Safety, tolerability, and efficacy of LiRIS 400 mg in women with interstitial cystitis/bladder pain syndrome with or without Hunner lesions. Issue 7 (20th July 2021)

• Record Type: Journal Article
• Authors: Evans, Robert; Kohan, Alfred; Moldwin, Robert; Radecki, Daniel; Geib, Till; Peters, Kenneth M.
• Is Part Of: Neurourology and urodynamics. Volume 40:Issue 7(2021)
• Page Start: 1730
• Page End: 1739
• Publication Date: 2021-07-20
• Subjects: intravesical -- lidocaine -- painful bladder syndrome -- phase 2; Urinary organs -- Periodicals; Urodynamics -- Periodicals; Urology -- Periodicals; 616.6
• DOI: 10.1002/nau.24702
• Languages: English
• ISSNs: 0733-2467

Abstract

Abstract: Aims: Two phase 2 studies were conducted to assess the efficacy and safety of lidocaine‐releasing intravesical system (LiRIS) in patients with interstitial cystitis/bladder pain syndrome (IC/BPS) with (Study 001; NCT02395042) or without, (Study 002; NCT02411110) Hunner lesions (HL). Methods: Both were multicenter, randomized, double‐blind, placebo‐controlled, and enrolled women aged ≥18 years. In Study 001, patients were randomized 2:1:1 to LiRIS 400 mg/LiRIS 400 mg, placebo/LiRIS 400 mg, or placebo/placebo for a continuous 28 (2 × 14)‐day period. In Study 002, patients were randomized 1:1 to LiRIS 400 mg or placebo for a continuous (single treatment) 14‐day period. Results: In total, 59 and 131 patients received treatment in Studies 001 and 002, respectively. There was no statistically significant difference in the primary endpoint, the change from baseline to Week 4 of follow‐up post‐removal in mean daily average bladder numeric rating scale (NRS) pain score in either study (Study 001: placebo/placebo, −1.6; LiRIS/LiRIS, −2.7, p = 0 .142; placebo/LiRIS, −2.5, p = 0.319; Study 002: LiRIS −1.2; placebo, −1.5, p = 0.505). There was no statistically significant difference between groups in daily worst NRS pain score, number of micturitions/day or urgency episodes/day. There was no clear trend for reduction in number of HL for LiRIS vs placebo. The frequency of treatment‐emergent adverse events was similar between treatment groups in both studies; most were mild or moderate intensity. Conclusion: These studies did not demonstrate a treatment effect of LiRIS 400 mg compared with placebo, either in patients with IC/BPS with HL, or in those without HL.