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Novel androgen receptor axis-targeted agents (ARATAs) have been developed for mCRPC and improved overall survival (OS). Here, we aimed to find predictors who will receive the greatest benefits from ARATAs.We previously performed a multicenter study to identify prognostic factors for metastatic hormone-sensitive prostate cancer (mHSPC, n = 148) and mCRPC (n = 99), and showed that the bone scan index (BSI) was one of the significant prognostic factors for 3-year OS (PROSTAT-BSI study). mHSPC progressed to mCRPC (n = 101), for which 69 patients were treated with (n = 39) or without ARATAs (n = 30, prior to the approval of ARATAs). The 69 patients were divided into two groups according to patient factors, and these cohorts were further divided into two subgroups by usage of ARATAs. OS was compared between subgroups in each group.The predictors were age (71.4 years), serum levels of C-reactive protein (≥0.16 ng/ml) and alkaline phosphatase (≥548 U/L), time to PSA progression after ADT (8.9 months), the lowest PSA level (≥1 ng/ml) after ADT, and the rate of PSA decline 3 months after ADT (0.987), whereas hemoglobin levels, PSA before ADT, Gleason scores, existence of visceral metastases, and BSI were not.The present study identified predictors for the effectiveness of ARATAs. The number of bone metastases (≒BSI), existence of visceral metastases, and Gleason scores, which were identified as high-risk factors in the LATITUDE study and disease volume in CHAARTED criteria, did not appear to be useful for predicting effectiveness from ARATAs.

Penile cancer is a rare cancer for which no medical guidelines have been established before in Japan. These guidelines aim to standardize, as much as possible, the therapeutic modality for penile cancer, for which empirical evidence is limited on a global scale, thereby bolstering therapeutic outcomes for patients with penile cancer. The new guidelines conform to the Minds Guide for Developing Clinical Practice Guidelines (2017) as much as possible. However, virtually no randomized comparative studies and meta-analyses based on such randomized studies have been conducted. Therefore, only the findings available at present were listed after conducting an exhaustive literature review of items with extremely low evidence levels and for which bodies of evidence and grades of recommendation were not evaluated. Clinical questions were set for items with a relatively large number of studies, including retrospective studies. However, since it is virtually impracticable to summarize bodies of evidence by systematic reviews, recommendation grades and evidence levels were discussed and determined by the consensus panel of the Preparatory Committee. The following were outlined: epidemiological, pathological, diagnostic, therapeutic, follow-up, and quality of life-related findings. Additionally, seven clinical questions were established to determine recommendation grades and evidence levels. We hope that these guidelines will prove to be useful to medical professionals engaged in clinical practice related to penile cancer in Japan and anticipate that critical reviews of the guidelines will lead to further refinement of the next edition.

OBJECTIVE To confirm if mirabegron 50 mg shows efficacy in women with overactive bladder and either urgency urinary incontinence or mixed urinary incontinence versus placebo. METHODS Post-hoc analyses were carried out using pooled data from a Japanese phase IIb and a phase III study. The primary efficacy end-point was baseline to end-of-treatment change in the mean number of micturitions/24 h. The secondary end-points were changes in the mean voided volume/micturition, mean number of urgency and incontinence episodes/24 h, and mean number of nocturia episodes/night. Other end-points were quality of life and incontinence normalization rates. RESULTS Women with urgency urinary incontinence (placebo n = 204, mirabegron n = 214) and mixed urinary incontinence (placebo n = 122, mirabegron n = 139) were included. Change in mean micturitions/24 h at end-of-treatment for mirabegron was statistically significant versus placebo in both populations; the effect size increased over time. For all secondary end-points, median changes for mirabegron were statistically significant versus placebo at end-of-treatment, except for nocturia for the urgency urinary incontinence population and urgency for the mixed urinary incontinence population. Mirabegron showed larger improvements versus placebo in all quality-of-life domains, except for general health perception in the urgency urinary incontinence population. Incontinence normalization rates for mirabegron were 47.2% and 49.6% in the urgency urinary incontinence and mixed urinary incontinence populations, respectively, versus 42.6% and 39.3% for placebo. CONCLUSIONS Mirabegron 50 mg significantly improved key overactive bladder symptoms versus placebo in women with urgency urinary incontinence, and it also improved most overactive bladder symptoms, including micturition frequency, in patients with mixed urinary incontinence. These findings support the benefits of using mirabegron in the female overactive bladder wet population.

The present article is an abridged English translation of the Japanese Clinical Guidelines for Female Lower Urinary Tract Symptoms (second edition), published in September 2019. These guidelines consist of a total of 212 pages and are unique worldwide in that they cover female lower urinary tract symptoms other than urinary incontinence. They contain two algorithms for "primary treatment" and "specialized treatment," respectively. These guidelines, consisting of six chapters, address a total of 26 clinical questions including: (i) treatment algorithms; (ii) what are female lower urinary tract symptoms?; (iii) epidemiology and quality of life; (iv) pathology and illness; (v) diagnosis; and (vi) treatment. When the patient's symptoms mainly involve voiding and post-micturition symptoms, specialized treatment should be considered. In the event of voiding symptoms concurrent with storage symptoms, residual urine should be measured; if the residual urine volume is

Objective To carry out an exploratory assessment of the efficacy and safety of TAS-303, a noradrenaline reuptake inhibitor, in women with stress urinary incontinence. Methods In a double-blind, placebo-controlled, early phase II study, women with stress urinary incontinence and stress urinary incontinence-predominant mixed urinary incontinence were randomized to a placebo or TAS-303 (3 or 6 mg) once daily for 8 weeks. The main efficacy end-points were mean percentage change in incontinence episode frequency per 24 h from baseline to week 8 (the primary end-point) and week 4. Results At week 8, the mean percentage change in incontinence episode frequency per 24 h was -34.73% in the TAS-303 3 mg group, -35.41% in the TAS-303 6 mg group and -28.07% in the placebo group (differences vs placebo, not significant). In patients with stress urinary incontinence, or incontinence episode frequency less than two episodes per 24 h at baseline, TAS-303 significantly reduced incontinence episode frequency versus placebo after 4 weeks; some secondary end-points also showed a tendency to improve in the same subgroups. No serious adverse events (e.g. central nervous system or cardiovascular effects) were observed; TAS-303 was well tolerated and had a favorable safety profile. Conclusion These findings suggest that TAS-303 is effective for improving stress urinary incontinence symptoms in some subgroups of patients with stress urinary incontinence. Therefore, further research is warranted.

Objectives Despite just a 4-year interval from the last version (2015) of the Clinical Practice Guidelines for Bladder Cancer, several dramatic paradigm shifts have occurred in the latest clinical practice regarding both the diagnosis and treatment of bladder cancer. Herein, we updated the 2019 version of the Clinical Practice Guidelines for Bladder Cancer under the instruction of the Japanese Urological Association. Methods We previously reported in a revision working position paper for Clinical Practice Guidelines for Bladder Cancer 2019 edition and described the methods of revision detail. Results The major points of change in the 2019 version are presented and explanations are given as follows: (i) introduction of the new reference assessment system; (ii) modification of the risk classification for non-muscle-invasive bladder cancer; (iii) addition of clinical questions for the new tumor-visible techniques in non-muscle-invasive bladder cancer; (iv) inclusion of minimally invasive surgeries for muscle-invasive bladder cancer and immune checkpoint inhibitors for locally advanced/metastatic muscle-invasive bladder cancer; (v) overview chapter of the histological variant of urothelial cancer and rare cancers of the bladder; and (vi) recommendation of follow up in non-muscle-invasive bladder cancer and muscle-invasive bladder cancer. Conclusions Guidelines should be updated based on the current evidence and updates carried out without delay. The hope is that this guidelines will be assessed by many urologists and will be the cornerstone for the next revision.

OBJECTIVE To evaluate the efficacy and safety of onabotulinumtoxinA (botulinum toxin type A) 100 U in patients with overactive bladder and urinary incontinence. METHODS This was a phase III, randomized, double-blind, placebo-controlled trial in Japanese patients who were inadequately managed with overactive bladder medications (anticholinergics and/or β3 -adrenergic receptor agonists). Eligible patients were randomized 1:1 to receive a single dose of either onabotulinumtoxinA or placebo into the detrusor muscle (n = 124 each). The primary end-point was the change in the number of daily urinary incontinence episodes at week 12 from baseline. Secondary end-points included volume voided per micturition, other symptomatic measures (urinary urgency incontinence, micturition, urgency and nocturia) and patient-reported outcomes. RESULTS In the onabotulinumtoxinA group, there was a significantly greater decrease from baseline in the mean number of daily urinary incontinence episodes compared with the placebo group (2.16; P

Objectives To investigate the efficacy of vibegron on nocturia in patients with overactive bladder. Methods Among the Japanese overactive bladder patients enrolled in the placebo‐controlled, multicenter, randomized, double‐blind phase 3 study of vibegron, a total of 669 patients with nocturia (≥1 nocturnal void) were included. Changes from baseline in micturition parameters were compared for vibegron treatment (50 and 100 mg/day) versus placebo. Correlations of hours of undisturbed sleep with the frequency of nocturnal voiding and the volume of the first nocturnal voiding were examined. Demographics and baseline characteristics contributing to reduction in the frequency of nocturnal voiding were also analyzed. Results At week 12, the frequency of nocturnal voiding was reduced from baseline by 0.74 and 0.78, respectively, for the vibegron 50 and 100 mg groups; the reductions were significant when compared with the placebo group (P < 0.05 and P < 0.001, respectively). The mean volume of nocturnal voids and the volume of the first nocturnal voiding were significantly greater in the vibegron groups than in the placebo group. The vibegron groups showed significant correlations of hours of undisturbed sleep with the changes in the frequency of nocturnal voiding and in the volume of the first nocturnal voiding. Vibegron treatment, no previous treatment with anticholinergics, ≥12 voids per day and hours of undisturbed sleep

Objectives To evaluate the long-term safety and efficacy of vibegron 50 mg and 100 mg, a novel β3 -adrenoreceptor agonist, in Japanese patients with overactive bladder. Methods This was a 1-year, multicenter, open-label, non-controlled study. After a 1-week observation phase, patients were treated with vibegron for 52 weeks. When the efficacy was insufficient after an 8-week treatment with 50 mg, the dose was increased to 100 mg and maintained for an additional 44 weeks. Results Among a total of 169 patients receiving one or more doses of vibegron, 118 (69.8%) received vibegron 50 mg for 52 weeks, and the dose was increased to 100 mg in 51 (30.2%) patients. The incidence of drug-related adverse events was 18.1% (21/116) in the vibegron 50 mg group and 11.8% (6/51) in the vibegron 100 mg group. Most frequent drug-related adverse events were dry mouth (3.0%), residual urine volume increased (3.0%), constipation (2.4%) and cystitis (1.8%). Statistically significant changes in overactive bladder symptom variables (daily means of micturitions, urgency episodes, urgency incontinence episodes, incontinence episodes and night-time frequency) from baseline were observed at week 4 and maintained until week 52. The condition of patients who did not respond well to vibegron 50 mg was much improved by increasing the dose to 100 mg. Vibegron improved the quality of life, and the proportion of patients' satisfaction after the treatment with vibegron was high. Conclusions Long-term (52-week) treatment with vibegron is safe, well-tolerated and effective in patients with overactive bladder.

Objective: To present the study design and rationale of Prostatic Cancer Registry of Standard Hormonal and Chemotherapy Using Bone Scan Index, a prospective study aiming to determine the role of the bone scan index, the amount of bone metastasis, in the treatment and prognosis of prostate cancer patients. Methods: A total of 237 patients were recruited at 30 hospitals in Japan. All had prostate cancer with bone metastasis and were scheduled to undergo either hormonal therapy (group H) or chemotherapy (group C). Bone scans were carried out with (99m)Tc-methylenediphosphonate. Follow-up studies are planned to continue for 3 years, and changes in biochemical and tumor markers in response to hormonal therapy and chemotherapy will be recorded in addition to skeletal-related events, recurrence, disease progression and death. Results: The basic characteristics of the patients (n = 200) at the time of registration during December 2016 were as follows: mean age 71 ± 8 years; median bone scan index calculated on-site 1.9% (range 0.02–13.3%); median number of hot spots 18 (range 1–128); median prostate-specific antigen 155 ng/mL (range 0.04–22 412 ng/mL); and the most frequent Gleason score 9 (47%). The prostate-specific antigen value was higher in group H than group C (288 vs 33 ng/mL, P < 0.0001), whereas bone scan indexes were comparable (1.7 vs 2.3%, not significant) between the two groups. Liver metastasis was more frequent in group C than group H (6.1% vs 0.8%, P = 0.035). Conclusions: The baseline characteristics of the Prostatic Cancer Registry of Standard Hormonal and Chemotherapy Using Bone Scan Index database have been established. This collaborative study can now proceed with clarifying the role of the bone scan index for patient management including treatment strategies and prognosis.

The present article is the abbreviated English translation of the Japanese guidelines for male lower urinary tract symptoms and benign prostatic hyperplasia updated as of the end of 2016. The target patients are men aged >50 years complaining of lower urinary tract symptoms, with or without benign prostatic hyperplasia, and the target readers are non-urological general physicians and urologists. Mandatory assessment for general physicians is medical history, physical examination, urinalysis and measurement of serum prostate-specific antigen. Additional mandatory assessment for urologists is symptoms and quality of life assessment by questionnaires, uroflowmetry, residual urine measurement, and prostate ultrasonography. Nocturia requires special attention, as it can result from nocturnal polyuria and/or sleep disturbance rather than lower urinary tract disorders. Functional lower urinary tract disorders with or without benign prostatic hyperplasia are primarily managed by conservative therapy and medications, such as α1 -blockers and phosphodiesterase-type 5 inhibitors. Use of other medications or combination pharmacotherapy is to be reserved for urologists. 5α-Reductase inhibitors and anticholinergics or β3 agonists are indicated for men with enlarged prostates and overactive bladder symptoms, respectively. Surgical intervention for bladder outlet obstruction is considered for persistent symptoms or benign prostatic hyperplasia-related comorbidities. Surgical modalities should be optimized by the patient's characteristics, performance of equipment and the surgeon's experience.

Digital rectal examination, serum prostate-specific antigen screening and transrectal ultrasound-guided biopsy are conventionally used as screening, diagnostic and surveillance tools for prostate cancer. However, they have limited sensitivity and specificity. In recent years, the role of multiparametric magnetic resonance imaging has steadily grown, and is now part of the standard clinical management in many institutions. In multiparametric magnetic resonance imaging, the morphological assessment of T2-weighted imaging is correlated with diffusion-weighted imaging, dynamic contrast-enhanced imaging perfusion and/or magnetic resonance spectroscopic imaging. Multiparametric magnetic resonance imaging is currently regarded as the most sensitive and specific imaging technique for the evaluation of prostate cancer, including detection, staging, localization and aggressiveness evaluation. This article presents an overview of multiparametric magnetic resonance imaging, and discusses the current role of multiparametric magnetic resonance imaging in the different fields of prostate cancer management.

Objectives To describe the clinicopathological features and oncological outcomes of renal cell carcinoma diagnosed in Japan in 2007, the results of the large-scale renal cell carcinoma registration study carried out by the Japanese Urological Association are reported. Methods The renal cell carcinoma survey was carried out by the Japanese Urological Association in 2012 to register newly diagnosed renal cell carcinoma cases in 2007 from 340 institutions nationwide. The survey included clinicopathological details, such as sex, age, family history, past history, smoking history, body mass index, reason for diagnosis, TNM classification, stage, histopathology, treatment and clinical outcomes. Results A total of 3663 cases diagnosed in 2007 were registered in this renal cell carcinoma registry program from 340 institutions. A total of 15 patients with a final diagnosis of oncocytoma were excluded, and 3648 cases of renal cell carcinoma were analyzed to evaluate oncological outcomes. The patients’ median age was 63.9 years (range 5.9–95.1 years). Clear cell renal cell carcinoma was the most common histological subtype (77.2%), followed by papillary (5.0%) and chromophobe (3.2%) renal cell carcinoma. The most common initial treatment was radical nephrectomy (72.6%), and the most common secondary treatment was cytokine therapy (13.1%). Five-year overall survival rates in stages I, II, III, and IV were 94.8%, 90.2%, 78.8% and 39.6%, respectively. The 5-year overall survival rates for clear cell, papillary and chromophobe renal cell carcinomas, and carcinoma of the collecting ducts of Bellini were 88.6%, 79.8%, 93.0% and 40.0%, respectively. Conclusions The present report is the first nationwide large-scale study to describe the clinicopathological characteristics and oncological outcomes of patients with renal cell carcinoma in Japan. Oncological outcomes depend on the clinical stage and histological subtype. Further investigations will be required to show improved oncological outcomes in the molecular targeted therapy era using the results of the present study as a baseline.

Objectives To investigate the efficacy of a once-daily oxybutynin patch for nocturia, and its influence on sleep quality in patients with overactive bladder. Methods We carried out post-hoc analysis of a phase III, randomized, double-blind, comparative study in which an oxybutynin patch was administered once daily for 12 weeks to Japanese patients with overactive bladder. Patients with a baseline mean of one or more episodes of nocturia per night (data from voiding diaries) were analyzed. The mean number of micturitions, mean voided volume per micturition, mean first voided volume at night, mean sleep duration, and hours of undisturbed sleep were compared between the once-daily oxybutynin patch group and the placebo group. All parameters were expressed as the least squares mean values. Results The analysis included 576 patients. The number of nocturia episodes decreased by 0.66 in the oxybutynin patch group versus 0.51 in the placebo group (P = 0.0249). Also, the voided volume per nocturnal micturition and the first voided volume at night showed a significant increase in the oxybutynin patch group compared with the placebo group (P = 0.0073 and P = 0.0005, respectively). The hours of undisturbed sleep showed significant prolongation by 76.14 min in the oxybutynin patch group versus 56.07 min in the placebo group (P = 0.0257). Conclusions Oxybutynin patch treatment reduces the number of nocturia episodes and prolongs the hours of undisturbed sleep, thus improving sleep quality and sleep-related quality of life in patients with overactive bladder.

Objectives To compare the surgical outcomes of laparoscopic radical prostatectomy and robot-assisted radical prostatectomy, including the frequency and location of positive surgical margins. Methods The study cohort comprised 708 consecutive male patients with clinically localized prostate cancer who underwent laparoscopic radical prostatectomy (n = 551) or robot-assisted radical prostatectomy (n = 157) between January 1999 and September 2012. Operative time, estimated blood loss, complications, and positive surgical margins frequency were compared between laparoscopic radical prostatectomy and robot-assisted radical prostatectomy. Results There were no significant differences in age or body mass index between the laparoscopic radical prostatectomy and robot-assisted radical prostatectomy patients. Prostate-specific antigen levels, Gleason sum and clinical stage of the robot-assisted radical prostatectomy patients were significantly higher than those of the laparoscopic radical prostatectomy patients. Robot-assisted radical prostatectomy patients suffered significantly less bleeding (P

Objectives To describe the clinical and pathological characteristics and oncological outcomes of testicular cancer diagnosed in Japan, we report the results of the testicular cancer registration carried out by the Japanese Urological Association. Methods Testicular cancer survey was conducted by the Japanese Urological Association in 2011 to register newly diagnosed testicular cancers in 2005 and 2008. The survey included details such as age, presenting symptoms, physical examination findings, tumor markers, histopathology, clinical stage, initial treatment and clinical outcomes. Results We analyzed 1121 cases of testicular primary germ cell tumor among 1157 registered patients. The median age was 37.0 years. Seminomas and non-seminomatous germ cell tumors accounted for 61.9% and 38.1%, respectively. Measurements of tumor markers were documented in 98.6% of the patients; however, there was an unsatisfactory uniform measurement of human chorionic gonadotropin, which made it difficult to evaluate the International Germ Cell Consensus Classification in all patients. The 1- and 3-year overall survival rates from the entire cohort were 98.3% and 96.8%, respectively. According to the International Germ Cell Consensus Classification, 3-year overall survival rates in the good, intermediate, and poor prognosis group were 99.1%, 100% and 79.9%, respectively. Conclusions The present report is the first large-scale study of the characteristics and survival of testicular cancer patients in Japan based on multi-institutional registry data, and showed a good prognosis even in an advanced stage. The improved survival attributed substantially to accurate diagnosis and effective multimodal treatment.

Objectives To describe the clinical and pathological characteristics and the outcomes of renal pelvic and ureteral cancer patients diagnosed in 2005 in Japan. Methods In 2011, data were collected from renal pelvic and ureteral cancer patients diagnosed in 2005. A total of 1509 registered patients from 348 institutions were analyzed. Epidemiology and survival were analyzed based on each cancer location and on cancer multiplicity. Results The 5-year overall survival of the 1509 patients was estimated at 0.64. Open surgery was carried out in 409 renal pelvic cancer cases (66.9%) and 315 ureteral cancer cases (63.0%). The retroperitoneal approach was common, and lymph node dissection was carried out in approximately one-third of open surgery cases and one-fifth of laparoscopic cases. Approximately 60% of the operated unilateral renal pelvic or ureteral cancer was diagnosed as invasive, and just 14.6% was diagnosed as stage pTa. Distribution of the estimated worst tumor grade was significantly different for renal pelvic cancer and ureteral cancer. Conclusions This article presents the first large population report of survival data in Japanese renal pelvic and ureteral cancer patients. In comparison with the Japanese bladder cancer database report in 1999–2001 from the Cancer Registration Committee of the Japanese Urological Association, the pathological characteristics of renal pelvic and ureteral cancer were diagnosed as aggressive.

Objective To evaluate the impact of pelvic floor reconstruction on lower urinary tract symptoms in patients with pelvic organ prolapse. Methods We carried out a prospective study at a single institution. A total of 223 female patients who underwent tension-free vaginal mesh surgery for pelvic organ prolapse between January 2006 and February 2010 were enrolled and prospectively evaluated. A total of 171 cases with concurrent stress urinary incontinence (76% of all cases) underwent concomitant transobturator tape sling. For evaluation of lower urinary tract symptoms, parameters included International Prostate Symptom Score, its quality of life score, International Consultation on Incontinence Questionnaires Short Form, overactive bladder questionnaire, maximal flow rate and postvoid residual. These parameters were evaluated at baseline, and at 3, 6 and 12 months after the surgery. Results The severity of International Prostate Symptom Score total scores significantly correlated with preoperative pelvic organ prolapse quantification stages, overactive bladder questionnaire total scores and International Consultation on Incontinence Questionnaires Short Form scores. A total of 37% of stage 4 showed ≥20 International Prostate Symptom Score (severe cases). Postvoid residual significantly increased in stage 4 compared with stage 2. Tension-free vaginal mesh improved International Prostate Symptom Score, overactive bladder questionnaire and International Consultation on Incontinence Questionnaires Short Form significantly, and also achieved grade 0 pelvic organ prolapse quantification in 91% of all cases at 1 year after surgery. Postvoid residual values significantly improved and remained stable for 1 year. Worse overactive bladder questionnaire score was a significant predictive factor for poor postoperative International Prostate Symptom Score. Conclusion The tension-free vaginal mesh plus transobturator tape procedure improves lower urinary tract symptoms in the majority of patients presenting pelvic organ prolapse.

Transvaginal or transrectal ultrasound was carried out in an adult female and a male volunteer during micturition. Although the male urethra was enclosed by the prostate, its construction and the function were almost identical to the female urethra. The anterior fibromuscular stroma was not a part of the prostate, but was a part of the urethral muscle. The urethra was surrounded by a thick single muscle unit, developed only on the anterior and lateral sides of the urethra. When the participant wished to urinate, the initial motion was not a bladder contraction, but an active opening of the urethral lumen by the muscle unit. The same unit closed the urethra when continence was kept. In conclusion, the main function of the urethra is thought to be not a closure, but an opening to control the entire micturition process, rather than the bladder being primarily responsible for the control of micturition.

Objectives: In 2001, the Cancer Registration Committee of the Japanese Urological Association initiated a data collection of prostate cancer patients into a computer-based database. The aim of the present study is to report the clinical and pathological characteristics and outcomes of prostate cancer patients diagnosed in 2004 in Japan. Methods: Overall, 11 385 patients from 239 institutions were registered into the database. After excluding 1105 patients because of insufficient data, duplication or insufficient follow up, 10 280 patients were eligible for the analysis. Most of them (10 198, 99.2%) were Japanese and 1195 (11.6%) had metastatic disease at the time of diagnosis. The mean and median follow up was 53.2 months and 61.5 months, respectively. Results: The 5-year overall and prostate cancer-specific survival rate was 89.7% and 94.8%, respectively. The 5-year prostate cancer-specific survival rate of M0 and M1 disease was 98.4% and 61.1%, respectively. For 8424 cases of organ-confined or regional disease, Japanese urologists used as the initial treatment hormone ablation therapy alone (3360, 39.9%), radical prostatectomy (3140, 38.1%), radiation therapy (1530, 18.2%) and watchful waiting (394, 4.7%) including active surveillance or palliative observation. Conclusions: This is the first large population report of survival data in Japanese prostate cancer patients. In Japan, the disease population, survival period with metastatic disease and ratio of patients having hormone ablation therapy differ from those in Western countries.

Objectives: To examine the effects of mature adipocyte-derived dedifferentiated fat (DFAT) cell transplantation on urethral tissue regeneration and sphincter function. Methods: Sixteen female Sprague–Dawley rats underwent vaginal distension (VD) for 3 h. Subsequently, green fluorescence protein (GFP)-labeled DFAT cells (1 × 106 in 20 µL saline, DFAT group, n = 8) or saline (20 µL, control group, n = 8) were injected into paraurethral connective tissue. Two weeks following VD, leak point pressure (LPP) was measured and an immunohistochemical analysis of the urethra was performed to evaluate urethral sphincter regeneration. Results: The VD model was characterized by atrophy of the urethral sphincter and showed a decrease in LPP. DFAT cell transplantation resulted in a significant improvement of LPP (DFAT group: 37.3 ± 6.4 vs control group: 21.7 ± 5.7 mmHg, P

Objective: To prospectively evaluate the efficacy of a tension-free vaginal mesh (TVM) procedure for pelvic organ prolapse (POP). Methods: Between December 2005 and April 2008, 310 female patients (mean age 67.2 years, range 42–84) with POP underwent TVM procedures at our institute. Fifty-six individuals were qualified as stage 2 according to the POP quantification system and 162 and 92 were stage 3 and 4, respectively. One hundred ninety-one patients underwent anterior TVM, and seven underwent posterior TVM. One hundred twelve cases underwent both anterior and posterior TVM procedures. Each patient was systematically assessed at 1, 3, 6 and 12 months after surgery. Quality of life (QOL) was also assessed by using the Short Form-36 and the prolapse-QOL questionnaires. Results: Perioperative complications were the following: five bladder injuries (1.6%), no rectal injuries and three hemorrhages greater than 400 mL (1.0%). The anatomical cure rate (% stage 0 cases) at 3, 6 and 12 months after surgery were 94.1%, 93.5%, and 92.3%, respectively. Short Form-36 and prolapse-QOL parameters were significantly improved, and maintained during the follow-up period. Postoperative complications were the following: five pelvic hematomas (1.6%), one wound infection (0.3%), 10 vaginal mesh extrusions (3.2%), and three cases of pelvic pain (1.0%). Complications concerning lower urinary tract function were: eight cases of postoperative stress urinary incontinence (2.6%), three cases of transient urinary retention (1.0%), and two cases of de novo overactive bladder (0.6%). Conclusions: The TVM procedure provides a good outcome at 1 year with a low incidence of surgical complications and recurrence. Further evaluation with a longer follow up is needed.

The objective of this study was to assess disease-associated pain and quality of life (QOL) in patients with prostate cancer (PC). A total of 102 PC patients (clinical stage B, C: 20, D2: 82) patients were enrolled. QOL was assessed using the Functional Assessment of Cancer Therapy, General and Prostate (FACT-G/P). Disease-specific pain response was assessed using the visual analog scale and the face rating scale. In patients with stage D2 PC, mean age, serum prostate-specific antigen level, and performance status were 72.5 ± 7.1 years (range, 55–88), 217 ± 467 ng/mL (range, 0.1–2600), and 1.4 (0–4), respectively. The score of physical well-being and FACT-P was significantly lower in stage D2 patients, compared with those of stage B/C (P = 0.02, 0.0088, respectively). Performance status, extent of disease, and the visual analog scale were related with a poor QOL score (P = 0.0054, 0.01

Objectives: We previously demonstrated that estrogen receptor-binding fragment-associated gene 9 (EBAG9) is a tumor promoting factor in renal cell carcinoma (Ogushi T, Cancer Res. 2005; 65: 3700). Here, we evaluated EBAG9 expression and its clinical significance in normal and malignant human testicular tissues. Methods: We investigated the expression of EBAG9 in 90 testicular specimens (28 benign testicular tissue and 62 testicular germ cell tumor samples) by immunohistochemistry using rabbit polyclonal anti-EBAG9 antibody. Results: Positive immunostaining of EBAG9 in the cytoplasm was found in 32 (52%) cancerous lesions, whereas the immunoreactivity of EBAG9 was weak in benign testicular tissues. Serum lactate dehydrogenaze (LDH) level was significantly higher in EBAG9-positive cases (715.0 ± 727.3) compared with the negative cases (221.4 ± 126.8) (P = 0.0016). The EBAG9-positive cases among the patients with advanced clinical stage (Stage II and III) more frequently belonged to the intermediate or poor risk group in the International Germ Cell Consensus Prognostic Classification System (IGCCPCS), compared with the EBAG9-negative cases (P = 0.0012). Conclusions: These findings suggest that increased expression of EBAG9 may play a significant role in cancer progression and aggressiveness in testicular germ cell tumors.

Objectives: Although the artificial urinary sphincter (AUS) is one of the most effective surgical treatments for severe urinary incontinence, little is known about its use in Japan. A nationwide survey was done to determine contemporary trends in AUS use and its long-term durability. Methods: Data on AUS units sold in Japan were provided directly by Takai Hospital Supply Co., Ltd., Tokyo, Japan, and a survey form was sent to all 44 institutes where AUS implantation had been carried out. The survey included various demographic and preoperative variables, surgical variables, and postoperative outcomes. Results: Between 1994 and 2007, a total of 100 AUS devices had been provided in Japan. Of the 44 institutes, 24 responded to the survey, and a total of 64 patients were enrolled in the study. Post-urological surgery incontinence accounted for 81.3% of the indications. During the mean follow-up of 50 months, mechanical failure occurred in four (6.2%), and the device was removed in 13 (20.3%) due to infection (14.0%), erosion (4.7%), or urination difficulty (1.5%). Of the 58 patients evaluated, 91.4% reported social continence. Five- and 10-year failure-free rates were 74.8% and 70.1%, respectively. On multivariate analysis, operative time was an independent predictor of treatment failure (P = 0.0334). Conclusions: Considering recent trends in prostate surgery, the AUS may be significantly underused in Japan. Although excellent long-term durability has been achieved, a learning effect appears to be evident. The Japanese urological community needs to provide appropriate patients with this treatment option.

Preface: We owe the success of the 2nd JUA/AUA joint Meeting at the 102nd Annual Meeting of the American Urological Association (19–24 May 2007, Anaheim, California, USA) entirely to the warm support of all the people concerned, including the moderators and panelists of both countries. Joint programs have been held by the societies of France and Latin America in recent years and China started holding the ‘World China’ last year. It has not been easy to maintain the joint meeting because of constraints in planning, financial support and the workforce, and therefore some societies have been unable to hold their meetings continuously. Nevertheless, there are long-term plans to hold the meeting with the cooperation of both AUA and JUA sharing the moderators and panelists. Fortunately, since CME Credit was adopted for our meeting, the AUA members who participated in our meeting were given credits. It is now time to consider the accreditation for the JUA members too. We would like to thank Professor Robert C Flanigan, the Secretary General of AUA, Professor Glenn M Preminger, the Chairman of AUA Office of Education and the staff of AUA and JUA for introduction CME. The meeting was a great success with more than 200 participants from both countries. We hope to keep holding the joint meeting and have plenty of ideas on themes and forms. We believe that this international program helps to establish a closer relationship between JUA and AUA in the scientific field. Luckily, the abstract of this program is arranged not only as a monograph but as part of this issue of the International Journal of Urology. I believe this is an excellent opportunity for us to promote our meeting to a broader audience. Akihiko Okuyama md, President of JUA Hideyuki Akaza md, Chairman of the International Committee of JUA

We performed a radical retropubic prostatectomy on a 59-year-old male patient who was diagnosed with prostatic carcinoma. Pathological findings revealed a ductal adenocarcinoma in the left lobe of the prostate, and a conventional well-differentiated adenocarcinoma in the right lobe. Immunohistochemistry revealed that CA19-9 was positive in the ductal adenocarcinoma, and prostate-specific antigen was positive in the conventional well-differentiated adenocarcinoma. Since there was an increase in the level of serum CA19-9, which had decreased postoperatively, along with the appearance of local recurrence and bone metastasis, we treated the patient with cisplatin and gemcitabine. As a result, the level of serum CA19-9 was normalized and a reduction of the metastatic focus was observed.

Purpose: Urinary citrate is a potent inhibitor of renal stone formation. Its excretion is regulated by Na+/dicarboxylate cotransporter-1 (NaDC-1), which is expressed on the apical membrane of renal proximal tubules. Many patients with calcium urolithiasis exhibit hypocitraturia, however, the mechanisms are not perfectly understood. We examined whether or not the I550V polymorphism in human NaDC-1 gene (hNaDC-1) influenced urinary citrate excretion. Materials and methods: I550V polymorphism was investigated in 105 patients with recurrent renal calcium stone formation (RSF) and 107 age-matched healthy volunteers with non-renal stone formation (NSF), using polymerase chain reaction (PCR) restriction fragment length polymorphism analysis and two 24-h urine samples. Results: Overall and in the RSF groups, subjects with a BB (homozygous for the digested Bcl-I allele) genotype exhibited a significantly lower urinary citrate excretion level than subjects with a bb (homozygous for the undigested allele) genotype. Genotype distributions between subjects with hypocitraturia and normocitraturia were significantly different, with the BB genotype being more frequently observed in subjects with hypocitraturia – both overall and in each of the RSF and NSF groups. Although the BB genotype was observed more frequently in the RSF group than in the NSF group, no statistical differences among the distributions of the three genotypes (BB, Bb [heterozygous] and bb) were observed between the RSF and NSF groups. Conclusion: These results suggest that the B allele of I550V polymorphism of hNaDC-1 may be associated with a reduction in urinary citrate excretion and contribute to hypocitraturia in recurrent renal stone formers.

Aim: To predict whether or not seminal vesicle invasion is present before radical prostatectomy, the relationships between clinical parameters and seminal vesicle invasion were analyzed. Methods: A review was conducted of 187 patients who had been clinically diagnosed with stages A2, B0, B1, B2 or C prostate cancer and who had undergone radical prostatectomy without neoadjuvant therapy. The parameters analyzed for potential predictors of seminal vesicle invasion before radical prostatectomy included age, clinical stage, serum prostate-specific antigen (PSA) level at biopsy, tumor differentiation of biopsy specimens and percentage of cancer positive cores by biopsy. For percentage of cancer positive cores by biopsy, 143 of 187 patients who underwent transrectal sextant biopsy or more than six transrectal ultrasound guided core biopsies were evaluated. These parameters were subjected to univariate and multivariate logistic regression analyses to identify predictors for seminal vesicle invasion. Results: The median age was 66.8 years (range 51–77 years). Of 187 patients, 27 (14.4%) had seminal vesicle invasion confirmed pathologically. There were significant differences in all parameters except for age between patients with positive and negative seminal vesicle invasion on univariate analysis. Multivariate analysis revealed that serum PSA level, tumor differentiation of biopsy specimens and percentage of cancer positive cores were significant independent predictors of seminal vesicle invasion. Conclusions: The results showed serum PSA level, tumor differentiation of biopsy specimens and percentage of cancer positive cores by biopsy before radical prostatectomy may be useful predictors for seminal vesicle invasion.

Aim: We evaluated the efficacy of an α1a/d blocker, naftopidil, on storage symptoms in patients with benign prostatic hyperplasia (BPH), using frequency/volume charts (FVC). Methods: A total of 81 patients with BPH (52–91 years, mean age 69.0 years) were studied. The inclusion criteria were: (i) one or more episode(s) of urinary urgency/day; (ii) a score of eight or more points on the International Prostate Symptom Score (I-PSS); and (iii) three or more points in any of the scores for three items (frequency, nocturia, and urgency) of the I-PSS. The patients received 50–75 mg/day of naftopidil for 6 weeks. All the patients were examined for 2-day FVC before and after the administration of naftopidil. I-PSS, quality of life index, and uroflowmetry were also evaluated. Results: Total I-PSS decreased from 19.1 to 10.5 points (P < 0.0001), with significant improvement of both storage and voiding symptom scores (P

We present a case of mumps orchitis after vaccination. A 35-year-old man visited the emergency unit of our hospital for fever and right testicular pain on 7 January 2012. Two weeks before the visit, he underwent vaccination for mumps. After 7 days of hospitalization, the patient recovered from fever and testicular pain. Scrotal magnetic resonance imaging suggested right orchitis, and an increased level of serum mumps immunoglobulin M and immunoglobulin G indicated an initial infection of mumps virus. The peak value of immunoglobulin G showed 106 enzyme immunoassay unit 5 weeks after vaccination, which was 10-fold higher than the ordinary rise of a vaccinated individual. This fact leads to two possibilities. One is this happened as an adverse event of vaccination, and the other is that he actually had a wild-type infection at the same time as vaccination. There are some reports regarding adverse events of mumps vaccine; however, they might include wild-type infection.

Background: The purpose of this study was to identify preoperative variables that would be useful in objectively selecting prostate cancer patients for nerve-sparing prostatectomy. Methods: Twenty-six patients with clinical T1c–T2c cancers were evaluated for cancerous involvement in the region of the neurovascular bundles (NVB) from prostatectomy specimens. Preoperative prostate-specific antigen (PSA) and pathologic features in systematic biopsy specimens also were reviewed. Results: A total of eight (31%) patients had cancerous involvement in the region of the NVB, including four on the right side, three on the left side and one on both sides. The percentage of each biopsy specimen occupied by the cancer was scored from zero to four and defined as the positive biopsy score. Preoperative PSA (P = 0.046), mean positive biopsy score (total sum of positive biopsy score divided by number of biopsy specimens; P = 0.001), number of cores containing cancer (P = 0.011), percentage of cores involved (P = 0.036) and maximum positive biopsy score (P < 0.001) were significant for predicting cancerous involvement in the NVB region using univariate analysis. However, only the mean positive biopsy score was independently significant according to multivariate analysis. To predict cancerous involvement in the region of each NVB, we found that ipsilateral mean positive biopsy score (total sum of corresponding positive biopsy score divided by number of ipsilateral biopsy specimens), number of cores involved on the ipsilateral side, percentage of cores involved on the ipsilateral side and maximum positive biopsy score on the ipsilateral side were significant predictive variables: the ipsilateral mean positive biopsy score being most appropriate for clinical practice. Conclusion: Ipsilateral mean positive biopsy score in systematic biopsy specimens can be an appropriate variable for selecting patients with localized prostate cancer for nerve-sparing prostatectomy.

We have experienced two cases of intravesical transobturator tape (TOT) tape successfully removed by laparoscopic transvesical procedure. Patient 1 was a 67-year-old woman complaining of irritative symptoms of the urinary bladder. In another hospital she had undergone anterior corporrhaphy and a TOT procedure to treat a cystocele and stress urinary incontinence (SUI) 17 months before the initial consultation. A cystoscopy revealed tape extrusion and adherent calculi at the 4 to 5 O'clock position of the bladder neck. After filling the bladder with carbon dioxide, three 5-mm ports were placed in lower abdomen directly into the bladder. The tape extruding from the bladder muscle layer was completely excised, and extirpated with the adherent calculi. The bladder mucosa and muscle layer were continuously sutured using 4-0 Vicryl (Ethicon Inc., Somerville, NJ, USA). The port entry sites were closed under direct vision using 4-0 Vicryl. SUI recurred 15 months later and a second TOT surgery was performed. Neither SUI nor mesh extrusion have been observed during the 18 months following the second TOT. Patient 2 was a 74-year-old woman. She consulted our hospital for the removal of an intravesically extruded tape and adherent calculi. She had undergone a vaginal hysterectomy and TOT surgery for uterine prolapse and SUI at another hospital 3 years before her visit. A cystoscopy revealed tape extrusion and adherent calculi on the right bladder wall. We performed an endoscopic transvesical extirpation of the intravesical foreign bodies in a same manner described below. There has been no recurrent SUI or mesh erosion during the 18-month follow up.

Objective: To determine the burden of male stress urinary incontinence (SUI) in Japan and to identify candidates for artificial urinary sphincter (AUS) implantation. Methods: In 2008, a survey form was sent to all 1202 training hospitals certified by the Japanese Urological Association. The survey included questions about the number of patients with moderate to severe SUI who could be candidates for AUS implantation, the etiology, and incidence of SUI in 2007. Results: Overall, 682 (56.7%) responded to the survey. The total number of patients was 1276. The most common reported etiology for SUI was post-radical prostatectomy (59.1%), followed by neurogenic bladder (23.0%), surgery for benign prostatic hyperplasia (10.3%), neobladder reconstruction (2.8%), urethral injury (2.4%), and others (2.4%). There were 203 new cases in 2007. Adjusted by the response rate, the prevalence and annual incidence were estimated to be 2235 and 358 cases, respectively. Conclusions: This survey confirms that a significant number of men suffer from moderate to severe SUI, with the majority of cases being post-prostatectomy incontinence. The Japanese urological community needs to provide appropriate treatment for these patients.

Interferon-related severe adverse events on the central nervous system are relatively rare, because interferon-alpha (INF-alpha) can not cross an intact blood-brain barrier. We experienced remarkable mental deterioration caused by INF-alpha administration in a 43-year-old man with renal cell carcinoma after surgical removal of a metastatic brain tumor. We detected a high concentration of INF-alpha in a cerebrospinal fluid sample, which was comparable to that in the serum at 24 h after the administration of INF-alpha; 5x10(6) IU i.m., suggesting that the blood-brain barrier was damaged somehow by the craniotomy. The mental deterioration improved shortly after discontinuation of the INF-alpha administration.

Since most cases of urachal cyst are asymptomatic, they are frequently detected after complication by infection. Ruptured urachal cysts are frequently detected after complication by severe infections such as sepsis. We report on a 31-year-old man who was diagnosed preoperatively as having an infected urachal cyst and the decision was made to follow the patient because primary excision was scheduled to be performed a few days later. Symptoms were transiently relieved, but the cyst ruptured during medical palliation. We treated this case with a two-stage surgical procedure.

A 56-year-old woman suffered from severe depression due to Cushing's syndrome with right adrenal adenoma. She had a normal mental state before developing Cushing's syndrome. Because of her depressive state, informed consent for the treatment could not be obtained, and oral administration of 1.5 g/day metyrapone was commenced. After two weeks, her mental state had markedly improved. She subsequently underwent a right adrenalectomy, and metyrapone administration was terminated on the day of surgery. Without modification on the replacement of corticosteroids, the postoperative course was uneventful. Preoperative management of Cushing's syndrome with metyrapone may be useful in cases of severe psychiatric disturbances due to hypercortisolism.

A 31-year-old male visited our clinic with a complaint of painless intrascrotal mass in the left side. He had been diagnosed with pulmonary sarcoidosis 6 years prior. Scrotal ultrasound revealed a distinct mass measuring 18 mm x 16 mm at the left epididymal tail. An epididymectomy was performed for treatment and pathological diagnosis. Four nodules shaped like testicular appendices were also found on the testicular surface and subsequently removed. Histopathological examination established that both the epididymal and appendix-like lesions consisted of non-caseating epithelioid granulomas with giant cells, and were diagnosed as sarcoidosis. The patient has no recurrence of intrascrotal lesions after 6-month follow up. This is the first report of intrascrotal involvement of sarcoidosis presenting like testicular appendices.

A case of tubulovillous adenoma arising in an augmented bladder is described. Ureteroileal substitution and ileocystoplasty was performed when the patient was 18 years old. She noticed gross hematuria 44 years after the surgery. Cystoscopy revealed a non-papillary multiple tumor at the site of ileovesical anastomosis and transurethral resection biopsy was performed. Histopathological examination revealed a tubulovillous adenoma. A tubulovillous adenoma developing at the augmented bladder is rare. To our knowledge, this is the second case in which a tubulovillous adenoma developed in an augmented bladder.