A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)

Condition(s) targeted: Overactive Bladder; Urinary Incontinence; Urge Incontinence

Intervention: Solifenacin succinate (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Astellas Medical Affairs Europe, Principal Investigator, Affiliation: University Hospital, Lund, Sweden

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.

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 design: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Assess the efficacy of solifenacin succinate 5mg od plus simplified bladder training vs solifenacin succinate 5mg od alone at 8 weeks in subjects with OAB symptoms

Secondary outcome:

Efficacy of a flexible dose regimen of solifenacin succinate 5mg or 10mg od plus simplified bladder training compared with a flexible dose regimen of solifenacin succinate 5mg or 10mg od alone at 16 weeks in subjects with overactive bladder symptoms

Compare subject perception of symptoms vs. treatment satisfaction

Compare the utility associated with QOL for subjects with OAB symptoms.

Assess the safety and tolerability of solifenacin succinate in subjects with OAB

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.

Minimum age: 18 Years. Gender(s): Both.

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

Tatabanya, Hungary

Concord, Australia

Parkville, Australia

Antwerp 2020, Belgium

Brussels 1090, Belgium

Gent 9000, Belgium

Gent, Belgium

La Louviere, Belgium

Liberec 460 63, Czech Republic

Olomouc 772 00, Czech Republic

Kortrijk 8500, Belgium

Brussels 1200, Belgium

Sint-Truiden 3800, Belgium

Jihlava 586 01, Czech Republic

Plzen 326 00, Czech Republic

Prague 147 00, Czech Republic

Toulouse 31400, France

Rouen, France

Valenciennes, France

Vernon, France

Thionville, France

Arras, France

Paris, France

Annecy Cedex, France

Marseille, France

Landerneau, France

Bordeaux, France

Saint Louis Cedex, France

Nyiregyhaza H-4400, Hungary

Budapest H-1145, Hungary

Budapest, Hungary

Kecskemet, Hungary

Milan 20092, Italy

Cinisello Balsamo, Italy

Genova, Italy

Bari, Italy

Naples, Italy

Como, Italy

Tilburg 5022, Netherlands

Leiden 2334, Netherlands

Zwijndrecht 331, Netherlands

Roermond 6043, Netherlands

Warsaw 00-846, Poland

Warsaw 02-520, Poland

St Petersburg 197098, Russian Federation

Moscow 117815, Russian Federation

Moscow 101000, Russian Federation

Moscow 119049, Russian Federation

Moscow 125206, Russian Federation

Moscow 119415, Russian Federation

Burgos, Spain

Santiago de Compostela, Spain

Manacor, Spain

Marbella, Spain

Santander, Spain

Aviles, Spain

Sevilla, Spain

Madrid, Spain

Istanbul, Turkey

Ankara, Turkey

Kogarah, New South Wales 2217, Australia

Randwick, New South Wales 2031, Australia

Auchenflower, Queensland 4066, Australia

Clayton, Victoria 3168, Australia

Starting date: May 2006
Last updated: June 27, 2007