To evaluate the efficacy and safety of intravesical KRP-116D, 50% dimethyl sulfoxide solution compared with placebo, in interstitial cystitis/bladder pain syndrome patients.
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.
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.
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.
International journal of urology : official journal of the Japanese Urological Association. 2021 Feb 12 [Epub ahead of print]
Naoki Yoshimura, Yukio Homma, Hikaru Tomoe, Atsushi Otsuka, Takeya Kitta, Naoya Masumori, Yoshiyuki Akiyama, Aya Niimi, Takahiko Mitsui, Masaharu Nanri, Takashige Namima, Mineo Takei, Akito Yamaguchi, Yuki Sekiguchi, Mitsuru Kajiwara, Shinya Kobayashi, Kaname Ameda, Yozo Ohashi, Sadaaki Sakamoto, Osamu Muraki, Toshihide Shishido, Shinji Kageyama, Koji Kokura, Homare Okazoe, Tomonori Yamanishi, Toyohiko Watanabe, Takashi Uno, Akira Ohinata, Tomohiro Ueda
Department of Urology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA., Japanese Red Cross Medical Center, Tokyo, Japan., Department of Pelvic Reconstructive Surgery/Urology, Tokyo Women's Medical University Medical Center East, Tokyo, Japan., Department of Urology, Hamamatsu University School of Medicine, Shizuoka, Japan., Department of Renal and Genitourinary Surgery, Graduate School of Medical Science, Hokkaido University, Hokkaido, Japan., Department of Urology, Sapporo Medical University School of Medicine, Hokkaido, Japan., Department of Urology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan., Department of Urology, University of Yamanashi Graduate School of Medical Sciences, Yamanashi, Japan., Nanri Urological Clinic, Saga, Japan., Department of Urology, Tohoku Rosai Hospital, Miyagi, Japan., Department of Urology, Harasanshin Hospital, Fukuoka, Japan., Female Urology, Women's Clinic LUNA Next Stage, Kanagawa, Japan., Department of Urology, Hiroshima Prefectural Hospital, Hiroshima, Japan., Miyanosawa Nephrourological Clinic, Hokkaido, Japan., Hokkaido Memorial Hospital of Urology, Hokkaido, Japan., Department of Urology, Japan Community Healthcare Organization Ritsurin Hospital, Kagawa, Japan., Department of Urology, Nakamura Hospital, Oita, Japan., Department of Urology, Fujita General Hospital, Fukushima, Japan., Department of Urology, Tokyo Medical University Hachioji Medical Center, Tokyo, Japan., Kageyama Urology Clinic, Shizuoka, Japan., Department of Urology, Takarazuka City Hospital, Hyogo, Japan., Department of Urology, KKR Takamatsu Hospital, Kagawa, Japan., Department of Urology, Continence Center, Dokkyo Medical University, Tochigi, Japan., Department of Urology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan., Clinical Development Center, Kyorin Pharmaceutical Co., Ltd., Tokyo, Japan., Department of Urology, Ueda Clinic, Kyoto, Japan.