Overactive Bladder
Conditions
Keywords
urge urinary incontinence
Brief summary
The primary objective of this study is to evaluate the efficacy of SSR240600C in women with overactive bladder compared to placebo using tolterodine as a study calibrator.
Interventions
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of overactive bladder
Exclusion criteria
* Stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history * Urinary incontinence due to cause other than detrusor overactivity (eg, overflow incontinence) * Current Urinary Tract Infection (UTI) or frequent UTIs * Urinary retention or other evidence of poor detrusor function * Pain during voiding or bladder pain without voiding * History of radiation cystitis or history of pelvic irradiation * History of interstitial cystitis or bladder related pain syndrome The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the number of micturitions per 24 hours | at week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in number of urge urinary incontinence episodes, in number of urgency episodes, in number of nocturia episodes, in volume of urine per void | at week 12 |
| Safety of SSR240600C | at week 12 |
| Quality of life | at week 12 |
Countries
Canada, Czechia, France, Germany, Netherlands, Portugal, United States
Outcome results
None listed