CONTROL THE URGE

Overactive bladder (OAB) is a medical condition affecting both women and men that is characterized by a sense of urgency to urinate, with or without urge incontinence usually with frequency and a complaint that the individual has to wake at night one or more times to void.

Urinary frequency, a symptom of OAB is typically defined as emptying of the bladder more than 8 times a day.

Urinary incontinence, or involuntary loss of urine, may be caused by many different conditions. When incontinence 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. This is different than stress incontinence which is a loss of urine associated with physical activity such as coughing and sneezing. Women who have had children may experience both stress and urge incontinence.

Requirements for Participation
In order to participate in this clinical research study, you must be at least 18 years old, and must have symptoms typical of overactive bladder for at least 3 months. Both women and men may participate.

You must have symptoms associated with overactive bladder, specifically:

Ø       Frequent urination

Ø       Symptoms of urinary urgency or strong, sudden desires to urinate

Ø       HAVE NOT been previously treated for Overactive Bladder with any anticholinergic medication.

Ø       Be able to read and willing to complete patient diaries and questionnaires throughout the study.

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

Study Medication
This investigational study is designed to evaluate the safety and effectiveness of an investigational medication in the treatment of overactive bladder in patients not previously exposed to anticholinergic drugs for the treatment of urgency associated with overactive bladder.

The study will last approximately 3 ½ months. Study participation will involve 6 study visits. About 700 subjects will be enrolled in this study.

The study has two parts, the screening visit and the treatment phase. The first visit is the Screening visit.  If eligible to participate you will return for 5 study visits over the next 12 weeks. These visits begin with a Baseline visit. Participants will be assigned study medication or placebo (a pill with no active ingredients) at the Baseline visit. This is a “Double-Blind” study which means that the study doctor, study staff and you will not know if you are receiving the investigational medication or the placebo, however the doctor can find out if medically necessary.
 

Required Testing
Study related physical exams, including a pelvic exam for females, vital signs and urine testing will be done free of charge. Patient diaries will need to be completed during the 3 or 7 day period immediately before each study visit.
 

Compensation
Eligible participants who are enrolled in the trial will receive up to $150.00 for being in this study. You will get $25.00 for each study visit you complete.  If you do not finish the study, you will only be paid for the visits you completed.

Investigators
Robert Spitz, MD, CCI
Richard Fraser, MD
 

Please note:
The preceding is an overview of this clinical trial and is intended to provide prospective patients with information that may help them decide whether to consider participating in the trial. There are additional details regarding study eligibility criteria, and details important to making a final decision regarding participating that are not listed on this page. These will be discussed with interested participants over the phone and in person by a member of Coastal Connecticut Research. All relevant information will be provided in the Informed Consent Form that must be reviewed by the prospective participant.

At Coastal Connecticut Research, we are excited to introduce this investigational medication to you, and hope that you will consider joining us in this trial.

If you would like more information, or to see if you qualify for this study, please contact study coordinators:

Lana Smith, R.N.

Diane Palmer, R.N.

Maria Mendez-Neff, B.S.

CALL TOLL FREE: 1-888-437-7092

IN THE NEW LONDON AREA:  CALL 443-4567

Or contact us by e-mail at CCRvolunteer@gmail.com