Differences in oncological benefits from second transurethral resection between white-light initial surgery and photodynamic diagnosis-guided initial surgery for primary high-risk non-muscle invasive bladder cancer.

OBJECTIVES: The aim of this study was to compare clinical outcomes between patients receiving second TUR after initial white-light transurethral resection of bladder tumor (WL-TURBT) and initial photodynamic diagnosis (PDD)-assisted TURBT. METHODS: A total of 1007 patients were divided into four groups based on the treatment pattern: WL-TURBT with second TUR (161 patients, WL-second group) or without second TUR (540 patients, WL-alone group) and PDD-TURBT with second TUR (112 patients, PDD-second group) or without second TUR (194 patients, PDD-alone group). Oncologic outcomes (bladder cancer recurrence, progression, urothelial cancer-specific mortality) and rates of residual tumor and risk stratification of non-muscle-invasive bladder cancer (NMIBC) after second TUR were evaluated. RESULTS: After propensity score-matching 121 patients were included each in the WL-alone and WL-second groups, and 63 patients each in the PDD-alone and PDD-second groups. In the WL group, the second TUR was significantly associated with improved progression-free (p = 0.012) and urothelial cancer-specific free survival (p = 0.011), but not with recurrence-free survival (p = 0.93). Patients initially treated with PDD-TURBT, and with a tumor diameter <30 mm and multifocality had a relatively high benefit from second TUR. The rates of residual tumor and risk stratification of NMIBC did not significantly differ between WL-TURBT and PDD-TURBT groups. CONCLUSIONS: Our findings suggested that a second TUR could be omitted after an initial PDD-TURBT in selected patients with high-risk NMIBC.

Impact on Japanese healthcare economics of photodynamic diagnosis-assisted transurethral resection of bladder tumor for non-muscle invasive bladder cancer: A multicenter retrospective cohort study.

OBJECTIVES: Bladder cancer, especially non-muscle invasive bladder cancer (NMIBC), is one of the most costly cancers owing to its long-term management. Photodynamic diagnosis-assisted transurethral resection of bladder tumor (PDD-TURBT) reduces the risk of intravesical recurrence. However, its impact on healthcare economics in Japan remains unclear. We evaluated the comprehensive medical costs of Japanese healthcare economics regarding PDD-TURBT. METHODS: This large-scale, multicenter, retrospective study included a dataset of 1531 patients who were diagnosed with primary NMIBC who underwent initial TURBT between April 2006 and June 2021. A one-to-one propensity-score matching analysis was used for an unbiased comparison based on postTURBT follow-up periods. The total medical costs, including hospitalization, surgical procedures for TURBT and salvage radical cystectomy, adjuvant intravesical therapies, and follow-up examinations, were compared between white light (WL)-TURBT and PDD-TURBT groups. RESULTS: After propensity-score matching, 468 patients each of WL- and PDD-TURBT groups were matched. Total costs were 510 337 128 and 514 659 328 ¥ in WL- and PDD-TURBT groups, respectively. The costs of adjuvant intravesical therapies, follow-up examinations, and salvage radical cystectomy in PDD-TURBT group were equivalent to or lower than those in WL-TURBT group. Furthermore, total costs of high- and highest-risk NMIBC in PDD-TURBT group were either equivalent or lower compared to those in WL-TURBT group. CONCLUSIONS: The total costs associated with PDD-TURBT were higher compared to WL-TURBT, while there is the potential of PDD-TURBT to reduce the burden on healthcare economics in limited cases.

Validation of the risk stratification newly defined in the Japanese Urological Association guidelines 2019 for non-muscle invasive bladder cancer: A multi-institutional collaborative study.

OBJECTIVES: To validate the risk stratification newly defined in the Japanese Urological Association guidelines 2019 for non-muscle invasive bladder cancer and provide a more accurate stratification model for a heterogeneous intermediate-risk group. METHODS: A total of 1610 patients, who underwent transurethral resection, diagnosed with non-muscle invasive bladder cancer in nine collaborating hospitals were retrospectively reviewed. They were classified into low-risk, intermediate-risk, high-risk, and highest-risk groups, and recurrence-free survival, progression-free survival, cancer-specific survival, and overall survival were compared among the groups. The intermediate-risk group was subdivided into two groups based on the multivariable Cox regression model of recurrence and progression risk factors, and a revised risk model was created. RESULTS: The progression-free survival, cancer-specific survival, and overall survival were well stratified, while the recurrence-free survival of the intermediate-risk group was the shortest among the four groups (p < 0.001). The independent risk factors for recurrence and progression-free survival in the intermediate-risk group were as follows: age ≥ 70 years, sex, multiple tumors, tumor size ≥3 cm, and recurrent cases. The intermediate-risk group was subdivided into two groups: favorable intermediate-risk group and unfavorable intermediate-risk group. The revised risk model showed significant differences. CONCLUSION: We validated the Japanese Urological Association guidelines 2019 stratification model. The revised risk model provided a more accurate treatment selection for this disease subset.

Remnant renal volume can predict prognosis of remnant renal function in kidney transplantation donors: a prospective observational study.

BACKGROUND: Safety and survival during and after donor nephrectomy (DN) are one of the main concerns in living kidney donors (LKDs). Therefore, kidney (left/right) to be procured should be determined after considering the difficulty of DN, as well as the preservation of remnant renal function (RRF). In this prospective study, we investigated the roles of computed tomography volumetry (CTV) in split renal function (SRF) and established a predictive model for RRF in LKDs. METHODS: We assessed 103 LKDs who underwent DN at our institute. The Volume Analyzer SYNAPSE VINCENT image analysis system were used as CTV. RRF was defined as the estimated glomerular filtration rate (eGFR) 12 months after DN. The association between various factors measured by CTV and RRF were investigated, and a role of CTV on prediction for RRF was assessed. RESULTS: The median age and the preoperative eGFR were 58 years and 80.7 mL/min/1.73m2, respectively. Each factor measured by CTV showed an association with RRF. The ratio of remnant renal volume to body surface area (RRV/BSA) could predict RRF. In addition, RRV/BSA could predict RRF more accurately when used together with age and 24-h creatinine clearance (CrCl). CONCLUSIONS: Our findings suggest that RRV/BSA measured by CTV can play an important role in predicting RRF, and a comprehensive assessment including age and CrCl is important to determine the kidney to be procured.

Clinical outcomes after intravesical bacillus Calmette-Guérin for the highest-risk non-muscle-invasive bladder cancer newly defined in the Japanese Urological Association Guidelines 2019.

OBJECTIVE: To assess the clinical outcomes of highest-risk non-muscle-invasive bladder cancer patients treated with intravesical bacillus Calmette-Guérin. METHODS: The medical charts of patients with non-muscle-invasive bladder cancer treated with intravesical bacillus Calmette-Guérin between 2000 and 2018 at a single institution were retrospectively reviewed. Patients were stratified into three groups (intermediate-, high- and highest-risk groups) according to the risk classification of the updated Japanese Urological Association guidelines 2019. Among the three groups, the intravesical recurrence-free survival and progression-free survival were estimated and compared, respectively. Furthermore, the different types of risk factors in the highest-risk group were analyzed. RESULTS: Of the 165 patients, 49 (30%) patients had intravesical recurrence and 23 (14%) patients showed progression to muscle-invasive disease during a median follow-up period of 53 months. Significant differences were not noted in the recurrence-free survival and progression-free survival among the three groups. Multivariable survival analysis of 74 patients in the highest-risk group showed that carcinoma in situ in the prostatic urethra was a significant predictor associated with recurrence (hazard ratio 3.20, P = 0.026) and progression (hazard ratio 4.36, P = 0.013). CONCLUSIONS: Intravesical bacillus Calmette-Guérin can control highest-risk non-muscle-invasive bladder cancer in most patients. Our findings might aid in decision-making regarding the treatment of this subset of patients who require intensive treatment, such as intravesical therapy with bacillus Calmette-Guérin and radical cystectomy.

[A Case of Bladder Squamous Cell Carcinoma with Neurogenic Bladder Caused by Myelomeningocele].

A 38-year-old woman with neurogenic bladder caused by myelomeningocele,who had been on clean intermittent self-catheterization for years,complained of gross hematuria. Computerized tomography, urinary cytology and cystoscopy failed to reveal causative lesions and the hematuria ceased spontaneously. Because gross hematuria recurred 2 years later,we examined the patient again and detected calcification of the urinary bladder. Mucosal lesions suspicious of bladder tumor were detected during the transurethral surgery for the calcified lesion,and we promptly performed biopsy. As a result,she was diagnosed with invasive bladder squamous cell carcinoma. Radical cystectomy and urinary diversion were performed and the histopathological diagnosis was pT3aN0. Adjuvant therapies were not performed. No recurrence has been observed for 36 months after the surgery.

[A Case of Small Cell Carcinoma of the Renal Pelvis].

A 84-year-old female visited our hospital with the chief complaint of asymptomatic gross hematuria. The computed tomography and magnetic resonance imaging revealed a large invasive tumor in the right renal pelvis. Metastatic workup was negative. On imaging studies and voided urine cytology, diagnosis of right renal pelvic cancer (cT3N0M0) was made. Laparoscopic right nephroureterectomy was performed. Histopathological examinations revealed a small cell carcinoma of the renal pelvis. The patient declined adjuvant chemotherapy and died 5 months after surgery. Primary small cell carcinoma of the renal pelvis is a rare disease. To our knowledge, this is the 29th case of primary small cell carcinoma of the renal pelvis in the world literature.

[Spontaneous Tumor Lysis Syndrome in a Patient with Testicular Malignant Lymphoma : A Case Report].

A 75-year-old man, highly suspected as having malignant lymphoma originating from his left testis, underwent exploratory orchiectomy for a definitive diagnosis. Laboratory examinations before the surgery showed high lactate dehydrogenase (652 IU/l), elevated serum creatinine level (1.85 mg/dl) and sIL-2R level (8,930 U/ml). As the postoperative course passed uneventfully, the patient was discharged from the hospital on the eighth day after the surgery. Ten days after the surgery the patient was transferred to the emergency room of the hospital complaining of severe abdominal pain and malaise. Laboratory examinations revealed highly elevated lactate dehydrogenase (2,807 IL/l), uric acid (24.9 mg/dl) and serum creatinine (5.31 mg/dl). Computed tomography demonstrated rapid growth of the retroperitoneal mass and occurrence of bilateral hydronephroses. Under the diagnosis of spontaneous tumor lysis syndrome, the patient was urgently treated with hemodialysis, steroidal pulse and rituximab following percutaneous nephrostomy for the right kidney. After improvement of the laboratory data, the patient was transferred to another hospital for the treatment of malignant lymphoma.

[A Case of Neurofibromatosis Type 1 Presenting Voiding Symptoms Caused by Giant Bladder Diverticulum].

A 40-year-old man complaining of voiding symptoms was referred to our hospital for further examinations and treatment of giant bladder diverticulum and possibly underlying neurogenic bladder dysfunction. Because computed tomography and magnetic resonance imaging revealed the presence of a tumorous lesion covering the bladder diverticulum, transurethral biopsy was performed to elucidate its pathological characteristics. Through the histopathological examination of the biopsy specimens the tumorous lesion was diagnosed as ganglioneuroma which was benign. The whole diverticulum with the concomitant tumor lesion was surgically excised. Full examination of the surgical specimen concluded the final histopathological diagnosis of the tumor to be plexiform neurofibroma. As multiple café-au-lait spots were found on the patient's skin, he was clinically diagnosed with neurofibromatosis type 1.

[Misdirection of a Catheter for Clean Intermittent Catheterization into the Upper Ureter in a Female Patient with Neurogenic Bladder Due to Myelomeningocele : A Case Report].

We report a case of misdirection of a catheter for clean intermittent catheterization (CIC) into the ureter. A four-year-old girl with neurogenic bladder due to myelomeningocele had been managed with CIC by her parents for several years. From about a month before her visit, macroscopic hematuria appeared intermittently followed by abdominal pain and fever-up for a short time which ceased spontaneously. As cystography demonstrated bilateral vesicoureteral reflux, we performed endoscopic intraureteral injection of Deflux[TM] and during the operation we confirmed influx of bloody urine from the right ureteral orifice but not from the left one. As computed tomography revealed a tubular foreign body located in the upper portion of the right ureter, another endoscopic operation was performed and it was removed successfully. The removed foreign body was identified as a disposable catheter that was used for CIC.

[Predictive Factors of Biochemical Recurrence in Positive Surgical Margin Patients by Radical Prostatectomy].

The predictive factors for biochemical recurrence (BCR) were investigated in patients with positive surgical margin of the extirpated prostate by radical retropubic prostatectomy (RRP). The records of 365 patients who underwent RRP in our hospital between January 2002 and December 2014 were retrospectively analyzed. Patients who had received additional therapy before or after RRP, who had not been followed up for more than a year after surgery, and who had pN1 lesions were excluded from the study. Positive surgical margin was observed in 112 cases. Prostate specific antigen (PSA) before surgery ≥20 ng/ml, biopsy positive core ratio ≥40%, Gleason score of the surgical specimen ≥8, and postoperative PSA nadir ≥0.01 ng/ml were identified as significant predictors of BCR.

[Predictive Factors of Positive Surgical Margin in Radical Prostatectomy].

To identify the predictive factors for positive surgical margin after radical prostatectomy, we retrospectively analyzed the records of 381 patients who underwent radical prostatectomy in our hospital between January 2002 and December 2014. Patients who had received hormonal therapy before surgery were excluded from the study. Positive surgical marginwas observed in121 cases (31.8%), and prostate specific antigen (PSA) before surgery ≧10 ng/ml (HR1.89 : 95%CI 1.17-3. 07) and BMI≧25 kg/m2 (HR2.73 : 95%CI 1.60-4. 68) were identified as significant predictors of positive surgical margin. The existence of PSM significantly correlated to the operation time of 240 minutes or longer (HR2.27 : 95%CI 1. 35-3.79), pT2c or higher local stage (HR2.08 : 95%CI 1.17-3.72) and 7 or higher Gleason score of the resected specimen(HR1.63 : 95%CI 1.03-2.59).

[Causative Bacterial Strains and Sensitivityto Antimicrobial Agents in Female Acute Uncomplicated Cystitis].

Recently, wide spreading of fluoloquinolone resistant Escherichia coli is a serious problem inthe treatment of urinary tract infection. To investigate the causative bacterial strains of female acute uncomplicated cystitis (AUC) in the community and their sensitivity to antimicrobial agents, we retrospectively reviewed the medical records of 215 female AUC patients treated at our clinics from April 2014 to June 2015. Two hundred and nineteen strains were isolated as the causative bacteria from the patients'urine samples, including E. coli of 179 strains (82%) followed by Klebsiella pneumoniae (5.5%). One hundred and forty five strains (81%) of the isolated E. coli were sensitive to levofloxacin, whereas 32 strains (17.9%) were levofloxacin-resistant. To fosfomycin, the isolated E. coli showed the highest sensitivity (93.9%) among all antimicrobial agents tested. In univariate analysis, factors associated with levofloxacinresistant E. coli included two or more episodes of cystitis within the past year and levofloxacin use at the latest episode of cystitis. Inmultivariate analysis, two or more episodes of cystitis withinthe past year were found to be associated with levofloxacinresistan ce (p＝0.004). To prevent the increasing prevalence of infections caused by antibiotic-resistant bacteria, it is important to confirm the sensitivity of the causative agents for optimal antimicrobial therapy. The community-based surveillance data should be collected and considered when selecting empirical antimicrobial agents.

[Multiple Recurrences in Perirenal Fatty Tissue 10 Years after Enucleation for Treatment of T1a Renal Cell Carcinoma : A Case Report].

A 71-year-old man underwent simple enucleation for T1a renal cell carcinoma of the left kidney 10 years ago, and, the capsule of the tumor was injured during that surgery. The histopathological diagnosis of the tumor was papillary renal cell carcinoma type1 pT1a, G2 and the surgical margin was negative. Eight years after the surgery, computed tomography (CT) scan imaging showed a mass 13 mm in diameter which was adjacent to the left kidney. In the following year, the mass had grown to 22 mm in diameter. Thus it was suspected as local recurrence of renal cell carcinoma. Magnetic resonance imaging revealed multiple tumors in the left perirenal fatty space and positron emission tomography CT showed abnormal uptake in the same lesions with a maximal standardized uptake value of 3.2. We diagnosed multiple local recurrences of renal cell carcinoma and planned open radical nephrectomy and extirpation of perirenal fat including tumors entirely. The histopathological diagnosis of the tumor was papillary renal cell carcinomas type 1, Fuhrman grade 2＞3. The patient had no recurrence or metastases 10 months after the surgery. It is possible that the tumor cells were disseminated during the first surgery due to an injury to the capsule of the tumor and resulted in multiple local recurrences.

[A Case of Penile Squamous Cell Carcinoma, Sarcomatoid Subtype].

A 70-year-old man was referred to our department for further examination and treatment of a painless penile mass of about 2cm. The patient first noticed the mass onlya few weeks before presentation. Diagnostic biopsy was interpreted as leiomyosarcoma. Through systemic examinations the clinical stage of his disease was diagnosed as cT2N0M0 and we performed total penectomy. Histopathological examination for the totallyresected tissue disclosed the concomitant presence of regions compatible to squamous cell carcinoma and the results of immunohistochemistrywere compatible with the diagnosis of squamous cell carcinoma, sarcomatoid subtype of the penis. One month after the surgery, multiple metastases to left inguinal lymph nodes and lungs developed, for which systemic chemotherapy by doxorubicin was ineffective and the patient died of respiratoryinsufficiencyfive months after presentation.

[Bladder Metastasis of Renal Cell Carcinoma 7 Years after Ex Vivo Partial Nephrectomy and Auto-Transplantation : A Case Report].

Metastasis of renal cell carcinoma (RCC) to urinary bladder is extremely rare. We report a case of metastasis arising from RCC to the urinary bladder 7 years after treatment of bilateral RCC. A 74-year-old man was diagnosed with bilateral multiple renal tumors (T1aN0M1, PUL, OSS) with two lesions in the right kidney and a solitary lesion of the left kidney in 2008. He underwent laparoscopic radical nephrectomy for the right side in September 2008. The next month, ex vivo partial nephrectomy and auto-transplantation was performed for the left kidney because the tumor was located very close to the collecting system. Metastatectomies for the lung and bone followed and the histopathological findings of all lesions were clear cell carcinoma. The following years went well without any recurrence. Seven years after the surgery, the patient complained of asymptomatic gross hematuria and cystoscopy revealed a solitary non-papillary tumor of the bladder. Transurethral resection of the tumor was performed in June 2015 and the histopathological diagnosis of the resected specimens was clear cell carcinoma. Because the additional immunohistochemical examinations were positive for CD10 and negative for CK7, we diagnosed the bladder tumor as metastasis arising from RCC. Direct dissemination of the tumor cells into the urinary tract during partial nephrectomy followed by implantation to the bladder mucosa is a probable mechanism of metastasis in this case.

Follow-up After Donor Nephrectomy in Living Kidney Donors: How to Manage Living Kidney Donors Postoperatively.

BACKGROUND/AIM: This study investigated the follow-up rate of living kidney donors and explored the factors related to continuous follow-up and remnant renal function, enabling the optimal management of living kidney donors. PATIENTS AND METHODS: We retrospectively evaluated 180 living kidney donors who underwent donor nephrectomies at our institute. Clinical information was obtained from medical charts, and remnant renal function was defined as the estimated glomerular filtration rate 12 months after donor nephrectomy. RESULTS: Overall, 6/180 donors (3.3%) were lost to follow-up within a year, and the follow-up rate gradually declined yearly. Independent risk factors for loss to follow-up included a follow-up period <60 months and graft survival of the recipient (p=0.002 and p=0.043, respectively). Recipient survival was correlated with loss to follow-up; however, this was not significant (p=0.051). Regarding remnant renal function, age ≥60 years, preoperative estimated glomerular filtration rate <74 ml/min/1.73 m2, and a Δsingle-kidney estimated glomerular filtration rate <9.3 ml/min/1.73m2 were independent risk factors for poorly preserved remnant renal function (p=0.036, p<0.0001, and p<0.0001, respectively). Using propensity score matching to adjust for preoperative factors, a Δsingle-kidney estimated glomerular filtration rate <9.3 ml/min/1.73 m2 was the only significant postoperative factor for poorly preserved remnant renal function (p=0.023). CONCLUSION: An increased 5-year follow-up rate could lead to an increase in long-term follow-up, and recipient prognosis may be correlated with the living kidney donor follow-up status. Furthermore, Δsingle-kidney estimated glomerular filtration rate was identified as a factor for establishing the optimal precision follow-up management of living kidney donors.

Validation of non-muscle-invasive bladder cancer risk stratification updated in the 2021 European Association of Urology guidelines.

Objective: The objective of this study is to validate the predictive ability of the 2021 European Association of Urology (EAU) risk model compared to that of existing risk models, including the 2019 EAU model and risk scoring tables of the European Organization for Research and Treatment of Cancer, Club Urologico Espanol de Tratamiento Oncologico, and Japanese Nishinihon Uro-oncology Extensive Collaboration Group. Patients and methods: This retrospective multi-institutional database study included two cohorts-3024 patients receiving intravesical bacillus Calmette-Guerin (BCG) treatment (BCG cohort) and 789 patients not receiving BCG treatment (non-BCG cohort). The Kaplan-Meier estimate and log-rank test were used to visualize and compare oncological survival outcomes after transurethral surgery among the risk groups. Harrell's concordance index (C-index) was used to evaluate the predictive ability of the models. Results: We observed a risk shift from the 2019 EAU risk grouping to the 2021 EAU risk grouping in a substantial number of patients. For progression, the C-index of the 2021 EAU model was significantly higher than that of the 2019 EAU model in both the BCG (0.617 vs. 0.572; P = 0.011) and non-BCG (0.718 vs. 0.560; P < 0.001) cohorts. According to the 2021 EAU model, 731 (24%) and 130 (16%) patients in the BCG and non-BCG cohorts, respectively, were considered to have a very high risk. Survival analysis showed no significant differences among the five very high-risk subgroups in both cohorts. A major limitation was potential selection bias owing to the retrospective nature of this study. Conclusions: The updated 2021 EAU model showed better stratification than the three existing risk models, especially for progression, in both cohorts, determining the most appropriate postoperative treatment and identifying patients requiring intensified surveillance or early cystectomy.

Additional oncological benefit of photodynamic diagnosis with blue light cystoscopy in transurethral resection for primary non-muscle-invasive bladder cancer: A comparative study from experienced institutes.

Objectives: The objective of this work is to evaluate the additional oncological benefit of photodynamic diagnosis (PDD) using blue-light cystoscopy in transurethral resection (TURBT) for primary non-muscle-invasive bladder cancer (NMIBC) based on the International Bladder Cancer Group (IBCG)-defined progression and the subsequent pathological pathways. Patients and Methods: We reviewed 1578 consecutive primary NMIBC patients undergoing white-light TURBT (WL-TURBT) or PDD-TURBT during 2006-2020. One-to-one propensity score-matching was performed using multivariable logistic regression to obtain balanced groups. IBCG-defined progression of NMIBC included stage-up and grade-up as well as conventional definitions such as the development of muscle-invasive BC or metastatic disease. Nine oncological endpoints were evaluated. Sankey diagrams were generated to visualize follow-up pathological pathways after the initial TURBT. Results: Comparison of event-free survival between the matched groups revealed that PDD use decreased the bladder cancer recurrence risk and IBCG-defined progression risk, whereas no significant difference was noted in conventionally defined progression. This was attributable to a reduced risk of stage-up, from Ta to T1, and grade-up. Sankey diagrams of the matched groups showed that patients with primary Ta low-grade tumour and first-recurrence Ta low-grade tumour did not have bladder recurrence or progression, while some of those in the WL-TURBT group developed recurrence after treatment. Conclusions: The multiple survival analysis demonstrated that the risk of IBCG-defined progression was significantly decreased by PDD use in NMIBC patients. Sankey diagrams revealed possible differences in pathological pathways after the initial TURBT between the two groups, demonstrating that repeated recurrence could be prevented by PDD use.

A prospective, single-arm trial of fluorescent ureteroscopy-assisted thulium-holmium:YAG dual laser ablation for upper urinary tract cancer: Study protocol of the FLUAM trial.

Background: Latest guidelines recommend kidney-sparing management as the primary treatment option for selected patients with upper urinary tract urothelial carcinoma (UTUC). One of the biggest issues of ureteroscopic laser ablation (ULA) is a high rate of surgical site recurrence, which is largely attributed to residual lesions at the initial ULA. Another clinical issue is a significant lack of non-invasive reliable detection tools of urinary recurrent tumors in this treatment setting. Methods: The FLUAM trial is a prospective, single-center, single-arm pilot trial to investigate the efficacy of 5-aminolevulinic acid-mediated photodynamic diagnosis (ALA-PDD)-assisted ULA for localized UTUC and the usefulness of the UroVysion® assay (multiprobe fluorescence in situ hybridization) as a monitoring test after the kidney-sparing treatment. After the screening and registration, a total of 20 patients with localized UTUC will undergo the initial ALA-PDD-assisted ULA followed by the second look ALA-PDD-assisted ureteroscopic examination. The primary endpoint is progression-free survival. Secondary endpoints include patient reported outcomes, diagnostic accuracy of UroVysion assay to detect tumor recurrence, adverse events, and safety of the intervention. Conclusion: The goal of this trial is to determine the potential benefit of ALA-PDD assistance in patients who undergo the ULA. The evidence of this novel technique is still limited. The results are expected to change the standard of care and lead to better management of localized UTUC. Trial registration: This clinical trial was prospectively registered with the Japan Registry of Clinical Trials on 23 June 2021. The reference number is jRCTs051210042, nara0023 (Certified Review Board of Nara Medical University).