A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on October 19, 2007
Link to the current ClinicalTrials.gov record.
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.
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
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
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.
- Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for> 3 months
- 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
Locations and Contacts
Antwerp 2020, Belgium
Brussels 1090, Belgium
Gent 9000, 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
Annecy Cedex, France
Saint Louis Cedex, France
Nyiregyhaza H-4400, Hungary
Budapest H-1145, Hungary
Milan 20092, Italy
Cinisello Balsamo, 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
Santiago de Compostela, Spain
Kogarah, New South Wales 2217, Australia
Randwick, New South Wales 2031, Australia
Auchenflower, Queensland 4066, Australia
Clayton, Victoria 3168, Australia
Last updated: June 27, 2007