Efficacy and safety of desmopressin orally disintegrating tablets 25 and 50 µg in male patients with nocturia: A Japanese real-world multicenter clinical study.

OBJECTIVES: To clarify Japanese real-world clinical data on the use of desmopressin 25 and 50 µg orally disintegrating tablets (ODT) for male patients with nocturia and evaluate the predictive factors to improve nighttime frequency. METHODS: We retrospectively accumulated real-world clinical data from 27 institutions in Japan. Male patients with two or more episodes of nocturia who received desmopressin ODT for nocturnal polyuria (NP) from 2019 through 2021 were included. The primary endpoint was the change of nighttime frequency until 3 months after desmopressin administration. The secondary endpoints were to clarify the persistence rate, adverse events, and predictive factors of decreasing nighttime frequency. RESULTS: A total of 118 patients were eligible to participate in this study. The persistence rate of desmopressin on the Kaplan-Meier curve at week 12 was 51.3. The reason for discontinuation was mainly the occurrence of adverse events in 67 patients (56.8%), particularly hyponatremia in 7 patients (5.9%). Nighttime frequencies at baseline, - 1 month and 1 - 3 months after desmopressin administration were 4.1 ± 1.3, 2.9 ± 1.4 (P < .01), and 2.6 ± 1.3 (P < .01), respectively. The mean nighttime urine volume voided at baseline was significantly larger in patients whose nighttime frequency decreased by two or more times than in those with a decrease of less than two times. CONCLUSIONS: Desmopressin 25 and 50 µg ODT treatments are feasible for male patients with NP in Japanese real-world clinical practice. Patients with higher voided volumes, particularly in the nighttime, may have great benefit from desmopressin.

Ureteral calculi secondary to a gradually migrated acupuncture needle.

We herein presented a case of calculi secondary to a migrated acupuncture needle. A 74-year-old woman with a history of acupuncture therapy for lumbago was referred to our hospital for treatment of ureteral and renal pelvic calculi. Abdominal multi-detector computed tomography scans showed ipsilateral hydronephrosis and two calculi secondary to a migrated acupuncture needle. First, a percutaneous nephrolithotomy was performed to extract two calculi and fine needle fragments from the pelvis. Subsequently, residual needle fragments and calculi in the ureter were then removed by flexible transurethral lithotripsy using a holmium laser. In the present case, the formation of the calculi was caused by a migrated acupuncture needle. Calculi and needle fragments were removed safely endoscopically because the whole calculi and needle fragments were located in the ureteral lumen.

[VESICOVAGINAL FISTULA CAUSED BY CYSTOCELE: A CASE REPORT].

Typical etiologies of vesicovaginal fistula (VVF) include obstructed labor, iatrogenic surgical injury, pelvic irradiation and cancer invasion. VVF caused by cystocele are very rare. To date, there are no documented cases in Japanese literature.A 74-year-old woman presented with near total incontinence. On physical examination, she was found to have severe cystocele and pressure necrosis of anterior vaginal wall, which caused partial breakdown of vaginal mucosa and VVF. She underwent vesicovaginal fistula repair using transvaginal and transabdominal approaches. Catheter drainage was performed for 10 days and postoperative cystogram showed no sign of leakage. She is currently symptom-free at 55 months.

Molecular-targeted Therapy and Surgery May Prolong Survival of Renal Cell Carcinoma Patients with Bone Metastasis: A Multi-institutional Retrospective Study in Japan.

AIM: To determine prognostic factors for overall survival (OS) in renal cell carcinoma (RCC) patients with bone metastasis in the targeted-therapy era. PATIENTS AND METHODS: We conducted a retrospective multi-institutional review of the medical records of 149 RCC patients with bone metastasis. Survival was estimated using the Kaplan-Meier method and compared with the log-rank test. Univariate and multivariate Cox proportional hazard regression analyses were performed to identify independent factors associated with OS. RESULTS: The median OS was 13.4 months. In multivariate analysis, molecular-targeted therapy, nephrectomy and surgery for bone metastasis were independent prognostic factors. Bone-modifying agents (BMAs) were not associated with OS. The median OS of patients receiving molecular-targeted therapy after diagnosis of bone metastasis was significantly better than that of those who did not receive targeted therapy. CONCLUSION: Molecular-targeted therapy, nephrectomy and surgery for bone metastasis should be considered for RCC patients with metastasis in the bones.

CLINICAL FEATURES OF 15 PATIENTS UNDER SURVEILLANCE FOR RENAL MASSES.

(Objective) We investigated the clinical features of patients under surveillance for localized renal masses. (Methods) This study was a retrospective analysis of 15 patients who were diagnosed as having clinically localized renal cell carcinoma and were placed under surveillance and 68 patients who underwent immediate radical operation for renal masses. (Results) The age at diagnosis in the surveillance group was significantly higher than in the immediate operation group (median, 81 vs. 65 years, respectively, P<0.01). The Charlson Comorbidity Index in the surveillance group was significantly higher than in the immediate operation group (median, 5 vs. 2, respectively, P<0.01) and 10 patients (67%) had complications, which was one of the reasons for surveillance. The median initial tumor size in the surveillance group was 2.5 cm (1.5-10.1). There was no significant difference in the tumor size between the two groups. During a median follow-up of 19 months (6-55) the median tumor growth rate was 0.29 cm per year (-0.19-0.65) in the surveillance group. Of the 15 patients with computed tomography follow-up, four underwent surgical resection of the renal masses after surveillance. The histological diagnosis was clear cell renal cell carcinoma in all four. During follow-up, two patients died of other causes and one patient had bone metastasis but there was no death related to the renal masses in the surveillance group. (Conclusions) The appropriateness of the surveillance should be considered when we initiate surveillance for patients with renal masses because metastasis was detected in one patient in this study. On the other hand, surveillance may be an acceptable management method for elderly or severely comorbid patients because there were two deaths from other causes in the surveillance group.

Palonosetron with aprepitant plus dexamethasone to prevent chemotherapy-induced nausea and vomiting during gemcitabine/cisplatin in urothelial cancer patients.

OBJECTIVES: To evaluate the appearance of chemotherapy-induced nausea and vomiting, and to compare the antiemetic efficacy of the triple combination of palonosetron, aprepitant and dexamethasone with that of our old regimen using first-generation 5-hydroxytryptamine 3-receptor antagonists and dexamethasone during gemcitabine and cisplatin chemotherapy in patients with advanced urothelial cancer. METHODS: We carried out a multi-institutional study including 122 patients who received gemcitabine and cisplatin for advanced urothelial cancer between February 2005 and January 2012. Uncontrolled chemotherapy-induced nausea and vomiting events were identified through records of nausea and vomiting, additional infusion, rescue medications, and/or records of food intake. RESULTS: First-generation 5-hydroxytryptamine 3-receptor antagonists (ondansetron or granisetron) plus dexamethasone were used for 75 patients (cohort 1), and palonosetron with dexamethasone plus aprepitant for 47 patients (cohort 2). Patients in cohort 2 had significantly higher complete response (defined as no emetic episodes and no rescue medication use) rates than those in cohort 1 during the overall phase in the first cycle (85.7% vs 65.3%, P = 0.012), and all cycles (78.7% vs 50.7%, P = 0.0019) of gemcitabine and cisplatin. Patients in cohort 2 were more likely to achieve more favorable chemotherapy-induced nausea and vomiting control; that is, a lower grade of nausea, vomiting or anorexia, lower incidence of rescue therapy required, and shorter time to become chemotherapy-induced nausea- and vomiting-free than patients in cohort 1. CONCLUSIONS: The present results show that palonosetron in combination with aprepitant and dexamethasone is more effective to prevent chemotherapy-induced nausea and vomiting in urothelial cancer patients treated with gemcitabine and cisplatin than first-generation 5-hydroxytryptamine 3-receptor antagonists plus dexamethasone.

[Rhabdomyolysis after radical nephrectomy in the lateral decubitus position: report of 2 cases].

Rhabdomyolysis is a rare perioperative complication, however, potentially lead to fatal outcome. We experienced 2 cases of rhabdomyolysis after radical nephrectomy and nephroureterectomy in the lateral decubitus position. (Case 1) A 40-years old man was seen in our hospital because of asymptomatic grosshematuria. Computed tomography revealed right renal pelvic cancer, cT3N0M0. Right radical nephroureterectomy, lymph node dissection, partial cystectomy was underwent, and the operation was finished without any trouble. At the post-operative day 1, serum creatinine level was elevated to the point of 4.2 mg/dl, and serum creatine kinase was 1,945 IU/l. Continuous hemodiafiltration (CHDF) was done at intensive-care unit (ICU), and serum creatinine and creatine kinase level were decreased. At the post-operative day 1, urine myoglobin level was prominently elevated (2,943.7 ng/ml), so we diagnosed acute renal failure due to rhabdomyolysis. (Case 2) A 40-years old man was incidentally pointed out of right renal tumor that was seen as renal cell carcinoma, cT1aN0M0. Open partial nephrectomy was underwent, and there was no trouble during the operation. After recovering from anesthesia, the patient felt left thigh pain strongly. Serum creatine kinase was 888 IU/L after the operation. At the postoperative day 1, serum creatine kinase level was markedly increased (31,138 IU/L). Serum creatinine level was 1.34 mg/dl. Urine and serum myoglobin level was prominently elevated (89,000 ng/ml and 8,634 ng/ml, respectively). We diagnosed it rhabdomyolysis, and he received large amount of fluid intravenously at intensive-care unit. Serum creatine kinase was peak out at the post-operative day 3 (20,709 IU/L), and hemodialysis was not performed.

[Treatment of hemodialyzed patient by targeted therapy in metastatic renal cell carcinoma: a case report].

Experience with treatment of hemodialyzed patients by targeted therapy is limited to the few cases reported. Little information has been provided on the safety and toxicity profile of temsirolimus and sorafenib when administered in hemodialyed patients with renal cell carcinoma (RCC). Herein, we report an RCC patient undergoing hemodialysis treated with temsirolimus and sorafenib for 16 months. The patient was a 69-year-old man who was diagnosed with right RCC. He underwent nephrectomy for a pT1b tumor in December 2002. Hemodialysis was introduced in July 2003 (7 months after nephrectomy). Seven years later, CT showed retroperitoneal nodal metastases. He was started on temsirolimus. Although 8 cycles of this therapy were done, we discontinued it because of progressive disease. The CTCAE (Common Terminology Criteria for Adverse Events) grade 3 adverse events were thrombopenia, but no adverse events of grade 4 or greater developed. Secondly, he was started on sorafenib. CT showed a partial response with a 45% decrease in tumor bulk using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. He has partial response for 13 months. He presented high blood pressure requiring pharmacological treatment, but no adverse events of grade 4 or greater developed. Patients with terminal renal failure can be offered temsirolimus and sorafenib treatment with close clinical and laboratory monitoring. Treatment of RCC patient undergoing hemodialysis by targeted therapy appears to be feasible and effective.

Lymph node metastasis mapping in extended lymphadenectomy to the level of the inferior mesenteric artery for bladder cancer.

BACKGROUND: The aim of this study was to evaluate the distribution of lymph node metastasis in extended lymphadenectomy for patients with bladder cancer. METHODS: We analyzed 31 patients who underwent extended lymphadenectomy at radical cystectomy for bladder cancer between April 2008 and February 2010. Specimens were evaluated as 14 separate packages from predesignated anatomical locations. The lymph node mapping was prospectively registered. RESULTS: The median lymph node count was 37 (range 19-68). Ten (32%) patients had lymph node metastasis. The positive rates at each lymph node site were 0% at the left internal iliac, 13% at the left obturator, 3.2% at the left external iliac, 6.5% at the right internal iliac, 10% at the right obturator, 16% at the right external iliac, 3.2% at the left common iliac, 3.2% at the right common iliac and 6.5% at the presacral node. No lymph node metastasis was detected in the Cloquet, paracaval, aortocaval or paraaortic nodes. One (3.2%) patient had a skip metastasis from the left obturator to the presacral node. CONCLUSIONS: Extended lymphadenectomy provides more accurate lymph node staging. We suggest that it is better to perform lymphadenectomy at least below the aortic bifurcation including the presacral node.

Prognostic value of surgical margin status for biochemical recurrence following radical prostatectomy.

OBJECTIVE: We evaluated the preoperative parameters to predict a positive surgical margin (SM) at radical prostatectomy for patients with prostate cancer. In addition, the prognostic factors for biochemical recurrence were determined in patients with positive SMs. METHODS: We retrospectively analysed 238 patients with prostate cancer who underwent retropubic radical prostatectomy and bilateral pelvic lymph node dissection from May 1985 to July 2005 in our hospital. Biochemical recurrence was defined as an increase of undetectable prostate-specific antigen (PSA) to 0.2 ng/ml or greater. RESULTS: Of the 238, 82 patients (34.4%) had positive SMs. On multivariate analysis, preoperative PSA (>/=10 ng/ml), clinical T stage (>/=T2a) and the positive core rate (>/=35%) were parameters that could predict a positive SM. During the median follow-up of 31.2 months, 48 patients (20.2%) developed biochemical recurrence. The 5-year biochemical progression-free survival rates were 81.7% and 62.6% in patients with negative and positive SMs, respectively (P < 0.001). In the Cox proportional hazards model, preoperative PSA of >/=20 ng/ml and a pathological T stage of pT3a/pT3b were significant risk factors for biochemical recurrence in patients with positive SMs. CONCLUSIONS: SM status at radical prostatectomy depends on preoperative PSA, clinical stage and the positive core rate. Patients with a positive SM had a higher risk for biochemical recurrence than those with a negative one. Patients with a positive margin had a higher risk for biochemical recurrence if they exhibited preoperative PSA of >/=20 ng/ml and/or pathological T stage of pT3a/pT3b.

Current survey of urinary tuberculosis in Hokkaido, Japan.

Urinary tuberculosis has been rare in recent years and its diagnosis is difficult because there are no disease-specific symptoms. We tried to clarify the occurrence of urinary tuberculosis in recent years in our area. During the past 5 years, there were 12 patients with urinary tuberculosis in the clinics that participated in this study. Their chief complaints were frequent voiding in 7 patients and gross hematuria in 3 patients. They were diagnosed by nucleic acid amplification tests and imaging modalities such as excretory urography, computed tomography, and/or cystoscopy. Most of the patients received multidrug treatment and had relatively favorable treatment outcomes. There has been a small but neglected number of patients with urinary tuberculosis in recent years. We should keep this rare and difficult-to-diagnose disease in mind and suspect it when patients complain of longstanding urinary symptoms with no obvious cause.

Disinfection by antiseptics in management of postoperative surgical wounds in urologic operations.

The objective of this study was to confirm that frequent disinfection by antiseptics is unnecessary on surgical wounds of urologic operations. Patients who received urologic operations were divided into 3 groups that had the same surgical dressings but different frequencies of disinfection and different antiseptics used. Surgical wounds were evaluated clinically and bacteriologically for the period until removal of sutures. Of the 97 patients randomly recruited for the study, 3 developed surgical-site infection (SSI). There was no significant difference in the incidence of SSI among the 3 groups. Bacterial counts of surgical wounds increased over time after operation, to similar extents in the 3 groups. The major isolate was Staphylococcus epidermidis, one of the normal florae on the skin. This strain was found at almost equal frequencies in all groups. In conclusion, our study suggested that covering with the surgical dressing without frequent disinfection by antiseptics was effective for prevention of SSI. Thus, traditional frequent disinfection should be abandoned.