Antidepressant Elavil®
Set for bladder pain study
BETHESDA, MD - The National Institutes of Health (NIH, www.nih.gov), part of the U.S. Dept. of Health and Human Services, repaired its National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) will test an antidepressant approved U.S. Food and Drug Administration (FDA) for its potential to alleviate bladder pain for which there is no known cause and no effective therapy. Thousands, if not millions, of patients may benefit. The study is funded by NIH.
Ten medical centers in the United States and Canada are recruiting adults newly-diagnosed with either painful bladder syndrome (PBS) or interstitial cystitis (IC) to learn if the oral drug amitriptyline (Elavil®) will reduce the pain and frequent urination that are hallmarks of the conditions. The centers make up the Interstitial Cystitis Clinical Research Network, sponsored by NIDDK at NIH.
PBS is defined by symptoms - frequent urination day and night and increasing pain as the bladder fills - according to the International Continence Society. The syndrome includes IC, which has been estimated to affect as many as 700,000 people, mostly women. Estimates for PBS vary widely, but as many as 10 million people may suffer from this condition.
The 270 participants will be assigned randomly to take up to 75 milligrams of amitriptyline or a placebo each day for 14 to 26 weeks. All will practice suppressing the urge to urinate for increasingly longer stretches until they can wait three or four hours before going to the bathroom. Participants will regulate when and how much they drink and avoid bladder irritants such as alcohol, acidic foods, and carbonated or caffeinated drinks.
Staff and patients will find out who received the amitriptyline when the study is finished. Medications and tests are free to participants.
Although amitriptyline is used primarily for depression, the way it works makes it useful for treating the pain of fibromyalgia, Multiple Sclerosis, and other chronic pain syndromes. Prior small studies in IC suggested the drug may be a wise choice for this syndrome as well, because it blocks nerve signals that trigger pain and may decrease muscle spasms in the bladder, helping to cut both pain and frequent urination. An average of 75 milligrams of amitriptyline a day may begin relieving IC pain within a week. In contrast, doses in the range of 150 to 300 milligrams are used generally to treat depression.
“Like so many potential treatments tried before it, amitriptyline looks promising, and we are desperate to find a safe and effective treatment for patients. Until the drug is tested rigorously, we won’t know its true value in these syndromes,” said Dr. Leroy M. Nyberg Jr., who oversees IC research sponsored by NIDDK. “We’ll never know if we are raising false hopes for patients, and spending health-care dollars unnecessarily on prescriptions, if we don’t do this study. It’s critical to base our treatment decisions on evidence.”
Eligibility criteria for the amitriptyline trial mark a major departure from two prior IC studies supported by NIDDK. This trial is enlisting newly-diagnosed adults and only those who haven’t received treatment.
Following up on earlier promising research supported by NIDDK, participants’ urine will be checked for substances that may, ultimately, lead to a definitive test for diagnosing IC and for measuring the effectiveness of potential treatments.
The participating centers are: Stanford University Medical Center (contact Debra Clay, R.N., 650-724-1753); Queen’s University in Kingston, Ontario (contact Sylvia Robb, R.N., 613-549-6666, ext 4778); Loyola University Medical Center in Maywood, IL (Judith Senka, R.N., 708-216-8495); Iowa City, IA, University of Iowa Hospitals and Clinic (Mary Eno, R.N., 319-384-9265); Baltimore, University of Maryland (Judith Murray, 410-328-5784); Henry Ford Hospital in Detroit (Jill Sullivan, R.N., 313-916-3140); William Beaumont Hospital in Royal Oak, MI (Eleanor Anton, R.N., 248-551-0885; University of Rochester (NY) Medical Center, (Kay Rust, R.N., 585-275-0133); University of Pennsylvania in Philadelphia (Lilliam Ribeiro, 215-615-3780); University of Washington/Seattle (Sharon Downing, R.N., 206-598-0850).