Comparison of mirabegron and vibegron for clinical efficacy and safety in female patients with overactive bladder: a multicenter prospective randomized crossover trial.

PURPOSE: To compare the efficacy and safety of mirabegron and vibegron in female OAB patients. METHODS: We conducted a multicenter, prospective, randomized crossover study of female patients with OAB. The patients were assigned to Group MV (mirabegron for 8 weeks, followed by vibegron for 8 weeks) or group VM (vibegron for 8 weeks, followed by mirabegron for 8 weeks). The primary endpoint was the change in OABSS from baseline, and the secondary endpoint was the change in FVC parameters. After completion of the study, each patient was asked which drug was preferable. RESULTS: A total of 83 patients were enrolled (40 and 43 in groups MV and VM, respectively). At 8th and 16th week, 33 and 29 in Group MV and 34 and 27 in Group VM continued to receive the treatment. The change in PVR was not significantly different between treatment with mirabegron and vibegron. The changes in OABSS, nighttime frequency, mean, and maximum voided volume were similar between mirabegron and vibegron. The mean change in the daytime frequency was greater in the vibegron than in the mirabegron. Of the 56 patients, 15 (27%) and 30 (53%) preferred mirabegron and vibegron, respectively. The remaining 11 patients (20%) showed no preference. The change in the urgency incontinence score during vibegron was better in patients who preferred vibegron to mirabegron. CONCLUSION: The efficacies of mirabegron and vibegron in female patients was similar. The patients' preference for vibegron could depend on the efficacy of vibegron for urgency incontinence.

Morphological examination of pelvic floor muscles in a rat model of vaginal delivery.

OBJECTIVE: This study investigated morphological changes in the composition of the pelvic floor muscles, degree of atrophy, and urethral function in a rat of simulated birth trauma induced by vaginal distension (VD) model. METHODS: Female Sprague-Dawley rats were classified into four groups: a sham group, and 1, 2, and 4 weeks post-VD (1 W, 2 W, and 4 W, respectively) groups. We measured the amplitude of urethral response to electrical stimulation (A-URE) to evaluate urethral function. After measuring the muscle wet weight of the pubococcygeus (Pcm) and iliococcygeus (Icm) muscles, histochemical staining was used to classify muscle fibers into Types I, IIa, and IIb, and the occupancy and cross-sectional area of each muscle fiber were determined. RESULTS: There were 24 Sprague-Dawley rats used. A-URE was significantly lower in the 1 W group versus the other groups. Muscle wet weight was significantly lower in the VD groups versus the sham group for Pcm. The cross-sectional area of Type I Pcm and Icm was significantly lower in the VD groups versus the sham group. Type I muscle fiber composition in Pcm was significantly lower in the VD groups versus the sham groupand lowest in the 2 W group. Type I muscle fiber composition in Icm was significantly lower in the 2 and 4 W groups versus the sham group. CONCLUSION: Muscle atrophy and changes in muscle composition in the pelvic floor muscles were observed even after improvements in urethral function. These results may provide insight into the pathogenesis of stress urinary incontinence after VD.

Validation of the area under the Watts factor curve during the voiding cycle as a novel parameter for diagnosing detrusor underactivity in females.

OBJECTIVE: Detrusor underactivity (DU) is a common cause of lower urinary tract symptoms (LUTS). To date, no consensus has been reached on the urodynamic criteria for defining DU. We previously proposed the area under the curve of the Watts factor (WF-AUC) as a new parameter for diagnosing DU. By comparing previously reported five criteria for DU and WF-AUC, we analyzed whether the WF-AUC could assess detrusor contraction in women with LUTS. METHODS: Using urodynamic data of consecutive 77 women with LUTS, first, we classified DU based on previously reported five criteria. Second, we assessed the potential correlation between multiple parameters and WF-AUC. Third, receiver operating characteristic curve analysis was performed to determine the cutoff value of WF-AUC for diagnosing DU based on previously reported five criteria. Fourth, a linear regression analysis was conducted and compared using multiple criteria and female bladder outlet obstruction index (BOOIf). RESULTS: WF-AUC was positively correlated with the maximum values of WF, bladder contractility index (BCI), and projected isovolumetric pressure 1 (PIP1) with correlation coefficients of 0.63, 0.57, and 0.34, respectively. AUC for diagnosing DU based on previously reported five criteria ranging from 0.773 to 0.896 with different cutoff values of AUC-WF. The Spearman's correlation test revealed that BOOIf was significantly correlated with BCI, but not Wmax, PIP1 and WF-AUC. CONCLUSIONS: This study demonstrated the non-inferiority of the WF-AUC compared to previously reported criteria for defining DU. Depending on the cutoff value, the WF-AUC could appropriately evaluate women with DU, regardless of the presence of BOO.

Gap analysis between trainees' subjective competencies and the competencies expected by instructors in urology: A need assessment survey in Japan.

OBJECTIVE: According to the rapid progress in surgical techniques, a growing number of procedures should be learned during postgraduate training periods. This study aimed to clarify the current situation regarding urological surgical training and identify the perception gap between trainees' competency and the competency expected by instructors in Japan. METHODS: Regarding the 40 urological surgical procedures selected via the Delphi method, we collected data on previous caseloads, current subjective autonomy, and confidence for future skill acquisition from trainees (<15 post-graduate years [PGY]), and the competencies when trainees became attending doctors expected by instructors (>15 PGY), according to a 5-point Likert scale. In total, 174 urologists in Hokkaido Prefecture, Japan were enrolled in this study. RESULTS: The response rate was 96% (165/174). In a large proportion of the procedures, caseloads grew with accumulation of years of clinical practice. However, trainees had limited caseloads of robotic and reconstructive surgeries even after 15 PGY. Trainees showed low subjective competencies at present and low confidence for future skill acquisition in several procedures, such as open cystectomy, ureteroureterostomy, and ureterocystostomy, while instructors expected trainees to be able to perform these procedures independently when they became attending doctors. CONCLUSION: Trainees showed low subjective competencies and low confidence for future skill acquisition in several open and reconstructive procedures, while instructors considered that these procedures should be independently performable by attending doctors. We believe that knowledge of these perception gaps is helpful to develop a practical training program.

[Three Cases of Bilateral Metachronous Testicular Tumors].

We present three cases of bilateral metachronous testicular tumors. The patient in case 1 had a history of left orchiectomy for undescended testis at the age of 19. The pathological findings revealed germ cell neoplasia in situ. Twenty-four years later (age＝43), he was diagnosed with right testicular tumor with lymph node and lung metastasis (stage IIIc). Right orchiectomy was performed, and the pathological finding showed nonseminomatous germ cell tumor. He underwent chemotherapy, followed by lymph node dissection and lung metastasectomy. The patient in case 2 had a history of left orchiectomy for testicular tumor at the age of 41. The pathological finding of the left testis revealed seminoma (stage IA). Nineteen years later (age＝60), he was diagnosed with right testicular tumor and underwent right orchiectomy. Herein, the pathological finding showed seminoma (stage IA). The patient in case 3 had a history of right orchiectomy for testicular tumor at the age of 25. The pathological findings revealed seminoma (stage IS), and he underwent adjuvant radiation of the para-aortic field without subsequent recurrence. Fourteen years later (age＝39), he was diagnosed with left testicular tumor and underwent left orchiectomy. The pathological finding revealed seminoma (stage IB). The patient underwent adjuvant carboplatin monotherapy to prevent recurrence. Due to the long interval between the occurrence of bilateral metachronous testicular tumors (mean＝19 years ; three cases), long-term observation is necessary to detect the possible occurrence of contralateral testicular tumors. Contralateral testicular biopsy might be considered at the time of orchiectomy for unilateral testicular tumor if associated with testicular atrophy and/or a history of undescended testis.

Internet research of utilization of social media in patients with urological disease and their families in Japan.

OBJECTIVES: To survey the utilization of social media (SoMe) in patients with urological disease and their families. METHODS: Among the panel members registered in NEO Marketing Inc. (Tokyo, Japan), 300 people who or whose families were visiting the urological department regularly were included. Study subjects were randomly chosen and surveyed using the questionnaire over the internet. RESULTS: This study included 203 (68%) males and 97 (32%) females. The mean age was 62 (21-85) in males and 49 (22-75) in females. One hundred and ten subjects (37%) had no account for any SoMe. The account holders of YouTube, Twitter, Facebook, Instagram, and TikTok were 119 (40%), 117 (39%), 101 (34%), 90 (30%), and 33 (11%), respectively. The proportions of account holders were different depending on gender, age, and platforms. Frequent viewers on YouTube, Twitter, Facebook, Instagram, and TikTok were 100 (84%), 89 (76%), 63 (62%), 66 (73%), and 24 (73%), respectively. Of 190 who had accounts for any SoMes, 64 (34%) found any information about urological diseases of themselves or their families. Among the all subjects, 162 (54%) thought that they would like to view the medical contents on SoMes submitted by medical societies. CONCLUSIONS: Patients with urological disease and their families in Japan occasionally utilize SoMe to obtain information on their diseases and prefer professional medical information on SoMe. The gender and age of SoMe users and the optimal platform should be considered when posting medical information on SoMe.

[Pre-Operative Factors Affecting Trifecta Achievement in the Initial Series of Robot-Assisted Partial Nephrectomy].

We investigated pre-operative factors affecting trifecta achievement in robot-assisted partial nephrectomy (RAPN). We retrospectively analyzed 81 patients who underwent RAPN from December 2016 to September 2021 with final malignant pathologies. Trifecta was defined as negative resection margin (RM),warm ischemic time (WIT) less than 25 minutes, and no severe perioperative complications (Clavien-Dindo＜III). Factors affecting trifecta achievement were analyzed using sex, age, body mass index, RENAL nephrometry score (low or moderate/high complexity), surgical approach (transabdominal or retroperitoneal), tumor diameter and surgical experiences of each surgeon. Negative RM, WIT less than 25 minutes, and no severe complications were obtained in 75 (93%), 65 (80%), and 79 patients (98%), respectively. The trifecta was achieved in 60 patients (74%). In multivariate regression analysis, surgical experience (OR:0.92, 95% CI : 0.86-0.99) was significantly associated with trifecta achievement. Receiver operating characteristic curve analysis identified 9 cases as the optimal cut-off values for the predication of trifecta achievement (AUC＝0.69,p ＝0.11). The achievement of WIT less than 25 minutes (65 vs 90%, p＜0.01) and trifecta (58 vs 84%,p ＜0.05) were significantly lower in surgical experiences less than 9 cases than in 9 or greater. We conclude that surgical experience in RAPN is an important factor affecting WIT and trifecta achievement in the initial series.

Efficacy of TAC-302 for patients with detrusor underactivity and overactive bladder: a randomized, double-blind, placebo-controlled phase 2 study.

PURPOSE: This multicenter, randomized, double-blind, placebo-controlled phase 2 study evaluated the efficacy and safety of TAC-302, a novel drug that restores neurite outgrowth, in patients with detrusor underactivity (DU) and overactive bladder (OAB). METHODS: After 2-4 weeks of observation, patients were randomized 2:1 to receive oral TAC-302 200 mg or placebo twice daily for 12 weeks. The primary endpoint was detrusor contraction strength, estimated by bladder contractility index (BCI) for males and projected isovolumetric pressure 1 (PIP1) for females. Secondary endpoints included changes in bladder voiding efficiency (BVE) and safety. RESULTS: Seventy-six patients were included (TAC-302, n = 52; placebo, n = 24). The mean (standard deviation [SD]) BCI for males was 64.6 (16.6) at baseline and 75.2 (21.1) at week 12 (p < 0.001) with TAC-302 (n = 27), and 61.3 (16.6) and 60.5 (16.7) (p = 0.82) with placebo (n = 11). The respective mean (SD) PIP1 for females was 18.8 (6.6) and 29.4 (9.4) (p < 0.001) with TAC-302 (n = 15), and 20.6 (7.5) and 25.5 (9.6) (p = 0.14) with placebo (n = 7). TAC-302 significantly increased BCI in males and BVE in both sexes. TAC-302 efficacy on OAB was not clearly shown. The incidences of adverse events (AEs), serious AEs, and AEs leading to dose interruption were similar between groups; no adverse drug reactions occurred. CONCLUSION: Considering the significant effects on BCI in males and BVE in both sexes, TAC-302 may benefit patients with DU. REGISTRATION: ClinicalTrials.gov Identifier NCT03175029 registered 6/5/2017.

[Clinical Significance of Preoperative Image Classification Systems in Robot-Assisted Laparoscopic Partial Nephrectomy].

Robot-assisted laparoscopic partial nephrectomy (RAPN) is being used in Japan as a less invasive procedure. RENAL nephrometry (RN) score, Preoperative Aspects and Dimensions Used for an Anatomical (PADUA) Classification and Simplified PADUA Renal (SPARE) nephrometry system are tumor-specific morphometry scoring systems used for predicting the difficulty of partial nephrectomy. Adherent perinephric fat (APF) is one of the patient-specific factors related to the difficulty of partial nephrectomy. Mayo Adhesive Probability (MAP) score measures the difficulty of partial nephrectomy due to APF. Whether these scoring systems were associated with perioperative outcome of RAPN was retrospectively analyzed in 57 patients who underwent RAPN by two experienced surgeons at our hospital from December 2016 to March 2020. Forty-five patients were male and 12 were female. The right side was resected in 25 and the left side in 32 patients. The approach was transperitoneal in 42 and retroperitoneal in 15 patients. There were significant correlations among RN, PADUA and SPARE scores, while MAP score was independent from the other scores. Warm ischemic time was significantly correlated with RN (r＝0.46, p＜0.001), PADUA (r＝0.45, p＜0.001) and SPARE scores (r＝0.44, p＜0.001). Time for console was significantly correlated with MAP score (r＝0.28, p＝0.035). In conclusion, RN and MAP scores might be useful parameters to predict warm ischemic time and time for console during RAPN, respectively.

[Comparison of Perioperative Outcomes between Open and Robot-Assisted Laparoscopic Radical Cystectomy].

We compared the perioperative outcomes of open (ORC) and robot-assisted laparoscopic radical cystectomy (RARC) for patients with bladder cancer. We retrospectively investigated the intraoperative and 90-day postoperative complications of ORC and RARC performed from March 2014 to September 2021 based on the medical records. Perioperative complications were categorized according to the Clavien- Dindo classification. We used the propensity score matching to adjust for the inherent bias of the different patient characteristics at baseline including gender, age, preoperative chemotherapy, and pathological T classification. Surgery time of RARC was significantly shorter than that of ORC, and blood transfusion was significantly less frequent in RARC than in ORC (3% vs 81%, p＜0.01). The rate of overall complications of Grade III/IV was lower in RARC (8%) than in ORC (25%) (P＝0.09). The prevalence of perioperative urinary tract infection, ileus, and abscess/infectious cyst was similar in ORC and RARC. In patients who underwent RARC, the complication rate was similar in extracorporeal and intracorporeal urinary diversion. Compared to ORC, RARC is more beneficial to reduce blood loss and severe complications.

[Treatment Outcome of Ureteral Reconstruction Surgery].

We retrospectively reviewed the surgical outcome of ureteral reconstruction that was performed in Asahikawa Medical University Hospital between 2005 and 2021. A total of 14 patients (3 males, 11 females; 15 ureters) were included in this analysis. The median age was 57 years old. The reason for ureteral reconstruction was ureteral injury or stenosis due to pelvic surgery in 9 patients, transurethral lithotripsy for ureteral stone in 3, ureteral invasion of sigmoid colon cancer in one and ovarian cancer in one. The site of ureteral reconstruction was proximal ureter in 2, middle in 3 and distal in 10. The surgical procedure was ureteroneocystostomy with Boari flap in 8 patients (57%), ureteroureterostomy in 4 (21%), transureteroureterostomy in one (7%), and transureteroureterostomy combined with Boari flap for bilateral ureteral stenosis in the remaining patient (7%). Postoperatively, vesicoureteral reflux, ileus and surgical site infection were observed in 3, 2 and 1 patient, respectively. No patient required nephrostomy or ureteral catheter, or any additional procedure after the surgery. There was no episode of febrile urinary tract infection after the surgery. The mean estimated glomerular filtration rate was, respectivery 75.8 and 78.5 ml/min/1.73 m2 before surgery and at 1-101 months (median of 18) after the surgery. In conclusion, satisfactory outcome was achieved after ureteral reconstruction surgery. We emphasize the importance of selecting the most appropriate procedure for ureteral reconstruction in each patient to prevent renal function deterioration and urinary tract infection.

Absorption of the orally active multikinase inhibitor axitinib as a therapeutic index to guide dose titration in metastatic renal cell carcinoma.

Purpose Axitinib is an orally active multikinase inhibitor currently used to treat patients with metastatic renal cell carcinoma (RCC). This study examined the pharmacokinetics of axitinib and the relationship between peak drug concentration (Cmax) and clinical outcomes in real-world practice. Methods Twenty patients with metastatic RCC treated with axitinib monotherapy were enrolled. Post-dose (1-4 h) blood samples were obtained, and axitinib Cmax in plasma was measured by liquid chromatography-tandem mass spectrometry. Efficacy endpoints were best overall response (per RECIST 1.1) and progression-free survival (PFS). The safety endpoint was the cumulative incidence of dose-limiting toxicities (DLTs). Results Large inter- and intra-individual variability in dose-adjusted Cmax was observed (0.02-11.2 ng/mL/mg). Axitinib absorption was significantly influenced by glucuronidation activity (P = 0.040). Cmax at steady state was significantly higher in responders than in non-responders (P = 0.013). The optimal Cmax cutoff to predict a clinical response was 12.4 ng/mL. The median PFS was significantly longer in patients who achieved an average steady state Cmax above the threshold than in those who did not (799 vs. 336 days; P = 0.047). The cumulative incidence of DLTs was significantly higher in patients with Cmax ≥ 40.2 ng/mL than in other patients (sub-hazard ratio, 4.13; 95% confidence interval, 1.27-13.5; P = 0.019). Conclusions The potential therapeutic window of axitinib Cmax in metastatic RCC was estimated at 12.4-40.2 ng/mL. Pharmacokinetically guided dose titration using therapeutic drug monitoring may improve the efficacy and safety of axitinib, warranting further investigation in a larger patient population.

Cardiovascular safety of vibegron, a new ß3-adrenoceptor agonist, in older patients with overactive bladder: Post-hoc analysis of a randomized, placebo-controlled, double-blind comparative phase 3 study.

AIMS: To examine the safety and efficacy of vibegron, a new ß3-adrenoceptor agonist, in patients aged ≥65 years, with a focus on the effects on cardiovascular system and overactive bladder (OAB) symptoms. METHODS: A post-hoc subgroup analysis was performed of a randomized, placebo-controlled, double-blind comparative phase 3 study of vibegron, including those assigned to receive either vibegron 50 mg (V50), vibegron 100 mg (V100), or placebo for 12 weeks. Subjects were stratified into two subgroups based on age: a <65-year subgroup and a ≥65-year subgroup. Safety (changes in systolic and diastolic blood pressure, pulse rate, and residual urine volume) and efficacy (changes in the numbers of micturitions, urgency episodes, urgency urinary incontinence [UUI] episodes, and the voided volume/micturition) were assessed in the subgroups treated with vibegron vs. placebo. RESULTS: There were no significant differences in the cardiovascular outcomes (blood pressure and pulse rate), nor in the changes in residual urine volume, between the V50/100 and placebo groups in the <65-year or ≥65-year subgroup after 12-week treatment. Adverse events were slightly increased in the ≥65-year subgroup. In the efficacy analysis, V50/100 demonstrated similar efficacy in the <65-year and ≥65-year subgroups; an increasing trend in the voided volume/micturition was observed in subjects aged ≥65 years compared to subjects aged <65 years. CONCLUSIONS: Vibegron was suggested to be similarly effective in patients ≥65 and <65 years and to have minimal influence on cardiovascular parameters.

Efficacy of vibegron, a novel ß3-adrenoreceptor agonist, on severe urgency urinary incontinence related to overactive bladder: post hoc analysis of a randomized, placebo-controlled, double-blind, comparative phase 3 study.

OBJECTIVE: To evaluate the efficacy of a novel and selective ß3-adrenoreceptor agonist vibegron on urgency urinary incontinence (UUI) in patients with overactive bladder (OAB). PATIENTS AND METHODS: A post hoc analysis was performed in patients with UUI (>0 episodes/day) who were assigned to receive vibegron or placebo in a vibegron phase 3 study. Patients were subclassified into mild/moderate (>0 to <3 UUI episodes/day) or severe UUI (≥3 UUI episodes/day) subgroup. Changes from baseline in number of UUI episodes/day, in number of urgency episodes/day, and in voided volume/micturition were compared between the groups. The percentage of patients who became UUI-free ('diary-dry' rate) and the response rate (percentage of patients with scores 1 [feeling much better] or 2 [feeling better] assessed by the Patient Global Impression scale [PGI]) were evaluated. RESULTS: Changes in numbers of UUI episodes at week 12 in the vibegron 50 mg, vibegron 100 mg and placebo groups, respectively, were -1.35, -1.47 and -1.08 in all patients, -1.04, -1.13 and -0.89 in the mild/moderate UUI subgroup, and -2.95, -3.28 and -2.10 in the severe UUI subgroup. The changes were significant in the vibegron 50 and 100 mg groups vs placebo regardless of symptom severity. Change in number of urgency episodes/day was significant in the vibegron 100 mg group vs placebo in all patients and in both severity subgroups. In the vibegron 50 mg group, a significant change vs placebo was observed in all patients and in the mild/moderate UUI subgroup. Change in voided volume/micturition was significantly greater in the vibegron 50 and 100 mg groups vs placebo in all patients, as well as in the both severity subgroups. Diary-dry rates in the vibegron 50 and 100 mg groups were significantly greater vs placebo in all patients and in the mild/moderate UUI subgroup. In the severe UUI subgroup, however, a significant difference was observed only in the vibegron 50 mg group. Response rates assessed by the PGI were significantly higher in the vibegron groups vs placebo in all patients and in the both severity subgroups. Vibegron administration, OAB duration ≤37 months, mean number of micturitions/day at baseline <12.0 and mean number of UUI episodes/day at baseline <3.0 were identified as factors significantly associated with normalization of UUI. CONCLUSIONS: Vibegron, a novel ß3-adrenoreceptor agonist, significantly reduced the number of UUI episodes/day and significantly increased the voided volume/micturition in patients with OAB including those with severe UUI, with the response rate exceeding 50%. These results suggest that vibegron can be an effective therapeutic option for OAB patients with UUI.

The early, long-term inhibition of brain-derived neurotrophic factor improves voiding, and storage dysfunctions in mice with spinal cord injury.

AIMS: We examined the time course of urodynamic changes and the effect of the short or long-term inhibition of brain-derived neurotrophic factor (BDNF) from the early phase after spinal cord injury (SCI) in mice. METHODS: The spinal cord of female C57BL/6N mice was completely transected. We examined filling cystometry and bladder BDNF levels at 10, 20, and 30 days after SCI, with an additional day-5 measurement of BDNF. In a separate group of mice, anti-BDNF antibody (Ab) (10 µg/kg/h) was subcutaneously administered using osmotic pumps from day 3 after SCI, and single-filling cystometry was performed at 10 and 30 days (7 and 27 days of treatment, respectively) after SCI. RESULTS: Compared to spinal intact mice, bladder mucosal BDNF was increased at each time point after SCI with the maximal level at day 5 after SCI. Voiding efficiency was lower at each time point after SCI than that of spinal intact mice. The number of non-voiding contractions (NVC) during bladder filling was gradually increased with time. In both 10- and 30-day SCI groups treated with anti-BDNF Ab, voiding efficiency was improved, and the duration of notch-like intravesical pressure reductions during voiding bladder contractions was prolonged. The number of NVC was significantly decreased only in 30-day SCI mice with 27-day anti-BDNF treatment. CONCLUSIONS: Overexpression of BDNF is associated with the deterioration of voiding efficiency after SCI. The early-started, long-term inhibition of BDNF improved voiding dysfunction and was also effective to reduce the later-phase development of detrusor overactivity after SCI.

Persistence Rate with Tadalafil for Treatment of Male Lower Urinary Tract Symptoms.

OBJECTIVES: We examined the persistence rate with tadalafil for treatment of male lower urinary tract symptoms (LUTS) and explored the factors relevant to withdrawal. PATIENTS AND METHODS: We retrospectively collected the data of male patients who received tadalafil treatment for LUTS. The persistence rate and the reason for withdrawal were investigated. RESULTS: A total of 155 patients were examined. Mean age and mean observation period were 71.9 (48-93) years and 15.1 (1-52) months, respectively. During the observation period, 74 patients (48%) withdrew tadalafil. The Kaplan-Meier curve indicated a 58% persistence rate at 1 year. The reasons for withdrawal included insufficient efficacy (31 patients, 42%), adverse events (21 patients, 28%), or symptom improvement (8 patients, 11%). Patients who continued tadalafil were significantly younger than those who withdrew it due to insufficient efficiency (71.4 ± 9.6 vs. 74.9 ± 9.1 years). CONCLUSIONS: Most patients withdrew tadalafil due to insufficient efficacy. Older patients are likely to withdraw the treatment because of insufficient efficacy, thus, tadalafil for male LUTS could be more effective for younger patients.

Clinical guidelines for the diagnosis and treatment of lower urinary tract dysfunction in patients with spinal cord injury.

The present article is an abridged English translation of the Japanese clinical guidelines for the diagnosis and treatment of lower urinary tract dysfunction in patients with spinal cord injury updated as of July 2019. The patients are adult spinal cord injured patients with lower urinary tract dysfunction; special consideration of pediatric and elderly populations is presented separately. The target audience is healthcare providers who are engaged in the medical care of patients with spinal cord injury. The mandatory assessment includes medical history, physical examination, frequency-volume chart, urinalysis, blood chemistry, transabdominal ultrasonography, measurement of post-void residual urine, uroflowmetry and video-urodynamic study. Optional assessments include questionnaires on the quality of life, renal scintigraphy and cystourethroscopy. The presence or absence of risk factors for renal damage and symptomatic urinary tract infection affects urinary management, as well as pharmacological treatments. Further treatment is recommended if the maximum conservative treatment fails to improve or prevent renal damage and symptomatic urinary tract infection. In addition, management of urinary incontinence should be considered individually in patients with risk factors for urinary incontinence and decreased quality of life.

[The Clinical Course of α1 Blocker Discontinuation in Patients with LUTS/BPH Receiving Combination Therapy of Dutasteride and α1 Blocker].

We retrospectively investigated the clinical course of α1 blocker discontinuation in patients who had lower urinary tract symptoms with benign prostate hypertrophy (LUTS/BPH) and received combination therapy ofdutasteride and α1 blocker. Among the patients with LUTS/BPH who had been receiving combination therapy, those who wished to reduce the number ofprescribed drugs and discontinue the use of α1 blocker because ofsymptom improvement were recruited in this study. Symptom scores including International Prostate Symptom Score (IPSS) and overactive bladder symptom score (OABSS), parameters ofuroflowmetry and prostate volume (PV) were evaluated at the time of α 1 blocker discontinuation. Twenty-two patients discontinued the use of α 1 blocker. The mean PV at the time of α 1 blocker discontinuation was 43.2 ml, and the mean duration ofcombination therapy was 39.4 months. In 11 (50%) patients, dutasteride monotherapy without α1 blocker was maintained for a mean follow-up of 10.5 months (9-12 months) after α1 blocker discontinuation (Non-resumption group). In the other 11 patients (50%), α1 blocker was resumed because ofthe patient's request to resume the use of α1 blocker (Resumption group). The mean length ofdutasteride monotherapy was 4. 5 months (1-8 months) in the resumption group. Compared with the non-resumption group, IPSS total score and storage sub-score ofIPSS at the time of α1 blocker discontinuation were significantly higher in the resumption group. Based on the ROC curve, IPSS total score <16, IPSS voiding/storage symptom score <7, OABSS <7 and PV 54 ml or more at the time of α1 blocker discontinuation were predictors ofnon-resumption of α1 blocker. These results suggest that if LUTS is controlled by a long-term combination therapy ofdutasteride and α1 blocker and still PV is large enough, α1 blocker can be discontinued.

[Initial Experiences of Dynamic Sentinel Lymph Node Biopsy (DSNB) in Patients with Penile Cancer].

We present 2 cases of penile cancer in which the inguinal lymph node was not palpable and inguinal lymph node dissection (ILND) could be safely avoided by conducting dynamic sentinel lymph node biopsy (DSNB). The first case was in a 54-year-old man complaining of penile tumor for at least 3 months. We performed partial penectomy and DSNB. The pathological diagnosis was squamous cell carcinoma (SCC), pT2-3. There was no cancer metastasis in sentinel nodes (0/2). There has been no recurrence for 6 years after operation. The second case was 65-year-old man suffering from penile tumor for at least 6 months. We performed partial penectomy and DSNB. The pathological diagnosis was SCC,pT2. There was no cancer metastasis in sentinel nodes (0/3). There has been no recurrence for 1 year after operation. ILND has been recommended for intermediate and high-risk penile cancer even in patients with non-palpable inguinal lymph nodes. However,the complication of ILND is very high. DSNB has the potential to avoid ILND if there is no cancer metastasis in sentinel nodes.

[Relationship between Early Complications after Radical Cystectomy and Psoas Muscle Mass].

Psoas muscle mass index (PMI) is related to sarcopenia. We examined whether PMI is associated with early complications after radical cystectomy. Seventy one male and 29 female patients who were 65 years old or older and who had undergone radical cystectomy at our hospital from April 2005 to March 2018 were retrospectively analyzed. Psoas muscle section area was measured manually on preoperative computed tomography (CT) scan and normalized by patient's height. Early postoperative complications of grade 3 or more occurred in 12 male (16.9%) and 5 female (17.2%) patients. PMI was lower in male patients who had early postoperative complications of grade 3 or more than in those without complications (5.61 vs 6.54 cm2 /m2, p=0. 08), although the difference was not statistically significant. There was suggested to be a relationship between early postoperative complications after radical cystectomy and preoperative PMI in elderly male patients.