AMITRIPTYLINE TO TREAT PAINFUL BLADDER SYNDROME

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Interstital cystitis is a chronic, painful inflammatory condition of the bladder wall first characterized in 1914 by Dr. Hunner. Efforts by the NIDDK/NIH, the Interstitial Cystitis Association and the lay press since the mid-1980's brought the disorder from obscurity to prominence with hundreds of millions of federal and private dollars spent in search for a cure. Despite these efforts, the disease is still poorly understood, poorly characterized, and treatment is mostly empirical and unsatisfactory. Painful bladder syndrome (PBS), as defined by the International Continence Society, is "the complaint of suprapubic pain related to bladder filling, accompanied by other symptoms, such as increased day-time and night-time frequency, in the absence of proven urinary infection or other obvious pathology." Although overlapping with interstitial cystitis (IC), PBS is a clinical description of disease based on the patient's symptoms, and does not depend on urodynamic or cystoscopic findings. This protocol will compare the efficacy, safety and tolerability of oral amitriptyline in "newly diagnosed", "treatment naive" PBS patients with matching placebo, all receiving a standard education/behavioral modification program.