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.
Primary Outcome Measures:
- Global Response Assessment (GRA) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Quality of life measures [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
- Urinary symptoms measures [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Urinary biomarkers [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Adherence to urinary educational/behavioral program [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
| Enrollment: |
271 |
| Study Start Date: |
February 2005 |
| Estimated Study Completion Date: |
December 2008 |
| Primary Completion Date: |
April 2008 (Final data collection date for primary outcome measure) |
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1: Active Comparator
Amitryptiline
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Drug: Amitriptyline
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.
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2: Placebo Comparator
Placebo will be dosed exactly as active arm.
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Other: Placebo
Placebo will be dosed exactly as active arm.
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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.
Purpose
