A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)

Urologic Diseases Clinical Trial

— BESIDE  

Official title:

A Randomized, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects Who Have Received Solifenacin for 4 Weeks and Warrant Additional Relief for Their OAB Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908829
• Other study ID #: 905-EC-012
• Secondary ID: 2012-005401-41
• Status: Completed
• Phase: Phase 3
• Start date: July 10, 2013
• Est. completion date: November 25, 2014

Study information

• Verified date: July 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to see if adding a new type of medication recently approved to treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) would be more effective in controlling incontinence than when using the antimuscarinic treatment alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2174
• Est. completion date: November 25, 2014
• Est. primary completion date: November 24, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Main Inclusion at Screening:

1. Subject has symptoms of OAB (urinary frequency and urgency with urgency incontinence) for >= 3 months prior to the screening visit

2. Subject is willing and able to complete the micturition diary and questionnaires correctly, including collection and measurement of urine output for 3 days prior to each visit;

3. Subject has symptoms of "wet" OAB (urinary frequency and urgency with incontinence or mixed incontinence with predominant urgency incontinence), and reports an average of at least 2 incontinence episodes per day.

• Main Inclusion at Run-in (Visit 2):

1. Subject experiences on average at least 1 episode of urgency (grade 3 or 4) with or without incontinence per 24-hour period during the 3-day micturition diary period.

2. Subject experiences on average at least 2 incontinence episodes per 24-hour period during the 3-day micturition diary period.

3. Subject experiences on average at least 8 micturitions (excluding incontinence episodes) per 24-hour period during the 3-day micturition diary period.

• Main Inclusion at Randomization (Visit 3):

1. Subject experiences at least 1 incontinence episode during the 3-day micturition diary period and wishes to increase their treatment for OAB symptoms.

Exclusion Criteria:

• Main Exclusion at Screening:

1. Subject in the opinion of the investigator has clinically significant Bladder Outlet Obstruction (BOO).

2. Subject has significant Post-void residual (PVR) volume (PVR > 150 ml).

3. Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator

4. Subject has an indwelling catheter or practices intermittent self catheterization.

5. Subject has evidence of a UTI.

6. Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs

7. Subject has moderate to severe hepatic impairment

8. Subject has severe renal impairment or End Stage Renal disease

9. Subject has a clinically significant abnormal Electrocardiogram (ECG)

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

11. Subject has a QTcF interval > 450 ms for males or > 470 ms for females or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).

12. Subject has received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.

13. Subject has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure = 180 mmHg and/or average diastolic blood pressure = 110 mmHg.

• Main Exclusion at Randomization (visit 3):

1. Subject has achieved 100% continence from Visit 2 to Visit 3 (no incontinence episodes are recorded in the 3 day diary administered for 3 days prior to Visit 3).

2. Subject does not desire an increase in study medication.

3. Subject has an average total daily urine volume > 3000ml as recorded in the micturition diary.

4. Subject has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure = 180 mmHg and/or average diastolic blood pressure = 110 mmHg.

5. Subject has a clinically significant abnormal ECG

Related Conditions & MeSH terms

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

Intervention

Drug:
• mirabegron 25 mg
Mirabegron was supplied as the marketed formulation in the 25 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.
• mirabegron 50 mg
Mirabegron was supplied as the marketed formulation in the 50 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.
• solifenacin 5 mg
Solifenacin was provided as the marketed formulation in the 5 mg strength. Medication was taken orally with a glass of water, with or without food.
• solifenacin 10 mg
Solifenacin was provided as the marketed formulation in the 10 mg strength. Medication was taken orally with a glass of water, with or without food.
• mirabegron 25 mg matching placebo
Matching placebo of mirabegron OCAS 25 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
• mirabegron 50 mg matching placebo
Matching placebo of mirabegron OCAS 50 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
• solifenacin 5 mg matching placebo
Matching placebo of solifenacin succinate 5 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
• solifenacin 10 mg matching placebo
Matching placebo of solifenacin succinate 10 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

Locations

Country	Name	City	State
Armenia	Site: 37402	Yerevan
Armenia	Site: 37403	Yerevan
Armenia	Site: 37405	Yerevan
Australia	Site: 61006	Adelaide
Australia	Site: 61001	Kogarah, Sydney
Australia	Site: 61016	Victoria
Austria	Site: 43008	Graz
Austria	Site: 43001	Innsbruck
Austria	Site: 43006	Innsbruck
Austria	Site: 43007	Linz
Austria	Site: 43002	Vienna
Austria	Site: 43004	Vienna
Austria	Site: 43005	Vienna
Austria	Site: 43010	Vienna
Austria	Site: 43011	Vienna
Austria	Site: 43012	Vienna
Austria	Site: 43003	Wels
Belgium	Site: 32007	Anderlecht
Belgium	Site: 32013	Deurne
Belgium	Site: 32009	Edegem
Belgium	Site: 32003	Gent
Belgium	Site: 32005	Gent
Belgium	Site: 32015	Kortrijk
Belgium	Site: 32008	Liege
Belgium	Site: 32014	Roeselare
Canada	Site: 15001	Barrie
Canada	Site: 15009	Bathurst
Canada	Site: 15006	Brampton
Canada	Site: 15015	Granby
Canada	Site: 15014	Kelowna
Canada	Site: 15007	Kitchener
Canada	Site: 15019	Sherbrooke
Canada	Site: 15012	Toronto
Canada	Site: 15013	Toronto
Canada	Site: 15016	Victoria
Canada	Site: 15047	Victoria
Canada	Site: 15018	Victoriaville
Czechia	Site: 42015	Brno
Czechia	Site: 42020	Melnik
Czechia	Site: 42018	Nachod
Czechia	Site: 42004	Plzen
Czechia	Site: 42021	Plzen
Czechia	Site: 42008	Prague
Czechia	Site: 42016	Prague 1
Czechia	Site: 42017	Praha 2
Czechia	Site: 42007	Praha 4
Czechia	Site: 42022	Praha 4
Denmark	Site: 45008	Aarhus N
Denmark	Site: 45003	Frederiksberg
Denmark	Site: 45009	Herlev
Denmark	Site: 45011	Odense C
Finland	Site: 35804	Helsinki (hus)
Finland	Site: 35805	Tampere
France	Site: 33018	Bordeaux Cedex
France	Site: 33017	Marseille
Georgia	Site: 99502	T'bilisi
Germany	Site: 49008	Bad Ems
Germany	Site: 49022	Berlin
Germany	Site: 49021	Hagenow
Germany	Site: 49011	Halle (Saale)
Germany	Site: 49004	Hamburg
Germany	Site: 49018	Henningsdorf
Germany	Site: 49009	Hettstedt
Germany	Site: 49017	Koblenz
Germany	Site: 49003	Lutherstadt Eisleben
Germany	Site: 49020	Reutlingen
Germany	Site: 49014	Sangerhausen
Greece	Site: 30001	Athens
Greece	Site: 30005	Heraklion, Crete
Greece	Site: 30002	Patras
Hungary	Site: 36003	Csongrad
Hungary	Site: 36011	Hajduszoboszlo
Hungary	Site: 36002	Nyiregyhaza
Hungary	Site: 36008	Salgotarjan
Hungary	Site: 36009	Szekszard
Ireland	Site: 35303	Cork
Ireland	Site: 35301	Dublin
Ireland	Site: 35309	Dublin
Ireland	Site: 35310	Dublin
Ireland	Site: 35306	Limerick
Ireland	Site: 35313	Mullingar
Ireland	Site: 35304	Tralee
Ireland	Site: 35305	Waterford
Israel	Site: 97201	Haifa
Israel	Site: 97202	Jerusalem
Israel	Site: 97207	Kfar Saba
Israel	Site: 97203	Petach Tikva
Israel	Site: 97205	Petach Tikva
Israel	Site: 97206	Tel Hashomer
Italy	Site: 39007	Avellino
Italy	Site: 39002	Cantanzaro
Italy	Site: 39010	Firenze
Italy	Site: 39006	Perugia
Italy	Site: 39013	Treviglio (BG)
Italy	Site: 39009	Varese
Lebanon	Site: 96101	Beirut
Netherlands	Site: 31008	Amsterdam
Norway	Site: 47005	Bekkestua
Norway	Site: 47002	Tonsberg
Norway	Site: 47003	Trondheim
Poland	Site: 48002	Kolbuszowa Dolna
Poland	Site: 48006	Krakow
Poland	Site: 48010	Lublin
Poland	Site: 48005	Piaseczno
Poland	Site: 48001	Warszawa
Poland	Site: 48008	Warszawa
Portugal	Site: 35104	Lisbon
Portugal	Site: 35105	Lisbon
Portugal	Site: 35102	Matosinhos
Portugal	Site: 35103	Porto
Portugal	Site: 35101	Setubal
Portugal	Site: 35106	Tomar
Romania	Site: 40016	Bucharest
Romania	Site: 40018	Bucharest
Romania	Site: 40012	Craiova
Romania	Site: 40019	Craiova
Romania	Site: 40003	Judetul Ilfov
Romania	Site: 40017	Oradea
Romania	Site: 40020	Timisoara
Russian Federation	Site: 70003	Moscow
Russian Federation	Site: 70004	Moscow
Russian Federation	Site: 70005	Moscow
Russian Federation	Site: 70008	Moscow
Russian Federation	Site: 70010	Moscow
Russian Federation	Site: 70011	Moscow
Russian Federation	Site: 70012	Moscow
Russian Federation	Site: 70024	Moscow
Russian Federation	Site: 70013	Rostove-on-Don
Russian Federation	Site: 70002	Saint Petersburg
Russian Federation	Site: 70006	Saint Petersburg
Russian Federation	Site: 70007	Saint Petersburg
Russian Federation	Site: 70009	Saint Petersburg
Russian Federation	Site: 70025	Saratov
Slovakia	Site: 42110	Bratislava
Slovakia	Site: 42114	Kosice
Slovakia	Site: 42113	Michalovce
Slovakia	Site: 42111	Nove Zamky
Slovakia	Site: 42112	Piestany
Slovakia	Site: 42108	Poprad
Slovakia	Site: 42109	Zilina
Slovenia	Site: 38601	Ljubljana
Slovenia	Site: 38606	Maribor
Slovenia	Site: 38607	Maribor
Slovenia	Site: 38610	Ptuj
Spain	Site: 34012	Barcelona
Spain	Site: 34016	Bilbao
Spain	Site: 34001	Getafe (Madrid)
Spain	Site: 34004	Madrid
Spain	Site: 34015	Madrid
Spain	Site: 34023	Mendaro
Spain	Site: 34021	Miranda de Ebro
Spain	Site: 34013	San Sebastian
Spain	Site: 34018	San Sebastian de los Reyes
Spain	Site: 34007	Sevilla
Spain	Site: 34020	Sevilla
Spain	Site: 34014	Vigo
Sweden	Site: 46004	Halmstad
Sweden	Site: 46013	Lund
Sweden	Site: 46014	Norrtalje
Sweden	Site: 46001	Stockholm
Sweden	Site: 46012	Stockholm
Sweden	Site: 46015	Umea
Switzerland	Site: 41008	Baden
Switzerland	Site: 41001	Frauenfeld
Turkey	Site: 90005	Ankara
Turkey	Site: 90008	Ankara
Turkey	Site: 90002	Izmir
Turkey	Site: 90003	Izmir
Turkey	Site: 90007	Kocaeli
Turkey	Site: 90004	Manisa
Turkey	Site: 90006	Sivas
United Kingdom	Site: 44007	Bristol
United Kingdom	Site: 44012	Cambridge
United Kingdom	Site: 44015	Cheltenham
United Kingdom	Site: 44019	Coventry
United Kingdom	Site: 44009	Garston
United Kingdom	Site: 44016	Kings Lynn
United Kingdom	Site: 44017	London
United Kingdom	Site: 44018	Northampton
United Kingdom	Site: 44010	Nottingham
United Kingdom	Site: 44008	Plymouth
United Kingdom	Site: 44013	Taunton
United Kingdom	Site: 44011	West Yorkshire
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Alexandria Clinical Research	Alexandria	Virginia
United States	Brooklyn Urology Research Group	Brooklyn	New York
United States	Meridien Research	Brooksville	Florida
United States	Associated Pharmaceutical Research Center, Inc.	Buena Park	California
United States	PMG Research of Raleigh, dba PMG Research of Cary	Cary	North Carolina
United States	The Urology Group	Cincinnati	Ohio
United States	Innovative Research of West FL	Clearwater	Florida
United States	North Idaho Urology	Coeur d'Alene	Idaho
United States	Providence Health Partners	Dayton	Ohio
United States	Advanced Urology Centers of New York	Garden City	New York
United States	Alliance Urology Specialists	Greensboro	North Carolina
United States	Best Quality Research Inc.	Hialeah	Florida
United States	Palmetto Professional Research	Hialeah	Florida
United States	MedStar Health Research Institute	Hyattsville	Maryland
United States	First Urology, PSC	Jeffersonville	Indiana
United States	The Clinical Trial Center	Jenkintown	Pennsylvania
United States	Beyer Research	Kalamazoo	Michigan
United States	Premier Medical Group of the Hudson Valley PC	Kingston	New York
United States	Urology Center of Central Florida	Kissimmee	Florida
United States	The American Institute of Research	Los Angeles	California
United States	Deaconess Gateway Health Center	Newburgh	Indiana
United States	Quality Clinical Research	Omaha	Nebraska
United States	Premier Medical Group of the Hudson Valley PC	Poughkeepsie	New York
United States	Wake Research Associates LLC	Raleigh	North Carolina
United States	Health Concepts	Rapid City	South Dakota
United States	Jean Brown Research	Salt Lake City	Utah
United States	Meridian Clinical Research, LLC	Savannah	Georgia
United States	Herman Clinical Research	Suwanee	Georgia
United States	Meridien Research	Tampa	Florida
United States	Stedman Clinical Trials	Tampa	Florida
United States	Genova Clinical Research	Tucson	Arizona
United States	Bayview Research Group	Valley Village	California
United States	Bay State Clinical Trials, Inc.	Watertown	Massachusetts
United States	Private Practice	West Palm Beach	Florida
United States	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe Ltd.

Countries where clinical trial is conducted

United States,  Armenia,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  Finland,  France,  Georgia,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Lebanon,  Netherlands,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Slovakia,  Slovenia,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours	The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. The analysis population consisted of the Full Analysis Set (FAS) which comprised of all the Randomized Analysis Set's (RAS) participants who met the following criteria: took at least 1 dose of double-blind study drug after randomization, reported at least 1 micturition in the baseline diary & at least 1 micturition postbaseline & reported at least 1 incontinence episode in the baseline diary. For participants who withdrew before EoT (week 12) and have no measurement available for that diary period, the Last Observation Carried Forward (LOCF) value during the double-blind study period was used as EoT value to derive the primary variable.	Baseline and end of treatment (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours	The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period.	Baseline and weeks 4, 8 & 12
Secondary	Change From Baseline in Mean Number of Micturitions Per 24 Hours	The average number of micturitions (voluntary urinations (excluding incontinence only episodes)) per 24 hours was derived from number of micturitions recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period (excluding incontinence only episodes).	Baseline and weeks 4, 8 & 12
Secondary	Number of Incontinence Episodes Reported During the 3-Day Diary	The number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from total number of incontinence episodes on valid diary days recorded during the 3-day micturition diary period.	Weeks 4, 8 and 12
Secondary	Change From Baseline in Mean Volume Voided (MVV) Per Micturition	MVV per micturition was defined as MVV (mL) per micturition during last 3 days of the 3-day micturition diary period. MVV per micturition was calculated as the sum of each volume voided for each record with volume voided > 0 on valid diary days divided by the total number of records with a volume voided > 0 on valid diary days during the 3-day micturition diary period.	Baseline and weeks 4, 8 & 12
Secondary	Change From Baseline to EoT in Corrected Micturition Frequency (CMF)	CMF was defined as the mean number of micturitions per 24 hours that participants would have at EoT if their fluid intake had remained unchanged since baseline. This was calculated by the MVV per Micturition at baseline multiplied by the mean number of micturitions per 24 hours at baseline divided by the MVV per micturition at EoT.	Baseline and EoT (up to 12 weeks)
Secondary	Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours	UI was defined as the complaint of involuntary urine leakage accompanied by or immediately preceded by urgency. UI was measured using the Patient Perception of Intensity of Urgency Scale (PPIUS), a patient reported outcome validated 5-point categorical scale rating the degree of associated urinary urgency severity (0=No urgency, I felt no need to empty my bladder, but did so for other reasons. 1=Mild, I could postpone voiding as long as necessary, without fear of wetting myself. 2= Moderate, I could postpone voiding for a short while, without fear of wetting myself. 3=Severe, I could not postpone voiding, but had to rush to the toilet in order not to wet myself. 4=Urgency incontinence, I leaked before arriving to the toilet). One urgency incontinence episode was counted for each record of the diary in which the following occurred: incontinence episode or 'both' was recorded & severity of urinary urgency recorded was 3 or 4.	Baseline and weeks 4, 8 & 12
Secondary	Number of UI Episodes Reported During the 3-Day Diary	Number of UI episodes was calculated using the number of UI episodes recorded on valid diary days during the 3-day micturition diary period. NOTE: Only urgency incontinence episodes recorded on a valid diary day were counted.	Weeks 4, 8 and 12
Secondary	Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours	An urgency episode was defined as the complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes (severity of 3 or 4) per 24 hours was defined as the average number of times a participant recorded an urgency episode (severity of 3 or 4) with or without incontinence per day during the 3-day micturition diary period. Measured using the PPIUS scale. This was calculated using the sum of each record with an urgency episode (severity of 3 or 4) recorded on a valid diary day divided by the number of valid diary days during the 3-day micturition diary period.	Baseline and weeks 4, 8 & 12
Secondary	Change From Baseline in Mean Number of Pads Per 24 Hours	The mean number of pads per 24 hours was defined as the average number of times a participant recorded a new pad used per day during the 3-day micturition diary period. This was calculated using the number of new pads used during valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period.	Baseline and weeks 4, 8 & 12
Secondary	Number of Pads Used During the 3-Day Diary	The number of pads used was defined as the number of times a participant recorded a new pad used during the 3-day micturition diary period. This was calculated using the sum of each record with new pad checked. Only records with new pad checked on a valid diary day were counted.	Weeks 4, 8 and 12
Secondary	Change From Baseline in Mean Number of Nocturia Episodes	Mean number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) while sleeping during the 3-day diary period, divided by the number of valid diary days during the diary period. Night time episode of incontinence only was not considered a nocturia episode. Nocturia episodes were counted for each micturition record which occurred between the date/time of going to bed with intention to sleep and the date/time of getting up with intention to stay awake on a valid diary day & which was accompanied by a sleep interruption. Nocturia only determined for those who were not night-shift workers.	Baseline and weeks 4, 8 & 12
Secondary	Number of Nocturia Episodes Reported Over 3-Day Diary	The number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) during sleeping time during the 3-day micturition diary period. This was calculated using the sum of each nocturia episode recorded on valid diary days during the 3-day micturition diary period.	Weeks 4, 8 and 12
Secondary	Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility	The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.	Baseline and EoT (up to 12 weeks)
Secondary	Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care	The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.	Baseline and EoT (up to 12 weeks)
Secondary	Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities	The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.	Baseline and EoT (up to 12 weeks)
Secondary	Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort	The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.	Baseline and EoT (up to 12 weeks)
Secondary	Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression	The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.	Baseline and EoT (up to 12 weeks)
Secondary	Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score	The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity).	Baseline and weeks 4, 8 & 12
Secondary	Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score	The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).	Baseline and weeks 4, 8 & 12
Secondary	Change From Baseline in OAB-q HRQL Subscale Score: Coping	The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).	Baseline and weeks 4, 8 & 12
Secondary	Change From Baseline in OAB-q HRQL Subscale Score: Concern	The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).	Baseline and weeks 4, 8 & 12
Secondary	Change From Baseline in OAB-q HRQL Subscale Score: Sleep	The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).	Baseline and weeks 4, 8 & 12
Secondary	Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction	The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).	Baseline and weeks 4, 8 & 12
Secondary	Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score	The TS-VAS rated participant satisfaction with treatment on a scale from 0 (No, not at all) to 10 (Yes, completely).	Baseline and weeks 4, 8 & 12
Secondary	Change From Baseline in Patient Perception Bladder Control (PPBC) Score	The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. PPBC score: 1-no problem, 2- some very minor problems, 3-some minor problems, 4-moderate problems, 5-severe problems, 6-many severe problems.	Baseline and weeks 4, 8 & 12
Secondary	Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC)	The PGIC was a 2-part questionnaire, assessing both the change in the participant's overall condition (Patient Impression in General Health (PIBS)) and change in bladder condition since the start of the study (Patient Impression in General Health (PIGH)) (from very much worse to very much improved). The CGIC was a single questionnaire assessing the participant's change in bladder condition since the beginning of the study (Clinician Impression in Bladder Symptoms (CIBS)).	End of treatment (up to 12 weeks)
Secondary	Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours	Incontinence was defined as any involuntary leakage of urine.	Weeks 4, 8 and 12
Secondary	Percentage of Participants With Zero Incontinence Episodes Postbaseline	Incontinence was defined as any involuntary leakage of urine.	Weeks 4, 8 and 12
Secondary	Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline	Micturitions were defined as voluntary urinations (excluding incontinence only episodes).	Weeks 4, 8 and 12
Secondary	Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score	The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity).	Weeks 4, 8 and 12
Secondary	Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score	HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).	Weeks 4, 8 and 12
Secondary	Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC	The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition.	Weeks 4, 8 and 12
Secondary	Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC	The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition.	Weeks 4, 8 and 12
Secondary	Number of Participants With Adverse Events (AEs)	AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures & which does not necessarily have a causal relationship with this treatment. Treatment-Emergent Adverse Event (TEAE) referred to an adverse event which started or worsened in the period from first double-blind medication intake until 30 days after the last double-blind medication intake.	From first dose of double blind treatment until 30 days after last dose (up to 16 weeks)
Secondary	Change From Baseline in Post Void Residual (PVR) Volume	PVR Volume was assessed by bladder scan.	Baseline and weeks 4, 8 & 12

External Links

•   Link to results on Astellas Clinical Study Results website