Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Bladder Diseases Interstitial Cystitis	Drug: Amitriptyline	Phase III

MedlinePlus related topics:

Bladder Diseases Interstitial Cystitis

ChemIDplus related topics:

Amitriptyline Amitriptyline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

Global Response Assessment (GRA)

Secondary Outcome Measures:

Quality of life measures
Urinary symptoms measures
Urinary biomarkers
Adherence to urinary educational/behavioral program
Adverse events

Estimated Enrollment:	270
Study Start Date:	February 2005
Estimated Study Completion Date:	May 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124306

Locations


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

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

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

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

United States, Michigan
	Henry Ford Hospital	Recruiting
	Detroit, Michigan, United States, 48202
	Contact: Jill Sullivan, R.N., B.S.N. 313-916-3140
	Contact: Michelle Peabody, R.N. (313) 916-8265
	Principal Investigator: David Burks, M.D.
	William Beaumont Hospital	Recruiting
	Royal Oak, Michigan, United States, 48073
	Contact: Eleanor Anton, R.N. 248-551-0885
	Principal Investigator: Kenneth Peters, M.D.

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

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

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

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

Sponsors and Collaborators

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

Investigators


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

More Information

Study ID Numbers:	ICCRN
First Received:	July 13, 2005
Last Updated:	July 10, 2007
ClinicalTrials.gov Identifier:	NCT00124306
Health Authority:	United States: Food and Drug Administration

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

painful bladder syndrome

interstitial cystitis

newly diagnosed

Study placed in the following topic categories:

Cystitis, Interstitial

Pregnancy Complications

Urologic Diseases

Urinary Bladder Diseases

Amitriptyline

Cystitis

Pain

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Male Urogenital Diseases

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Adrenergic Uptake Inhibitors

Physiological Effects of Drugs

Psychotropic Drugs

Pharmacologic Actions

Antidepressive Agents, Tricyclic

Female Urogenital Diseases and Pregnancy Complications

Female Urogenital Diseases

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Analgesics

Peripheral Nervous System Agents

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on May 08, 2008

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00124306