Benign Prostatic Hyperplasia
Conditions
Brief summary
The purpose of this study was to determine the safety and effectiveness of different doses of botulinum toxin Type A in treating lower urinary tract symptoms due to benign prostatic hyperplasia.
Interventions
BIOLOGICALbotulinum toxin Type A
Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.
DRUGnormal saline
Normal Saline (Placebo) transperineal or transrectal injection on Day 1.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Lower urinary tract symptoms due to benign prostatic hyperplasia * Enlarged prostate volume by rectal ultrasound
Exclusion criteria
* Previous prostate surgery * Previous or current diagnosis of prostate cancer * Use of other medications for the treatment of prostatic hyperplasia * Urinary tract infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12 | Baseline, Week 12 | The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72 | Baseline, Week 72 | The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement. |
| Change From Baseline in Peak Urine Flow Rate | Baseline, Week 12, Week 72 | Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement. |
| Change From Baseline in Transitional Zone Prostate Volume | Baseline, Week 12, Week 72 | Measurement of the transitional zone prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement. |
| Change From Baseline in Post-Void Residual | Baseline, Week 2, Week 12, Week 72 | Post-void residual urine volume was assessed by bladder scan or ultrasound on all participants at baseline and various time-points during the study. After voiding, any residual urine volume in the bladder was measured. A negative change from baseline indicates improvement. |
| Change From Baseline in Total Prostate Volume | Baseline, Week 12, Week 72 | Measurement of the prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain | Baseline, Week 12, Week 72 | The IIEF is a 15-item questionnaire filled out by the patient to assess erectile function over the past 4 weeks that contains five domains. The score for the erectile function domain is the sum of scores for Questions 1, 2, 3, 4, 5 and 15 for a total possible score of 1 to 30. A higher score indicates a better outcome. A positive change from baseline indicates improvement. |
Countries
Australia, Austria, Canada, Czechia, France, Germany, Italy, Slovakia, South Korea, Taiwan, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin Type A 300 U Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1. | 97 |
| Botulinum Toxin Type A 200 U Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1. | 94 |
| Botulinum Toxin Type A 100 U Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1. | 95 |
| Placebo (Normal Saline) Placebo (Normal Saline) transperineal or transrectal injection on Day 1. | 94 |
| Total | 380 |
Baseline characteristics
| Characteristic | Botulinum Toxin Type A 300 U | Botulinum Toxin Type A 200 U | Botulinum Toxin Type A 100 U | Placebo (Normal Saline) | Total |
|---|---|---|---|---|---|
| Age, Customized 45 to 65 Years | 48 Participants | 46 Participants | 56 Participants | 44 Participants | 194 Participants |
| Age, Customized >65 Years | 49 Participants | 48 Participants | 39 Participants | 50 Participants | 186 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 97 Participants | 94 Participants | 95 Participants | 94 Participants | 380 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 41 / 94 | 46 / 93 | 53 / 94 | 55 / 92 |
| serious Total, serious adverse events | 9 / 94 | 16 / 93 | 10 / 94 | 11 / 92 |
Outcome results
Primary
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12
The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.
Time frame: Baseline, Week 12
Population: Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300 U | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12 | Baseline | 21.3 Score on a scale | Standard Deviation 6.03 |
| Botulinum Toxin Type A 300 U | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12 | Change from baseline at Week 12 (N=86,89,93,90) | -5.6 Score on a scale | Standard Deviation 7.73 |
| Botulinum Toxin Type A 200 U | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12 | Change from baseline at Week 12 (N=86,89,93,90) | -6.3 Score on a scale | Standard Deviation 7.13 |
| Botulinum Toxin Type A 200 U | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12 | Baseline | 20.2 Score on a scale | Standard Deviation 5.8 |
| Botulinum Toxin Type A 100 U | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12 | Change from baseline at Week 12 (N=86,89,93,90) | -6.6 Score on a scale | Standard Deviation 6.87 |
| Botulinum Toxin Type A 100 U | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12 | Baseline | 21.5 Score on a scale | Standard Deviation 5.42 |
| Placebo (Normal Saline) | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12 | Change from baseline at Week 12 (N=86,89,93,90) | -5.5 Score on a scale | Standard Deviation 6.33 |
| Placebo (Normal Saline) | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12 | Baseline | 20.7 Score on a scale | Standard Deviation 5.44 |
Secondary
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72
The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.
Time frame: Baseline, Week 72
Population: Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300 U | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72 | Baseline | 21.3 Score on a scale | Standard Deviation 6.03 |
| Botulinum Toxin Type A 300 U | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72 | Change from baseline at Week 72 (N=64,61,66,58) | -5.0 Score on a scale | Standard Deviation 6.5 |
| Botulinum Toxin Type A 200 U | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72 | Change from baseline at Week 72 (N=64,61,66,58) | -4.1 Score on a scale | Standard Deviation 6.4 |
| Botulinum Toxin Type A 200 U | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72 | Baseline | 20.2 Score on a scale | Standard Deviation 5.8 |
| Botulinum Toxin Type A 100 U | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72 | Baseline | 21.5 Score on a scale | Standard Deviation 5.42 |
| Botulinum Toxin Type A 100 U | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72 | Change from baseline at Week 72 (N=64,61,66,58) | -4.7 Score on a scale | Standard Deviation 7.15 |
| Placebo (Normal Saline) | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72 | Baseline | 20.7 Score on a scale | Standard Deviation 5.44 |
| Placebo (Normal Saline) | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72 | Change from baseline at Week 72 (N=64,61,66,58) | -4.3 Score on a scale | Standard Deviation 7.15 |
Secondary
Change From Baseline in Peak Urine Flow Rate
Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement.
Time frame: Baseline, Week 12, Week 72
Population: Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300 U | Change From Baseline in Peak Urine Flow Rate | Baseline | 10.4 milliliters (mL)/second | Standard Deviation 2.7 |
| Botulinum Toxin Type A 300 U | Change From Baseline in Peak Urine Flow Rate | Change from baseline to Week 72 (N=59,56,64,53) | 2.0 milliliters (mL)/second | Standard Deviation 4.67 |
| Botulinum Toxin Type A 300 U | Change From Baseline in Peak Urine Flow Rate | Change from baseline to Week 12 (N=81,80,86,77) | 1.8 milliliters (mL)/second | Standard Deviation 4.65 |
| Botulinum Toxin Type A 200 U | Change From Baseline in Peak Urine Flow Rate | Baseline | 10.6 milliliters (mL)/second | Standard Deviation 2.83 |
| Botulinum Toxin Type A 200 U | Change From Baseline in Peak Urine Flow Rate | Change from baseline to Week 72 (N=59,56,64,53) | 2.4 milliliters (mL)/second | Standard Deviation 5.18 |
| Botulinum Toxin Type A 200 U | Change From Baseline in Peak Urine Flow Rate | Change from baseline to Week 12 (N=81,80,86,77) | 2.0 milliliters (mL)/second | Standard Deviation 4.98 |
| Botulinum Toxin Type A 100 U | Change From Baseline in Peak Urine Flow Rate | Change from baseline to Week 12 (N=81,80,86,77) | 2.7 milliliters (mL)/second | Standard Deviation 5.21 |
| Botulinum Toxin Type A 100 U | Change From Baseline in Peak Urine Flow Rate | Baseline | 9.6 milliliters (mL)/second | Standard Deviation 2.57 |
| Botulinum Toxin Type A 100 U | Change From Baseline in Peak Urine Flow Rate | Change from baseline to Week 72 (N=59,56,64,53) | 2.0 milliliters (mL)/second | Standard Deviation 4.07 |
| Placebo (Normal Saline) | Change From Baseline in Peak Urine Flow Rate | Baseline | 10.1 milliliters (mL)/second | Standard Deviation 2.82 |
| Placebo (Normal Saline) | Change From Baseline in Peak Urine Flow Rate | Change from baseline to Week 72 (N=59,56,64,53) | 2.3 milliliters (mL)/second | Standard Deviation 4.31 |
| Placebo (Normal Saline) | Change From Baseline in Peak Urine Flow Rate | Change from baseline to Week 12 (N=81,80,86,77) | 2.8 milliliters (mL)/second | Standard Deviation 4.74 |
Secondary
Change From Baseline in Post-Void Residual
Post-void residual urine volume was assessed by bladder scan or ultrasound on all participants at baseline and various time-points during the study. After voiding, any residual urine volume in the bladder was measured. A negative change from baseline indicates improvement.
Time frame: Baseline, Week 2, Week 12, Week 72
Population: Participants from the safety population (includes all randomized and treated participants) with data available for analyses at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300 U | Change From Baseline in Post-Void Residual | Baseline | 73.0 milliliters (mL) | Standard Deviation 57.07 |
| Botulinum Toxin Type A 300 U | Change From Baseline in Post-Void Residual | Change from baseline at Week 2 (N=76,82,80,78) | 5.4 milliliters (mL) | Standard Deviation 64.06 |
| Botulinum Toxin Type A 300 U | Change From Baseline in Post-Void Residual | Change from baseline at Week 12 (N=88,84,89,82) | 7.5 milliliters (mL) | Standard Deviation 78.18 |
| Botulinum Toxin Type A 300 U | Change From Baseline in Post-Void Residual | Change from baseline at Week 72 (N=66,60,65,60) | 10.9 milliliters (mL) | Standard Deviation 73.27 |
| Botulinum Toxin Type A 200 U | Change From Baseline in Post-Void Residual | Change from baseline at Week 2 (N=76,82,80,78) | 10.9 milliliters (mL) | Standard Deviation 88.62 |
| Botulinum Toxin Type A 200 U | Change From Baseline in Post-Void Residual | Change from baseline at Week 12 (N=88,84,89,82) | 9.0 milliliters (mL) | Standard Deviation 81.23 |
| Botulinum Toxin Type A 200 U | Change From Baseline in Post-Void Residual | Change from baseline at Week 72 (N=66,60,65,60) | -12.4 milliliters (mL) | Standard Deviation 54.31 |
| Botulinum Toxin Type A 200 U | Change From Baseline in Post-Void Residual | Baseline | 69.7 milliliters (mL) | Standard Deviation 54.93 |
| Botulinum Toxin Type A 100 U | Change From Baseline in Post-Void Residual | Change from baseline at Week 12 (N=88,84,89,82) | -1.4 milliliters (mL) | Standard Deviation 62.82 |
| Botulinum Toxin Type A 100 U | Change From Baseline in Post-Void Residual | Change from baseline at Week 2 (N=76,82,80,78) | -1.4 milliliters (mL) | Standard Deviation 65.01 |
| Botulinum Toxin Type A 100 U | Change From Baseline in Post-Void Residual | Change from baseline at Week 72 (N=66,60,65,60) | 14.0 milliliters (mL) | Standard Deviation 75.97 |
| Botulinum Toxin Type A 100 U | Change From Baseline in Post-Void Residual | Baseline | 66.1 milliliters (mL) | Standard Deviation 55.59 |
| Placebo (Normal Saline) | Change From Baseline in Post-Void Residual | Change from baseline at Week 72 (N=66,60,65,60) | 6.0 milliliters (mL) | Standard Deviation 69.79 |
| Placebo (Normal Saline) | Change From Baseline in Post-Void Residual | Change from baseline at Week 2 (N=76,82,80,78) | 1.6 milliliters (mL) | Standard Deviation 61.03 |
| Placebo (Normal Saline) | Change From Baseline in Post-Void Residual | Baseline | 64.3 milliliters (mL) | Standard Deviation 51.89 |
| Placebo (Normal Saline) | Change From Baseline in Post-Void Residual | Change from baseline at Week 12 (N=88,84,89,82) | 3.2 milliliters (mL) | Standard Deviation 57.92 |
Secondary
Change From Baseline in Total Prostate Volume
Measurement of the prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.
Time frame: Baseline, Week 12, Week 72
Population: Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300 U | Change From Baseline in Total Prostate Volume | Baseline | 48.78 milliliter (mL) | Standard Deviation 16.8 |
| Botulinum Toxin Type A 300 U | Change From Baseline in Total Prostate Volume | Change from baseline at Week 72 (N=65,60,67,57) | -3.58 milliliter (mL) | Standard Deviation 9.773 |
| Botulinum Toxin Type A 300 U | Change From Baseline in Total Prostate Volume | Change from baseline at Week 12 (N=86,84,88,82) | -3.40 milliliter (mL) | Standard Deviation 10.046 |
| Botulinum Toxin Type A 200 U | Change From Baseline in Total Prostate Volume | Baseline | 48.40 milliliter (mL) | Standard Deviation 16.325 |
| Botulinum Toxin Type A 200 U | Change From Baseline in Total Prostate Volume | Change from baseline at Week 72 (N=65,60,67,57) | -2.82 milliliter (mL) | Standard Deviation 11.194 |
| Botulinum Toxin Type A 200 U | Change From Baseline in Total Prostate Volume | Change from baseline at Week 12 (N=86,84,88,82) | -3.65 milliliter (mL) | Standard Deviation 9.255 |
| Botulinum Toxin Type A 100 U | Change From Baseline in Total Prostate Volume | Change from baseline at Week 12 (N=86,84,88,82) | -3.54 milliliter (mL) | Standard Deviation 9.823 |
| Botulinum Toxin Type A 100 U | Change From Baseline in Total Prostate Volume | Baseline | 47.54 milliliter (mL) | Standard Deviation 16.917 |
| Botulinum Toxin Type A 100 U | Change From Baseline in Total Prostate Volume | Change from baseline at Week 72 (N=65,60,67,57) | -1.77 milliliter (mL) | Standard Deviation 10.714 |
| Placebo (Normal Saline) | Change From Baseline in Total Prostate Volume | Baseline | 47.23 milliliter (mL) | Standard Deviation 14.867 |
| Placebo (Normal Saline) | Change From Baseline in Total Prostate Volume | Change from baseline at Week 72 (N=65,60,67,57) | -2.69 milliliter (mL) | Standard Deviation 10.875 |
| Placebo (Normal Saline) | Change From Baseline in Total Prostate Volume | Change from baseline at Week 12 (N=86,84,88,82) | -4.59 milliliter (mL) | Standard Deviation 8.392 |
Secondary
Change From Baseline in Transitional Zone Prostate Volume
Measurement of the transitional zone prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.
Time frame: Baseline, Week 12, Week 72
Population: Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300 U | Change From Baseline in Transitional Zone Prostate Volume | Baseline | 20.78 milliliters (mL) | Standard Deviation 14.657 |
| Botulinum Toxin Type A 300 U | Change From Baseline in Transitional Zone Prostate Volume | Change from baseline at Week 72 (N=64,59,65,55) | 0.19 milliliters (mL) | Standard Deviation 7.655 |
| Botulinum Toxin Type A 300 U | Change From Baseline in Transitional Zone Prostate Volume | Change from baseline at Week 12 (N=83,82,86,79) | -0.23 milliliters (mL) | Standard Deviation 6.516 |
| Botulinum Toxin Type A 200 U | Change From Baseline in Transitional Zone Prostate Volume | Baseline | 21.75 milliliters (mL) | Standard Deviation 12.931 |
| Botulinum Toxin Type A 200 U | Change From Baseline in Transitional Zone Prostate Volume | Change from baseline at Week 72 (N=64,59,65,55) | -0.94 milliliters (mL) | Standard Deviation 8.119 |
| Botulinum Toxin Type A 200 U | Change From Baseline in Transitional Zone Prostate Volume | Change from baseline at Week 12 (N=83,82,86,79) | -0.76 milliliters (mL) | Standard Deviation 8.085 |
| Botulinum Toxin Type A 100 U | Change From Baseline in Transitional Zone Prostate Volume | Change from baseline at Week 12 (N=83,82,86,79) | -0.02 milliliters (mL) | Standard Deviation 8.445 |
| Botulinum Toxin Type A 100 U | Change From Baseline in Transitional Zone Prostate Volume | Baseline | 21.00 milliliters (mL) | Standard Deviation 14.188 |
| Botulinum Toxin Type A 100 U | Change From Baseline in Transitional Zone Prostate Volume | Change from baseline at Week 72 (N=64,59,65,55) | -0.35 milliliters (mL) | Standard Deviation 8.808 |
| Placebo (Normal Saline) | Change From Baseline in Transitional Zone Prostate Volume | Baseline | 20.73 milliliters (mL) | Standard Deviation 13.21 |
| Placebo (Normal Saline) | Change From Baseline in Transitional Zone Prostate Volume | Change from baseline at Week 72 (N=64,59,65,55) | -1.35 milliliters (mL) | Standard Deviation 6.801 |
| Placebo (Normal Saline) | Change From Baseline in Transitional Zone Prostate Volume | Change from baseline at Week 12 (N=83,82,86,79) | -0.27 milliliters (mL) | Standard Deviation 6.551 |
Post Hoc
Change From Baseline in IPSS at Week 12 in Patients Previously Treated With Alpha-blockers
The International Prostate Symptom Score (IPSS) is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.
Time frame: Baseline, Week 12
Population: Participants from the Intent-to-treat population previously treated with alpha-blockers with data available for analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300 U | Change From Baseline in IPSS at Week 12 in Patients Previously Treated With Alpha-blockers | Change from baseline at Week 12 (N=44,35,52,42) | -5.1 Score on a scale | Standard Deviation 7.76 |
| Botulinum Toxin Type A 300 U | Change From Baseline in IPSS at Week 12 in Patients Previously Treated With Alpha-blockers | Baseline | 21.3 Score on a scale | Standard Deviation 6.2 |
| Botulinum Toxin Type A 200 U | Change From Baseline in IPSS at Week 12 in Patients Previously Treated With Alpha-blockers | Change from baseline at Week 12 (N=44,35,52,42) | -6.6 Score on a scale | Standard Deviation 5.91 |
| Botulinum Toxin Type A 200 U | Change From Baseline in IPSS at Week 12 in Patients Previously Treated With Alpha-blockers | Baseline | 19.6 Score on a scale | Standard Deviation 6.15 |
| Botulinum Toxin Type A 100 U | Change From Baseline in IPSS at Week 12 in Patients Previously Treated With Alpha-blockers | Baseline | 21.9 Score on a scale | Standard Deviation 5.65 |
| Botulinum Toxin Type A 100 U | Change From Baseline in IPSS at Week 12 in Patients Previously Treated With Alpha-blockers | Change from baseline at Week 12 (N=44,35,52,42) | -5.4 Score on a scale | Standard Deviation 5.17 |
| Placebo (Normal Saline) | Change From Baseline in IPSS at Week 12 in Patients Previously Treated With Alpha-blockers | Change from baseline at Week 12 (N=44,35,52,42) | -3.5 Score on a scale | Standard Deviation 6.12 |
| Placebo (Normal Saline) | Change From Baseline in IPSS at Week 12 in Patients Previously Treated With Alpha-blockers | Baseline | 20.4 Score on a scale | Standard Deviation 5.32 |
Other Pre-specified
Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain
The IIEF is a 15-item questionnaire filled out by the patient to assess erectile function over the past 4 weeks that contains five domains. The score for the erectile function domain is the sum of scores for Questions 1, 2, 3, 4, 5 and 15 for a total possible score of 1 to 30. A higher score indicates a better outcome. A positive change from baseline indicates improvement.
Time frame: Baseline, Week 12, Week 72
Population: Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 300 U | Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain | Baseline | 15.4 Score on a scale | Standard Deviation 10.2 |
| Botulinum Toxin Type A 300 U | Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain | Change from baseline at Week 72 (N=61,54,61,58) | 0.8 Score on a scale | Standard Deviation 7.17 |
| Botulinum Toxin Type A 300 U | Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain | Change from baseline at Week 12 (N=80,72,83,79) | 0.1 Score on a scale | Standard Deviation 6.66 |
| Botulinum Toxin Type A 200 U | Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain | Baseline | 14.6 Score on a scale | Standard Deviation 10.7 |
| Botulinum Toxin Type A 200 U | Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain | Change from baseline at Week 72 (N=61,54,61,58) | 0.5 Score on a scale | Standard Deviation 4.56 |
| Botulinum Toxin Type A 200 U | Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain | Change from baseline at Week 12 (N=80,72,83,79) | -0.2 Score on a scale | Standard Deviation 5.54 |
| Botulinum Toxin Type A 100 U | Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain | Change from baseline at Week 12 (N=80,72,83,79) | -0.9 Score on a scale | Standard Deviation 6.93 |
| Botulinum Toxin Type A 100 U | Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain | Baseline | 17.2 Score on a scale | Standard Deviation 10.19 |
| Botulinum Toxin Type A 100 U | Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain | Change from baseline at Week 72 (N=61,54,61,58) | -1.5 Score on a scale | Standard Deviation 7.34 |
| Placebo (Normal Saline) | Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain | Baseline | 16.7 Score on a scale | Standard Deviation 10.29 |
| Placebo (Normal Saline) | Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain | Change from baseline at Week 72 (N=61,54,61,58) | -0.9 Score on a scale | Standard Deviation 7.95 |
| Placebo (Normal Saline) | Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain | Change from baseline at Week 12 (N=80,72,83,79) | 1.3 Score on a scale | Standard Deviation 7.86 |