At a glance
ClinicalIndex Comparison Record- ✓Bladder pain or discomfort score ≥3 on 0-10 scale over previous 4 weeks
- ✓Abnormal urinary frequency score ≥3 on 0-10 scale over previous 4 weeks
- ✓Symptoms present for at least 6 weeks prior to screening
- ✕Known allergy or intolerance to amitriptyline or its components
- ✕Currently receiving amitriptyline, other tricyclic antidepressants, SSRIs, SNRIs, or MAOIs
- ✕Prior treatment with tricyclics, hydroxyzine, antihistamines, pentosanpolysulfate, DMSO, intravesical therapy, biofeedback, or pelvic floor physical therapy for PBS
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Multicenter Clinical Trial to Evaluate the Efficacy of Amitriptyline for the Treatment of Painful Bladder Syndrome (PBS) in Newly Diagnosed Patients
In Brief
A Phase 3 clinical trial evaluating Amitriptyline and Placebo for Bladder Diseases and Interstitial Cystitis. Completed, enrolled 271 participants across 10 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Amitriptyline will be titrated over a 6-week period as tolerated, to a maximum dose of 75mg. During the 6-week titration period, the patient who cannot tolerate a scheduled increased dose may adjust the medication dose for tolerance by tapering down one 25mg tablet.
Placebo will be dosed exactly as active arm.