Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)

Overactive Bladder (OAB) Clinical Trial

— PILLAR  

Official title:

A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02216214
• Other study ID #: 178-MA-1005
• Status: Completed
• Phase: Phase 4
• Start date: October 7, 2014
• Est. completion date: January 2, 2018

Study information

• Verified date: January 2021
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 888
• Est. completion date: January 2, 2018
• Est. primary completion date: November 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria assessed at Visit 1 (Screening):

• Subject is willing and able to complete the micturition diary and questionnaires correctly.

• Subject has symptoms of wet overactive bladder (OAB) (urinary frequency and urgency with incontinence) for greater than or equal to 3 months prior to Screening.

• Subject agrees not to participate in another interventional study from the time of screening until the final study visit.

Inclusion Criteria assessed after placebo run-in period at Visit 3 (Baseline):

• Subject continues to meet all inclusion criteria of Visit 1.

• Subjects must experience at least one incontinence episode in the placebo run-in period based on the 3-day micturition diary.

• Subject must experience at least 3 episodes of urgency (grade 3 or 4) based on the 3-day micturition diary.

• Subject must experience an average of greater than or equal to 8 micturitions/day based on the 3-day micturition diary.

Exclusion Criteria assessed at Visit 1 (Screening):

• Subject has ongoing symptoms suggestive of bladder outlet obstruction (BOO) or history of BOO that is currently not well controlled.

• Subject has Post-Void Residual Volume (PVR) greater than 150 mL.

• Subject has neurogenic bladder or neurological dysfunction or injury which could affect the lower urinary tract or nerve supply.

• Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the Investigator (for female subjects confirmed by a cough provocation test). Subjects with a history of stress incontinence that is currently treated (e.g. remote history of surgery for stress incontinence) may be included as long as they pass cough provocation test.

• Subject has an indwelling catheter or practices intermittent self-catheterization.

• Subject has evidence of Urinary Tract Infection (UTI). Urine culture and sensitivity will be performed for positive leukocytes, or nitrites, or turbidity, or at the investigator's discretion and will be confirmed with a culture greater than 100,000 cfu/mL. If a subject has a UTI at Screening (Visit 1), the subject can be rescreened after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture).

• Subject has a chronic inflammatory condition such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs (i.e., within the confines of the pelvis including the bladder and rectum in both sexes and the uterus, ovaries, and fallopian tubes in females; organs of the lower gastrointestinal tract are not necessarily considered pelvic organs as the distal ascending colon, the full transverse colon and proximal portion of the descending colon are in the abdomen).

• Subject resides in a nursing home.

• Subject is likely to enter a hospital or nursing home due to medical instability within the next 6 months in the opinion of the Investigator.

• Subject has received intravesical injection in the past 12 months with botulinum toxin, resiniferatoxin, or capsaicin.

• Subject has received electro-stimulation therapy for OAB (e.g. sacral nerve stimulation or Percutaneous Tibial Nerve Stimulation [PTNS]).

• Subject began or has changed a bladder training program or pelvic floor exercises less than 30 days prior to Screening.

• Subject has moderate or severe hepatic impairment defined as Child-Pugh Class B or C.

• Subject has severe renal impairment defined as estimated creatinine clearance less than 29 mL/min determined by Estimated Glomerular Filtration Rate (eGFR, Cockroft-Gault, or MDRD formulae). A subject with end stage renal disease or undergoing dialysis is also not a candidate for the study.

• Subject has severe uncontrolled hypertension, which is defined as a sitting systolic blood pressure greater than or equal to 180 mmHg and/or diastolic blood pressure greater than or equal to 110 mmHg.

• Subject has evidence of QT prolongation on electrocardiogram (ECG) defined as QTc greater than 450 msec for males, QTc greater than 470 msec for females or a known history of QT prolongation.

• Subject has a clinically significant ECG abnormality, as determined by the Investigator.

• Subject has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2x upper limit of normal (ULN), or ?-GT greater than 3x ULN and considered clinically significant by the Investigator.

• Subject has a hypersensitivity to any components of mirabegron, other ß-AR agonists, or any of the inactive ingredients.

• Subject has any clinically significant condition, which in the opinion of the Investigator makes the subject unsuitable for study participation.

• Subject has been treated with an experimental device within 28 days or received an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to Screening.

• Subject has a concurrent malignancy or history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.

• Subject with current history of alcohol and/or drug abuse.

• Subject is using prohibited medications which cannot be stopped safely during the period.

• Subject has stopped, started or changed the dose of a restricted medication within the last 30 days prior to Screening.

• Subject is involved in the conduct of the study as an employee of the Astellas group, third party associated with the study, or the study site team.

• Subject has previously received mirabegron.

Exclusion Criteria assessed after placebo run-in period at Visit 3 (Baseline):

• Subject fulfills any exclusion criteria of Visit 1 (subject does not need to repeat screening assessments [PVR, cough provocation test, chemistry/hematology/urinalysis]).

• Subject was non-compliant during 2-week placebo run-in period, defined as taking less than 80% or greater than 120% of study medication.

• Subject has any systolic blood pressure measurement > 180 mmHg or diastolic blood pressure measurement > 110 in the 3-day diary or during the baseline visit.

Related Conditions & MeSH terms

• Overactive Bladder (OAB)
• Urinary Bladder, Overactive

Intervention

Drug:
• Mirabegron
oral tablet
• Placebo
oral tablet

Locations

Country	Name	City	State
Canada	Site CA00155	Brampton	Ontario
Canada	Site CA00123	Corunna	Ontario
Canada	Site CA00130	Edmonton	Alberta
Canada	Site CA00126	Hamilton	Ontario
Canada	Site CA00164	Lévis	Quebec
Canada	Site CA00118	London	Ontario
Canada	Site CA00158	Montreal	Quebec
Canada	Site CA00073	Point Claire	Quebec
Canada	Site CA00106	Point Claire	Quebec
Canada	Site CA00129	Quebec
Canada	Site CA00160	Quebec
Canada	Site CA00116	Sarnia	Ontario
Canada	Site CA00061	Sherbrooke	Quebec
Canada	Site CA00156	Sherbrooke	Quebec
Canada	Site CA00169	Sudbury	Ontario
Canada	Site CA00168	Toronto	Ontario
Canada	Site CA00074	Vancouver	British Columbia
United States	Site US00067	Akron	Ohio
United States	Site US00140	Albuquerque	New Mexico
United States	Site US00176	Anaheim	California
United States	Site US00009	Anchorage	Alaska
United States	Site US00025	Annapolis	Maryland
United States	Site US00104	Augusta	Kansas
United States	Site US00175	Austin	Texas
United States	Site US00048	Beverly Hills	California
United States	Site US00142	Beverly Hills	California
United States	Site US00159	Billings	Montana
United States	Site US00041	Boise	Idaho
United States	Site US00032	Bristol	Tennessee
United States	Site US00091	Brockton	Massachusetts
United States	Site US00016	Brooklyn	New York
United States	Site US00064	Brooksville	Florida
United States	Site US00153	Charlotte	North Carolina
United States	Site US00154	Chattanooga	Tennessee
United States	Site US00050	Cincinnati	Ohio
United States	Site US00095	Cleveland	Ohio
United States	Site US00026	Colorado Springs	Colorado
United States	Site US00132	Concord	North Carolina
United States	Site US00080	Coral Gables	Florida
United States	Site US00002	DeBary	Florida
United States	Site US00001	DeLand	Florida
United States	Site US00017	DeLand	Florida
United States	Site US00004	Denver	Colorado
United States	Site US00039	Denver	Colorado
United States	Site US00113	East Brunswick	New Jersey
United States	Site US00018	Edgewater	Florida
United States	Site US00024	Edina	Minnesota
United States	Site US00085	Fargo	North Dakota
United States	Site US00027	Fleming Island	Florida
United States	Site US00053	Franklin	Tennessee
United States	Site US00056	Grand Rapids	Michigan
United States	Site US00122	Greensboro	North Carolina
United States	Site US00060	Greenwood	Indiana
United States	Site US00150	Hawaiian Gardens	California
United States	Site US00151	Hialeah	Florida
United States	Site US00131	Houston	Texas
United States	Site US00066	Huntsville	Alabama
United States	Site US00174	Hurst	Texas
United States	Site US00046	Jeffersonville	Indiana
United States	Site US00179	Jupiter	Florida
United States	Site US00003	Kalamazoo	Michigan
United States	Site US00057	Kissimmee	Florida
United States	Site US00172	Lake Charles	Louisiana
United States	Site US00076	Lakeland	Florida
United States	Site US00014	Las Vegas	Nevada
United States	Site US00063	Little Rock	Arkansas
United States	Site US00081	Little Rock	Arkansas
United States	Site US00034	Los Angeles	California
United States	Site US00112	Los Angeles	California
United States	Site US00062	Madison	Wisconsin
United States	Site US00084	Mentor	Ohio
United States	Site US00029	Miami	Florida
United States	Site US00037	Miami	Florida
United States	Site US00042	Miami	Florida
United States	Site US00015	Middleburg Heights	Ohio
United States	Site US00148	Mobile	Alabama
United States	Site US00082	Moncks Corner	South Carolina
United States	Site US00162	Mount Pleasant	South Carolina
United States	Site US00010	Murrieta	California
United States	Site US00052	Nashville	Tennessee
United States	Site US00006	New Bedford	Massachusetts
United States	Site US00111	New Brunswick	New Jersey
United States	Site US00040	New London	Connecticut
United States	Site US00170	Newport News	Virginia
United States	Site US00105	Newton	Kansas
United States	Site US00070	Norfolk	Nebraska
United States	Site US00086	Norfolk	Virginia
United States	Site US00102	Norman	Oklahoma
United States	Site US00007	North Miami	Florida
United States	Site US00045	Overland Park	Kansas
United States	Site US00180	Pittsburgh	Pennsylvania
United States	Site US00021	Pompano Beach	Florida
United States	Site US00035	Port Orange	Florida
United States	Site US00103	Portland	Oregon
United States	Site US00161	Raleigh	North Carolina
United States	Site US00093	Saginaw	Michigan
United States	Site US00075	Saint Petersburg	Florida
United States	Site US00036	Salt Lake City	Utah
United States	Site US00044	Salt Lake City	Utah
United States	Site US00068	San Antonio	Texas
United States	Site US00071	San Antonio	Texas
United States	Site US00100	San Antonio	Texas
United States	Site US00135	San Diego	California
United States	Site US00139	San Diego	California
United States	Site US00144	Santa Maria	California
United States	Site US00137	Sartell	Minnesota
United States	Site US00005	Savannah	Georgia
United States	Site US00167	Seattle	Washington
United States	Site US00083	Stanford	California
United States	Site US00098	Tacoma	Washington
United States	Site US00099	Tampa	Florida
United States	Site US00019	Tucson	Arizona
United States	Site US00020	Tucson	Arizona
United States	Site US00090	Washington	District of Columbia
United States	Site US00145	Watertown	Massachusetts
United States	Site US00134	West Des Moines	Iowa
United States	Site US00023	West Jordan	Utah
United States	Site US00043	Williamsville	New York
United States	Site US00165	Wilmington	North Carolina
United States	Site US00166	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Global Development, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours	A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period.	Baseline and EOT (up to 12 weeks)
Primary	Change From Baseline to EOT in Mean Number of Incontinence Episodes Per 24 Hours	An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated as the average number of times a participant recorded an incontinence episode per day during the 3-day micturition diary period.	Baseline and EOT (up to 12 weeks)
Secondary	Change From Baseline to EOT in Mean Volume Voided Per Micturition	The mean volume voided per micturition during 3 days of the 3-day micturition diary period.	Baseline and EOT (up to 12 weeks)
Secondary	Change From Baseline to EOT in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score	The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 questions, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.	Baseline and EOT (up to 12 weeks)
Secondary	Change From Baseline to EOT in OAB-q: Health Related Quality of Life (HRQL) Total Score	The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.	Baseline and EOT (up to 12 weeks)
Secondary	Change From Baseline to EOT in Patient Perception of Bladder Condition (PPBC)	The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition.	Baseline and EOT (up to 12 weeks)
Secondary	Change From Baseline to EOT in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours	Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode with a severity of grade 3 or 4, assessed by participants based on the PPIUS, where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per 24 hours was calculated as the average number of times a participant recorded an urgency episode (grade 3 and/or 4) with or without incontinence per day during the 3-day micturition diary period.	Baseline and EOT (up to 12 weeks)
Secondary	Change From Baseline to EOT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency episodes was calculated as the average number of times a participant recorded an urgency incontinence episode per day during the 3-day micturition diary period.	Baseline and EOT (up to 12 weeks)
Secondary	Change From to EOT in Mean Number of Nocturia Episodes Per 24 Hours	A nocturia episode was defined as waking at night one or more time to void (i.e., any voiding associated with sleep disturbance between the date/time the participant goes to bed with the intention to sleep until the date/time the participant gets up in the morning with the intention to stay awake). A night time episode of incontinence only is not considered a nocturia episode. The mean number of nocturia episodes per 24 hours was calculated as the average number of times a participant recorded a nocturia episode per day during the 3-day micturition diary period.	Baseline and EOT (up to 12 weeks)
Secondary	Change From Baseline to EOT in Barthel Index of Daily Living Score	The Barthel Index consists of 10 items that measure a person's daily functioning; specifically the activities of daily living and mobility. The total possible score ranges from 0 to 20, with lower scores indicating increased disability.	Baseline and EOT (up to 12 weeks)
Secondary	Change From Baseline to EOT in Vulnerable Elder Survey-13 (VES-13) Score	The VES-13 is a simple function-based tool for screening community-dwelling populations to identify older persons at risk for health deterioration. The VES-13 considers age, self-related health, limitation in physical function, and functional disabilities. The total possible score ranges from 0 to 10, with higher scores indicating increased disability.	Baseline and EOT (up to 12 weeks)
Secondary	Change From Baseline to EOT in PPIUS	The PPIUS is a 5-point categorical scale used by participants to rate the degree of associated urgency for each micturition and/or incontinence episode they experienced. categories include: 0 - No urgency, I felt no need to empty my bladder, but did so for other reasons; 1 - Mild urgency, I could postpone voiding as long as necessary, without fear of wetting myself; 2 - Moderate urgency, I could postpone voiding for a short while, without fear of wetting myself; 3 - Severe urgency, I could not postpone voiding, but had to rush to the toilet in order not to wet myself; 4 - Urge incontinence, I leaked before arriving at the toilet. Scores were recorded in the micturition diary.	Baseline and EOT (up to 12 weeks)
Secondary	Change From Baseline to EOT in OAB-q HRQL Subscale Scores	The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.	Baseline and EOT (up to 12 weeks)
Secondary	Change From Baseline to EOT in Treatment Satisfaction Visual Analog Scale (TS-VAS)	The TS-VAS is a visual analog scale that asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) to 100 (Yes, completely).	Baseline and EOT (up to 12 weeks)
Secondary	Change From Baseline to EOT in University of Alabama, Birmingham - Life Space Assessment (UAB-LSA)	The UAB-LSA measures mobility in terms of the spatial extent of a person's life. Life space is defined based upon the distance a person routinely travels to perform activities over this time frame. The UAB-LSA includes determining how far and how often the person leaves his or her place of residence and the degree of independence the person has. Each level of life space represents a distance further from the room where one sleeps: 0 - Mobility limited to the room where one sleeps; 1 - Mobility limited to within one's dwelling; 2 - Mobility limited to the space just proximal to one's personal living space (for instance, a porch, patio, or yard just outside the home or hallway outside of an apartment); 3 - Mobility limited to one's neighborhood; 4 - Mobility limited to one's town; 5 - Mobility outside one's town. The total scores ranges from 0-120, where a higher score indicates greater mobility.	Baseline and EOT (up to 12 weeks)
Secondary	Change From Baseline in Number of Incontinence Episodes Reported During 3-Day Diary Prior to Each Visit	An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes were calculated as the total number of the incontinence episodes recorded during the 3-day micturition diary period.	Baseline and Weeks 4, 8 and EOT (up to 12 weeks)
Secondary	Change From Baseline in Number of Pads During 3-Day Diary Prior to Each Visit	The number of pads were calculated as the number of times a participant records a new pad used during the 3-day micturition diary period. No data were collected for the number of pads used due to a failure in the programming of the diary used for data collection.	Baseline and EOT (up to 12 weeks)
Secondary	Percentage of Participants Who Achieved Micturition Frequency Normalization	Participants who achieved micturition frequency normalization were defined as participants who had at least 8 micturitions per 24 hours at baseline and less than 8 micturitions per 24 hours post-baseline.	End of treatment (up to 12 weeks)
Secondary	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours	An incontinence episode was defined as the complaint of any involuntary leakage of urine. Participants with 50% reduction in mean number of incontinence episodes per 24 hours were defined as participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at each visit.	End of treatment (up to 12 weeks)
Secondary	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours	An incontinence episode was defined as the complaint of any involuntary leakage of urine. Participants with zero incontinence episodes per 24 hours were defined as participants who had no incontinence episodes per 24 hours during the treatment period at each visit.	End of treatment (up to 12 weeks)
Secondary	Percentage of Participants With = 10-Point Improvement From Baseline in OAB-q HRQL Subscales	The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. Participants with = 10-point improvement from baseline in OAB-q HRQL subscales were defined as participants with at least 10-point improvement from baseline in OAB-q Subscales at each visit.	End of treatment (up to 12 weeks)
Secondary	Percentage of Participants With = 1-Point Improvement From Baseline in PPBC	The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. Participants with = 1-point improvement from baseline in PPBC were defined as participants with at least 1-point improvement from baseline in PPBC at each visit.	End of treatment (up to 12 weeks)
Secondary	Percentage of Participants Major (= 2-Point) Improvement From Baseline in PPBC	The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. Participants with = 2-point improvement from baseline in PPBC were defined as participants with at least 1-point improvement from baseline in PPBC at each visit.	End of treatment (up to 12 weeks)
Secondary	Number of Participants With Adverse Events (AEs)	Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. AEs were considered as serious if resulted in in death, was life-threatening resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required inpatient hospitalization or led to prolongation of hospitalization and other medically important events.	From first dose of study drug up to 30 days after last dose of study drug (up to 13 weeks)
Secondary	Change From Baseline to EOT in Montreal Cognitive Assessment (MoCA) Score	The MoCA was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points, with lower scores indicating worse cognitive function.	Baseline and EOT (up to 12 weeks)
Secondary	Change From Baseline in Post-void Residual Volume (PVR)	PVR was assessed by ultrasonography or bladder scan.	Baseline and EOT (up to 12 weeks)

External Links

•   Link to results on Astellas Clinical Study Results website