Jan. 16, 2008
UI study seeks men with urinary problems
Men age 45 and older with urinary problems are invited to participate in a University of Iowa research study to compare the safety and effectiveness of two dosages of an investigational medication to placebo (inactive substance) in reducing symptoms.
Eligible participants may have the following symptoms: weak or intermittent flow, straining to urinate, feeling that the bladder does not completely empty, or urgent/frequent urination (especially at night). These symptoms may be signs of Bladder Outlet Obstruction (BOO) or Lower Urinary Tract Symptoms (LUTS). LUTS is not a urinary tract infection.
Men with recent heart or blood pressure disease or a history of cancer, except for successfully treated skin cancer, are not eligible to participate. In addition, men with a current urinary tract infection or more than three urinary tract infections in the past 12 months are not eligible.
The study will involve a screening visit and at least five additional visits to UI Hospitals and Clinics over 13 to 16 weeks. Participants will randomly be assigned to take one of two dosages of the study medication or a placebo, and all participants will be asked to keep a diary of urinary habits for some, but not all, days during the study period.
The screening visit and final study visit will include blood and urine tests, physical examinations, electrocardiogram and some specific urological tests. At other visits, only blood and urological tests will be conducted. The study medication(s) and all study tests will be provided at no cost. Compensation for each completed visit and parking also is available.
The UI is one of approximately 50 centers in the United States and Europe taking part in the study. The investigation is funded by Astellas Pharma U.S., Inc.
The lead investigator is Karl Kreder, M.D., professor of urology at the UI Roy J. and Lucille A. Carver College of Medicine.
For more information, call 319-384-9265. You may also e-mail firstname.lastname@example.org.
STORY SOURCE: University of Iowa Health Science Relations, 5137 Westlawn, Iowa City, Iowa 52242-1178