Trial Information

Summary: Overactive bladder (OAB) is a medical condition affecting both women and men that is characterized by a sense of urgency to urinate, usually with frequency and sometimes the need to wake at night to empty your bladder. Urinary frequency, a symptom of OAB is typically defined as emptying of the bladder more than 8 times a day in 24 hours. Urinary leakage may be caused by many different conditions. When leakage is due to OAB, it is associated with strong sudden desires or urges to urinate, and an inability to make it to the bathroom in time.

COMPENSATION: Eligible patients will receive up to $200.00

The purpose of this study is to evaluate the safety and efficacy of the investigational drug fesoterodine in comparison to an approved drug tolterodine and placebo (dummy drug) for overactive bladder. In order to achieve this evaluation in an unbiased manner the study patient will be randomly assigned to one of three treatment groups to receive 14 weeks of study treatment and includes up to 5 study visits. There will be about 2400 people participating in this study. Study related physical exams, including electrocardiogram, vital signs, collection of blood sample, and urine testing will be done free of charge. Subject diaries and questionnaires must be completed as requested and failure to do so could affect your eligibility to continue in the study.

Inclusion Criteria:

• Male or female and greater than or equal to 18 years old
• Must have symptoms typical of overactive bladder for at least 3 months prior to screening/enrollment visit
• Symptoms of frequency (urinate frequently-greater than or equal to an average of 8 times per 24 hours), urgency (sudden desire to urinate which is difficult to control), and urgency incontinence accidental loss of urine)
• Be able to read and willing to complete subject diaries and questionnaires throughout the study

Exclusion Criteria:

• Neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson’s disease, which are known or suspected of influencing the subject’s bladder function
• Significant pelvic organ prolapse
• History of lower urinary tract/pelvic surgery (surgery for incontinence, prolapse, or benign prostate enlargement, surgery to remove uterus) within the past 6 months

Additional inclusion and exclusion criteria apply and will be reviewed with you.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.