Effect of Amitriptyline on Symptoms in Treatment Naïve Patients With Interstitial Cystitis/Painful Bladder Syndrome
Purpose
Amitriptyline is frequently used to treat patients with interstitial cystitis/painful bladder syndrome. The evidence to support this practice is derived mainly from a small, single site clinical trial and case reports.
Materials and Methods
We conducted a multicenter, randomized, double-blind, placebo controlled clinical trial of amitriptyline in subjects with interstitial cystitis/painful bladder syndrome who were naïve to therapy. Study participants in both treatment arms received a standardized education and behavioral modification program. The drug dose was increased during a 6-week period from 10 up to 75 mg once daily. The primary outcome was a patient reported global response assessment of symptom improvement evaluated after 12 weeks of treatment.
Results
A total of 271 subjects were randomized and 231 (85%) provided a global response assessment at 12 weeks of followup. Study participants were primarily women (83%) and white (74%), with a median age of 38 years. In an intent to treat analysis (271) the rate of response of subjects reporting moderate or marked improvement from baseline in the amitriptyline and placebo groups was 55% and 45%, respectively (p = 0.12). Of the subgroup of subjects (207) who achieved a drug dose of at least 50 mg, a significantly higher response rate was observed in the amitriptyline group (66%) compared to placebo (47%) (p = 0.01).
Conclusions
When all randomized subjects were considered, amitriptyline plus an education and behavioral modification program did not significantly improve symptoms in treatment naïve patients with interstitial cystitis/painful bladder syndrome. However, amitriptyline may be beneficial in persons who can achieve a daily dose of 50 mg or greater, although this subgroup comparison was not specified in advance.
Key Words: cystitis, interstitial, amitriptyline, patient education as topic
Abbreviations and Acronyms: AE, adverse event, EBMP, education and behavioral modification program, GRA, global response assessment, IC, interstitial cystitis, PBS, painful bladder syndrome
Supported by cooperative agreements U01 DK65209, 5U01 DK65255-06, U01 DK65271, U01 DK65213, U01 DK65214, U01 DK65215, U01 DK65178, U01 DK65190, U01 DK65192, U01 DK65255, U01 DK65267, U01 DK65271, 5U01 DK65202 from the National Institute of Diabetes and Digestive and Kidney Diseases.
Clinical Trial Registration NCT00124306 (www.clinicaltrials.gov).
Supplementary material for this article can be obtained at the Urological Pelvic Pain Collaborative Research Network (UPPCRN) website, www.cceb.upenn.edu/uppcrn.
For another article on a related topic see page 2070.
Editor's Note: This article is the fourth of 5 published in this issue for which category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 2104 and 2105.
PII: S0022-5347(09)03405-3
doi:10.1016/j.juro.2009.12.106
© 2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc All rights reserved.
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