The efficacy of onabotulinumtoxinA and solifenacin was significantly higher than that of placebo. However, onabotulinumtoxinA showed significantly greater decreases in urinary incontinence than solifenacin with a third of patients achieving a 100% incontinence reduction. No unexpected safety signals were observed.
Patients with neurogenic detrusor overactivity who completed 4 years of onabotulinumtoxinA treatment experienced a consistent duration of treatment effect and year-to-year improvements in urinary incontinence and quality of life with no new safety signals.
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.
The urologist should be familiar with this growing cause of renal colic in patients on indinavir therapy. Pure indinavir stones are radiolucent and have a soft, gelatinous endoscopic appearance. Conservative treatment is successful in most patients and if intervention is deemed medically necessary, endoscopic stent placement should be the procedure of choice.
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