A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.

Urologic Diseases Clinical Trial

— BEYOND  

Official title:

A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects With Overactive Bladder (OAB) Treated With Antimuscarinics and Dissatisfied Due to Lack of Efficacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638000
• Other study ID #: 178-EC-001
• Secondary ID: 2011-005713-37
• Status: Completed
• Phase: Phase 3
• First received: July 9, 2012
• Last updated: November 20, 2017
• Start date: June 12, 2012
• Est. completion date: April 24, 2013

Study information

• Verified date: November 2017
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1887
• Est. completion date: April 24, 2013
• Est. primary completion date: April 24, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Subject has symptoms of OAB (urinary frequency and urgency with or without urgency incontinence) for at least 3 months

• Subject is currently or has previously received at least one antimuscarinic agent intended to treat their OAB. The last antimuscarinic must have been taken for at least 4 weeks and taken within 6 months prior to the Screening Visit

Exclusion Criteria:

• Female subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential is sexually active and not practicing a highly reliable method of birth control

• Subject has neurogenic bladder

• 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)

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

• Subject has diabetic neuropathy

• Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs

• Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis, toxic megacolon, myasthenia gravis or any other medical condition which makes the use of anticholinergics contraindicated

• The subject is currently receiving or has a history of treatment with intravesical botulinum toxin (cosmetic use is acceptable) or resiniferatoxin within 9 months prior to screening

• Subject receives non-drug treatment including electro-stimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to screening)

• Subject has moderate to severe hepatic impairment

• Subject has severe renal impairment or end stage renal disease

• Subject has severe uncontrolled hypertension

• Subject has a clinically significant abnormal electrocardiogram (ECG) or has a known history of QT prolongation or currently taking medication known to prolong the QT interval

• Subject has a known or suspected hypersensitivity to solifenacin, mirabegron or any of the inactive ingredients

• Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening

• Subject has been treated with an experimental device within 30 days or received an experimental agent within the longer of 30 days or five half-lives

• Subject is using prohibited medications which cannot be stopped safely at the Screening Visit. Subject is excluded if using restricted medications not meeting protocol-specified criteria

• Subject's last antimuscarinic treatment was solifenacin

Related Conditions & MeSH terms

• Urinary Bladder Diseases
• Urinary Bladder, Overactive
• Urologic Diseases

Intervention

Drug:
• Mirabegron
oral tablet
• Solifenacin succinate
oral tablet

Locations

Country	Name	City	State
Armenia	Site: 37401	Yerevan
Armenia	Site: 37402	Yerevan
Armenia	Site: 37403	Yerevan
Armenia	Site: 37404	Yerevan
Armenia	Site: 37406	Yerevan
Austria	Site: 43006	Baden
Austria	Site: 43014	Graz
Austria	Site: 43015	Innsbruck
Austria	Site: 43013	Linz
Austria	Site: 43005	Oberwart
Austria	Site: 43002	Vienna
Austria	Site: 43011	Vienna
Austria	Site: 43003	Wels
Belarus	Site: 37501	Minsk
Belarus	Site: 37502	Minsk
Belarus	Site: 37504	Vitebsk
Belgium	Site: 32006	Brussels
Belgium	Site: 32008	Deurne
Belgium	Site: 32001	Edegem
Belgium	Site: 32004	Gent
Belgium	Site: 32007	Leuven
Belgium	Site: 32005	Liege
Bulgaria	Site: 35902	Burgas
Bulgaria	Site: 35909	Haskovo
Bulgaria	Site: 35901	Lovech
Bulgaria	Site: 35905	Plovdiv
Bulgaria	Site: 35903	Sofia
Bulgaria	Site: 35906	Sofia
Bulgaria	Site: 35908	Sofia
Canada	Site: 10010	Abbotsford
Canada	Site: 10011	Barrie
Canada	Site: 10001	Bathurst
Canada	Site: 10003	Brampton
Canada	Site: 10005	Brantford
Canada	Site: 10007	Kingston
Canada	Site: 10002	Montreal
Canada	Site: 10009	Sherbrooke
Canada	Site: 10004	Toronto
Canada	Site: 10008	Victoria
Czechia	Site: 42004	Bohumin
Czechia	Site: 42003	Brno
Czechia	Site: 42001	Hradec Kralove
Czechia	Site: 42002	Jihlava
Czechia	Site: 42006	Plzen-Lochotin
Czechia	Site: 42008	Prague
Czechia	Site: 42005	Prague 1
Czechia	Site: 42007	Prague 4
Denmark	Site: 45002	Aalborg
Denmark	Site: 45001	Aarhus N
Denmark	Site: 45005	Frederiksbjerg
Denmark	Site: 45004	Hvidovre
Denmark	Site: 45003	Odense C
Finland	Site: 35802	Jyvaskyla
Finland	Site: 35801	Oulu
Finland	Site: 35804	Tampere
France	Site: 33010	Angers
France	Site: 33007	Colmar Cedex
France	Site: 33011	Dijon
France	Site: 33002	Marseille
France	Site: 33006	Marseille
France	Site: 33013	Nimes
France	Site: 33004	Orleans Cedex 2
France	Site: 33001	Paris Cedex 20
France	Site: 33005	Paris Cedex 20
France	Site: 33003	Rouen
France	Site: 33014	Suresnes Cedex
France	Site: 33017	Tours
France	Site: 33015	Valence
Georgia	Site: 99501	Tbilisi
Georgia	Site: 99502	Tbilisi
Georgia	Site: 99503	Tbilisi
Germany	Site: 49006	Bad Ems
Germany	Site: 49009	Halle Saale
Greece	Site: 30005	Alexandroupoli
Greece	Site: 30001	Athens
Greece	Site: 30007	Athens
Greece	Site: 30009	Athens
Greece	Site: 30006	Herakleion
Greece	Site: 30008	Larisa
Greece	Site: 30004	Patras
Greece	Site: 30002	Thessaloniki
Greece	Site: 30010	Thessaloniki
Hungary	Site: 36003	Budapest
Hungary	Site: 36004	Budapest
Hungary	Site: 36005	Csongrad
Hungary	Site: 36006	Nyiregyhaza
Hungary	Site: 36001	Salgotarjan
Hungary	Site: 36002	Szekszard
Ireland	Site: 35304	Cork
Ireland	Site: 35301	Dublin
Ireland	Site: 35302	Dublin
Ireland	Site: 35306	Dublin
Ireland	Site: 35303	Tralee
Ireland	Site: 35305	Waterford
Italy	Site: 39001	Avellino
Italy	Site: 39005	Catanzaro
Italy	Site: 39003	Cinisello Balsamo
Italy	Site: 39002	Florence
Italy	Site: 39008	Milan
Italy	Site: 39010	Pavia
Italy	Site: 39006	Perugia
Italy	Site: 39007	Treviglio
Kazakhstan	Site: 77705	Almaty
Kazakhstan	Site: 77706	Almaty
Kazakhstan	Site: 77702	Astana
Kazakhstan	Site: 77703	Astana
Latvia	Site: 37103	Liepaja
Latvia	Site: 37101	Riga
Latvia	Site: 37102	Riga
Lebanon	Site: 96103	Achrafieh
Lebanon	Site: 96102	Jbeil
Lithuania	Site: 37001	Kaunas
Lithuania	Site: 37003	Vilnius
Netherlands	Site: 31010	Amsterdam
Netherlands	Site: 31005	Eindhoven
Netherlands	Site: 31004	Enschede
Netherlands	Site: 31007	Nijmegen
Netherlands	Site: 31001	Tilburg
Netherlands	Site: 31008	Utrecht
Netherlands	Site: 31006	Zwolle
Norway	Site: 47002	Hamar
Norway	Site: 47001	Tonsberg
Norway	Site: 47005	Trondheim
Poland	Site: 48007	Kolbuszowa Dolna
Poland	Site: 48006	Krakow
Poland	Site: 48001	Lublin
Poland	Site: 48004	Piaseczno
Poland	Site: 48003	Warsaw
Poland	Site: 48005	Wroclaw
Portugal	Site: 35104	Lisbon
Portugal	Site: 35105	Lisbon
Portugal	Site: 35102	Matosinhos
Portugal	Site: 35103	Porto
Portugal	Site: 35101	Setubal
Russian Federation	Site: 70001	Moscow
Russian Federation	Site: 70002	Moscow
Russian Federation	Site: 70003	Moscow
Russian Federation	Site: 70005	Moscow
Russian Federation	Site: 70006	Moscow
Russian Federation	Site: 70007	Moscow
Russian Federation	Site: 70008	Moscow
Russian Federation	Site: 70011	Moscow
Russian Federation	Site: 70009	Saint Petersburg
Russian Federation	Site: 70010	Saint Petersburg
Russian Federation	Site: 70012	Saint Petersburg
Russian Federation	Site: 70013	Saint Petersburg
Russian Federation	Site: 70004	St. Petersburg
Slovakia	Site: 42104	Galanta
Slovakia	Site: 42106	Martin
Slovakia	Site: 42103	Piestany
Slovakia	Site: 42101	Poprad
Slovakia	Site: 42105	Trencin
Slovakia	Site: 42102	Zilina
Slovenia	Site: 38603	Ljubljana
Slovenia	Site: 38604	Ljubljana
Slovenia	Site: 38601	Maribor
Slovenia	Site: 38602	Maribor
Slovenia	Site: 38606	Novo Mesto
Spain	Site: 34001	Barcelona
Spain	Site: 34002	Barcelona
Spain	Site: 34009	Bilbao
Spain	Site: 34003	Madrid
Spain	Site: 34004	Madrid
Spain	Site: 34005	Madrid
Spain	Site: 34011	Mendaro
Spain	Site: 34013	Murcia
Spain	Site: 34010	San Sebastian
Spain	Site: 34014	Sevilla
Spain	Site: 34012	Valencia
Sweden	Site: 46007	Gothenburg
Sweden	Site: 46004	Halmstad
Sweden	Site: 46005	Karlshamn
Sweden	Site: 46003	Norrtalje
Sweden	Site: 46001	Stockholm
Sweden	Site: 46002	Stockholm
Sweden	Site: 46006	Uppsala
Switzerland	Site: 41001	Frauenfeld
Switzerland	Site: 41003	Zurich
Turkey	Site: 90003	Ankara
Turkey	Site: 90005	Ankara
Turkey	Site: 90011	Denizli
Turkey	Site: 90007	Diyarbakir
Turkey	Site: 90004	Istanbul
Turkey	Site: 90001	Izmir
Turkey	Site: 90008	Izmir
Turkey	Site: 90009	Manisa
Turkey	Site: 90010	Sivas
Ukraine	Site: 38007	Chernivtsi
Ukraine	Site: 38004	Dnepropetrovsk
Ukraine	Site: 38001	Kharkov
Ukraine	Site: 38002	Kiev
Ukraine	Site: 38003	Lviv
United Kingdom	Site: 44027	Aberdeen
United Kingdom	Site: 44029	Birmingham
United Kingdom	Site: 44025	Cambridge
United Kingdom	Site: 44030	Chichester
United Kingdom	Site: 44028	Croydon
United Kingdom	Site: 44003	Devon
United Kingdom	Site: 44001	Edgbaston
United Kingdom	Site: 44011	Glasgow
United Kingdom	Site: 44023	Harrow
United Kingdom	Site: 44006	Kent
United Kingdom	Site: 44012	Leeds
United Kingdom	Site: 44019	Leicester
United Kingdom	Site: 44008	Liverpool
United Kingdom	Site: 44010	London
United Kingdom	Site: 44017	London
United Kingdom	Site: 44013	Newcastle upon Tyne
United Kingdom	Site: 44022	Northwood
United Kingdom	Site: 44021	Nottingham
United Kingdom	Site: 44009	Plymouth
United Kingdom	Site: 44007	Reading
United Kingdom	Site: 44005	Sheffield
United Kingdom	Site: 44020	Southampton
United Kingdom	Site: 44026	Taunton
United Kingdom	Site: 44002	West Yorkshire
United Kingdom	Site: 44024	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe Ltd.

Countries where clinical trial is conducted

Armenia,  Austria,  Belarus,  Belgium,  Bulgaria,  Canada,  Czechia,  Denmark,  Finland,  France,  Georgia,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Kazakhstan,  Latvia,  Lebanon,  Lithuania,  Netherlands,  Norway,  Poland,  Portugal,  Russian Federation,  Slovakia,  Slovenia,  Spain,  Sweden,  Switzerland,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours	A micturition is any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.	Baseline and final visit (up to Week 12)
Secondary	Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period	A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE; defined as any untoward medical occurrence in a patient administered a study drug) that started or worsened in the period from the first double-blind medication intake until 30 days after the last double-blind medication intake. The following TEAEs were selected for inclusion in the analysis: Dry mouth (aptyalism, dry mouth, dry throat), constipation (constipation), blurred vision (vision blurred, myopia, refraction disorder, accommodation disorder).	From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks)
Secondary	Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours		Baseline and Week 4, Week 8, Week 12
Secondary	Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit	An incontinence episode is any involuntary leakage of urine. The total number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.	Week 4, Week 8, Week 12
Secondary	Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours	An incontinence episode is any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.	Baseline and Week 4, Week 8, Week 12
Secondary	Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit	An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The total number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.	Week 4, Week 8, Week 12
Secondary	Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours	An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.	Baseline and Week 4, Week 8, Week 12
Secondary	Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	An urgency episode is a sudden compelling desire to pass urine immediately followed by an incontinent event or the patient having to rush to the toilet and make it in time; severity recorded as 3 (severe urgency) or 4 (urgency incontinence) on the Patient Perception of the Intensity of Urgency Scale (PPIUS) validated scale. The mean number of urgency episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.	Baseline and Week 4, Week 8, Week 12
Secondary	Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency	Urgency level was rated by the participant during the 3-day micturition diary period using the PPIUS 5-point categorical scale: 0. No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urgency incontinence.	Baseline and Week 4, Week 8, Week 12
Secondary	Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit	The total number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.	Week 4, Week 8, Week 12
Secondary	Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment	The mean number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.	Baseline and Week 4, Week 8 , Week 12
Secondary	Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit	A nocturia episode is defined as waking at night =1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The total number of nocturia episodes were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.	Week 4, Week 8, Week 12
Secondary	Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment	A nocturia episode is defined as waking at night =1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.	Baseline and Week 4, Week 8, Week 12
Secondary	Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit	A responder is defined as a participant who has =8 micturitions at baseline and has <8 micturitions per 24 hours during the treatment period at each specified visit, where change from baseline is <0.	Week 4, Week 8, Week 12
Secondary	Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit	A responder is defined as a participant with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at specified visit.	Week 4, Week 8, Week 12
Secondary	Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit	A responder is defined as a participant who reported incontinence episodes at baseline and reported no incontinence episodes during the treatment period at specified visit.	Week 4, Week 8, Week 12
Secondary	Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire	The European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).	Baseline and Week 4
Secondary	Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire	The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).	Baseline and Week 4
Secondary	Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire	The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).	Baseline and Week 4
Secondary	Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire	The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).	Baseline and Week 4
Secondary	Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire	The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).	Baseline and Week 4
Secondary	Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire	The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).	Baseline and Week 8
Secondary	Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire	The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).	Baseline and Week 8
Secondary	Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire	The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).	Baseline and Week 8
Secondary	Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire	The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).	Baseline and Week 8
Secondary	Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire	The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).	Baseline and Week 8
Secondary	Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire	The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).	Baseline and Week 12
Secondary	Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire	The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).	Baseline and Week 12
Secondary	Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire	The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).	Baseline and Week 12
Secondary	Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire	The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).	Baseline and Week 12
Secondary	Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire	The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).	Baseline and Week 12
Secondary	Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire	The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).	Baseline and final visit (up to Week 12)
Secondary	Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire	The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).	Baseline and final visit (up to Week 12)
Secondary	Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire	The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).	Baseline and final visit (up to Week 12)
Secondary	Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire	The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).	Baseline and final visit (up to Week 12)
Secondary	Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire	The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).	Baseline and final visit (up to Week 12)
Secondary	Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)	The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, scored from 1 to 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 indicates an improvement.	Baseline and Week 4, Week 8, Week 12
Secondary	Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q	The OAB-q is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping, concern, sleep, social interaction). The total score is 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 indicates an improvement.	Baseline and Week 4, Week 8, Week 12
Secondary	Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)	The Patient Perception of Bladder Condition (PPBC) questionnaire is a single-item questionnare used to assess participants' perceptions and impressions of their bladder condition. Participants assessed their bladder condition using a 6-point categorical 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.	Baseline and Week 4, Week 8, Week 12
Secondary	Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)	The Treatment Satisfaction (TS)-Visual Analogue Scale (VAS) was a self-rated scale with the participant answering the question "Are you satisfied with your treatment?" and placing a vertical mark on a line from 0 (No, not at all) to 10 (Yes, completely).	Baseline and Week 12
Secondary	Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale	The Treatment Satisfaction (TS)-Likert Scale was a self-rated scale with the participant answering the question "How satisfied were you with your treatment?" with on a scale from 1 (extremely dissatisfied) to 7 (extremely satisfied).	Baseline and Week 12
Secondary	Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: = 10 Points Improvement in OAB-q at Week 12 and Final Visit	A responder is defined as a participant with =10 points improvement in symptom bother from baseline.	Baseline to Week 12
Secondary	Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: =10 Points Improvement in OAB-q at Week 12 and Final Visit	A responder is defined as a participant with >=10 points improvement in the total HRQL score from baseline.	Baseline to Week 12
Secondary	Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: =1, =2, =3, =4, =5, and 6-point Improvement From Baseline to Week 12	A responder is defined as a participant with =1, =2, =3, =4, =5 or 6-point improvement from baseline in TS-Likert scale.	Baseline to Week 12
Secondary	Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: =1, =2, =3, =4, =5, and 6-point Improvement From Baseline to Final Visit	A responder is defined as a participant with >=1 or >=2 or >=3 or >=4 or >=5 or 6-point improvement from baseline in TS-Likert scale.	Baseline to final visit (up to Week 12)
Secondary	Percentage of Participants With Improvement in PPBC: =1 Point Improvement at Week 12 and Final Visit	A responder is defined as a participant with =1 point improvement in PPBC from baseline.	Baseline to Week 12
Secondary	Percentage of Participants With Major Improvement in PPBC: =2 Point Improvement at Week 12 and Final Visit	A responder is defined as a participant with =2 point improvement in PPBC from baseline.	Baseline to Week 12

External Links

•   Link to results on Astellas Clinical Study Results website