Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)

Last updated: October 28, 2013
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Overall Status: Completed

Phase

3

Condition

Gynecological Infections

Urinary Incontinence

Urinary Tract Infections

Treatment

N/A

Clinical Study ID

NCT00124306
ICCRN (IND)
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must report bladder pain/discomfort score of 3 or greater on a 0-10 Likertscale over the previous 4 weeks.

  • Participant must report a symptom score of abnormal urinary frequency of 3 or greateron a 0-10 Likert scale over the previous 4 weeks.

  • Symptoms of abnormal urinary frequency and bladder pain/discomfort must have beenpresent for at least six weeks prior to screening visit.

Exclusion

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 reuptakeinhibitor (SNRI), or monoamine oxidase (MAO) inhibitor antidepressants.

  • Previous treatment with amitriptyline or other tricyclics, hydroxyzine or otherantihistamines for bladder symptoms; pentosanpolysulfate; DMSO or any otherintravesical therapy, biofeedback or pelvic floor physical therapy for PBS symptoms

Study Design

Total Participants: 271
Study Start date:
February 01, 2005
Estimated Completion Date:
December 31, 2008

Study 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.

Connect with a study center

  • Queen's University

    Kingston, Ontario K7L 2Y7
    Canada

    Site Not Available

  • Stanford University Medical Center

    Stanford, California 94305
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinic

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • William Beaumont Hospital

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.