Trial · NCT01589263
Effectiveness of onaBoNT-A vs Oral Tamsulosin in Men With BPH and LUTS
NCT01589263, Phase 2, Completed, VA Office of Research and Development; results first posted 2021-10-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effectiveness of onaBoNT-A vs Oral Tamsulosin in Men With BPH and LUTS. Trials, record NCT01589263. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01589263
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness of onaBoNT-A vs Oral Tamsulosin in Men With BPH and LUTS
- NCT number
- NCT01589263
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Benign Prostatic Hyperplasia, Lower Urinary Track Symptoms
- Interventions
- onaBoNT-A + placebo, Tamsulosin + placebo
- First posted
- 2012-05-01
- Last updated
- 2021-10-05
- Results first posted
- 2021-10-05
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | American Urologic Association Symptom Score (AUASS) | 3 months | AUA Symptom Score on a scale of 0 to 35, 35 is the worse outcome and 0 is the best outcome. |
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 | American Urologic Association Symptom Score (AUASS) | 3 months | Volunteers were randomized on a 1:1 assignment by the MEDVAMC Research Pharmacy to either: ARM 1: BoNT-A 200 U prostate injection and placebo oral capsule daily or ARM 2: Placebo prostate injection (saline) and Tamsulosin 0.4 mg capsule daily. | score on a scale | MEAN |
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 |
|---|---|---|---|---|---|
| American Urologic Association Symptom Score (AUASS) | ARM 1: onaBoNT-A + Placebo | 18.66 | Standard Deviation 0.07 | score on a scale | |
| American Urologic Association Symptom Score (AUASS) | ARM 2: Saline + Tamsulosin | 14.16 | Standard Deviation 0.05 | score on a scale |
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 | ARM 1: onaBoNT-A + Placebo | 9 | |
| Overall Study | STARTED | ARM 2: Saline + Tamsulosin | 12 | |
| Overall Study | COMPLETED | ARM 1: onaBoNT-A + Placebo | 9 | |
| Overall Study | COMPLETED | ARM 2: Saline + Tamsulosin | 12 | |
| Overall Study | NOT COMPLETED | ARM 1: onaBoNT-A + Placebo | 0 | |
| Overall Study | NOT COMPLETED | ARM 2: Saline + Tamsulosin | 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 | Unrelated | Gastrointestinal disorders | ARM 1: onaBoNT-A + Placebo | 1 | 9 | 1 |
| other | Unrelated | Gastrointestinal disorders | ARM 2: Saline + Tamsulosin | 0 | 12 | 0 |
| serious | Unrelated | Gastrointestinal disorders | ARM 1: onaBoNT-A + Placebo | 1 | 9 | 1 |
| serious | Unrelated | Gastrointestinal disorders | ARM 2: Saline + Tamsulosin | 0 | 12 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ARM 1: onaBoNT-A + Placebo | 0 | 9 |
| Total, all-cause mortality | ARM 2: Saline + Tamsulosin | 0 | 12 |
| Total, other adverse events | ARM 1: onaBoNT-A + Placebo | 1 | 9 |
| Total, other adverse events | ARM 2: Saline + Tamsulosin | 0 | 12 |
| Total, serious adverse events | ARM 1: onaBoNT-A + Placebo | 1 | 9 |
| Total, serious adverse events | ARM 2: Saline + Tamsulosin | 0 | 12 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ARM 1: onaBoNT-A + Placebo vs ARM 2: Saline + Tamsulosin: deaths from any cause | Trial comparisons |
| ARM 1: onaBoNT-A + Placebo vs ARM 2: Saline + Tamsulosin: 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/NCT01589263
GET https://conductscience.org/api/trials/v1/NCT01589263/registered