New Study Tests Amitriptyline for Painful Bladder Syndrome
A new study will test an FDA-approved antidepressant 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 the National Institutes of Health
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 the National Institute
of Diabetes and Digestive and Kidney Diseases (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
The 270 participants will be randomly assigned 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 3 or 4 hours before going
to the bathroom. Participants will also 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 primarily used 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 also 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
generally used 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. But until the drug is rigorously tested
we won’t know its true value in these syndromes,” said
Leroy M. Nyberg Jr., Ph.D., M.D., who oversees IC research sponsored
by NIDDK. “And we’ll never know if we are raising false
hopes for patients, and unnecessarily spending health care dollars
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. The current
trial is enlisting newly diagnosed adults and only those who have
not yet 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.
ICCRN Clinical Centers and Investigators
Stanford University Medical Center
Christopher Payne, M.D.
Rodney Anderson, M.D.
Rajesh Shinghal, M.D.
Contact: Debra Clay, R.N. - Research Coordinator
Canada, Kingston, Ontario
J. Curtis Nickel, M.D.
Laurel Emerson, R.N. CCRP
Contact: Joe Downey, M.Sc., CCRP - Research Coordinator
Sylvia Robb, R.N. - Research Associate
(613) 549-6666, Ext 4778
Loyola University Medical Center
Marypat Fitzgerald, M.D.
Linda Brubaker, M.D.
Contact: Judith Senka, R.N. - Research Coordinator
Iowa, Iowa City
University of Iowa Hospitals and Clinic
Karl Kreder, M.D.
Michael O’Donnell, M.D.
Contact: Mary Eno, R.N. - Research Coordinator
Kelley O’Berry - Recruitment Coordinator
University of Maryland
Toby Chai, M.D.
Susan Keay, M.D.
Contact: Judith Murray, CCRC - Research Coordinator
Henry Ford Hospital
David Burks, M.D.
Contact: Jill Sullivan, R.N., B.S.N. - Research Coordinator
Michelle Peabody, R.N. - Research Coordinator
Michigan, Royal Oak
William Beaumont Hospital
Kenneth Peters, M.D.
Contact: Eleanor Anton, R.N. - Research Coordinator
New York, Rochester
University of Rochester Medical Center
Robert Mayer, M.D.
Edward M. Messing, M.D.
Contact: Elizabeth Smith, B.S. - Research Coordinator
Kay Rust, R.N., M.S.N., F.N.P - Research Coordinator
University of Pennsylvania
Philip Hanno, M.D.
Diane Newman, R.N.C., M.S.N., CRNP
Contact: Lilliam Ribeiro, B.S. - Research Coordinator
University of Washington
Richard E. Berger, M.D.
Jane Miller, M.D.
Elizabeth A. Miller, M.D.
Contact: Sharon Downing, R.N. - Research Coordinator