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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 643
- Primary Endpoint
- Change from baseline in mean number of micturitions per 24 hours after 8 weeks
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
2
Solifenacin succinate and simplified bladder training
Intervention: Simplified bladder training (Behavioral)
1
Solifenacin succinate
Intervention: Solifenacin succinate (Drug)
Outcomes
Primary Outcomes
Change from baseline in mean number of micturitions per 24 hours after 8 weeks
Time Frame: 8 weeks
Secondary Outcomes
- Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours(8 and 16 weeks)
- Change from baseline in number of pads used(8 and 16 weeks)
- Incidence and severity of adverse events(8 and 16 weeks)
- Change from baseline in mean number of micturitions per 24 hours after 16 weeks(16 weeks)
- Change from baseline in mean urgency frequency per 24 hours(8 and 16 weeks)