Transurethral Resection Research Articles

A double blinded randomized prospective trial of comparison between control and study group, nefopam versus tramadol on shivering scores after spinal anesthesia in patients undergoing Transurethral resection of prostate

IntroductionShivering is a common and distressing complication that can occur after subarachnoid block (SAB) in patients, particularly those undergoing transurethral resection of the prostate (TURP) due to the use of irrigating fluid and older age group. This study aims to compare the effectiveness of nefopam and tramadol in reducing intraoperative shivering compared to a control group, in Indian patients. MethodologyThis study is a double-blinded randomized control trial with a total of 99 patients undergoing elective TURP under SAB were enrolled. The patients were randomly divided into three groups (GT, GN, and GC): GT received tramadol (0.5 mg kg-1) and GN received nefopam (0.15 mg kg-1). Both tramadol and nefopam were premixed into 100 ml of normal saline (NS) and GC received 100 ml NS, given over 15 min just before SAB. The induction protocol was the same for all groups, and shivering score, hemodynamic parameters, and body temperature (BT) were recorded. ResultsThe overall incidence of shivering was 29.67 % (27/91), with the lowest incidence being in GN (16.67 %, 5/30), followed by GT (22.58 %, 7/31) and GC (50 %, 15/30). Both nefopam and tramadol resulted in a significant (p < 0.05) decrease in the incidence of shivering compared to control. Among the hemodynamic parameters and BT, no significant difference was seen between GT, GN, and GC (p > 0.05). ConclusionBoth nefopam and tramadol were effective in reducing the incidence but the severity was controlled better with nefopam during TURP under SAB.

Ureteral cancer successfully treated with laparoscopic nephroureterectomy with temporary intraoperative occlusion of the internal iliac artery for pelvic arteriovenous malformation.

Pelvic arteriovenous malformation is often a source of intraoperative bleeding. Here, we report our experience with a case of ureteral cancer with pelvic arteriovenous malformation treated using laparoscopic nephroureterectomy with temporary intraoperative occlusion of the internal iliac artery. A 75-year-old man presented to our hospital with asymptomatic macro-hematuria. Contrast-enhanced computed tomography revealed right ureteral tumor with no apparent metastases, and right pelvic arteriovenous malformation. Three months later, multiple bladder cancers were identified and the patient underwent trans-urethral resection of bladder tumor. The pathological diagnosis was urothelial carcinoma, pTa. We performed right laparoscopic nephroureterectomy with temporary intraoperative occlusion of the internal iliac artery. There was little intraoperative bleeding, and the surgery was safely completed. The pathological diagnosis was urothelial carcinoma, pT2 + Tis. A patient showing ureteral cancer with pelvic arteriovenous malformation was safely treated using laparoscopic nephroureterectomy with temporary occlusion of the internal iliac artery.

Design and Evaluation of Inorganic/Organic Hybrid Bio-composite for Site-Specific Oral Delivery of Darifenacin

Benign hyperplasia (BHP) is a common disorder that affects men over the age of 60 years. Transurethral resection of the prostate (TURP) is the gold standard for operative treatment, but a range of drugs are also available to improve quality of life and to reduce BHP-associated urinary tract infections and complications. Darifenacin, an anti-muscarinic agent, has been found effective for relieving symptoms of overactive bladder associated with BHP, but the drug has poor solubility and bioavailability, which are major challenges in product development. An inorganic/organic bio-composite with gastric pH-resistant property was synthesized for the targeted oral delivery of Darifenacin to the lower gastrointestinal tract (GIT). This development was accomplished through co-precipitation of calcium carbonate in quince seed-based mucilage. The FTIR, XRD, DSC, and TGA results showed good drug-polymer compatibility, and the SEM images showed calcite formation in the quince hydrogel system. After 72 h, the drug release of 34% and 75% were observed in acidic (0.1N HCl) and 6.8 pH phosphate buffer, respectively. A restricted/less drug was permeated through gastric membrane (21.8%) as compared to permeation through intestinal membrane (65%.) The developed composite showed significant reduction in testosterone-induced prostatic hyperplasia (2.39 ± 0.12***) as compared to untreated diseased animal group. No sign of organ toxicity was observed against all the developed composites. In this study, we developed an inorganic–organic composite system that is highly biocompatible and effective for targeting the lower GIT, thereby avoiding the first-pass metabolism of darifenacin.Graphical

Transurethral balloon dilation safety and efficacy in patients with recurrent bladder neck contracture after transurethral interventions

Introduction. Currently, urologists are divided on which method is most effective for treating bladder neck contracture (BNC) after surgery: transurethral resection (TUR) or incision.Objective. The study aimed to assess the balloon dilation safety and success in patients with recurrent bladder neck contracture (BNC) after endoscopic surgery for benign prostatic hyperplasia (BPH).Materials &amp; Methods. This study involved 110 patients with recurrent BNC after transurethral interventions for BPH. All patients underwent TUR of the bladder neck and were divided into 2 groups: group A (n = 45) included men who, after TUR, additionally underwent repeated balloon dilation, while the control group B (n = 65) included men who were treated with alpha-blockers alone.Results. In 9 months after TUR and 3 months after the fourth balloon dilation procedure in group A, the mean international prostate symptom score (IPSS) decreased from 20.1 ± 8.4 to 17.2 ± 7.4, and the IPSS-quality of life (QoL) was 4.2 ± 1.2 (p &gt; 0.05). In group B, they were 21.7 ± 7.7 and 4.7 ± 1.1 (p &gt; 0.05), respectively. Additionally, the mean flow rate in group A was 13.2 ± 5.4 ml/s, while in group B, it was 8.7 ± 4.9 ml/s (p &lt; 0.05). There was a significant decrease in the post-void residual urine volume (PVR) from 76.2 ± 96.1 ml to 37.6 ± 55.1 ml in group A, whereas, in group B, it increased from 63.0 ± 36.9 ml to 79.4 ± 71.6 ml (p &gt; 0.05). Also, 28.0% of patients of group B, and 13.3% of patients of group A underwent repeated TUR of the bladder neck in 9 months follow-up period (p &lt; 0.05).Conclusion. Balloon dilation procedure is a relatively safe less invasive procedure and can reduce the BNC recurrence rate and consequently the rate of repeated transurethral interventions.

En-bloc resection of non-muscle invasive urinary bladder tumors using low power Holmium laser-A new promise.

Urinary bladder tumors are one of the most common urological malignancies. Traditionally, it has been initially managed with conventional trans-urethral resection of urinary bladder tumors (cTURBT) which has certain drawbacks and complications. Efforts have been made to find newer methods for management. In this study, we have used low power Holmium laser en-bloc resection and have assessed its safety, efficacy and feasibility. Forty patients have been included in this prospective observational study who underwent low power Holmium laser en-bloc resection of urinary bladder tumor after taking Institutional ethical committee clearance and informed consent from all the patients. Intra-operative and post-operative data were collected. The average tumor size was 21.68 ± 9.55 mm. Out of those, 65% of the patients had a tumor less than 3 cm in size. Fourteen patients (35%) had tumors at multiple sites. The average duration of resection per tumor was 24.84 ± 6.83 min. None of the cases required conversion to cTURBT. There was no obturator reflex or urinary bladder perforation in any of the cases. Detrusor muscle was present in the histopathology reports of 92.5% patients. The average duration of catheterization was 1.82 ± 0.61 days. For NMIBC's, low power Holmium laser en-bloc resection is a safe procedure with minimum risk of complications. High rate of detrusor-positive specimens indicates its efficacy and feasibility.

Bladder-Preserving Trimodality Treatment for High-Grade T1 Bladder Cancer: Results From Phase II Protocol NRG Oncology/RTOG 0926.

To investigate the use of radiation with radiosensitizing chemotherapy following repeated transurethral resection (trimodality therapy) as an alternative to radical cystectomy in T1 bladder cancer which has failed Bacillus Calmette-Guerin (BCG). Patients with recurrent T1 bladders who had failed BCG and were recommended to undergo cystectomy were treated with trimodality therapy. The primary end point was 3-year freedom from cystectomy. Secondary end points were distant metastasis at 3 and 5 years, local recurrence, disease-specific and overall survival (OS), and safety. This single-arm phase II study enrolled 37 patients. Efficacy and safety were evaluated in 34 patients after three exclusions. The median follow-up was 5.1 years. The 3-year freedom from cystectomy rate was 88% (lower one-sided 97.5% confidence limit [CI], 72%), meeting the primary study goal. OS at 3 and 5 years was 69% (95% CI, 54 to 85) and 56% (95% CI, 39 to 74), respectively. The distant metastasis rates at 3 and 5 years were 12% (95% CI, 4 to 26) and 19% (95% CI, 7 to 34), respectively. Eight patients died due to urothelial cancer, 12 exhibited local recurrence at 3 years (cumulative incidence: 32%; 95% CI, 17 to 48), 18 experienced grade 3 adverse events, mostly hematological, and one developed grade 4 neutropenia. Trimodality therapy is an effective potential alternative to radical cystectomy for recurrent high-grade T1 urothelial cancer of the bladder. At 3 years, 88% of the patients remained free of cystectomy.

Non-inferiority, randomised, open-label clinical trial on the effectiveness of transurethral microwave thermotherapy compared to prostatic artery embolisation in reducing severe lower urinary tract symptoms in men with benign prostatic hyperplasia: study protocol for the TUMT-PAE-1 trial

BackgroundOne-fourth of men older than 70 years have lower urinary tract symptoms (LUTS) that impair their quality of life. Transurethral resection of the prostate (TURP) is considered the gold standard for surgical treatment of LUTS caused by benign prostatic hyperplasia (BPH) that cannot be managed conservatively or pharmacologically. However, TURP is only an option for patients fit for surgery and can result in complications. Transurethral microwave thermotherapy (TUMT) and prostatic artery embolisation (PAE) are alternative minimally invasive surgical therapies (MISTs) performed in an outpatient setting. Both treatments have shown to reduce LUTS with a similar post-procedure outcome in mean International Prostate Symptom Score (IPSS). It is however still unknown if TUMT and PAE perform equally well as they have never been directly compared in a randomised clinical trial. The objective of this clinical trial is to assess if PAE is non-inferior to TUMT in reducing LUTS secondary to BPH.MethodsThis study is designed as a multicentre, non-inferiority, open-label randomised clinical trial. Patients will be randomised with a 1:1 allocation ratio between treatments. The primary outcome is the IPSS of the two arms after 6 months. The primary outcome will be evaluated using a 95% confidence interval against the predefined non-inferiority margin of + 3 points in IPSS. Secondary objectives include the comparison of patient-reported and functional outcomes at short- and long-term follow-up. We will follow the patients for 5 years to track long-term effect. Assuming a difference in mean IPSS after treatment of 1 point with an SD of 5 and a non-inferiority margin set at the threshold for a clinically non-meaningful difference of + 3 points, the calculated sample size was 100 patients per arm. To compensate for 10% dropout, the study will include 223 patients.DiscussionIn this first randomised clinical trial to compare two MISTs, we expect non-inferiority of PAE to TUMT. The most prominent problems with MIST BPH treatments are the unknown long-term effect and the lack of proper selection of candidates for a specific procedure. With analysis of the secondary outcomes, we aspire to contribute to a better understanding of durability and provide knowledge to guide treatment decisions.Trial registrationClinicalTrials.gov NCT05686525. Registered on January 17, 2023, https://clinicaltrials.gov/study/NCT05686525.

Effect of accumulating experience on diagnostic performance of VI-RADS in bladder cancer

PurposeMRI-based VI-RADS score aids in differentiating MIBC and NMIBC, but the experience's impact remains unexplored. We aimed to determine the effect of accumulating experience in the diagnostic performance of VI-RADS. MethodsIn our previously published series 71 primary bladder cancer patients who underwent multiparametric MRI before the transurethral resection were analyzed. The radiologist who assessed the VI-RADS scores at the time the study was performed, re-evaluated all cases after 3 years, in a blinded fashion. During these three years, more than 300 additional bladder MRIs were performed for VI-RADS assessment. The diagnostic performances of the initial and subsequent VI-RADS analyses were compared. Moreover, VIRADS results obtained by a newly trained abdominal radiologist was also compared with experienced radiologist's results. For this study, VI-RADS ≥3 was accepted for predicting MIBC. ResultsOverall 71 patients [62 (87.3 %) males, 67.4 ± 10.2 years] who underwent bladder MRI before TURBT were included. Histopathology revealed MIBC in 16 (26.2 %) cases.The initial MRI analysis revealed VI-RADS score ≥ 3 in 36 (50.7 %) cases. The sensitivity and specificity for depicting MIBC were 75 % and 56.4 % respectively. The subsequent MRI analysis revealed VI-RADS score ≥ 3 in 23 (32.4 %) cases. The sensitivity and specificity were 93.8 % and 85.5 % respectively. The MRI analysis performed by the recently trained abdominal radiologist revealed VI-RADS score ≥ 3 in 24 (33.8 %) cases. The sensitivity and specificity were 87.5 % and 56.4 % respectively. ConclusionThe diagnostic performance of VI-RADS for the interpretation of bladder MRI can improve over time by increasing the experience of the urogenital radiologist.

A single-center retrospective comparison of pT1 substaging methods in bladder cancer.

Substaging of T1 urothelial cancer is associated with tumor progression and its reporting is recommended by international guidelines. However, it has not been integrated in risk stratification tools and there is no agreement on the best method to use for its reporting. We aimed to investigate the applicability, interobserver variability, and prognostic value of histological landmark based and micrometric (aggregate linear length of invasive carcinoma (ALLICA), microscopic vs. extensive system, Rete Oncologica Lombarda (ROL) system) substaging methods. A total of 79 patients with the primary diagnosis of T1 urothelial cancer treated with conventional transurethral resection and adjuvant BCG therapy between 2000 and 2020 at the Medical University of Vienna were included. The anatomical and metrical substaging systems were evaluated using agreement rate, Cohen's kappa, Kendall's tau, and Spearman rank correlation. Prognostic value for high-grade recurrence or T2 progression was evaluated in uni- and multivariable analysis. Applicability and reproducibility were good to moderate and varied between substaging methods. Obstacles are mainly due to fragmentation of samples. Anatomical substaging was associated with progression in univariable and multivariable analysis. In our cohort, we could only identify anatomical landmark-based substaging to be prognostic for T2 progression. A major obstacle for proper pathological assessment is fragmentation of samples due to operational procedure. Avoiding such fragmentation might improve reproducibility and significance of pathological T1 substaging of urothelial cancer.

Intrathecal Dexmedetomidine as an Adjuvant to Low Dose Hyperbaric 0.5% Bupivacaine on Haemodynamic Parameters in Patients Undergoing Transurethral Resection of Prostate.

To determine the role of dexmedetomidine in potentiating the local anaesthetic efficacy of a low dose of bupivacaine when used as an adjuvant. A prospective, double-blind, randomised study. Place and Duration of the Study: Department of Anaesthesia, Sindh Institute of Urology and Transplantation, Karachi, Pakistan, from July 2021 to February 2022. One hundred and eight patients of ASA physical class I-III undergoing transurethral resection of the prostate (TURP) under sub-arachnoid block (SAB) were enroled and distributed into two equal groups. Group BUPIPURE (BP) was given 7.5 mg of pure 0.5% hyperbaric bupivacain whereas group BUPIDEX (BD) was given 6 mg of 0.5% hyperbaric bupivacain with 3 μg dexmedetomidine intrathecally. The effects in Both groups were compared using chi-square and unpaired t-tests. A significance level of p <0.05 was used to evaluate the statistical significance. Both groups demonstrated a steady decrease in mean heart rate (mean HR 98.9-62.7 per minute as compared to 79.1-59.4 per minute in groups BP and BD, respectively), however, no patient reached to HR <50/min. Group BP had a higher HR variability than group BD. The two groups' median peak sensory levels were similar. However, a statistically significant difference was revealed in the time taken for 2-segment regression (87.5 ± 11.3 min vs. 115.5 ± 6.2 min p <0.001 in BP and BD), as well as the time to reach T10 sensory level (13.56 ± 2.5 min vs. 10.9 ± 3.0 min p <0.001). In patients having TURP, intrathecal dexmedetomidine combined with low-dose bupivacaine results in a quicker start, extended sensory and motor block, and a decreased need for rescue analgesics. Adjuvants, Dexmedetomidine, Spinal anaesthesia, Transurethral Resection of Prostate.

EFFECTIVENESS OF CONTINUOUS AUTOMATIC BLADDER IRRIGATION BASED ON INTERNET OF THINGS IN TRANS URETHRAL RESECTION OF PROSTATE: ANALYSIS OF NURSES' KNOWLEDGE AND READINESS

Transurethral Resection of the Prostate (TURP) is a minimally invasive surgical procedure commonly performed to treat benign prostatic hyperplasia. However, complications such as TURP Syndrome can occur if the procedure is not performed correctly. Continuous Automatic Bladder Irrigation (CABI) based on the Internet of Things (IoT) is a technology developed to minimize the risk of these complications. This study aims to analyze the relationship between the knowledge and readiness of nurses in implementing IoT-based CABI on TURP complications at the Jombang Regional General Hospital. Quantitative methods were used in this study, including data collection techniques through observation and questionnaires. The results showed that nurse readiness significantly affected the effectiveness of CABI implementation and decreased TURP complications. The implications of this study indicate the importance of training and education for nurses in using IoT-based technology.

HoLEP Learning Curve-Resident Perspective: Survey of Senior Residents from High-Volume Tertiary Center.

Objective: We aim to report the learning curve and experience performing holmium laser enucleation of the prostate (HoLEP) from a resident standpoint trained at a tertiary high-volume center. Methods: An electronic survey was distributed to 10 surveyees that included recently graduated chief residents trained at Indiana University in the past 3 years i.e., between 2020 and 2022 with a 100% response rate. The questionnaire focused on HoLEP training experience based on a recently established mentorship curriculum in training the residents through each individual step of the surgery. Results: The average learning curve for performing HoLEP was reported to be greater than 25 cases with 50% of the residents reporting >50 cases to master the technique. The surgical difficulty of steps of the HoLEP were rated on a subjective scale of 1-5: 1 = very easy, 2 = easy, 3 = neutral, 4 = hard, and 5 = very hard. The common challenging steps in decreasing the order of difficulty as reported are performing apical enucleation, joining anterior and posterior planes, and dividing anterior commissure with a mean rating of 3.5, 3.1, and 3.1, respectively. The most difficult aspect of the surgery to master was performing apical dissection (60%). Comparing operative parameters for HoLEP with transurethral resection of the prostate in aspects of resection volume and times, 70% of candidates reported it better for HoLEP whereas 20% had similar times for both procedures. A total of 90% of the residents felt confident to offer HoLEP as part of their practice without the need for any further training. Regarding the initial challenge of including HoLEP surgery in practice, the majority (60%) reported difficulty with equipment set up in their practice while 20% reported difficulty maintaining efficient operating room (OR) times and turnover. Conclusion: We believe HoLEP can be performed immediately after residency training and incorporated into practice with high volume, repeated exposure to HoLEP surgery throughout residency based on study results. The average learning curve reported for performing HoLEP was greater than 25 cases.

Consensus document on the implications of standardization of BCG supply in the management of patients with non-muscle-invasive bladder cancer

Patients with non-muscle-invasive bladder cancer (NMIBC) in the intermediate and high-risk groups must receive adjuvant treatment with intravesical Bacillus Calmette–Guérin (BCG) following transurethral resection (TUR), as it reduces the risk of recurrence and presumably the risk of progression as well. Optimization of BCG efficacy is achieved by administering maintenance therapy. However, since many immunological aspects of the mechanism of action of BCG in the bladder remain unknown, the implementation of the optimal dose, number of instillations, strains and adequate maintenance regimen over the last decades has been heterogeneous. Additionally, this has hindered the interpretation of efficacy in terms of oncologic outcomes. This, together with the shortages of BCG in recent years, have forced scientific societies to adapt their clinical practice guidelines and modify their protocols of adjuvant treatment with BCG. This includes changes to strains, doses, and maintenance during this period of time. This consensus document evaluates the current status of adjuvant BCG treatment and the implications of BCG supply availability in the treatment of patients with NMIBC. It also addresses the implementation of novel therapies that will improve cancer prognosis and the quality of life of patients with NMIBC in the future.

1963O JCOG1019: An open-label, non-inferiority, randomised phase III study comparing the effectiveness of watchful waiting (WW) and intravesical Bacillus Calmette-Guérin (BCG) in patients (Pts) with high-grade pT1 (HGT1) bladder cancer with pT0 on the second transurethral resection (TUR) specimen

1963O JCOG1019: An open-label, non-inferiority, randomised phase III study comparing the effectiveness of watchful waiting (WW) and intravesical Bacillus Calmette-Guérin (BCG) in patients (Pts) with high-grade pT1 (HGT1) bladder cancer with pT0 on the second transurethral resection (TUR) specimen

The prognostic impact of tumor location in nonmuscle-invasive bladder cancer patients undergoing transurethral resection: insights from a cohort study utilizing Chinese multicenter and SEER registries.

Most bladder cancers are nonmuscle invasive bladder cancer (NMIBC), and transurethral resection of bladder tumors (TURBT) is the standard treatment. However, postoperative recurrence remains a significant challenge, and the influence of bladder tumor location on prognosis is still unclear. This study aims to investigate how tumor location affects the prognosis of NMIBC patients undergoing TURBT and to identify the optimal surgical approach. A multicenter study was conducted, which included Chinese NMIBC data from 15 hospitals (1996-2019) and data from 17 registries of the Surveillance, Epidemiology, and End Results database (SEER) (2000-2020). Patients initially diagnosed with NMIBC and undergoing TURBT or partial cystectomy were analyzed, with cases lost to follow-up or with missing data excluded. The study investigated the overall survival (OS), disease-specific survival (DSS), and recurrence-free survival (RFS) among patients with different tumor locations. Kaplan-Meier, Cox regression, and propensity score matching methods were employed to explore the association between tumor location and prognosis. Stratified populations were analyzed to minimize bias. This study included 118477 NMIBC patients and highlighted tumor location as a crucial factor impacting post-TURBT prognosis. Both anterior wall and dome tumors independently predicted adverse outcomes in two cohorts. For anterior wall tumors, the Chinese cohort showed hazard ratios (HR) for OS of 4.35 ( P <0.0001); RFS of 2.21 ( P <0.0001); SEER cohort OS HR of 1.10 ( P =0.0001); DSS HR of 1.13 ( P =0.0183). Dome tumors displayed similar trends [Chinese NMIBC cohort OS HR of 7.91 ( P <0.0001); RFS HR of 2.12 ( P <0.0001); SEER OS HR of 1.05 ( P =0.0087); DSS HR of 1.14 ( P =0.0006)]. Partial cystectomy significantly improved the survival of dome tumor patients compared to standard TURBT treatment ( P <0.01). This study reveals the significant impact of tumor location in NMIBC patients on the outcomes of TURBT treatment, with tumors in the anterior wall and bladder dome showing poor post-TURBT prognosis. Compared to TURBT treatment, partial cystectomy improves the prognosis for bladder dome tumors. This study provides guidance for personalized treatment and prognosis management for NMIBC patients.

Documento de consenso sobre las implicaciones de la normalización del suministro del Bacillus Calmette-Guérin en el manejo del paciente con tumor vesical no-músculo invasivo (TVNMI)

Patients with non-muscle-invasive bladder cancer (NMIBC) in the intermediate and high-risk groups must receive adjuvant treatment with intravesical Bacillus Calmette-Guerin (BCG) following transurethral resection (TUR), as it reduces the risk of recurrence and presumably the risk of progression as well. Optimization of BCG efficacy is achieved by administering maintenance therapy. However, since many immunological aspects of the mechanism of action of BCG in the bladder remain unknown, the implementation of the optimal dose, number of instillations, strains and adequate maintenance regimen over the last decades has been heterogeneous. Additionally, this has hindered the interpretation of efficacy in terms of oncologic outcomes. This, together with the shortages of BCG in recent years, have forced scientific societies to adapt their clinical practice guidelines and modify their protocols of adjuvant treatment with BCG. This includes changes to strains, doses, and maintenance during this period of time. This consensus document evaluates the current status of adjuvant BCG treatment and the implications of BCG supply availability in the treatment of patients with NMIBC. It also addresses the implementation of novel therapies that will improve cancer prognosis and the quality of life of patients with NMIBC in the future.

Video Demonstration of Step-by-step Technique of Bipolar Transurethral Resection of Prostate as: An Educational Tool for Residents

Video Demonstration of Step-by-step Technique of Bipolar Transurethral Resection of Prostate as: An Educational Tool for Residents

Assessing the Quality of Transurethral Resection of Bladder Tumour (TURBT) Operation Notes in Line With EAU Guidelines

Assessing the Quality of Transurethral Resection of Bladder Tumour (TURBT) Operation Notes in Line With EAU Guidelines

A Pilot Study of the CD38 Antagonist Daratumumab in Patients with Metastatic Renal Cell Carcinoma or Muscle-Invasive Bladder Cancer.

We performed a pilot study of daratumumab (an mAb directed against CD38) in muscle-invasive bladder cancer (MIBC) and treatment-refractory metastatic renal cell carcinoma (mRCC). Patients with MIBC underwent baseline transurethral resection of the bladder tumor followed by four weekly doses of daratumumab prior to cystectomy. Patients with mRCC underwent baseline and sequential biopsies after eight weekly doses. The primary endpoint was safety. The secondary endpoints were pathologic complete response rate for the MIBC cohort and objective response rate and progression-free survival for the mRCC cohort. Exploratory analyses included immune monitoring and overall survival. A Bayesian sequential monitoring design for toxicity was used for excessive toxicity. In both the MIBC (n = 8) and mRCC (n = 8) cohorts, no toxicity events were encountered. In the MIBC cohort, one patient experienced pathologic complete response rate. In the mRCC cohort, no objective responses were reported, and the median progression-free survival was 1.5 months (95% confidence interval, 1.1-1.8 months). Immune monitoring found significant reductions in NK cells in circulation in both cohorts after treatment. In the tissue analysis, IHC found evidence of diminished CD38 presence in mRCC with treatment, whereas the baseline levels in MIBC were low. Treatment with daratumumab was safe. No signal of efficacy was detected in mRCC, and conclusions on the activity in MIBC were limited. Evidence of daratumumab targeting CD38 was detected in circulating immune cells and within the tumor microenvironment of mRCC and MIBC. In this prospective clinical trial of daratumumab, treatment in patients with MIBC and mRCC was safe. Limited efficacy was observed. Treatment with daratumumab resulted in CD38-expressing immune cell subsets to be targeted both in circulation and within the tumor microenvironment.

Effect of Self -Care Guidelines on Potential Post-Operative Complications after Transurethral Resection of the Bladder Cancer

Effect of Self -Care Guidelines on Potential Post-Operative Complications after Transurethral Resection of the Bladder Cancer