Detrusor pressure (Pdet) measures the force the detrusor muscle is exerting. This pressure is required to expel urine from the bladder during normal voiding. A high detrusor pressure may be observed in the presence of outflow tract obstruction. Detrusor pressure at maximum urinary flow rate (PdetQmax) was evaluated using simultaneous recording of urinary voiding by an uroflowmeter during detrusor pressure evaluation by cystometry.

Full analysis set (FAS) population consisted of participants who received at least one dose of double-blind treatment and had both urodynamic measurements at baseline and one or both measured at any post-baseline on-treatment visit. Last observation carried forward (LOCF) imputation was used.

Healthy micturitions result in complete emptying of the bladder. Post Void Residual (PVR) is the volume of urine retained after voiding (post-void residual urine). Post void residual volume was assessed by abdominal ultrasound. An increasing PVR over time is an indicator of abnormal bladder function or detrusor decompensation.

End-of-treatment is the last post-baseline assessment during the treatment period.

Least squares (LS) means were adjusted for pooled center and the Baseline value.

Full analysis set (FAS) population with available data at each time point (as indicated by "N"). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.

The maximum flow rate (Qmax) during a micturition (urination) was recorded using uroflowmetry. A reduction in maximum flow rate may be due to an obstruction of the bladder outlet or a failure of the detrusor muscle to aid in expelling urine.

Full analysis set (FAS) population consisted of participants who received at least one dose of double-blind treatment and had urodynamic measurements at baseline and post-baseline on-treatment visit. Last observation carried forward (LOCF) imputation was used.

The Bladder Contractility Index (BCI) is a value used to measure the degree of contractility. BCI was calculated using the following formula:

BCI = pdetQmax + 5Qmax.

Strong contractility is a BCI > 150, normal contractility is a BCI of 100-150 and weak contractility is a BCI of < 100.

LS means were adjusted for pooled center and Baseline value.

Full analysis set (FAS) population; Last observation carried forward (LOCF) imputation was used.

Percent Bladder Voiding Efficiency (BVE) is a product of bladder contractility against the urethral resistance and is measured according to the degree of bladder emptying. BVE is expressed as a percentage and is calculated using the formula:

Bladder Voiding efficiency = (Voided volume x 100)/maximum cystometric capacity.

A higher number indicates a higher voiding efficiency.

LS means were adjusted for pooled center and Baseline value.

Full analysis set (FAS) population; Last observation carried forward (LOCF) imputation was used.

Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug.

Safety analysis set population consisted of participants who received at least 1 dose of double-blind treatment.

The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms and is based on the answers to 7 questions concerning urinary symptoms:

• Sensation of incomplete emptying
• Repeat urinating after 2 hours (frequency)
• Start and stop several times (intermittency)
• Urgency
• Weak stream
• Straining
• Nocturia

Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).

Least squares (LS) means were adjusted for pooled center and the Baseline value.

Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.

The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 questions relating to urination (incomplete emptying, intermittency, weak stream and straining) and ranges from 0 to 20 (asymptomatic to very symptomatic).

Least squares (LS) means were adjusted for pooled center and the Baseline value.

Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.

The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 questions relating to storage symptoms (frequency, urgency and nocturia) and ranges from 0 to 15 (asymptomatic to very symptomatic).

Least squares (LS) means were adjusted for pooled center and the Baseline value.

Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.

The patient perception of bladder condition (PPBC) questionnaire asks participants to assess their bladder condition using a 6-point validated Likert scale which ranges from 1 (does not cause me any problems at all) to 6 (causes me many severe problems).

Least squares (LS) means were adjusted for pooled center and the Baseline value.

Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.

A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.

Least squares (LS) means were adjusted for pooled center and the Baseline value.

Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.

For each micturition and/or incontinence episode participants rated the degree of associated urgency (the sudden compelling desire to pass urine, which is difficult to defer) according to the following scale: 0: No Urgency, felt no need to empty my bladder but did so for another reason; 1: Mild urgency, could postpone passing water for as long as necessary; 2: Moderate urgency, could postpone passing water for a short while; 3: Severe urgency, could not postpone passing water; 4: Urge incontinence, leaked before reaching the toilet. An urgency episode is defined as an episode with urgency severity of three or higher.

The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.

Least squares (LS) means were adjusted for pooled center and the Baseline value.

Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.

The mean number of incontinence episodes (the involuntary leakage of urine) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.

Least squares (LS) means were adjusted for pooled center and the Baseline value.

Full analysis set (FAS) population who had 3-day averaged incontinence episodes >0 at Baseline and with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.

The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.

Least squares (LS) means were adjusted for pooled center and the Baseline value.

Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.

Male lower urinary tract symptoms were assessed by the ICIQ MLUTS questionnaire which consists of 13 questions regarding urinary symptoms. Each question is answered by the participant on a scale from 0 (never) to 4 (all the time). The total symptom score ranges from 0 to 52, where larger scores correspond to worse conditions.

Least squares (LS) means were adjusted for pooled center and the Baseline value.

Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as "N"). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.

The degree to which urinary symptoms bothered participants was assessed by the ICIQ MLUTS questionnaire which consists of 13 symptom bother questions. Each question is answered by the participant on a scale from 0 (not at all) to 10 (a great deal). The total bother score ranges from 0 to 130, where larger scores correspond to worse outcomes.

Least squares (LS) means were adjusted for pooled center and the Baseline value.

Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as "N"). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.

Quality of life was assessed by the ICIQ-LUTSqol questionnaire which consists of 19 questions regarding daily activities affected by urinary problems. Participants responded to each question on a scale from 1 (not at all) to 4 (a lot). The total symptom score ranges from 19 to 76, where larger scores correspond to a lesser quality of life).

Least squares (LS) means were adjusted for pooled center and the Baseline value.

Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as "N"). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.

Participants were asked to rate how much their urinary symptoms interfered overall with their everyday life on a scale from 0 (not at all) to 10 (a great deal).

Least squares (LS) means were adjusted for pooled center and the Baseline value.

Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as "N"). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.