Research ArticlePain

Continuous Intravesical Lidocaine Treatment for Interstitial Cystitis/Bladder Pain Syndrome: Safety and Efficacy of a New Drug Delivery Device

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Science Translational Medicine  18 Jul 2012:
Vol. 4, Issue 143, pp. 143ra100
DOI: 10.1126/scitranslmed.3003804

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In her painting Los Dos Fridas, Frida Kahlo depicts two versions of herself: one healthy and one after the bus crash that left her in pain for the rest of her life. People who suffer from chronic pain can relate, often dividing their lives into two halves–one before the pain and one after chronic pain changed everything. Now, through the use of a clever drug delivery device, Nickel et al. offer some hope of relief for millions of women who suffer from chronic interstitial cystitis (bladder pain syndrome) (IC/BPS).

A chronic urological condition, IC/BPS is characterized by debilitating bladder pain, urinary urgency, and frequent voiding. Because oral therapies offer little to no symptomatic relief, physicians have attempted to deliver the local anesthetic lidocaine directly into the bladder. However, although this localized treatment gave some immediate relief, the drug is diluted or voided from the bladder within 1 hour, making repeat procedures necessary to control symptoms. A previous attempt to design an in-bladder device with sustained drug release failed because patients could not tolerate the discomfort caused by the device, likely because of its large size (10 to 15 cm).

In the new work, Nickel et al. report the design of a new, smaller, water-permeable device that contains solid lidocaine minitablets that are dissolved over time by water from the urine. The decrease in device size was made possible by using solid-state drug rather than drug in solution. The second lumen of the new device carried a nickel titanium wire that assumed a bladder-retentive pretzel form once inside the bladder. A phase 1 safety-assessment trial of empty devices in healthy volunteers showed high retention and tolerability. Subsequent phase 1b studies were conducted in women with moderate to severe IC/BPS, and treatment with the drug-loaded device showed clinically meaningful reductions in pain, urgency, voiding frequency, and disease questionnaires. In cystoscopic examinations, five of six patients showed resolution of bladder lesions. Follow-up after device removal revealed that pain reduction persisted for several months, allowing the patients a chance to feel like their healthy selves once again.