Overactive Bladder
Conditions
Keywords
Overactive Bladder, Benign Prostatic Hyperplasia, Vibegron, Beta-3 adrenergic receptor (β3-AR), β3-AR agonist
Brief summary
This study will assess the long-term safety of vibegron when dosed up to 52 weeks in men with overactive bladder (OAB) symptoms on pharmacological therapy for Benign Prostatic Hyperplasia (BPH) who previously completed treatment in Study URO-901-3005 (NCT03902080).
Interventions
DRUGVibegron
oral administration
Sponsors
Urovant Sciences GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Long-term extension
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant has completed participation of the 24-week double-blind treatment period in Study URO-901-3005 (NCT03902080) and demonstrated compliance with the study procedures and study medication schedule in the opinion of the investigator. * Participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * Participant has the ability to continue to receive a stable dose of Benign Prostatic Hyperplasia (BPH) treatment with either a) alpha blocker monotherapy or b) alpha blocker +5-ARI. * In the opinion of the investigator, the participant is able and willing to comply with the requirements of the protocol, including completing study questionnaires and the Bladder Diary.
Exclusion criteria
* Participant experienced any Serious Adverse Event in Study URO-901-3005 that was reported as possibly or probably related to study treatment by the investigator. * Participant is using any prohibited medications * Participant has uncontrolled hyperglycemia (defined as fasting blood glucose \>150 milligrams per deciliter \[mg/dL\] or 8.33 millimoles per Liter \[mmol/L\] and/or non-fasting blood glucose \>200 mg/dL or 11.1 mmol/L) based on most recent available lab results in Study URO-901-3005 or uncontrolled in the opinion of the investigator. * Participant has uncontrolled hypertension (systolic blood pressure of ≥180 millimeters of mercury \[mmHg\] and/or diastolic blood pressure of ≥100 mmHg) or has a resting heart rate (by pulse) \>100 beats per minute. * Participant has systolic blood pressures ≥160 mmHg but \<180 mmHg, unless deemed by the investigator as safe to proceed in this study and able to complete the study per protocol. * Participant has current evidence of any clinically significant condition, therapy, lab abnormality, or other circumstances that might, in the opinion of the investigator, confound the results of the study, interfere with the participant's ability to comply with study procedures, or make participation in the study not in the participant's best interest.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Heart Rate | Baseline; Week 52 | Heart Rate was measured with the participant in the sitting position. Baseline is defined as the last recorded value on or prior to the date of randomization in the parent study URO-901-3005. CFB was calculated as maximum post-Baseline value minus Baseline value. |
| Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%) | Up to Week 52 | Adverse events were collected in participants from time each participant provided informed consent in parent study through Follow-up Visit (approximately 5 days after the last dose of study drug) in this extension study (URO-901-3006 \[NCT03902080\]). For the 28-Week Vibegron group, AEs recorded prior to initiation of vibegron (ie, while receiving placebo in the parent study) were reported as AEs in the parent study. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAE of \>5% has been reported. |
| Number of Participants With Clinically Significant Changes in Hematology Parameters | Up to Week 52 | Blood samples were collected for the analysis of hematology parameters - Hematocrit, hemoglobin, platelet count, white blood cells (WBC \[total and differential\]), and red blood cells (RBC). |
| Number of Participants With Clinically Significant Changes in Chemistry Parameters | Up to Week 52 | Blood samples were collected for the analysis of chemistry parameters - Albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, calcium, chloride, creatininea, glucose (fasting or nonfasting), potassium, sodium, total bilirubin, direct bilirubin, blood urea nitrogen (BUN), and total cholesterol. |
| Number of Participants With Clinically Significant Changes in Urinary Parameters | Up to Week 52 | Urine samples were collected for the analysis of urinary parameters- Blood, glucose, protein, specific gravity, microscopic exam (RBCs, WBCs, epithelial cells, and bacteria), potential of hydrogen (pH) and color |
| Number of Participants With Clinically Significant Changes in Coagulation Parameter | Up to Week 52 | Blood samples were collected for the analysis of coagulation parameters- international normalized ratio (INR), prothrombin time (PT) and activated partial thromboplastin time (APTT). |
| Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Baseline; Week 52 | Blood pressure measurements were taken with the participant in the sitting position. Baseline is defined as the last recorded value on or prior to the date of randomization in the parent study URO-901-3005. Change from Baseline was calculated as maximum post-Baseline value minus Baseline value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at Week 52 in the Average Number of Urgency Episodes Per Day | Baseline; Week 52 | The number of urgency episodes was defined as the number of times a participant checked that they had the need to urinate immediately as indicated on the Bladder Diary. Average number of daily urgency episodes at each study visit was calculated as the total number of urgency episodes using records within the diary analysis visit windows divided by non-missing diary days. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value. |
| Change From Baseline at Week 52 in the Average Number of Nocturia Episodes Per Night | Baseline; Week 52 | A nocturia episode is defined as waking to pass urine during the main sleep period as indicated on the Bladder diary. Average number of nocturia episode at each study visit was calculated as the total number of nocturia episode recorded within the diary analysis visit windows divided by non-missing diary days. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value. |
| Change From Baseline at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day in Participants With Incontinence | Baseline; Week 52 | The number of UUI episodes was defined as the number of times a participant checked that they had urge as the main reason for leakage. Average UUI episodes per day at each study visit was calculated as total number of UUI episodes within the diary analysis visit windows divided by non-missing diary days. The UUI was analyzed for participants with UI at Baseline. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline at Week 52 in the Average of the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall) | Baseline; Week 52 | The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS is based on 7 questions concerning urinary symptoms and 1 question concerning quality of life. Each question concerning urinary symptoms allows the participant to choose 1 out of 6 answers indicating increasing severity of the symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Higher scores represent greater severity of symptoms. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline at Week 52 in the Average Volume Voided Per Micturition | Baseline; Week 52 | Total volume voided was calculated using all urinary volumes collected regardless of whether participant checked Urinated in Toilet or not. Average volume voided per micturition at each study visit was calculated as the total volume voided recorded divided by the number of micturitions with volume recorded. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline at Week 52 in the Average Number of Micturition Episodes Per Day | Baseline; Week 52 | Micturition is defined as Urinated in Toilet as indicated on Bladder Diary. Micturition episodes are the number of times participants voided in the toilet as indicated on the Bladder Diary, either by marking the 'urinated in toilet' question as yes or recording non-zero volume voided. Average number of micturition episodes/day was calculated using records within the diary analysis visit divided by non-missing diary days (diary days with at least one void reported). A Diary Day is defined as the time between when the participants gets up for the day (ie, the time the participant got up for the day yesterday to the time participant got up for the day today; approximately a 24-hour period). The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value. |
Countries
Poland, United States
Participant flow
Pre-assignment details
A total of 276 participants who completed Study URO-901-3005 (NCT03902080) were enrolled in Study URO-901-3006 (NCT04103450) and received at least 1 dose of open-label study drug (vibegron).
Participants by arm
| Arm | Count |
|---|---|
| 52-Week Vibegron Group Participants in Study URO-901-3005 who had been randomized to receive vibegron 75 mg once daily, orally will continue to receive same treatment in Study URO-901-3006, for an additional 28 weeks. Thus, participants will receive total 52 weeks of 75 mg vibegron treatment. No dosage adjustments were allowed. | 142 |
| 28-Week Vibegron Group Participants in Study URO-901-3005 who had been randomized to receive the placebo will receive study treatment of vibegron 75 mg once daily, orally for 28 weeks during the open label extension period. No dosage adjustments were allowed. | 134 |
| Total | 276 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 2 |
| Overall Study | Lack of Efficacy | 3 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Other | 1 | 1 |
| Overall Study | Physician Decision | 1 | 2 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 3 |
Baseline characteristics
| Characteristic | 28-Week Vibegron Group | Total | 52-Week Vibegron Group |
|---|---|---|---|
| Age, Continuous | 67.9 Years STANDARD_DEVIATION 8.17 | 67.6 Years STANDARD_DEVIATION 8.39 | 67.4 Years STANDARD_DEVIATION 8.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 31 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 112 Participants | 239 Participants | 127 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 134 Participants | 276 Participants | 142 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 142 | 0 / 134 |
| other Total, other adverse events | 17 / 142 | 3 / 134 |
| serious Total, serious adverse events | 2 / 142 | 3 / 134 |
Outcome results
Primary
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Blood pressure measurements were taken with the participant in the sitting position. Baseline is defined as the last recorded value on or prior to the date of randomization in the parent study URO-901-3005. Change from Baseline was calculated as maximum post-Baseline value minus Baseline value.
Time frame: Baseline; Week 52
Population: SAF-Ext Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 52-Week Vibegron Group | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP | -1.2 Millimeters of mercury | Standard Deviation 12.5 |
| 52-Week Vibegron Group | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP | 0.2 Millimeters of mercury | Standard Deviation 8.79 |
| 28-Week Vibegron Group | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP | 0.1 Millimeters of mercury | Standard Deviation 9.31 |
| 28-Week Vibegron Group | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP | 1.1 Millimeters of mercury | Standard Deviation 6.82 |
Primary
Change From Baseline in Heart Rate
Heart Rate was measured with the participant in the sitting position. Baseline is defined as the last recorded value on or prior to the date of randomization in the parent study URO-901-3005. CFB was calculated as maximum post-Baseline value minus Baseline value.
Time frame: Baseline; Week 52
Population: SAF Ext Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 52-Week Vibegron Group | Change From Baseline in Heart Rate | 3.3 Beats per minute | Standard Deviation 9.24 |
| 28-Week Vibegron Group | Change From Baseline in Heart Rate | -0.7 Beats per minute | Standard Deviation 7.98 |
Primary
Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%)
Adverse events were collected in participants from time each participant provided informed consent in parent study through Follow-up Visit (approximately 5 days after the last dose of study drug) in this extension study (URO-901-3006 \[NCT03902080\]). For the 28-Week Vibegron group, AEs recorded prior to initiation of vibegron (ie, while receiving placebo in the parent study) were reported as AEs in the parent study. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAE of \>5% has been reported.
Time frame: Up to Week 52
Population: SAF-Ext Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 52-Week Vibegron Group | Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%) | Any SAE | 2 Participants |
| 52-Week Vibegron Group | Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%) | Any non-SAE | 17 Participants |
| 28-Week Vibegron Group | Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%) | Any SAE | 3 Participants |
| 28-Week Vibegron Group | Number of Participants With Any Serious Adverse Event, and Treatment Emergent Adverse Event (>5%) | Any non-SAE | 3 Participants |
Primary
Number of Participants With Clinically Significant Changes in Chemistry Parameters
Blood samples were collected for the analysis of chemistry parameters - Albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, calcium, chloride, creatininea, glucose (fasting or nonfasting), potassium, sodium, total bilirubin, direct bilirubin, blood urea nitrogen (BUN), and total cholesterol.
Time frame: Up to Week 52
Population: SAF-Ext Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 52-Week Vibegron Group | Number of Participants With Clinically Significant Changes in Chemistry Parameters | 0 Participants |
| 28-Week Vibegron Group | Number of Participants With Clinically Significant Changes in Chemistry Parameters | 0 Participants |
Primary
Number of Participants With Clinically Significant Changes in Coagulation Parameter
Blood samples were collected for the analysis of coagulation parameters- international normalized ratio (INR), prothrombin time (PT) and activated partial thromboplastin time (APTT).
Time frame: Up to Week 52
Population: SAF Ext Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 52-Week Vibegron Group | Number of Participants With Clinically Significant Changes in Coagulation Parameter | 0 Participants |
| 28-Week Vibegron Group | Number of Participants With Clinically Significant Changes in Coagulation Parameter | 0 Participants |
Primary
Number of Participants With Clinically Significant Changes in Hematology Parameters
Blood samples were collected for the analysis of hematology parameters - Hematocrit, hemoglobin, platelet count, white blood cells (WBC \[total and differential\]), and red blood cells (RBC).
Time frame: Up to Week 52
Population: SAF-Ext Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 52-Week Vibegron Group | Number of Participants With Clinically Significant Changes in Hematology Parameters | 0 Participants |
| 28-Week Vibegron Group | Number of Participants With Clinically Significant Changes in Hematology Parameters | 0 Participants |
Primary
Number of Participants With Clinically Significant Changes in Urinary Parameters
Urine samples were collected for the analysis of urinary parameters- Blood, glucose, protein, specific gravity, microscopic exam (RBCs, WBCs, epithelial cells, and bacteria), potential of hydrogen (pH) and color
Time frame: Up to Week 52
Population: SAF Ext Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 52-Week Vibegron Group | Number of Participants With Clinically Significant Changes in Urinary Parameters | 0 Participants |
| 28-Week Vibegron Group | Number of Participants With Clinically Significant Changes in Urinary Parameters | 0 Participants |
Secondary
Change From Baseline at Week 52 in the Average Number of Micturition Episodes Per Day
Micturition is defined as Urinated in Toilet as indicated on Bladder Diary. Micturition episodes are the number of times participants voided in the toilet as indicated on the Bladder Diary, either by marking the 'urinated in toilet' question as yes or recording non-zero volume voided. Average number of micturition episodes/day was calculated using records within the diary analysis visit divided by non-missing diary days (diary days with at least one void reported). A Diary Day is defined as the time between when the participants gets up for the day (ie, the time the participant got up for the day yesterday to the time participant got up for the day today; approximately a 24-hour period). The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Time frame: Baseline; Week 52
Population: Full Analysis Set Extension (FAS-Ext) comprises of all OAB participants who took at least one dose of vibegron in the extension study and have at least one evaluable change from Baseline micturition measurement in this study. Note that the 28-week vibegron group is not included in the change from baseline at Week 52 outcome analyses because this group receieved study treatment for 28 weeks only and no data is avaliable to report at 52 weeks of treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 52-Week Vibegron Group | Change From Baseline at Week 52 in the Average Number of Micturition Episodes Per Day | -2.43 Micturition Episodes per Day | Standard Error 0.299 |
Secondary
Change From Baseline at Week 52 in the Average Number of Nocturia Episodes Per Night
A nocturia episode is defined as waking to pass urine during the main sleep period as indicated on the Bladder diary. Average number of nocturia episode at each study visit was calculated as the total number of nocturia episode recorded within the diary analysis visit windows divided by non-missing diary days. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Time frame: Baseline; Week 52
Population: Full Analysis Set Extension (FAS-Ext) comprises of all OAB participants who took at least one dose of vibegron in the extension study and have at least one evaluable change from Baseline micturition measurement in this study. Note that the 28-week vibegron group is not included in the change from baseline at Week 52 outcome analyses because this group receieved study treatment for 28 weeks only and no data is avaliable to report at 52 weeks of treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 52-Week Vibegron Group | Change From Baseline at Week 52 in the Average Number of Nocturia Episodes Per Night | -1.01 Nocturia Episodes per Night | Standard Error 0.144 |
Secondary
Change From Baseline at Week 52 in the Average Number of Urgency Episodes Per Day
The number of urgency episodes was defined as the number of times a participant checked that they had the need to urinate immediately as indicated on the Bladder Diary. Average number of daily urgency episodes at each study visit was calculated as the total number of urgency episodes using records within the diary analysis visit windows divided by non-missing diary days. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Time frame: Baseline; Week 52
Population: Full Analysis Set Extension (FAS-Ext) comprises of all OAB participants who took at least one dose of vibegron in the extension study and have at least one evaluable change from Baseline micturition measurement in this study. Note that the 28-week vibegron group is not included in the change from baseline at Week 52 outcome analyses because this group receieved study treatment for 28 weeks only and no data is avaliable to report at 52 weeks of treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 52-Week Vibegron Group | Change From Baseline at Week 52 in the Average Number of Urgency Episodes Per Day | -2.90 Urgency Episodes per Day | Standard Error 0.422 |
Secondary
Change From Baseline at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day in Participants With Incontinence
The number of UUI episodes was defined as the number of times a participant checked that they had urge as the main reason for leakage. Average UUI episodes per day at each study visit was calculated as total number of UUI episodes within the diary analysis visit windows divided by non-missing diary days. The UUI was analyzed for participants with UI at Baseline. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Week 52
Population: Full Analysis Set Extension (FAS-Ext) comprises of all OAB participants who took at least one dose of vibegron in the extension study and have at least one evaluable change from Baseline micturition measurement in this study. Note that the 28-week vibegron group is not included in the change from baseline at Week 52 outcome analyses because this group receieved study treatment for 28 weeks only and no data is avaliable to report at 52 weeks of treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 52-Week Vibegron Group | Change From Baseline at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day in Participants With Incontinence | -0.75 UUI Episodes per day | Standard Error 0.773 |
Secondary
Change From Baseline at Week 52 in the Average of the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall)
The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS is based on 7 questions concerning urinary symptoms and 1 question concerning quality of life. Each question concerning urinary symptoms allows the participant to choose 1 out of 6 answers indicating increasing severity of the symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Higher scores represent greater severity of symptoms. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Week 52
Population: Full Analysis Set Extension (FAS-Ext) comprises of all OAB participants who took at least one dose of vibegron in the extension study and have at least one evaluable change from Baseline micturition measurement in this study. Note that the 28-week vibegron group is not included in the change from baseline at Week 52 outcome analyses because this group receieved study treatment for 28 weeks only and no data is avaliable to report at 52 weeks of treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 52-Week Vibegron Group | Change From Baseline at Week 52 in the Average of the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall) | -3.5 Scores on a scale | Standard Error 0.31 |
Secondary
Change From Baseline at Week 52 in the Average Volume Voided Per Micturition
Total volume voided was calculated using all urinary volumes collected regardless of whether participant checked Urinated in Toilet or not. Average volume voided per micturition at each study visit was calculated as the total volume voided recorded divided by the number of micturitions with volume recorded. The last recorded value on or prior to the date of randomization in the parent study URO-901-3005 is defined as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Week 52
Population: Full Analysis Set Extension (FAS-Ext) comprises of all OAB participants who took at least one dose of vibegron in the extension study and have at least one evaluable change from Baseline micturition measurement in this study. Note that the 28-week vibegron group is not included in the change from baseline at Week 52 outcome analyses because this group receieved study treatment for 28 weeks only and no data is avaliable to report at 52 weeks of treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 52-Week Vibegron Group | Change From Baseline at Week 52 in the Average Volume Voided Per Micturition | 20.56 Milliliters | Standard Error 6.75 |