Benign Prostatic Hyperplasia
Conditions
Keywords
Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy
Brief summary
The purpose of this study is to evaluate the function of the bladder and urethra during urinary storage or voiding in men with signs and symptoms of benign prostatic hyperplasia treated with either placebo or tadalafil.
Interventions
DRUGTadalafil
20 mg tadalafil tablet taken by mouth once a day for 12 weeks.
DRUGPlacebo
Placebo tablet taken by mouth once a day for 12 weeks.
Sponsors
ICOS Corporation
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men 40 years of age or older with Lower Urinary Tract Symptoms (LUTS) with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 1. * Agree not to use any other approved or experimental medications for Benign Prostate Hyperplasia (BPH)-Lower Urinary Tract Symptoms, including alpha blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, or herbal preparations at any time during the study. * Have not taken finasteride or dutasteride therapy for at least 4 months prior to Visit 2; have not taken any other LUTS therapy (including herbal preparations) or PDE5 inhibitors for at least 4 weeks prior to Visit 2. * Have had BPH-LUTS for greater than 6 months prior to Visit 1.
Exclusion criteria
* Any pelvic surgical procedure on the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery. * History of urethral obstruction due to stricture, valves, sclerosis, or tumor. * Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease, multiple sclerosis). * History of cardiac conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study. * History of angina requiring treatment with nitrates. * Prostate Specific Antigen (PSA) greater than 10 nanogram/milliliter (ng/ml) at Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax) | Baseline and 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies | Baseline and 12 weeks | Total bladder capacity was defined as Vcomp + PVRcath (obtained when the bladder was full). |
| Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies | Baseline and 12 weeks | Qave was measured during free-flow tests using a standard calibrated flow meter. |
| Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies | Baseline and 12 weeks | — |
| Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies | Baseline and 12 weeks | Qmax was measured during free-flow tests using a standard calibrated flow meter. |
| Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies | Baseline and 12 weeks | Bladder voiding efficiency was defined as (Vcomp/total bladder capacity) X 100 (obtained when the bladder was full). |
| Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies | Baseline and 12 weeks | Qmax was measured duirng pressure-flow tests. |
| Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies | Baseline and 12 weeks | Qave was measured during pressure-flow tests. |
| Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies | Baseline and 12 weeks | PVRcath is the volume of urine remaining int he bladder after voiding, measured by catheterization. |
| Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies | Baseline and 12 weeks | Max Pdet was defined as the maximum detrusor pressure observed during voiding. |
| Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies | Baseline and 12 weeks | BCI was derived from the equation PdetQmax + 5Qmax. Scores: \<100 means weak, 100-150 menas normal, \>150 means strong. A decrease means a decrease in contractility of the bladder. |
| Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies | Baseline and 12 weeks | BOOI, formerly known as the Abrams-Griffith number, was derived from the equation PdetQmax - 2Qmax. Scores: \<20 means unobstructed, 20-40 means equivocol, \>40 means obstructed. An increase means worsening of obstruction, a decreased means lessening of obstruction (improvement). |
| Presence of Involuntary Detrusor Contractions During Bladder Filling | Baseline and 12 weeks | — |
| Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction | Baseline and 12 weeks | Assessed in participants with involuntary detrusor contractions during the bladder filling at both baseline and endpoint. |
| Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score | 12 weeks | The IPSS Total Score is obtained by combining the scores of the responses to the 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. |
| Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests | Baseline and 12 weeks | Laboratory tests that were statistically significant and clinically adverse would be reported for safety. |
| Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies | Baseline and 12 weeks | Vcomp was defined as the volume of voided urine measured during pressure-flow tests. |
Countries
Greece, Portugal, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo placebo tablet taken by mouth once a day for 12 weeks | 101 |
| Tadalafil 20 mg tadalafil tablet taken by mouth once a day for 12 weeks | 99 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Entry Criteria Not Met | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Sponsor Decision | 1 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 4 |
Baseline characteristics
| Characteristic | Placebo | Tadalafil | Total |
|---|---|---|---|
| Age Continuous | 59.03 years STANDARD_DEVIATION 9.69 | 58.16 years STANDARD_DEVIATION 8.82 | 58.60 years STANDARD_DEVIATION 9.26 |
| Baseline Benign Prostatic Hyperplasia (BPH) Lower Urinary Tract Symptom (LUTS) Severity Missing Baseline Measure | 1 participants | 2 participants | 3 participants |
| Baseline Benign Prostatic Hyperplasia (BPH) Lower Urinary Tract Symptom (LUTS) Severity Moderate (IPSS <20) | 34 participants | 35 participants | 69 participants |
| Baseline Benign Prostatic Hyperplasia (BPH) Lower Urinary Tract Symptom (LUTS) Severity Severe (IPSS ≥20) | 66 participants | 62 participants | 128 participants |
| Bladder Outlet Obstruction Index (BOOI) Equivocal (BOOI 20-40) | 35 participants | 34 participants | 69 participants |
| Bladder Outlet Obstruction Index (BOOI) Obstructed (BOOI > 40) | 33 participants | 34 participants | 67 participants |
| Bladder Outlet Obstruction Index (BOOI) Unobstructed (BOOI < 20) | 33 participants | 31 participants | 64 participants |
| Body Mass Index (BMI) | 29.44 kilograms/square centimeters (kg/cm^2) STANDARD_DEVIATION 4.47 | 29.45 kilograms/square centimeters (kg/cm^2) STANDARD_DEVIATION 4.93 | 29.45 kilograms/square centimeters (kg/cm^2) STANDARD_DEVIATION 4.69 |
| Body Weight | 92.94 kilograms STANDARD_DEVIATION 16.55 | 93.90 kilograms STANDARD_DEVIATION 16.49 | 93.42 kilograms STANDARD_DEVIATION 16.49 |
| Duration of Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms (BPH LUTS) 1 year to 3 years | 36 participants | 30 participants | 66 participants |
| Duration of Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms (BPH LUTS) > 3 years | 52 participants | 57 participants | 109 participants |
| Duration of Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms (BPH LUTS) 6 months to 1 year | 13 participants | 12 participants | 25 participants |
| Erectile Dysfunction Severity Mild | 20 participants | 22 participants | 42 participants |
| Erectile Dysfunction Severity Moderate | 31 participants | 31 participants | 62 participants |
| Erectile Dysfunction Severity Severe | 9 participants | 5 participants | 14 participants |
| Height | 177.56 centimeters STANDARD_DEVIATION 8.07 | 178.58 centimeters STANDARD_DEVIATION 7.5 | 178.07 centimeters STANDARD_DEVIATION 7.79 |
| Postvoid Residual Volume by Ultrasound | 59.30 milliliters STANDARD_DEVIATION 60.87 | 45.65 milliliters STANDARD_DEVIATION 49.58 | 52.51 milliliters STANDARD_DEVIATION 55.82 |
| Presence of Erectile Dysfunction No | 41 participants | 41 participants | 82 participants |
| Presence of Erectile Dysfunction Yes | 60 participants | 58 participants | 118 participants |
| Previous Alpha-Blocker Therapy No | 79 participants | 78 participants | 157 participants |
| Previous Alpha-Blocker Therapy Yes | 22 participants | 21 participants | 43 participants |
| Previous Therapy for Benign Prostatic Hyperplasia No | 67 participants | 70 participants | 137 participants |
| Previous Therapy for Benign Prostatic Hyperplasia Yes | 34 participants | 29 participants | 63 participants |
| Prostate Specific Antigen (PSA) | 1.60 nanograms per milliliter STANDARD_DEVIATION 1.13 | 1.51 nanograms per milliliter STANDARD_DEVIATION 1.14 | 1.55 nanograms per milliliter STANDARD_DEVIATION 1.13 |
| Race/Ethnicity American Indian or Alaska Native | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity Asian | 3 participants | 2 participants | 5 participants |
| Race/Ethnicity Black or African American | 12 participants | 13 participants | 25 participants |
| Race/Ethnicity Hispanic or Latino | 8 participants | 8 participants | 16 participants |
| Race/Ethnicity White | 78 participants | 75 participants | 153 participants |
| Region of Enrollment Canada | 2 participants | 4 participants | 6 participants |
| Region of Enrollment United States | 99 participants | 95 participants | 194 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 101 Participants | 99 Participants | 200 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 28 / — | 55 / — |
| serious Total, serious adverse events | 2 / — | 3 / — |
Outcome results
Primary
Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax)
Time frame: Baseline and 12 weeks
Population: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax) | Baseline | 54.83 centimeters of water (cm H20) | Standard Deviation 27.36 |
| Placebo | Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax) | Change from Baseline to 12 Week Endpoint | 1.92 centimeters of water (cm H20) | Standard Deviation 19.71 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax) | Baseline | 56.87 centimeters of water (cm H20) | Standard Deviation 29.67 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax) | Change from Baseline to 12 Week Endpoint | -2.95 centimeters of water (cm H20) | Standard Deviation 15.92 |
p-value: 0.068ANOVA
Secondary
Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies
BCI was derived from the equation PdetQmax + 5Qmax. Scores: \<100 means weak, 100-150 menas normal, \>150 means strong. A decrease means a decrease in contractility of the bladder.
Time frame: Baseline and 12 weeks
Population: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies | Baseline | 102.28 units on a nomogram | Standard Deviation 32.84 |
| Placebo | Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies | Change from Baseline to 12 Week Endpoint | 4.43 units on a nomogram | Standard Deviation 20.86 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies | Baseline | 108.32 units on a nomogram | Standard Deviation 32.14 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies | Change from Baseline to 12 Week Endpoint | -1.04 units on a nomogram | Standard Deviation 20.37 |
p-value: 0.09ANOVA
Secondary
Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies
BOOI, formerly known as the Abrams-Griffith number, was derived from the equation PdetQmax - 2Qmax. Scores: \<20 means unobstructed, 20-40 means equivocol, \>40 means obstructed. An increase means worsening of obstruction, a decreased means lessening of obstruction (improvement).
Time frame: Baseline and 12 weeks
Population: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies | Baseline | 35.84 units on a nomogram | Standard Deviation 30.87 |
| Placebo | Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies | Change from Baseline to 12 Week Endpoint | 0.92 units on a nomogram | Standard Deviation 22.1 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies | Baseline | 36.28 units on a nomogram | Standard Deviation 33.14 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies | Change from Baseline to 12 Week Endpoint | -3.71 units on a nomogram | Standard Deviation 17.56 |
p-value: 0.113ANOVA
Secondary
Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies
Bladder voiding efficiency was defined as (Vcomp/total bladder capacity) X 100 (obtained when the bladder was full).
Time frame: Baseline and 12 weeks
Population: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies | Baseline | 84.01 milliliters | Standard Deviation 14.56 |
| Placebo | Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies | Change from Baseline to 12 Week Endpoint | -0.52 milliliters | Standard Deviation 16.31 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies | Baseline | 85.85 milliliters | Standard Deviation 13.44 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies | Change from Baseline to 12 Week Endpoint | 1.85 milliliters | Standard Deviation 16.22 |
p-value: 0.34ANOVA
Secondary
Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction
Assessed in participants with involuntary detrusor contractions during the bladder filling at both baseline and endpoint.
Time frame: Baseline and 12 weeks
Population: Number of participants in the Primary Analysis Population with involuntary detrusor contractions during bladder filling at both baseline and endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction | Baseline | 120.55 milliliters | Standard Deviation 82.5 |
| Placebo | Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction | Change from Baseline to 12 Week Endpoint | 27.86 milliliters | Standard Deviation 128.2 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction | Baseline | 164.00 milliliters | Standard Deviation 108.31 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction | Change from Baseline to 12 Week Endpoint | 28.56 milliliters | Standard Deviation 106.67 |
Secondary
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
The IPSS Total Score is obtained by combining the scores of the responses to the 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Time frame: 12 weeks
Population: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score | Baseline | 22.01 units on a scale | Standard Deviation 5.72 |
| Placebo | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score | Change from Baseline to 12 Week Endpoint | -5.04 units on a scale | Standard Deviation 6.93 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score | Baseline | 21.46 units on a scale | Standard Deviation 5.63 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score | Change from Baseline to 12 Week Endpoint | -9.13 units on a scale | Standard Deviation 6.9 |
p-value: <0.001ANOVA
Secondary
Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies
Max Pdet was defined as the maximum detrusor pressure observed during voiding.
Time frame: Baseline and 12 weeks
Population: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies | Baseline | 67.13 centimeters of water (cm H20) | Standard Deviation 31.66 |
| Placebo | Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies | Change from Baseline to 12 Week Endpoint | -0.48 centimeters of water (cm H20) | Standard Deviation 28.19 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies | Baseline | 72.20 centimeters of water (cm H20) | Standard Deviation 38.65 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies | Change from Baseline to 12 Week Endpoint | -2.11 centimeters of water (cm H20) | Standard Deviation 24.08 |
p-value: 0.838ANOVA
Secondary
Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies
Qave was measured during free-flow tests using a standard calibrated flow meter.
Time frame: Baseline and 12 weeks
Population: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies | Baseline | 7.10 millilters per second | Standard Deviation 4.37 |
| Placebo | Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies | Change from Baseline to 12 Week Endpoint | -0.01 millilters per second | Standard Deviation 4.11 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies | Baseline | 7.23 millilters per second | Standard Deviation 4.18 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies | Change from Baseline to 12 Week Endpoint | 1.00 millilters per second | Standard Deviation 3.04 |
p-value: 0.113ANOVA
Secondary
Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies
Qave was measured during pressure-flow tests.
Time frame: Baseline and 12 weeks
Population: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies | Baseline | 4.67 milliliters per second | Standard Deviation 2.44 |
| Placebo | Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies | Change from Baseline to 12 Week Endpoint | 0.45 milliliters per second | Standard Deviation 1.66 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies | Baseline | 5.50 milliliters per second | Standard Deviation 2.68 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies | Change from Baseline to 12 Week Endpoint | 0.58 milliliters per second | Standard Deviation 1.91 |
p-value: 0.609ANOVA
Secondary
Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies
Qmax was measured during free-flow tests using a standard calibrated flow meter.
Time frame: Baseline and 12 weeks
Population: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies | Change from Baseline to 12 Week Endpoint | 0.52 milliliters per second | Standard Deviation 7.83 |
| Placebo | Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies | Baseline | 13.03 milliliters per second | Standard Deviation 7.34 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies | Baseline | 14.75 milliliters per second | Standard Deviation 10.7 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies | Change from Baseline to 12 Week Endpoint | 0.01 milliliters per second | Standard Deviation 8.83 |
p-value: 0.626ANOVA
Secondary
Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies
Qmax was measured duirng pressure-flow tests.
Time frame: Baseline and 12 weeks
Population: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies | Baseline | 9.49 milliliters per second | Standard Deviation 4.9 |
| Placebo | Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies | Change from Baseline to 12 Week Endpoint | 0.50 milliliters per second | Standard Deviation 2.91 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies | Baseline | 10.29 milliliters per second | Standard Deviation 4.46 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies | Change from Baseline to 12 Week Endpoint | 0.38 milliliters per second | Standard Deviation 2.92 |
p-value: 0.838ANOVA
Secondary
Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies
PVRcath is the volume of urine remaining int he bladder after voiding, measured by catheterization.
Time frame: Baseline and 12 weeks
Population: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies | Baseline | 59.62 milliliters | Standard Deviation 66.74 |
| Placebo | Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies | Change from Baseline to 12 Week Endpoint | -1.85 milliliters | Standard Deviation 80.92 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies | Baseline | 48.99 milliliters | Standard Deviation 65.73 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies | Change from Baseline to 12 Week Endpoint | -9.13 milliliters | Standard Deviation 70.36 |
p-value: 0.4ANOVA
Secondary
Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies
Total bladder capacity was defined as Vcomp + PVRcath (obtained when the bladder was full).
Time frame: Baseline and 12 weeks
Population: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies | Baseline | 327.95 milliliters | Standard Deviation 165.66 |
| Placebo | Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies | Change from Baseline to 12 Week Endpoint | -17.53 milliliters | Standard Deviation 182.62 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies | Baseline | 316.79 milliliters | Standard Deviation 187.31 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies | Change from Baseline to 12 Week Endpoint | -14.88 milliliters | Standard Deviation 187.1 |
p-value: 0.864ANOVA
Secondary
Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies
Time frame: Baseline and 12 weeks
Population: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies | Baseline | 258.56 milliliters | Standard Deviation 134.21 |
| Placebo | Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies | Change from Baseline to 12 Week Endpoint | -4.10 milliliters | Standard Deviation 151.82 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies | Baseline | 268.22 milliliters | Standard Deviation 149.77 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies | Change from Baseline to 12 Week Endpoint | -5.17 milliliters | Standard Deviation 151.73 |
p-value: 0.837ANOVA
Secondary
Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies
Vcomp was defined as the volume of voided urine measured during pressure-flow tests.
Time frame: Baseline and 12 weeks
Population: Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies | Baseline | 294.10 milliliters | Standard Deviation 147.74 |
| Placebo | Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies | Change from Baseline to 12 Week Endpoint | 3.31 milliliters | Standard Deviation 140.46 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies | Baseline | 296.64 milliliters | Standard Deviation 143.3 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies | Change from Baseline to 12 Week Endpoint | 13.51 milliliters | Standard Deviation 99.64 |
p-value: 0.427ANOVA
Secondary
Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests
Laboratory tests that were statistically significant and clinically adverse would be reported for safety.
Time frame: Baseline and 12 weeks
Population: All randomized participants.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Placebo | Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests | 0 significant and clinically adverse labs | 0.41 |
| Tadalafil | Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests | 0 significant and clinically adverse labs | 0.33 |
Secondary
Presence of Involuntary Detrusor Contractions During Bladder Filling
Time frame: Baseline and 12 weeks
Population: Number of participants randomized, had started study medication, had both a baseline and an end of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Presence of Involuntary Detrusor Contractions During Bladder Filling | Not Present at Endpoint | 55 participants |
| Placebo | Presence of Involuntary Detrusor Contractions During Bladder Filling | Present at Both Baseline and Endpoint | 22 participants |
| Placebo | Presence of Involuntary Detrusor Contractions During Bladder Filling | Present at Baseline | 33 participants |
| Placebo | Presence of Involuntary Detrusor Contractions During Bladder Filling | Not Present at Baseline | 58 participants |
| Placebo | Presence of Involuntary Detrusor Contractions During Bladder Filling | Present at Endpoint | 36 participants |
| Placebo | Presence of Involuntary Detrusor Contractions During Bladder Filling | Present at Baseline Only | 11 participants |
| Placebo | Presence of Involuntary Detrusor Contractions During Bladder Filling | Present at Endpoint Only | 14 participants |
| Placebo | Presence of Involuntary Detrusor Contractions During Bladder Filling | Present at Neither Baseline nor Endpoint | 44 participants |
| Tadalafil | Presence of Involuntary Detrusor Contractions During Bladder Filling | Present at Neither Baseline nor Endpoint | 43 participants |
| Tadalafil | Presence of Involuntary Detrusor Contractions During Bladder Filling | Not Present at Endpoint | 53 participants |
| Tadalafil | Presence of Involuntary Detrusor Contractions During Bladder Filling | Present at Endpoint | 31 participants |
| Tadalafil | Presence of Involuntary Detrusor Contractions During Bladder Filling | Present at Both Baseline and Endpoint | 18 participants |
| Tadalafil | Presence of Involuntary Detrusor Contractions During Bladder Filling | Present at Endpoint Only | 13 participants |
| Tadalafil | Presence of Involuntary Detrusor Contractions During Bladder Filling | Present at Baseline | 28 participants |
| Tadalafil | Presence of Involuntary Detrusor Contractions During Bladder Filling | Present at Baseline Only | 10 participants |
| Tadalafil | Presence of Involuntary Detrusor Contractions During Bladder Filling | Not Present at Baseline | 56 participants |