Device efficacious for treating IC with Hunner’s lesions

Rochester, MI-A novel lidocaine-releasing intravesical system (LiRIS, Allergan) demonstrated promising efficacy and safety in a small proof-of-concept study investigating its use as a treatment for women suffering from interstitial cystitis (IC) with Hunner’s lesions, reported Kenneth M. Peters, MD, at the AUA annual meeting in San Diego.

The two-center, phase Ib study analyzed efficacy data for seven patients who underwent cystoscopic insertion of the novel lidocaine delivery device on days 0 and 14. Evaluations of Hunner’s lesions were performed on days 14 and 28, and women were followed for 12 weeks after device removal.

The results showed improvements in lesion number, severity, and size by day 14. Corresponding with the lesion changes, the women benefited with reductions in pain, voiding frequency, and other IC-related symptoms and problems that were sustained during the post-treatment follow-up. No significant safety concerns emerged.

Dr. Peters“Previously, the only management options available for IC patients with Hunner’s lesions has been surgery to cauterize the lesions or injection of the lesions with a steroid. Although this study includes a very small population, we are excited about the potential of the lidocaine-releasing system for treating IC in patients with and without Hunner’s lesions. Now, we are looking forward to the results from ongoing phase II double-blind randomized trials,” said Dr. Peters, professor and chair in urology, Oakland University William Beaumont School of Medicine, Rochester, MI.

Dr. Peters and Anthony Cantwell, MD, of Daytona Beach, FL, were the study investigators.

The intravesical system contains 400 mg of lidocaine, and releases its load over a period of 14 days. It was previously shown to have potential benefit as a treatment for IC in a study including 16 women, of whom six had Hunner’s lesions (Sci Transl Med 2012; 4:143ra100).

The study investigating the intravesical lidocaine delivery system in a pure Hunner’s lesion population enrolled 10 patients who had a mean age of 57 years. Eligibility criteria required a pain Numeric Rating Scale (NRS) score of 3 to 9.5, presence of at least one Hunner’s lesion at a screening cystoscopy, and at least eight daily voids.

One patient who received only one treatment, one who expelled the device prior to day 28, and one who did not complete follow-up were excluded from the per-protocol efficacy analysis.

Next: Improvements seen in six of seven women

Improvements seen in six of seven women

Cystoscopic examinations performed at day 14 showed reductions in lesion area, number, and/or severity in six (86%) of seven women, and all women had evidence of response at day 28.

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“Anecdotally, I have not seen any recurrences after resolution of Hunner’s lesion among women I have followed out to 1 year,” Dr. Peters told Urology Times.

Mean NRS pain score was 5.5 at baseline. Statistically significant mean decreases were achieved at day 14 (–2.97), day 28 (–4.27), and at the end of follow-up (–4.4; p≤.029 for all values).

The mean number of daily voids was 18 at baseline and was already significantly reduced by day 7. Further improvement was seen after placement of the second device, and the mean daily void number remained significantly reduced from baseline through day 56 (week 4 of post-treatment follow-up).

O’Leary-Sant Interstitial Cystitis Symptom Index/Interstitial Cystitis Problem Index scores also decreased progressively while the device was in place. Significant reductions from baseline were achieved at day 28 and maintained through at least day 56.

Six of the ten women experienced a treatment-emergent adverse event. Two of the events were determined to be procedure-related, two were device-constituent-related, and there were single cases each of dysuria and pollakiuria.

“Because the treatment involves placement of a device into an inflamed bladder, I was concerned about tolerability. A few patients had complaints, but those were mostly in the first 24 hours, and otherwise the LiRIS was surprisingly very well-tolerated,” Dr. Peters told Urology Times.

The ongoing phase II trials include two protocols that are separately enrolling women with IC with and without Hunner’s lesions. Interventions include placement of a matching placebo device and one or two 14-day placements of the lidocaine delivery. Changes in Hunner’s lesions will be evaluated with computer-assisted analysis of bladder video mapping.

Dr. Peters is a consultant for Allergan, Inc., which supported the study.

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