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OVERACTIVE BLADDER
CONTROL THE URGE
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
STUDY DESCRIPTION: 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:
Neurological 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 more information, or to see if you qualify for this study,
please contact study coordinators:
Carolyn Eustace, RA
Karen Cuddy, RN
(860) 443-4567
or contact us by e-mail at
CCRvolunteer@gmail.com
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