UC San Diego Researchers Looking for Participants in Investigational Drug Research Study
Nearly 35 percent of women over 40 experience a potentially embarrassing problem called “urinary urge incontinence (UUI).” It can affect exercise, travel, work and sex, yet most women would rather suffer in silence than discuss it with friends or a physician.
BRIDGES (Bring Simple Urge Incontinence Diagnosis and Treatment to Providers)—a research study being conducted by Dr. Elizabeth Barrett-Connor and her colleagues at the University of California at San Diego and at San Francisco and a number of other academic sites around the country—aims to study whether participant responses to a simple questionnaire can provide an accurate diagnosis of UUI and whether the investigational drug, fesoterodine, is more effective than a placebo in reducing the frequency of UUI.
This research study is divided into 2 parts. The first part is a randomized, placebo-controlled study in which participants have a 50/50 chance of receiving either fesoterodine or placebo. The second part begins at the end of 12 weeks, when participants will be given an opportunity to continue in the “extension study” for 9 additional months. In this part of the study, everyone will be given fesoterodine. No one will receive placebo.
Urge incontinence can be described as having a sudden need to urinate with an inability to control leakage and it affects women from all walks of life.
Elizabeth Barrett-Connor, MD
“Studies show that up to one half of sanitary napkins and pantiliners are purchased for urinary leaks not menstruation” said Barrett-Connor. “Finding ways to help women who experience urge incontinence is long overdue."
Who and How Many Can Participate?
- Women age 18 and over who have experienced urge urinary incontinence for at least three months
- Enrolling about 636 women
- At 15 different sites throughout the United States
- Approximately 40 women will enroll at UCSD Prevention Studies Clinic
The study is supported by Pfizer, Inc.
For more information, please call the recruitment coordinator at: 858-822-5844.
Fesoterodine is an FDA-approved drug for people with symptoms of urge urinary incontinence, urgency, and urinary frequency and is available by prescription.
About Elizabeth Barrett-Connor, M.D.
Elizabeth Barrett-Connor, M.D., is a Distinguished Professor and Division Chief of Epidemiology in the Department of Family and Preventive Medicine at the UC San Diego School of Medicine. Her pioneering work spans many areas including cardiovascular disease, diabetes, cancer, osteoporosis, memory loss and exogenous and endogenous hormones.
Barrett-Connor is founder and director of the Rancho Bernardo Heart and Chronic Disease Study, begun in 1972, with continuous support from the NIH. She is/was principal investigator of several multi-center clinical trials including the Postmenopausal Estrogen/Progestin Interventions (PEPI) study, the Heart and Estrogen-Progestin Replacement Study (HERS), the Raloxifene Use in The Heart (RUTH) study, and Diabetes Prevention Program Follow-up Study (DPPOS).
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Media Contact: Kim Edwards, 619-543-6163, kedwards@edu