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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00337558




Registration number
NCT00337558
Ethics application status
Date submitted
14/06/2006
Date registered
16/06/2006
Date last updated
18/09/2014

Titles & IDs
Public title
A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)
Scientific title
Solifenacin Succinate in a Flexible Dose Regimen With Simplified Bladder Training Versus Solifenacin Succinate in a Flexible Dose Regimen Alone in a Prospective, Randomized, Parallel Group, Overactive Bladder Symptom Study
Secondary ID [1] 0 0
905-EC-003
Universal Trial Number (UTN)
Trial acronym
SOLAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overactive Bladder 0 0
Urinary Incontinence 0 0
Urge Incontinence 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Solifenacin succinate
Behaviour - Simplified bladder training

Experimental: 1 - Solifenacin succinate

Experimental: 2 - Solifenacin succinate and simplified bladder training


Treatment: Drugs: Solifenacin succinate
tablet

Behaviour: Simplified bladder training
Instructions
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in mean number of micturitions per 24 hours after 8 weeks
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Change from baseline in mean number of micturitions per 24 hours after 16 weeks
Timepoint [1] 0 0
16 weeks
Secondary outcome [2] 0 0
Change from baseline in mean urgency frequency per 24 hours
Timepoint [2] 0 0
8 and 16 weeks
Secondary outcome [3] 0 0
Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours
Timepoint [3] 0 0
8 and 16 weeks
Secondary outcome [4] 0 0
Change from baseline in number of pads used
Timepoint [4] 0 0
8 and 16 weeks
Secondary outcome [5] 0 0
Incidence and severity of adverse events
Timepoint [5] 0 0
8 and 16 weeks

Eligibility
Key inclusion criteria
- Symptoms of overactive bladder (including urinary frequency, urgency with/without urge
incontinence) for> 3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Clinically significant outflow obstruction

- Significant post void residual volume

- Significant stress incontinence or mixed stress/urge incontinence where stress is the
predominant factor as determined by the investigator.

- Patient with a neurological cause for abnormal detrusor activity.

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2007
Sample size
Target
Accrual to date
Final
643
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
- Kogarah
Recruitment hospital [2] 0 0
- Randwick
Recruitment hospital [3] 0 0
- Auchenflower
Recruitment hospital [4] 0 0
- Clayton
Recruitment hospital [5] 0 0
- Concord
Recruitment hospital [6] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
- Concord
Recruitment postcode(s) [6] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerp
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Belgium
State/province [3] 0 0
Gent
Country [4] 0 0
Belgium
State/province [4] 0 0
Kortrijk
Country [5] 0 0
Belgium
State/province [5] 0 0
La Louviere
Country [6] 0 0
Belgium
State/province [6] 0 0
Sint-Truiden
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Jihlava
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Liberec
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Olomouc
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Plzen
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Prague
Country [12] 0 0
France
State/province [12] 0 0
Annecy Cedex
Country [13] 0 0
France
State/province [13] 0 0
Arras
Country [14] 0 0
France
State/province [14] 0 0
Bordeaux
Country [15] 0 0
France
State/province [15] 0 0
Landerneau
Country [16] 0 0
France
State/province [16] 0 0
Marseille
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
France
State/province [18] 0 0
Rouen
Country [19] 0 0
France
State/province [19] 0 0
Saint Louis Cedex
Country [20] 0 0
France
State/province [20] 0 0
Thionville
Country [21] 0 0
France
State/province [21] 0 0
Toulouse
Country [22] 0 0
France
State/province [22] 0 0
Valenciennes
Country [23] 0 0
France
State/province [23] 0 0
Vernon
Country [24] 0 0
Hungary
State/province [24] 0 0
Budapest
Country [25] 0 0
Hungary
State/province [25] 0 0
Kecskemet
Country [26] 0 0
Hungary
State/province [26] 0 0
Nyiregyhaza
Country [27] 0 0
Hungary
State/province [27] 0 0
Tatabanya
Country [28] 0 0
Italy
State/province [28] 0 0
Bari
Country [29] 0 0
Italy
State/province [29] 0 0
Cinisello Balsamo
Country [30] 0 0
Italy
State/province [30] 0 0
Como
Country [31] 0 0
Italy
State/province [31] 0 0
Genova
Country [32] 0 0
Italy
State/province [32] 0 0
Milan
Country [33] 0 0
Italy
State/province [33] 0 0
Naples
Country [34] 0 0
Netherlands
State/province [34] 0 0
Leiden
Country [35] 0 0
Netherlands
State/province [35] 0 0
Roermond
Country [36] 0 0
Netherlands
State/province [36] 0 0
Tilburg
Country [37] 0 0
Netherlands
State/province [37] 0 0
Zwijndrecht
Country [38] 0 0
Poland
State/province [38] 0 0
Warsaw
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Moscow
Country [40] 0 0
Russian Federation
State/province [40] 0 0
St Petersburg
Country [41] 0 0
Spain
State/province [41] 0 0
Aviles
Country [42] 0 0
Spain
State/province [42] 0 0
Burgos
Country [43] 0 0
Spain
State/province [43] 0 0
Madrid
Country [44] 0 0
Spain
State/province [44] 0 0
Manacor
Country [45] 0 0
Spain
State/province [45] 0 0
Marbella
Country [46] 0 0
Spain
State/province [46] 0 0
Santander
Country [47] 0 0
Spain
State/province [47] 0 0
Santiago de Compostela
Country [48] 0 0
Spain
State/province [48] 0 0
Sevilla
Country [49] 0 0
Turkey
State/province [49] 0 0
Ankara
Country [50] 0 0
Turkey
State/province [50] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Astellas Pharma Inc
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Astellas Pharma Europe B.V.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will look at a drug for OAB (solifenacin) in combination with a non drug treatment
(bladder training) compared to the drug on its own. The study will compare the symptoms of
OAB by assessing patient diaries and other patient reported outcomes.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00337558
Trial related presentations / publications
Mattiasson A, Masala A, Morton R, Bolodeoku J; SOLAR Study Group. Efficacy of simplified bladder training in patients with overactive bladder receiving a solifenacin flexible-dose regimen: results from a randomized study. BJU Int. 2010 Apr;105(8):1126-35. doi: 10.1111/j.1464-410X.2009.08910.x. Epub 2009 Oct 10.
Public notes

Contacts
Principal investigator
Name 0 0
Astellas Medical Affairs Europe
Address 0 0
University Hospital, Lund, Sweden
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00337558