Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS) (IC01)
Bladder Diseases, Interstitial Cystitis
About this trial
This is an interventional treatment trial for Bladder Diseases focused on measuring painful bladder syndrome, interstitial cystitis, newly diagnosed
Eligibility 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
Sites / Locations
- Stanford University Medical Center
- Loyola University Medical Center
- University of Iowa Hospitals and Clinic
- University of Maryland
- Henry Ford Hospital
- William Beaumont Hospital
- University of Rochester Medical Center
- University of Pennsylvania
- University of Washington
- Queen's University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
1
2
Amitryptiline
Placebo will be dosed exactly as active arm.