Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)

Completed · Phase 3 · Has a placebo group

Conditions studied: Bladder Diseases, Interstitial Cystitis

In brief

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.

Key facts

Study ID

NCT00124306

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

271

Starts

2005-02-01

Expected to finish

2008-12-01

Last updated by the study team

2026-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Stanford University Medical Center — Stanford, California, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• University of Iowa Hospitals and Clinic — Iowa City, Iowa, United States
• University of Maryland — Baltimore, Maryland, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• University of Rochester Medical Center — Rochester, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Washington — Seattle, Washington, United States
• Queen's University — Kingston, Ontario, Canada

Full record on ClinicalTrials.gov

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