Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2010 May;183(5):1853-8.
doi: 10.1016/j.juro.2009.12.106. Epub 2010 Mar 29.

Effect of amitriptyline on symptoms in treatment naïve patients with interstitial cystitis/painful bladder syndrome

Harris E Foster Jr  1 , Philip M Hanno, J Curtis Nickel, Christopher K Payne, Robert D Mayer, David A Burks, Claire C Yang, Toby C Chai, Karl J Kreder, Kenneth M Peters, Emily S Lukacz, Mary P FitzGerald, Liyi Cen, J Richard Landis, Kathleen J Propert, Wei Yang, John W Kusek, Leroy M Nyberg; Interstitial Cystitis Collaborative Research Network
Collaborators, Affiliations
Randomized Controlled Trial

Effect of amitriptyline on symptoms in treatment naïve patients with interstitial cystitis/painful bladder syndrome

Harris E Foster Jr et al. J Urol. 2010 May.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00124306.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Study Design: Interventions and Study Drug Dose Escalation Schedule
Figure 2
Figure 2
Consort Diagram for Flow of Subjects through Study Phases, by Treatment Arm
See this image and copyright information in PMC

References

    1. Rovner E, Propert KJ, Brensinger C, et al. Treatments used in women with interstitial cystitis: the interstitial cystitis data base (ICDB) study experience. The Interstitial Cystitis Data Base Study Group. Urology. 2000;56:940. - PubMed
    1. van Ophoven A, Pokupic S, Heinecke A, et al. A prospective, randomized, placebo controlled, double-blind study of amitriptyline for the treatment of interstitial cystitis. J Urol. 2004;172:533. - PubMed
    1. Hanno PM, Buehler J, Wein AJ. Use of amitriptyline in the treatment of interstitial cystitis. J Urol. 1989;141:846. - PubMed
    1. Baldessarini RJ. Drug and the treatment of Psychiatric disorders. Goodman and Gilman’s the pharmacological basis of therapeutics. 1985:387.
    1. Barrett DM, Wein AJ. Adult and Pediatric Urology 2. Vol. 1. Anonymous Year Book Medical Publishers Inc; 1987. Voiding dysfunction: Diagnosis, classification, and management; p. 863.

Publication types

Associated data