Trial · NCT01107392
Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
NCT01107392, Phase 2, Completed, Allergan; results first posted 2014-04-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. Trials, record NCT01107392. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01107392
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
- NCT number
- NCT01107392
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 315 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- botulinum toxin Type A, Normal saline
- First posted
- 2010-04-21
- Last updated
- 2019-05-03
- Results first posted
- 2014-04-04
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12 | Baseline, Week 12 | IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement. |
| Secondary | Change From Baseline in the Total International Prostate Symptom Score (IPSS) | Baseline, Week 6, Week 24 | IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement. |
| Secondary | Change From Baseline in Peak Urine Flow Rate | Baseline, Weeks 6, 12 and 24 | Urinary flow was determined by uroflowmetry measured in milliliters/second (mL/sec). An increase from Baseline indicated improvement. |
| Secondary | Duration of Effect | 24 Weeks | Duration of effect was calculated from the time of the first follow-up visit with a ≥ 4-point reduction from Baseline in IPSS to the next visit when the IPSS change from Baseline was \< 4-points. |
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 | Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12 | Baseline, Week 12 | Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Total International Prostate Symptom Score (IPSS) | Baseline, Week 6, Week 24 | Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Peak Urine Flow Rate | Baseline, Weeks 6, 12 and 24 | Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement with data available for this outcome measure. | mL/sec | MEAN |
| SECONDARY | Duration of Effect | 24 Weeks | Modified Intent-to-treat population included all randomized and treated patients with at least one post-baseline IPSS measurement. Only patients with at least a 4-point reduction from Baseline in total IPSS were included in the analysis. | Weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12 | Botulinum Toxin Type A | Baseline | 21.8 | Standard Deviation 4.90 | Score on a scale |
| Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12 | Placebo (Normal Saline) | Baseline | 21.5 | Standard Deviation 4.56 | Score on a scale |
| Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12 | Botulinum Toxin Type A | Change from Baseline at Week 12 | -6.3 | Standard Deviation 6.61 | Score on a scale |
| Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12 | Placebo (Normal Saline) | Change from Baseline at Week 12 | -5.6 | Standard Deviation 5.86 | Score on a scale |
| Change From Baseline in the Total International Prostate Symptom Score (IPSS) | Botulinum Toxin Type A | Baseline | 21.8 | Standard Deviation 4.90 | Score on a scale |
| Change From Baseline in the Total International Prostate Symptom Score (IPSS) | Placebo (Normal Saline) | Baseline | 21.5 | Standard Deviation 4.56 | Score on a scale |
| Change From Baseline in the Total International Prostate Symptom Score (IPSS) | Botulinum Toxin Type A | Change from Baseline at Week 6 (n=156,156) | -5.4 | Standard Deviation 5.84 | Score on a scale |
| Change From Baseline in the Total International Prostate Symptom Score (IPSS) | Placebo (Normal Saline) | Change from Baseline at Week 6 (n=156,156) | -5.3 | Standard Deviation 5.27 | Score on a scale |
| Change From Baseline in the Total International Prostate Symptom Score (IPSS) | Botulinum Toxin Type A | Change from Baseline at Week 24 (n=152,154) | -6.3 | Standard Deviation 6.43 | Score on a scale |
| Change From Baseline in the Total International Prostate Symptom Score (IPSS) | Placebo (Normal Saline) | Change from Baseline at Week 24 (n=152,154) | -6.0 | Standard Deviation 5.79 | Score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 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 | 158 | |
| Overall Study | STARTED | Placebo (Normal Saline) | 157 | |
| Overall Study | COMPLETED | Botulinum Toxin Type A | 153 | |
| Overall Study | COMPLETED | Placebo (Normal Saline) | 154 | |
| Overall Study | NOT COMPLETED | Botulinum Toxin Type A | 5 | |
| Overall Study | NOT COMPLETED | Placebo (Normal Saline) | 3 |
Source ClinicalTrials.gov
Adverse events34
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 | Prostatic specific antigen increased | Investigations | Botulinum Toxin Type A | 6 | 158 | |
| other | Prostatic specific antigen increased | Investigations | Placebo (Normal Saline) | 10 | 157 | |
| other | Haematuria | Renal and urinary disorders | Botulinum Toxin Type A | 23 | 158 | |
| other | Haematuria | Renal and urinary disorders | Placebo (Normal Saline) | 18 | 157 | |
| other | Haematospermia | Reproductive system and breast disorders | Botulinum Toxin Type A | 13 | 158 | |
| other | Haematospermia | Reproductive system and breast disorders | Placebo (Normal Saline) | 16 | 157 | |
| serious | Retinal detachment | Eye disorders | Botulinum Toxin Type A | 1 | 158 | |
| serious | Retinal detachment | Eye disorders | Placebo (Normal Saline) | 0 | 157 | |
| serious | Inguinal hernia | Gastrointestinal disorders | Botulinum Toxin Type A | 1 | 158 | |
| serious | Inguinal hernia | Gastrointestinal disorders | Placebo (Normal Saline) | 0 | 157 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Botulinum Toxin Type A | ||
| Total, all-cause mortality | Placebo (Normal Saline) | ||
| Total, other adverse events | Botulinum Toxin Type A | 42 | 158 |
| Total, other adverse events | Placebo (Normal Saline) | 44 | 157 |
| Total, serious adverse events | Botulinum Toxin Type A | 5 | 158 |
| Total, serious adverse events | Placebo (Normal Saline) | 8 | 157 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24508634 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Botulinum Toxin Type A vs Placebo (Normal Saline): 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/NCT01107392
GET https://conductscience.org/api/trials/v1/NCT01107392/events?page=2