300 Units Botulinum Toxin Type A | ||
| Total, other adverse events | 100 Units Botulinum Toxin Type A | 46 | 68 |
| Total, other adverse events | 300 Units Botulinum Toxin Type A | 41 | 66 |
| Total, serious adverse events | 100 Units Botulinum Toxin Type A | 7 | 68 |
| Total, serious adverse events | 300 Units Botulinum Toxin Type A | 5 | 66 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21791356 | RESULT |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01DK060817 | Minimally Invasive Surgical Therapies Consortium for BPH | HIRST, KATHRYN | GEORGE WASHINGTON UNIVERSITY | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2001 to 2004 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 100 Units Botulinum Toxin Type A vs 300 Units Botulinum Toxin Type A: Improvement in the AUA Symptom Score Index by 30% From Baseline Within the First 12 Weeks After Injection. | Trial comparisons |
| 100 Units Botulinum Toxin Type A vs 300 Units Botulinum Toxin Type A: serious adverse events | 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/NCT00451191
GET https://conductscience.org/api/trials/v1/NCT00451191/registered