Trial Information

Summary: Research study for women with overactive bladder.

One in four women between the ages of 30 and 59 has experienced urinary incontinence, the involuntary leakage of urine from the bladder. Many of these women will not seek treatment because of embarrassment, or will think that urinary leakage is a normal consequence of aging. However, most forms of urinary incontinence have physical causes that can be treated at any age.

One common cause of urinary incontinence is overactive bladder (OAB), in which the bladder muscle contracts unnecessarily. Women with OAB may need to urinate more frequently, and experience strong and sudden urges to urinate, often leading to urinary leakage.

Women with OAB are being sought for participation in a clinical research study. The purpose of this clinical research study is to evaluate the safety and effectiveness of an investigational medication for the treatment of OAB. Participation in this research study involves up to seven visits to the local physician's office over a period of up to fifteen weeks. Volunteers will receive study-related medical care including study-related examinations, lab tests, and study medication at no cost.

Inclusion Criteria

• Be females ages 18 to 65
• Be experiencing overactive bladder with symptoms of urge incontinence associated with urinary urgency
• Urinate frequently (approximately ten times daily or more)
• Experience involuntary loss of urine (urinary incontinence) on average once per day
• Experience urinary (the strong and sudden need to urinate) on average once per day

Exclusion Criteria

• Have a history of interstitial cystitis or bladder-related pain
• Have urinary incontinence that is predominantly stress incontinence
• Have urinary incontinence due to causes other than overactive bladder (e.g., overflow incontinence or intrinsic sphincter deficiency)
• Have had recent (within 30 days), chronic or recurrent (>4/year) urinary tract infections or bladder stones
• Have had surgery for incontinence
• Have had in the past month, or are intending to start, therapies for overactive bladders such as electrostimulation, biofeedback, or bladder training therapy (behavioral therapy) or use of pessaries or implants
• Have nerve disease that could affect the lower urinary tract or nerve supply, such as multiple sclerosis, Parkinson's disease, or spinal cord injury
• Have major depressive disorder or depression as part of a bipolar disorder or general anxiety disorders
• Have a history of hypersensitivity, allergic reaction, or intolerance to NK1-antagonists
• Have taken antidepressants or other psychoactive drugs, including SSRIs, MAOIs, and benzodiazepines, within the past two weeks.

There are more than 40 participating research centers across the United States and Canada.

For more information, contact the local physician's office below.

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Trial listings updated: June 1, 2008 at 5:45:32 AM