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 an 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.

Condition	Intervention	Phase
painful bladder syndrome Interstitial Cystitis	Drug: Amitriptyline	Phase III

Further Study Details: 

Primary Outcomes: Global Response Assessment (GRA)
Secondary Outcomes: Quality of Life Measures; Urinary symptoms measures; Urinary Biomarkers; Adherence to urinary educational/behavioral program; Adverse Events
Expected Total Enrollment:  270

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00124306

California
      Stanford University Medical Center, Stanford,  California,  94305,  United States; Recruiting
Illinois
      Loyola University Medical Center, Maywood,  Illinois,  60153,  United States; Recruiting
Iowa
      University of Iowa Hospitals and Clinic, Iowa City,  Iowa,  52242,  United States; Recruiting
Maryland
      University of Maryland, Baltimore,  Maryland,  21201,  United States; Recruiting
Michigan
      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States; Recruiting
      William Beaumont Hospital, Royal Oak,  Michigan,  48073,  United States; Recruiting
New York
      University of Rochester Medical Center, Rochester,  New York,  14642,  United States; Recruiting
Pennsylvania
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Washington
      University of Washington, Seattle,  Washington,  98195,  United States; Recruiting
Canada, Ontario
      Queen''''s University, Kingston,  Ontario,  K7L 2Y7,  Canada; Recruiting

Study chairs or principal investigators

Leroy M. Nyberg, Jr., Ph.D, M.D.,  Study Director,  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)   

Study ID Numbers:  ICCRN
Last Updated:  August 1, 2005
Record first received:  July 26, 2005
ClinicalTrials.gov Identifier:  NCT00124306
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02