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.

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.

[Interstitial cystitis in urology clinic: current status and problems].

PURPOSE: We examined the complications in the diagnosis and treatment of interstitial cystitis in daily clinical practice. MATERIALS AND METHODS: The study included 82 patients who were suspected of having interstitial cystitis at our hospital from March 2002 to April 2013. All hydrodistention procedures were performed with the aid of an anesthesiologist, as recommended by the Ministry of Health, Labour, and Welfare since April 2010. RESULTS: Of the 82, 20 patients were male and 62 were female, (mean age at diagnosis 53 years.) Six of the suspected cases did not have interstitial cystitis. Of the 67 patients diagnosed with interstitial cystitis during hydrodistention, 29 (43%) did not experience pain. The time taken to diagnose these asymptomatic patients was longer than that taken for those who experienced pain. Twenty-eight patients (42%) discontinued treatment because it was ineffective. CONCLUSION: Interstitial cystitis has been widely recognized, but general physicians are unable to provide a diagnosis and suggest aggressive treatment because of difficulty associated in the treatment and diagnosis. To resolve these issues, physicians should be keep in mind that interstitial cystitis involves a hypersensitive bladder, and that some patients may not experience pain. Further, knowledge about Hunner's ulcer is essential. We believe that the most important points are improving health insurance about facility criteria of hydrodistention, and evaluating behavioral modification and dietary manipulation.

[EARLY EXPERIENCE OF INTRAVESICAL INSTILLATION OF DIMETHYL SULFOXIDE 50% SOLUTION FOR HUNNER TYPE INTERSTITIAL CYSTITIS IN A CLINIC].

(Objectives) To analyze the early observations in intravesical instillation of dimethyl sulfoxide (DMSO) 50% solution for Hunner-type interstitial cystitis (HIC) in our clinic and discuss possible factors affecting outcomes and future tasks. (Materials and methods) Seven patients who received DMSO therapy upon HIC relapse after transurethral resection of Hunner lesions with hydrodistension were enrolled for this study. For DMSO, 50 mL of 50% intravesical solution was administered six times every two weeks. Treatment evaluation was conducted using O'Leary & Sant Interstitial Cystitis Symptom and Problem Indexes (ICSI and ICPI), numerical rating scale (NRS) for bladder pain (0-10 points), and the post-treatment variations for which the pre-treatment values of the 24-hour urinary frequency, the average voided volume, and the maximum voided volume were used. The patient satisfaction survey was conducted with a questionnaire, and cystoscopy was conducted for all cases before and after treatment. (Results) All the patients were females with an average age of 58.3 years old. According to the Society of Interstitial cystitis of Japan Severity Criteria, 5 of the 7 cases showed a moderate level. No severe side effects were observed, and all the patients achieved six times administration. Changes in the points from the pre-treatment baseline values to the post-treatment values were -6.1, -9.1, and -10.0 for Pain NRS, ICSI, and ICPI, respectively. In addition, the 24-hour urinary frequency decreased by 5.34 times, while the average voided volume and the maximum voided volume increased to 60.3 mL and 75.7 mL, respectively. Subjective symptoms of all the patients improved, and cystoscopy revealed the disappearance or remission of Hunner lesions. (Conclusions) If Hunner lesions can be diagnosed, DMSO therapy could be used effectively and safely for HIC. The therapy is also promising for use as a future initial therapy. Therefore, the accurate diagnosis of Hunner lesions will be more important in the future.

Renal-tissue damage induced by laparoscopic partial nephrectomy using microwave tissue coagulator.

BACKGROUND AND PURPOSE: The microwave coagulator is a useful instrument that enables surgeons to perform partial nephrectomy without vascular clamping. The extent of postoperative thermal damage in surgically spared renal tissue has not been well examined. The present study was conducted to evaluate the tissue damage caused by microwave coagulation in laparoscopic partial nephrectomy (LPN) for small renal tumors. MATERIALS AND METHODS: Seven cases of LPN with a microwave tissue coagulator were entered in the present study. The median tumor diameter was 1.5 cm, and the median size of the resected specimen was 2.2 cm. Postoperative tissue damage was evaluated by contrast-enhanced CT 1 month after surgery. Surgically spared renal-tissue volume and functioning renal-tissue volume were estimated from the images by NIH Image 1.62 software. RESULTS: Postoperative CT revealed unenhanced renal tissue adjacent to the surgical margin. The median estimated volumes of surgically spared and functioning renal tissue were 96.1% (range 74.3%-99.8%) and 88.4% (range 68.0%-92.7%) of preoperative normal renal tissue, respectively. The percentile volume of functioning to surgically spared renal tissue ranged from 89.9% to 96.0% (median 92.8%). CONCLUSIONS: The microwave coagulator enables us to carry out partial nephrectomy without vascular clamping. Although 96% of normal renal tissue was surgically spared, 4% to 10% of this tissue was nonfunctioning as a result of microwave-induced thermal damage.

Prostate-specific antigen assay using whole blood samples spotted on filter paper and its application to mass screening for prostate cancer.

AIM: The disc assay system for prostate-specific antigen (PSA) is a novel technique using a small amount of whole blood on filter paper. The accuracy of this assay system and its feasibility for use in prostate cancer mass screening were evaluated. METHODS: In the first arm of the study, to evaluate the accuracy of the disc assay system, PSA values were determined by both a disc assay system and a standard serum assay system using the same blood samples obtained from 420 outpatients. In the second arm of the study, the feasibility and reliability of the disc assay system were examined in prostate cancer mass screening. A total of 2475 men were screened by the disc assay (disc group) and 3348 men were screened by the standard serum assay (serum group) in the first step of mass screening. In the second step of the screening in the disc group, 101 men underwent PSA tests by a standard serum assay, then the first PSA values determined by the disc assay were compared with the second PSA values determined by the standard serum assay. In the second step of the screening in the serum group, 94 men underwent additional PSA tests by a serum assay, and then the first PSA values were compared with the second PSA values. Two men in each group were excluded from analysis because the true PSA values of the first step were not available (more than 50 ng/mL). RESULTS: The PSA values determined by the disc assay closely correlated with those obtained by the standard assay (r = 0.987) in 295 outpatients with PSA levels between 1.0 and 20 ng/mL. In the PSA mass screening, the PSA values determined in the first step closely correlated with those in the second step both in the disc group (r = 0.916) and in the serum group (r = 0.845). A significant dissociation of the two PSA values was observed in seven of 99 men in the disc group and in three of 92 men in the serum group. However, there was no statistical significance in the incidence of dissociation in the two PSA values between the disc group and the serum group. CONCLUSIONS: The disc assay system seems to be a sensitive and accurate assay system. The feasibility and reliability of the disc assay system were well demonstrated in the field during prostate cancer mass screening.