The current issue of Urology Times highlights the report of Dr. Ken Peters’ presentation at the AUA annual meeting concerning the LiRIS device. This lidocaine-releasing intravesical system (LiRIS) was developed at the Massachusetts Institute of Technology, Cambridge, by Certus Biomedical (later renamed Taris) and began a clinical testing program in 2009. The interstitial cystitis/bladder pain syndrome (IC/BPS) application for the technology was subsequently acquired by Allergan.
The initial study in 16 women with BPS showed an efficacy signal (pain, urgency, voiding frequency, and disease questionnaires), but the unexpected finding of resolution of Hunner lesions in five of the six patients with ESSIC type 3C disease was a catalyst for significant excitement and further clinical trials.
Peters et al reported on a two-center phase Ib trial of 10 patients with Hunner lesions. Of the seven followed per protocol, all had resolution of the inflammatory patches by day 28 after two 14-day device instillations. Pain and frequency also improved. Hunner lesions have not recurred in patients followed out to 1 year.
Ongoing phase II trials in the United States and abroad in patients both with and without Hunner lesions in which both a placebo device and 14 or 28 days of treatment are administered will determine whether we have a new therapy for BPS and who are the best candidates. This will be one of the few clinical trials where Hunner lesions will be treated as a distinct phenotype.
While the numbers are small, there is reason to hope that this technology will be useful in the treatment of BPS using lidocaine and/or perhaps other pharmaceutical agents delivered directly to the bladder over a sustained period. Ideally, newer iterations of the device would decompose in the bladder, obviating the need for endoscopic removal and making the entire procedure truly noninvasive.
Taris is currently pursuing the use of this device for delivering intravesical therapies to treat bladder cancer, overactive bladder, chronic urinary infection, and other pathologies. It is certainly possible that its use for BPS will not only prove to be successful in phase II and phase III trials, but also that it will be only the initial application of this promising drug delivery system.
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