Benign Prostatic Hyperplasia
Conditions
Brief summary
The primary purpose of this clinical trial is to evaluate the change in the International Prostate Symptom Score (IPSS) total score from the beginning of the study to the end of the study for subjects randomized to tadalafil 5mg once a day dosing and placebo once a day dosing for 12 weeks of treatment.
Interventions
DRUGTadalafil
5 mg once a day
DRUGPlacebo
once a day
DRUGTamsulosin
0.2 mg once a day
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have Benign Prostatic Hyperplasia - Lower Urinary Tract Symptoms (BPH-LUTS) for at least 6 months prior to Visit 1. * Agree not to use any other approved or experimental treatments for erectile dysfunction or BPH-LUTS during the study. * Have not taken Finasteride therapy for at least 3 months prior to Visit 2. * Have not taken Dutasteride therapy for at least 6 months prior to Visit 2. * Have an International Prostate Symptom Score (IPSS) total score greater than or equal to 13 at Visit 2.
Exclusion criteria
* Prostate Specific Antigen (PSA) greater than 10.0 nanograms per milliliter (ng/mL) at Visit 1. * Bladder Post Void Residual (PVR) greater than or equal to 300 mL by ultrasound at Visit 1. * History of pelvic surgery, prostatectomy, radiotherapy, penile implant surgery, lower urinary tract malignancy or trauma. * Urinary tract infection or inflammation or current antibiotic therapy for urinary tract infection at Visit 1. * Glycosylated hemoglobin (HbA1c) greater than 9% at Visit 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score | baseline, 12 weeks | The IPSS Total Score is obtained by combining the scores of the responses to 1 through 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score | baseline, 4 and 8 weeks | The IPSS Total Score is obtained by combining the scores of the responses to 1 through 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. |
| Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore | baseline, 4, 8, and 12 weeks | The IPSS voiding (obstructive) subscore is defined as sum of scores for Questions 1, 3, 5, and 6 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS voiding subscore will be reported as missing for that visit. Subscore totals range from 0 to 20; higher scores are indicative of greater obstruction. |
| Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore | baseline, 4, 8, and 12 weeks | IPSS Question 7 is used to assess the frequency of nocturia. Scores range from 0 (low frequency of nocturia) to 5 (high frequency of nocturia). |
| Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II) | baseline, 12 weeks | The BPH-BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range of 0 to 13; higher scores represent increased perceived impact of BPH-LUTS on overall health. If scores for any component question were missing for a visit, BPH-BII was reported as missing for that visit. |
| Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies | 12 weeks | A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants who indicated they were worse (scores of 5, 6, or 7), no change (score of 4), or better (scores of 1, 2, or 3). |
| Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore | baseline, 4, 8, and 12 weeks | The IPSS storage (irritative) subscore is defined as sum of scores for Questions 2, 4, and 7 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS storage subscore will be reported as missing for that visit. Subscore totals range from 0 to 15; higher scores are indicative of greater irritation. |
| Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | baseline, 12 weeks | Patient-completed diary that measures daytime frequency (waking voids) and nocturia (sleeping voids). Average number of waking voids per week, average number of sleeping voids per week, and average number of total voids (sleeping+waking) per week are reported. |
| Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary | baseline, 12 weeks | A patient-completed diary that measures urinary incontinence (UI) (leaks). Number of UI leaks per week are reported. |
| Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary | baseline, 12 weeks | A patient-completed diary that measures terminal dribble (dribble in the end of urination) and post-micturition dribble (dribble after urination). |
| Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) | baseline, 12 weeks | Qmax: defined as the peak urine flow rate (measured in milliliters per second \[mL/second\] using a standard calibrated flowmeter); and Qmean, defined as the mean urine flow rate (measured in mL/second using a standard calibrated flowmeter). |
| Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp) | baseline, 12 weeks | Vcomp, defined as the volume of voided urine (measured in milliliters \[mL\]). |
| Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies | 12 weeks | Measures clinician's perception of patient improvement of illness at the time of assessment compared with start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants whose clinician indicated they were worse (scores of 5, 6, or 7), no change (score of 4), or better (scores of 1, 2, or 3). |
Countries
South Korea
Participant flow
Pre-assignment details
There were three periods to this study. Period 1 was a 4-week Screening/Washout Period. 196 subjects screened (45 failures). Period 2 was a 4-week Placebo Run-in Period. Period 3 was a 12-week Treatment Period (151 subjects randomized).
Participants by arm
| Arm | Count |
|---|---|
| Placebo by mouth once a day | 51 |
| Tadalafil 5 mg by mouth once a day | 51 |
| Tamsulosin 0.2 mg by mouth once a day | 49 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 1 |
| Overall Study | Entry Criteria Not Met | 2 | 0 | 0 |
| Overall Study | Lack of Efficacy | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Tadalafil | Tamsulosin | Total |
|---|---|---|---|---|
| Age Continuous | 62.2 years STANDARD_DEVIATION 6.8 | 61.2 years STANDARD_DEVIATION 6.6 | 61.5 years STANDARD_DEVIATION 6.4 | 61.6 years STANDARD_DEVIATION 6.6 |
| Body Mass Index | 24.8 kilograms/meters squared (kg/m^2) STANDARD_DEVIATION 2.2 | 24.7 kilograms/meters squared (kg/m^2) STANDARD_DEVIATION 2.3 | 24.4 kilograms/meters squared (kg/m^2) STANDARD_DEVIATION 2.1 | 24.6 kilograms/meters squared (kg/m^2) STANDARD_DEVIATION 2.2 |
| Duration of Erectile Dysfunction (ED) 1 Year or More | 29 participants | 23 participants | 18 participants | 70 participants |
| Duration of Erectile Dysfunction (ED) <3 Months | 0 participants | 1 participants | 0 participants | 1 participants |
| Duration of Erectile Dysfunction (ED) 3 Months to < 6 Months | 2 participants | 3 participants | 1 participants | 6 participants |
| Duration of Erectile Dysfunction (ED) 6 Months to < 1 Year | 5 participants | 3 participants | 5 participants | 13 participants |
| Erectile Dysfunction (ED) No | 15 participants | 21 participants | 25 participants | 61 participants |
| Erectile Dysfunction (ED) Yes | 36 participants | 30 participants | 24 participants | 90 participants |
| Etiology of Erectile Dysfunction (ED) Mixed | 17 participants | 15 participants | 12 participants | 44 participants |
| Etiology of Erectile Dysfunction (ED) Organic | 16 participants | 10 participants | 11 participants | 37 participants |
| Etiology of Erectile Dysfunction (ED) Psychogenic | 2 participants | 0 participants | 0 participants | 2 participants |
| Etiology of Erectile Dysfunction (ED) Unknown | 1 participants | 5 participants | 1 participants | 7 participants |
| Height | 168.6 centimeters STANDARD_DEVIATION 5.2 | 168.6 centimeters STANDARD_DEVIATION 5.5 | 167.3 centimeters STANDARD_DEVIATION 4.6 | 168.2 centimeters STANDARD_DEVIATION 5.1 |
| Lower Urinary Tract Symptoms Severity Moderate (IPSS < 20) | 35 participants | 35 participants | 33 participants | 103 participants |
| Lower Urinary Tract Symptoms Severity Severe (IPSS ≥20) | 16 participants | 16 participants | 16 participants | 48 participants |
| Postvoid Residual Volume (PRV) | 34.4 milliliters STANDARD_DEVIATION 35.7 | 30.9 milliliters STANDARD_DEVIATION 33.8 | 42.0 milliliters STANDARD_DEVIATION 59.6 | 35.7 milliliters STANDARD_DEVIATION 44.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 51 Participants | 51 Participants | 49 Participants | 151 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Korea, Republic of | 51 participants | 51 participants | 49 participants | 151 participants |
| Severity of Erectile Dysfunction (ED) Mild | 17 participants | 22 participants | 13 participants | 52 participants |
| Severity of Erectile Dysfunction (ED) Moderate | 14 participants | 5 participants | 7 participants | 26 participants |
| Severity of Erectile Dysfunction (ED) Severe | 5 participants | 3 participants | 4 participants | 12 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 51 Participants | 51 Participants | 49 Participants | 151 Participants |
| Weight | 70.7 kilograms STANDARD_DEVIATION 8.1 | 70.1 kilograms STANDARD_DEVIATION 7.5 | 68.4 kilograms STANDARD_DEVIATION 7.6 | 69.7 kilograms STANDARD_DEVIATION 7.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / — | 4 / — | 11 / — |
| serious Total, serious adverse events | 0 / — | 2 / — | 2 / — |
Outcome results
Primary
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 1 through 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: baseline, 12 weeks
Population: Primary analysis was performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score | Baseline | 17.3 units on a scale | Standard Deviation 5 |
| Placebo | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score | 12 Week Change | -4.2 units on a scale | Standard Deviation 4.8 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score | Baseline | 17.1 units on a scale | Standard Deviation 5.4 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score | 12 Week Change | -5.8 units on a scale | Standard Deviation 4.6 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score | Baseline | 17.7 units on a scale | Standard Deviation 5 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score | 12 Week Change | -5.6 units on a scale | Standard Deviation 5.3 |
p-value: 0.073ANCOVA
p-value: 0.186ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II)
The BPH-BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range of 0 to 13; higher scores represent increased perceived impact of BPH-LUTS on overall health. If scores for any component question were missing for a visit, BPH-BII was reported as missing for that visit.
Time frame: baseline, 12 weeks
Population: Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II) | Baseline | 6.2 units on a scale | Standard Deviation 2.8 |
| Placebo | Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II) | 12 Week Change | -2.0 units on a scale | Standard Deviation 2.7 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II) | Baseline | 6.1 units on a scale | Standard Deviation 2.9 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II) | 12 Week Change | -2.2 units on a scale | Standard Deviation 2.9 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II) | Baseline | 6.2 units on a scale | Standard Deviation 3.1 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II) | 12 Week Change | -1.7 units on a scale | Standard Deviation 2.6 |
p-value: 0.691ANCOVA
p-value: 0.415ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary
A patient-completed diary that measures urinary incontinence (UI) (leaks). Number of UI leaks per week are reported.
Time frame: baseline, 12 weeks
Population: Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary | Baseline | 0.8 average number per week | Standard Deviation 3.6 |
| Placebo | Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary | 12 Week Change | -0.3 average number per week | Standard Deviation 3.5 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary | 12 Week Change | 0.7 average number per week | Standard Deviation 2.5 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary | Baseline | 1.1 average number per week | Standard Deviation 5.4 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary | 12 Week Change | -0.3 average number per week | Standard Deviation 4.9 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary | Baseline | 1.6 average number per week | Standard Deviation 5 |
p-value: 0.208Wilcoxon Rank Sum
p-value: 0.985Wilcoxon Rank Sum
Secondary
Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary
Patient-completed diary that measures daytime frequency (waking voids) and nocturia (sleeping voids). Average number of waking voids per week, average number of sleeping voids per week, and average number of total voids (sleeping+waking) per week are reported.
Time frame: baseline, 12 weeks
Population: Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | 12 Week Change Total Voids | -1.6 average number per week | Standard Deviation 9.2 |
| Placebo | Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | 12 Week Change Sleeping Voids | -1.3 average number per week | Standard Deviation 3.5 |
| Placebo | Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | Baseline Total Voids | 58.6 average number per week | Standard Deviation 13 |
| Placebo | Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | 12 Week Change Waking Voids | -0.3 average number per week | Standard Deviation 8.7 |
| Placebo | Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | Baseline Sleeping Voids | 10.3 average number per week | Standard Deviation 7.8 |
| Placebo | Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | Baseline Waking Voids | 48.2 average number per week | Standard Deviation 11.2 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | Baseline Sleeping Voids | 9.8 average number per week | Standard Deviation 6.7 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | Baseline Total Voids | 56.7 average number per week | Standard Deviation 13.3 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | 12 Week Change Total Voids | -4.4 average number per week | Standard Deviation 9.7 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | 12 Week Change Sleeping Voids | -2.3 average number per week | Standard Deviation 3.8 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | Baseline Waking Voids | 46.9 average number per week | Standard Deviation 11.1 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | 12 Week Change Waking Voids | -2.1 average number per week | Standard Deviation 8.7 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | 12 Week Change Total Voids | -2.7 average number per week | Standard Deviation 8.9 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | Baseline Waking Voids | 48.4 average number per week | Standard Deviation 16.9 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | 12 Week Change Sleeping Voids | -1.4 average number per week | Standard Deviation 4 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | 12 Week Change Waking Voids | -1.3 average number per week | Standard Deviation 7.6 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | Baseline Sleeping Voids | 7.9 average number per week | Standard Deviation 5.4 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | Baseline Total Voids | 56.3 average number per week | Standard Deviation 19.2 |
p-value: 0.254Wilcoxon Rank Sum
p-value: 0.359Wilcoxon Rank Sum
p-value: 0.098Wilcoxon Rank Sum
p-value: 0.632Wilcoxon Rank Sum
p-value: 0.102Wilcoxon Rank Sum
p-value: 0.348Wilcoxon Rank Sum
Secondary
Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean)
Qmax: defined as the peak urine flow rate (measured in milliliters per second \[mL/second\] using a standard calibrated flowmeter); and Qmean, defined as the mean urine flow rate (measured in mL/second using a standard calibrated flowmeter).
Time frame: baseline, 12 weeks
Population: Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) | Baseline Qmax | 10.5 milliliters per second | Standard Deviation 3.6 |
| Placebo | Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) | 12 Week Change Qmax | 2.8 milliliters per second | Standard Deviation 5.6 |
| Placebo | Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) | Baseline Qmean | 5.7 milliliters per second | Standard Deviation 2.3 |
| Placebo | Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) | 12 Week Change Qmean | 2.0 milliliters per second | Standard Deviation 3.1 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) | 12 Week Change Qmean | 1.5 milliliters per second | Standard Deviation 2.9 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) | Baseline Qmax | 11.4 milliliters per second | Standard Deviation 3.2 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) | Baseline Qmean | 6.1 milliliters per second | Standard Deviation 2.1 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) | 12 Week Change Qmax | 2.4 milliliters per second | Standard Deviation 5.2 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) | 12 Week Change Qmean | 1.0 milliliters per second | Standard Deviation 3.4 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) | 12 Week Change Qmax | 1.9 milliliters per second | Standard Deviation 4.8 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) | Baseline Qmean | 6.2 milliliters per second | Standard Deviation 3 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) | Baseline Qmax | 11.7 milliliters per second | Standard Deviation 4.6 |
p-value: 0.838ANCOVA
p-value: 0.831ANCOVA
p-value: 0.696ANCOVA
p-value: 0.257ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp)
Vcomp, defined as the volume of voided urine (measured in milliliters \[mL\]).
Time frame: baseline, 12 weeks
Population: Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp) | Baseline | 220.0 milliliters | Standard Deviation 67.7 |
| Placebo | Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp) | 12 Week Change | 21.4 milliliters | Standard Deviation 128.9 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp) | 12 Week Change | 19.7 milliliters | Standard Deviation 109.2 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp) | Baseline | 233.2 milliliters | Standard Deviation 86.7 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp) | 12 Week Change | 23.9 milliliters | Standard Deviation 89.3 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp) | Baseline | 236.6 milliliters | Standard Deviation 78.4 |
p-value: 0.709ANCOVA
p-value: 0.494ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary
A patient-completed diary that measures terminal dribble (dribble in the end of urination) and post-micturition dribble (dribble after urination).
Time frame: baseline, 12 weeks
Population: Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary | Baseline Post Micturation Dribble | 14.3 average number per week | Standard Deviation 27 |
| Placebo | Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary | Baseline Terminal Micturation Dribble | 68.7 average number per week | Standard Deviation 35.8 |
| Placebo | Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary | 12 Week Change Terminal Micturation Dribble | -11.7 average number per week | Standard Deviation 36.9 |
| Placebo | Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary | 12 Week Change Post Micturation Dribble | -0.8 average number per week | Standard Deviation 29.5 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary | Baseline Post Micturation Dribble | 17.8 average number per week | Standard Deviation 29.8 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary | Baseline Terminal Micturation Dribble | 69.8 average number per week | Standard Deviation 37 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary | 12 Week Change Post Micturation Dribble | -4.8 average number per week | Standard Deviation 27.4 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary | 12 Week Change Terminal Micturation Dribble | 1.6 average number per week | Standard Deviation 31.9 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary | 12 Week Change Post Micturation Dribble | -7.6 average number per week | Standard Deviation 34.9 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary | Baseline Terminal Micturation Dribble | 77.5 average number per week | Standard Deviation 29.9 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary | 12 Week Change Terminal Micturation Dribble | -8.5 average number per week | Standard Deviation 33.1 |
| Tamsulosin | Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary | Baseline Post Micturation Dribble | 25.5 average number per week | Standard Deviation 32.6 |
p-value: 0.595Wilcoxon Rank Sum
p-value: 0.704Wilcoxon Rank Sum
p-value: 0.439Wilcoxon Rank Sum
p-value: 0.385Wilcoxon Rank Sum
Secondary
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore
The IPSS storage (irritative) subscore is defined as sum of scores for Questions 2, 4, and 7 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS storage subscore will be reported as missing for that visit. Subscore totals range from 0 to 15; higher scores are indicative of greater irritation.
Time frame: baseline, 4, 8, and 12 weeks
Population: Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore | Baseline (n=50, n=50, n=49) | 6.7 units on a scale | Standard Deviation 2 |
| Placebo | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore | 4 Week Change (n=50, n=49, n=49) | -0.8 units on a scale | Standard Deviation 2.1 |
| Placebo | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore | 8 Week Change (n=47, n=50, n=48) | -0.9 units on a scale | Standard Deviation 2 |
| Placebo | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore | 12 Week Change (n=47, n=48, n=48) | -1.6 units on a scale | Standard Deviation 2.1 |
| Tadalafil | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore | 12 Week Change (n=47, n=48, n=48) | -2.2 units on a scale | Standard Deviation 2.4 |
| Tadalafil | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore | Baseline (n=50, n=50, n=49) | 6.7 units on a scale | Standard Deviation 2.7 |
| Tadalafil | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore | 8 Week Change (n=47, n=50, n=48) | -1.6 units on a scale | Standard Deviation 2.5 |
| Tadalafil | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore | 4 Week Change (n=50, n=49, n=49) | -1.4 units on a scale | Standard Deviation 2.4 |
| Tamsulosin | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore | 12 Week Change (n=47, n=48, n=48) | -1.8 units on a scale | Standard Deviation 2.7 |
| Tamsulosin | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore | 4 Week Change (n=50, n=49, n=49) | -1.7 units on a scale | Standard Deviation 2.1 |
| Tamsulosin | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore | 8 Week Change (n=47, n=50, n=48) | -1.9 units on a scale | Standard Deviation 2.3 |
| Tamsulosin | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore | Baseline (n=50, n=50, n=49) | 6.5 units on a scale | Standard Deviation 2.6 |
p-value: 0.137ANCOVA
p-value: 0.009ANCOVA
p-value: 0.118ANCOVA
p-value: 0.018ANCOVA
p-value: 0.207ANCOVA
p-value: 0.581ANCOVA
Secondary
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore
IPSS Question 7 is used to assess the frequency of nocturia. Scores range from 0 (low frequency of nocturia) to 5 (high frequency of nocturia).
Time frame: baseline, 4, 8, and 12 weeks
Population: Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore | 12 Week Change (n=47, n=48, n=48) | -0.5 units on a scale | Standard Deviation 0.9 |
| Placebo | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore | 8 Week Change (n=47, n=50, n=48) | -0.4 units on a scale | Standard Deviation 0.7 |
| Placebo | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore | 4 Week Change (n=50, n=49, n=49) | -0.3 units on a scale | Standard Deviation 0.9 |
| Placebo | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore | Baseline (n=50, n=50, n=49) | 2.0 units on a scale | Standard Deviation 1.1 |
| Tadalafil | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore | 8 Week Change (n=47, n=50, n=48) | -0.4 units on a scale | Standard Deviation 1 |
| Tadalafil | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore | 4 Week Change (n=50, n=49, n=49) | -0.4 units on a scale | Standard Deviation 0.9 |
| Tadalafil | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore | Baseline (n=50, n=50, n=49) | 1.8 units on a scale | Standard Deviation 1 |
| Tadalafil | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore | 12 Week Change (n=47, n=48, n=48) | -0.5 units on a scale | Standard Deviation 0.9 |
| Tamsulosin | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore | 4 Week Change (n=50, n=49, n=49) | -0.3 units on a scale | Standard Deviation 1 |
| Tamsulosin | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore | Baseline (n=50, n=50, n=49) | 1.7 units on a scale | Standard Deviation 1 |
| Tamsulosin | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore | 12 Week Change (n=47, n=48, n=48) | -0.5 units on a scale | Standard Deviation 1.1 |
| Tamsulosin | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore | 8 Week Change (n=47, n=50, n=48) | -0.4 units on a scale | Standard Deviation 1.2 |
p-value: 0.206ANCOVA
p-value: 0.457ANCOVA
p-value: 0.892ANCOVA
p-value: 0.593ANCOVA
p-value: 0.887ANCOVA
p-value: 0.762ANCOVA
Secondary
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore
The IPSS voiding (obstructive) subscore is defined as sum of scores for Questions 1, 3, 5, and 6 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS voiding subscore will be reported as missing for that visit. Subscore totals range from 0 to 20; higher scores are indicative of greater obstruction.
Time frame: baseline, 4, 8, and 12 weeks
Population: Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore | 4 Week Change (n=50, n=49, n=49) | -2.0 units on a scale | Standard Deviation 4 |
| Placebo | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore | Baseline (n=50, n=50, n=49) | 10.6 units on a scale | Standard Deviation 3.7 |
| Placebo | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore | 8 Week Change (n=47, n=50, n=48) | -2.3 units on a scale | Standard Deviation 4.1 |
| Placebo | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore | 12 Week Change (n=47, n=48, n=48) | -2.7 units on a scale | Standard Deviation 3.6 |
| Tadalafil | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore | 12 Week Change (n=47, n=48, n=48) | -3.6 units on a scale | Standard Deviation 3.4 |
| Tadalafil | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore | 4 Week Change (n=50, n=49, n=49) | -2.6 units on a scale | Standard Deviation 3.1 |
| Tadalafil | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore | 8 Week Change (n=47, n=50, n=48) | -3.1 units on a scale | Standard Deviation 3.1 |
| Tadalafil | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore | Baseline (n=50, n=50, n=49) | 10.4 units on a scale | Standard Deviation 3.8 |
| Tamsulosin | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore | 12 Week Change (n=47, n=48, n=48) | -3.9 units on a scale | Standard Deviation 3.6 |
| Tamsulosin | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore | Baseline (n=50, n=50, n=49) | 11.2 units on a scale | Standard Deviation 3.7 |
| Tamsulosin | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore | 8 Week Change (n=47, n=50, n=48) | -3.1 units on a scale | Standard Deviation 3.8 |
| Tamsulosin | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore | 4 Week Change (n=50, n=49, n=49) | -2.4 units on a scale | Standard Deviation 3.1 |
p-value: 0.306ANCOVA
p-value: 0.762ANCOVA
p-value: 0.203ANCOVA
p-value: 0.464ANCOVA
p-value: 0.169ANCOVA
p-value: 0.243ANCOVA
Secondary
Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 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: baseline, 4 and 8 weeks
Population: Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score | 4 Week Change (n=50, n=49, n=49) | -2.8 units on a scale | Standard Error 0.6 |
| Placebo | Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score | 8 Week Change (n=47, n=50, n=48) | -3.3 units on a scale | Standard Error 0.7 |
| Tadalafil | Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score | 4 Week Change (n=50, n=49, n=49) | -4.0 units on a scale | Standard Error 0.6 |
| Tadalafil | Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score | 8 Week Change (n=47, n=50, n=48) | -4.8 units on a scale | Standard Error 0.6 |
| Tamsulosin | Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score | 4 Week Change (n=50, n=49, n=49) | -4.0 units on a scale | Standard Error 0.6 |
| Tamsulosin | Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score | 8 Week Change (n=47, n=50, n=48) | -4.8 units on a scale | Standard Error 0.7 |
p-value: 0.155ANCOVA
p-value: 0.155ANCOVA
p-value: 0.108ANCOVA
p-value: 0.112ANCOVA
Secondary
Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies
Measures clinician's perception of patient improvement of illness at the time of assessment compared with start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants whose clinician indicated they were worse (scores of 5, 6, or 7), no change (score of 4), or better (scores of 1, 2, or 3).
Time frame: 12 weeks
Population: Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies | No Change | 5 participants |
| Placebo | Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies | Worse | 0 participants |
| Placebo | Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies | Better | 43 participants |
| Tadalafil | Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies | No Change | 8 participants |
| Tadalafil | Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies | Better | 41 participants |
| Tadalafil | Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies | Worse | 0 participants |
| Tamsulosin | Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies | Worse | 4 participants |
| Tamsulosin | Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies | Better | 40 participants |
| Tamsulosin | Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies | No Change | 4 participants |
p-value: 0.429Cochran-Mantel-Haenszel
p-value: 0.304Cochran-Mantel-Haenszel
Secondary
Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants who indicated they were worse (scores of 5, 6, or 7), no change (score of 4), or better (scores of 1, 2, or 3).
Time frame: 12 weeks
Population: Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies | No Change | 10 participants |
| Placebo | Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies | Worse | 1 participants |
| Placebo | Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies | Better | 37 participants |
| Tadalafil | Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies | No Change | 5 participants |
| Tadalafil | Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies | Worse | 1 participants |
| Tadalafil | Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies | Better | 43 participants |
| Tamsulosin | Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies | Worse | 3 participants |
| Tamsulosin | Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies | Better | 38 participants |
| Tamsulosin | Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies | No Change | 7 participants |
p-value: 0.176Cochran-Mantel-Haenszel
p-value: 0.921Cochran-Mantel-Haenszel