Efficacy and safety of intravesical instillation of KRP‐116D (50% dimethyl sulfoxide solution) for interstitial cystitis/bladder pain syndrome in Japanese patients: A multicenter, randomized, double‐blind, placebo‐controlled, clinical study

Abstract

To evaluate the efficacy and safety of intravesical KRP-116D, 50% dimethyl sulfoxide solution compared with placebo, in interstitial cystitis/bladder pain syndrome patients. Methods: Japanese interstitial cystitis/bladder pain syndrome patients with an O'Leary-Sant Interstitial Cystitis Symptom Index score of ≥9, who exhibited the bladder-centric phenotype of interstitial cystitis/bladder pain syndrome diagnosed by cystoscopy and bladder-derived pain, were enrolled. Patients were allocated to receive either KRP-116D (n = 49) or placebo (n = 47). The study drug was intravesically administered every 2 weeks for 12 weeks. Results: For the primary endpoint, the change in the mean O'Leary-Sant Interstitial Cystitis Symptom Index score from baseline to week 12 was À5.2 in the KRP-116D group and À3.4 in the placebo group. The estimated difference between the KRP-116D and placebo groups was À1.8 (95% confidence interval À3.3, À0.3; P = 0.0188). Statistically significant improvements for KRP-116D were also observed in the secondary endpoints including O'Leary-Sant Interstitial Cystitis Problem Index score, micturition episodes/24 h, voided volume/micturition, maximum voided volume/micturition, numerical rating scale score for bladder pain, and global response assessment score. The adverse drug reactions were mild to moderate, and manageable. Conclusions: This first randomized, double-blind, placebo-controlled trial shows that KRP-116D improves symptoms, voiding parameters, and global response assessment, compared with placebo, and has a well-tolerated safety profile in interstitial cystitis/ bladder pain syndrome patients with the bladder-centric phenotype.

Current Status of Intravesical Therapies for Bladder Pain Syndrome (BPS): A Narrative Review of Emerging Evidence

“…Yoshimura reported the largest randomised study investigating effects of DMSO and the only one to satisfy our inclusion criteria [16]. Across 24 centres, 96 patients were enrolled in a 12-week treatment course.…”

Medical uses for silver nitrate in the urinary tract (Review)

“…In the field of urology, intravesical injection therapy is conventionally used in the treatment of patients by injecting various liquid drugs (e.g., silver nitrate, dimethyl sulfoxide, lidocaine, phenol and steroids) into the bladder to reach the entire surface tissue of the bladder (52)(53)(54). The therapeutic application of silver nitrate is reportedly effective for a wide variety of urological diseases (Table I).…”

Management of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients

“…A multicenter, randomized, placebo-controlled trial examining DMSO compared with placebo in 96 patients was recently published in Japan in 2021 [9]. The mean O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score at week 12 decreased by −5.2 in the DMSO group compared with a decrease by −3.4 in the placebo group, with a statistically significant difference between the groups.…”