Clinical trial NCT00337558: A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Urinary Incontinence
Urge Incontinence
Keywords: treatment outcomes
Overactive bladder
Solifenacin succinate
urinary incontinence
urge incontinence
frequency
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Europe B.V.
First posted: 2006-06-16
Enrollment: 643
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Subjects are screened between day -14 and day -1.

At day 0 subjects will enter a randomized, parallel group study. After fulfilling all selection criteria, subjects will be randomized to one of two treatment arms, solifenacin 5mg with bladder training or solifenacin 5mg alone. After 8 weeks of treatment subjects will be sub divided; subjects on solifenacin 5mg with bladder training will be given the option to increase dose and be divided into solifenacin 5mg with bladder training or solifenacin 10mg with bladder training. Subjects on solifenacin alone, will also be given the option to increase dose and be divided into solifenacin 5mg alone and solifenacin 10mg alone.

There are 5 visits in total: visit 1(screening), visit 2 (randomisation), visit 3 (week 4), visit 4 (week 8), telephone visit (week 12) and visit 5 (week 16)

All subjects receive medication in the form of solifenacin succinate 5mg tablets (two tablets for 10mg) (Company code: YM905, Company serial number: RVG29151)

Subjects randomized to bladder training will receive a single sheet of instructions for bladder training.

Eligibility criteria: Inclusion Criteria:

* Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for\> 3 months

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

Primary outcomes:
measure: Change from baseline in mean number of micturitions per 24 hours after 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline in mean number of micturitions per 24 hours after 16 weeks
timeFrame: 16 weeks
measure: Change from baseline in mean urgency frequency per 24 hours
timeFrame: 8 and 16 weeks
measure: Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours
timeFrame: 8 and 16 weeks
measure: Change from baseline in number of pads used
timeFrame: 8 and 16 weeks
measure: Incidence and severity of adverse events
timeFrame: 8 and 16 weeks
Other outcomes:
Locations:
city: Kogarah
country: Australia
state: New South Wales
city: Randwick
country: Australia
state: New South Wales
city: Auchenflower
country: Australia
state: Queensland
city: Clayton
country: Australia
state: Victoria
city: Concord
country: Australia
city: Parkville
country: Australia
city: Antwerp
country: Belgium
city: Brussels
country: Belgium
city: Brussels
country: Belgium
city: Gent
country: Belgium
city: Gent
country: Belgium
city: Kortrijk
country: Belgium
city: La Louviere
country: Belgium
city: Sint-Truiden
country: Belgium
city: Jihlava
country: Czech Republic
city: Liberec
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Plzen
country: Czech Republic
city: Prague
country: Czech Republic
city: Annecy Cedex
country: France
city: Arras
country: France
city: Bordeaux
country: France
city: Landerneau
country: France
city: Marseille
country: France
city: Paris
country: France
city: Rouen
country: France
city: Saint Louis Cedex
country: France
city: Thionville
country: France
city: Toulouse
country: France
city: Valenciennes
country: France
city: Vernon
country: France
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Kecskemet
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Tatabanya
country: Hungary
city: Bari
country: Italy
city: Cinisello Balsamo
country: Italy
city: Como
country: Italy
city: Genova
country: Italy
city: Milan
country: Italy
city: Naples
country: Italy
city: Leiden
country: Netherlands
city: Roermond
country: Netherlands
city: Tilburg
country: Netherlands
city: Zwijndrecht
country: Netherlands
city: Warsaw
country: Poland
city: Warsaw
country: Poland
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Aviles
country: Spain
city: Burgos
country: Spain
city: Madrid
country: Spain
city: Manacor
country: Spain
city: Marbella
country: Spain
city: Santander
country: Spain
city: Santiago de Compostela
country: Spain
city: Sevilla
country: Spain
city: Ankara
country: Turkey
city: Istanbul
country: Turkey
Study officials:
affiliation: University Hospital, Lund, Sweden
name: Astellas Medical Affairs Europe
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.