Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)

Condition(s) targeted: Bladder Diseases; Interstitial Cystitis

Intervention: Amitriptyline (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Official(s) and/or principal investigator(s):
Leroy M. Nyberg, Jr., Ph.D, M.D., Study Director, Affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

This is a randomized clinical trial study to test the efficacy and safety of amitriptyline in the treatment of patients newly diagnosed with painful bladder syndrome (PBS). 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 interstitial cystitis (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. Although amitriptyline is a Food and Drug Administration (FDA)-approved medication 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 interstitial cystitis (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 relieve the symptoms of pain and frequent urination.

Official title: A Randomized Multicenter Clinical Trial to Evaluate the Efficacy of Amitriptyline for the Treatment of Painful Bladder Syndrome (PBS) in Newly Diagnosed Patients

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Global Response Assessment (GRA)

Secondary outcome:

Quality of life measures

Urinary symptoms measures

Urinary biomarkers

Adherence to urinary educational/behavioral program

Adverse events

Detailed description: The current trial is recruiting newly diagnosed adults who have not yet received treatment. Approximately 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 participants will be given techniques to 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.

Ten medical centers in the United States and Canada are recruiting adults newly diagnosed with either painful bladder syndrome (PBS) or interstitial cystitis (IC).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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participant must report bladder pain/discomfort score of 3 or greater on a 0-10 Likert

scale over the previous 4 weeks.

- Participant must report a symptom score of abnormal urinary frequency of 3 or greater

on a 0-10 Likert scale over the previous 4 weeks.

- Symptoms of abnormal urinary frequency and bladder pain/discomfort must have been

present for at least six weeks prior to screening visit.

Exclusion Criteria:

- Known allergy or intolerance to amitriptyline or any of its components.

- Currently receives treatment with amitriptyline or other tricyclic antidepressant,

selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), or monoamine oxidase (MAO) inhibitor antidepressants.

- Previous treatment with amitriptyline or other tricyclics, hydroxyzine or other

antihistamines for bladder symptoms; pentosanpolysulfate; DMSO or any other intravesical therapy, biofeedback or pelvic floor physical therapy for PBS symptoms

Stanford University Medical Center, Stanford, California 94305, United States; Recruiting
Debra Clay, R.N., B.S.N., Phone: 650-724-1753
Christopher Payne, M.D., Principal Investigator

Loyola University Medical Center, Maywood, Illinois 60153, United States; Recruiting
Judith Senka, R.N., Phone: 708-216-8495
Marypat Fitzgerald, M.D., Principal Investigator

University of Iowa Hospitals and Clinic, Iowa City, Iowa 52242, United States; Recruiting
Mary Eno, R.N., Phone: 319-384-9265
Kelley O'Berry, Phone: (319) 384-5064
Karl Kreder, M.D., Principal Investigator

University of Maryland, Baltimore, Maryland 21201, United States; Recruiting
Judith Murray, CCRC, Phone: 410-328-5784
Toby Chai, M.D., Principal Investigator

Henry Ford Hospital, Detroit, Michigan 48202, United States; Recruiting
Jill Sullivan, R.N., B.S.N., Phone: 313-916-3140
Michelle Peabody, R.N., Phone: (313) 916-8265
David Burks, M.D., Principal Investigator

William Beaumont Hospital, Royal Oak, Michigan 48073, United States; Recruiting
Eleanor Anton, R.N., Phone: 248-551-0885
Kenneth Peters, M.D., Principal Investigator

University of Rochester Medical Center, Rochester, New York 14642, United States; Recruiting
Elizabeth Smith, B.S., Phone: 585-275-0989
Kay Rust, RN, MSN, FNP, Phone: (585) 275-0133
Robert Mayer, M.D., Principal Investigator

Queen's University, Kingston, Ontario K7L 2Y7, Canada; Recruiting
Sylvia Robb, R.N., Phone: (613) 549-6666, Ext: 4778
Joe Downey, M.Sc., CCRP., Phone: (613) 533-2894
J. Curtis Nickel, M.D., Principal Investigator

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Recruiting
Lilliam Ribeiro, B.S., Phone: 215-615-3780
Kaitlyn Daniels, Phone: (215) 349-5874
Philip Hanno, M.D., Principal Investigator

University of Washington, Seattle, Washington 98195, United States; Recruiting
Sharon Downing, R.N., Phone: 206-598-0850
Richard E. Berger, M.D., Principal Investigator

Starting date: February 2005
Ending date: May 2007
Last updated: July 10, 2007