Status:
COMPLETED
Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
University of Pennsylvania
Conditions:
Bladder Diseases
Interstitial Cystitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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-...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
271 Patients enrolled
Trial Details
Trial ID
NCT00124306
Start Date
February 1 2005
End Date
December 1 2008
Last Update
October 7 2025
Active Locations (10)
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1
Stanford University Medical Center
Stanford, California, United States, 94305
2
Loyola University Medical Center
Maywood, Illinois, United States, 60153
3
University of Iowa Hospitals and Clinic
Iowa City, Iowa, United States, 52242
4
University of Maryland
Baltimore, Maryland, United States, 21201