Ontology highlight
ABSTRACT: Objective
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 -5.2 in the KRP-116D group and -3.4 in the placebo group. The estimated difference between the KRP-116D and placebo groups was -1.8 (95% confidence interval -3.3, -0.3; 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.
SUBMITTER: Yoshimura N
PROVIDER: S-EPMC8247858 | biostudies-literature | 2021 May
REPOSITORIES: biostudies-literature
Yoshimura Naoki N Homma Yukio Y Tomoe Hikaru H Otsuka Atsushi A Kitta Takeya T Masumori Naoya N Akiyama Yoshiyuki Y Niimi Aya A Mitsui Takahiko T Nanri Masaharu M Namima Takashige T Takei Mineo M Yamaguchi Akito A Sekiguchi Yuki Y Kajiwara Mitsuru M Kobayashi Shinya S Ameda Kaname K Ohashi Yozo Y Sakamoto Sadaaki S Muraki Osamu O Shishido Toshihide T Kageyama Shinji S Kokura Koji K Okazoe Homare H Yamanishi Tomonori T Watanabe Toyohiko T Uno Takashi T Ohinata Akira A Ueda Tomohiro T
International journal of urology : official journal of the Japanese Urological Association 20210212 5
<h4>Objective</h4>To evaluate the efficacy and safety of intravesical KRP-116D, 50% dimethyl sulfoxide solution compared with placebo, in interstitial cystitis/bladder pain syndrome patients.<h4>Methods</h4>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. Patie ...[more]