Trial reportInternational journal of urology : official journal of the Japanese Urological Association2021
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.
Trial report in International journal of urology : official journal of the Japanese Urological Association, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 33 citations in OpenAlex.
- Intravesical Interferon Therapy vs Hyaluronic Acid for Pain Among Female Individuals With Interstitial Cystitis: A Randomized Clinical Trial.JAMA network open · 2024Trial
- The O'Leary-Sant Interstitial Cystitis Symptom Index is a clinically useful indicator of treatment outcome in patients with interstitial cystitis/bladder pain syndrome with Hunner lesions: A post hoc analysis of the Japanese phase III trial of KRP-116D, 50% dimethyl sulfoxide solution.International journal of urology : official journal of the Japanese Urological Association · 2022Trial
- Enhanced mucosal contractile activity following rapid, reversible inhibition of bladder activity by dimethyl sulfoxide (DMSO).World journal of urology · 2026Article
- Effect of Intravesical Administration of Steroid Enemas on an Experimental Autoimmune Interstitial Cystitis-Like Mouse Model.Neurourology and urodynamics · 2026Article
- Spray-freeze-drying aprepitant with hydroxypropyl cellulose increases nasal bioavailability.International journal of pharmaceutics: X · 2026Article
- Angiogenesis, Angiogenic Factors, and Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).International journal of urology : official journal of the Japanese Urological Association · 2026Review
- Animal Models of Hunner-Type Interstitial Cystitis.International journal of urology : official journal of the Japanese Urological Association · 2026Review
- Long-Term Clinical Outcomes of Transurethral Resection of Hunner Lesions Combined With Bladder Hydrodistension for Patients With Interstitial Cystitis at a Tertiary Referral Center in Japan.International journal of urology : official journal of the Japanese Urological Association · 2025Article
- 2025 Canadian Urological Association Guideline: Selected treatment recommendations for interstitial cystitis/bladder pain syndrome.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2025Article
- Management Strategies for Patients with Non-Infectious Cystitis: A Review of the Literature.Current urology reports · 2024Review
- Efficacy and safety of intravesical dimethyl sulfoxide treatment for patients with refractory Hunner-type interstitial cystitis: Real-world data postofficial approval in Japan.International journal of urology : official journal of the Japanese Urological Association · 2024Observational
- Circadian Rhythms Fluctuate the Treatment Effects of Intravesical Treatments on Rat Urinary Frequency Models.Veterinary medicine international · 2024Article
- Th1/17 polarization and potential treatment by an anti-interferon-γ DNA aptamer in Hunner-type interstitial cystitis.iScience · 2023Article
- Animal models of interstitial cystitis/bladder pain syndrome.Frontiers in physiology · 2023Review
- Reply to "Interstitial Cystitis - A Consequence of Weakened Uterosacral Ligaments Failing to Support Visceral Plexuses and Bladder Stretch Receptors and Therefore Potentially Curable?"International neurourology journal · 2022Article
- Chronic Pelvic Pain: A Comprehensive Review.Cureus · 2022Review
- Flavonoid Nobiletin Attenuates Cyclophosphamide-Induced Cystitis in Mice through Mechanisms That Involve Inhibition of IL-1β Induced Connexin 43 Upregulation and Gap Junction Communication in Urothelial Cells.International journal of molecular sciences · 2022Article
- Current Understanding and Future Perspectives of Interstitial Cystitis/Bladder Pain Syndrome.International neurourology journal · 2021Article
Corrections and comments
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Authors and funding
29 authors at 20 institutions in 3 countries.
Funding
Abstract
objectiveTo evaluate the efficacy and safety of intravesical KRP-116D, 50% dimethyl sulfoxide solution compared with placebo, in interstitial cystitis/bladder pain syndrome patients.
methodsJapanese 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.
resultsFor 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.
conclusionsThis 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.