Category: Latest Articles

Management of chronic primary pelvic pain syndromes

October 7, 2021/by

Objectives

To assess the role of music in reducing the pain and anxiety associated with flexible cystoscopy using a blinded trial design.

Patients and Methods

A patient-blinded randomised control trial of music during flexible cystoscopy was performed comparing the pain, measured by visual analogue scale (VAS), anxiety, measured by the State-Trait Anxiety Inventory (STAI), and vital signs of 109 patients across two public hospitals in New South Wales, Australia. The purpose and hypothesis of the study was concealed from patients until after results had been collected.

Results

There were no statistically significant differences detected between the No Music and Music groups in VAS pain score (mean [SD] 2.04 [1.94] vs 2.10 [1.90], P = 0.86), change in STAI anxiety score (mean [SD] 4.87 [9.87] vs 6.8 [11.07], P = 0.33) or post-procedural vital signs (mean [SD] heart rate 74 [14] vs 72 [13] beats/min, P = 0.66; systolic blood pressure 144 [20] vs 141 [19] mmHg, P = 0.47) between the two groups.

Conclusion

Music does not appear to decrease perceived pain or anxiety when used during flexible cystoscopy. These findings may differ from the literature due to several factors, most significantly blinding of participants, but also potentially due to the ethnic composition of the study population or lack of choice of music.

Association of prior local therapy and outcomes with PD(L)1 inhibitor in advanced urothelial cancer

October 1, 2021/by

Abstract

Objectives

To compare clinical outcomes with anti-PD(L)1 immune checkpoint inhibitors (ICIs) in patients with advanced urothelial carcinoma (aUC) who have vs have not undergone radical surgery (RS) or radiation (RT) prior to developing metastatic disease.

Patients and Methods

We performed a retrospective cohort study collecting clinicopathological, treatment and outcomes data for patients with aUC receiving ICIs across 25 institutions. We compared outcomes (observed response rate [ORR], progression-free survival [PFS], overall survival [OS]) between patients with vs without prior RS, and by type of prior locoregional treatment (RS vs RT vs no locoregional treatment). Patients with de novo advanced disease were excluded. Analysis was stratified by treatment line (first [1st] & second or greater [2nd+]). Logistic regression was used to compare ORR; Kaplan-Meier analysis and Cox regression for PFS and OS. Multivariable models were adjusted for known prognostic factors.

Results

We included 562 patients (1st line: 342 and 2nd+: 220). There was no difference in outcomes based on prior locoregional treatment among those treated with 1st line ICI. In the 2nd+ line, prior RS was associated with higher ORR (adjusted odds ratio [aOR] 2.61 [95% CI 1.19-5.74]), longer OS (adjusted hazard ratio [aHR] 0.61 [95% CI 0.42-0.88]) and PFS (aHR 0.63 [95% CI 0.45-0.89]) vs no prior RS. This association remained significant when the type of prior locoregional treatment (RS and RT) was modeled separately.

Conclusion

Prior RS prior to developing advanced disease was associated with better outcomes in patients with aUC treated with ICI in the 2nd+, but not in the 1st line setting. While further validation is needed, our findings can have implications on prognostic estimates in clinical discussions and benchmarking for clinical trials. Limitations include retrospective nature, lack of randomization, possible selection and confounding biases.

Issue Information

October 1, 2021/by Admin

Objectives

To assess the role of music in reducing the pain and anxiety associated with flexible cystoscopy using a blinded trial design.

Patients and Methods

A patient-blinded randomised control trial of music during flexible cystoscopy was performed comparing the pain, measured by visual analogue scale (VAS), anxiety, measured by the State-Trait Anxiety Inventory (STAI), and vital signs of 109 patients across two public hospitals in New South Wales, Australia. The purpose and hypothesis of the study was concealed from patients until after results had been collected.

Results

There were no statistically significant differences detected between the No Music and Music groups in VAS pain score (mean [SD] 2.04 [1.94] vs 2.10 [1.90], P = 0.86), change in STAI anxiety score (mean [SD] 4.87 [9.87] vs 6.8 [11.07], P = 0.33) or post-procedural vital signs (mean [SD] heart rate 74 [14] vs 72 [13] beats/min, P = 0.66; systolic blood pressure 144 [20] vs 141 [19] mmHg, P = 0.47) between the two groups.

Conclusion

Music does not appear to decrease perceived pain or anxiety when used during flexible cystoscopy. These findings may differ from the literature due to several factors, most significantly blinding of participants, but also potentially due to the ethnic composition of the study population or lack of choice of music.

Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions: A Cochrane review

September 29, 2021/by

Abstract

Objectives

To assess the effects of device-based circumcisions compared with standard surgical techniques in adolescent and adult males (10 years old and above).

Methods

We performed a comprehensive search with no restrictions to the language of publication or publication status. We included randomised controlled trials (RCTs) of device-based circumcisions compared to standard surgical dissection-based circumcision conducted by health professionals in a medical setting. We reported study results as risk ratios (RR) or mean differences (MD) using 95% confidence intervals (CI) and a random-effects model. We used the GRADE approach to evaluate the overall certainty of the evidence for each outcome.

Results

Eighteen trials met the inclusion criteria. These trials did not report severe adverse events (11 trials, 3472 participants). There may be a slight increase in moderate adverse events for devices compared to surgical techniques (RR 1.31, 95% CI 0.55 to 3.10; I2= 68%; 10 trials, 3370 participants; low-certainty evidence); this corresponds to 8 more (ranging from 15 fewer to 84 more) moderate adverse events per 1000 participants. We are uncertain about the difference in mild adverse events between groups when devices are used compared to surgical techniques (RR 1.09, 95% CI 0.44 to 2.72; I2 = 91%; 10 trials, 3370 participants; very low-certainty evidence).

Conclusions

We found no serious adverse events using a circumcision device compared to surgical techniques. Still, they may slightly increase moderate adverse effects, and it is unclear whether there is a difference in mild adverse effects. High-quality trials evaluating this intervention are needed to provide further certainty regarding the rates of adverse events. Clinicians, patients and policymakers can use these results combined with their contextual factors to inform the best approach that suits their healthcare settings.

Perioperative continuation of aspirin, oral anticoagulants or bridging with therapeutic low‐molecular weight heparin does not increase intraoperative blood loss and blood transfusion rate in cystectomy patients: An observational cohort study

September 29, 2021/by

Abstract

Objective

To assess if uninterrupted anticoagulant agents administration affects blood loss and blood transfusion during open radical cystectomy and urinary diversion.

Material and Methods

We conducted an observational single-centre cohort study of a consecutive series of 1430 cystectomy patients, between 2000 and 2020. Blood loss was depicted according to body weight and duration of surgery (ml/kg/h), and blood transfusion. Group with anticoagulant agents was considered if surgery was performed with uninterrupted low-dose aspirin (ASS), oral anticoagulants (OAC) with international normalized ratio (INR) goal of 2-2.5, or bridging with therapeutic low weight molecular heparin (LMWH). Outcomes were intraoperative blood loss, blood transfusion rate (separately analysed if administered within 24 h perioperatively or >24 h after surgery) and the 90d major adverse cardiac events (MACE) rate. We used propensity score (PS) matching analysis to adjust for imbalances between groups with or without anticoagulant agents.

Results

PS-matched median blood loss was 2.10 ml/kg/h [interquartile range (IQR) 1.50-2.94] in patients with anticoagulant agents vs. 2.11 ml/kg/h without anticoagulant agents [IQR: 1.47-2.94]; Padj>0.99. PS-matched blood transfusion rates were 26.2% vs. 35.1% (Padj=0.875) within 24 h perioperatively and 57.0% vs. 55.0% (Padj=0.680) if administered >24 h postoperatively. A sub-analysis of the three different anticoagulant agents could not detect any significance between ASS, OAC, or LMWH. The PS-matched incidence of MACE was 9.1% in the group with anticoagulant agents and 8.1% in those without anticoagulant agents; Padj>0.99. Limitations include selection bias and retrospective analysis from prospectively assessed data.

Conclusions

Perioperative continuation of ASS, uninterrupted OAC with low INR goal or bridging with LMWH had no impact on blood loss and transfusion rate in cystectomy patients. Therefore, there might be no compulsive need for discontinuation of anticoagulant agents.

Research Highlights

September 28, 2021/by

Objective

To contribute to the debate regarding the minimum volume of radical cystectomies (RCs) that a hospital should perform by evaluating the association between hospital volume (HV) and postoperative mortality.

Patients and Methods

Patients who underwent RC for bladder cancer between 1 January 2008 and 31 December 2018 were retrospectively identified from the Netherlands Cancer Registry. To create a calendar-year independent measure, the HV of RCs was calculated per patient by counting the RCs performed in the same hospital in the 12 months preceding surgery. The relationship of HV with 30- and 90-day mortality was assessed by logistic regression with a non-linear spline function for HV as a continuous variable, which was adjusted for age, tumour, node and metastasis (TNM) stage, and neoadjuvant treatment.

Results

The median (interquartile range; range) HV among the 9287 RC-treated patients was 19 (12–27; 1–75). Of all the included patients, 208 (2.2%) and 518 (5.6%) died within 30 and 90 days after RC, respectively. After adjustment for age, TNM stage and neoadjuvant therapy, postoperative mortality slightly increased between an HV of 0 and an HV of 25 RCs and steadily decreased from an HV of 30 onwards. The lowest risks of postoperative mortality were observed for the highest volumes.

Conclusion

This paper, based on high-quality data from a large nationwide population-based cohort, suggests that increasing the RC volume criteria beyond 30 RCs annually could further decrease postoperative mortality. Based on these results, the volume criterion of 20 RCs annually, as recently recommended by the European Association of Urology Guideline Panel, might therefore be reconsidered.

‘Case of the Month’ from Herlev and Gentofte Hospital, Denmark: metastatic prostate cancer in a man with late‐onset hypogonadism following testosterone‐replacement therapy

September 28, 2021/by

Objective

To contribute to the debate regarding the minimum volume of radical cystectomies (RCs) that a hospital should perform by evaluating the association between hospital volume (HV) and postoperative mortality.

Patients and Methods

Patients who underwent RC for bladder cancer between 1 January 2008 and 31 December 2018 were retrospectively identified from the Netherlands Cancer Registry. To create a calendar-year independent measure, the HV of RCs was calculated per patient by counting the RCs performed in the same hospital in the 12 months preceding surgery. The relationship of HV with 30- and 90-day mortality was assessed by logistic regression with a non-linear spline function for HV as a continuous variable, which was adjusted for age, tumour, node and metastasis (TNM) stage, and neoadjuvant treatment.

Results

The median (interquartile range; range) HV among the 9287 RC-treated patients was 19 (12–27; 1–75). Of all the included patients, 208 (2.2%) and 518 (5.6%) died within 30 and 90 days after RC, respectively. After adjustment for age, TNM stage and neoadjuvant therapy, postoperative mortality slightly increased between an HV of 0 and an HV of 25 RCs and steadily decreased from an HV of 30 onwards. The lowest risks of postoperative mortality were observed for the highest volumes.

Conclusion

This paper, based on high-quality data from a large nationwide population-based cohort, suggests that increasing the RC volume criteria beyond 30 RCs annually could further decrease postoperative mortality. Based on these results, the volume criterion of 20 RCs annually, as recently recommended by the European Association of Urology Guideline Panel, might therefore be reconsidered.

Urological imaging in the pregnant patient

September 28, 2021/by

Objective

To contribute to the debate regarding the minimum volume of radical cystectomies (RCs) that a hospital should perform by evaluating the association between hospital volume (HV) and postoperative mortality.

Patients and Methods

Patients who underwent RC for bladder cancer between 1 January 2008 and 31 December 2018 were retrospectively identified from the Netherlands Cancer Registry. To create a calendar-year independent measure, the HV of RCs was calculated per patient by counting the RCs performed in the same hospital in the 12 months preceding surgery. The relationship of HV with 30- and 90-day mortality was assessed by logistic regression with a non-linear spline function for HV as a continuous variable, which was adjusted for age, tumour, node and metastasis (TNM) stage, and neoadjuvant treatment.

Results

The median (interquartile range; range) HV among the 9287 RC-treated patients was 19 (12–27; 1–75). Of all the included patients, 208 (2.2%) and 518 (5.6%) died within 30 and 90 days after RC, respectively. After adjustment for age, TNM stage and neoadjuvant therapy, postoperative mortality slightly increased between an HV of 0 and an HV of 25 RCs and steadily decreased from an HV of 30 onwards. The lowest risks of postoperative mortality were observed for the highest volumes.

Conclusion

This paper, based on high-quality data from a large nationwide population-based cohort, suggests that increasing the RC volume criteria beyond 30 RCs annually could further decrease postoperative mortality. Based on these results, the volume criterion of 20 RCs annually, as recently recommended by the European Association of Urology Guideline Panel, might therefore be reconsidered.

Dynamic biomarker and imaging changes from a phase II study of pre‐ and post‐surgical sunitinib

September 22, 2021/by

Objectives

To assess the long-term treatment efficacy of low-dose-rate (LDR) brachytherapy for the treatment of localized prostate cancer.

Patients and Methods

Cause-of-death annotation in our prospective database was supplemented with death certificate information obtained via an internal audit of patients treated from 1999 to 2017 with LDR prostate brachytherapy as monotherapy or as combination with androgen deprivation therapy and/or external beam radiotherapy. Overall and disease-specific survival were the primary outcomes, estimated with Kaplan–Meier and competing risks multi-state models. Clinical variables influencing mortality were assessed with Cox proportional hazards regression in a sub-analysis of men to assess the predictive value of prostate-specific antigen (PSA) level at 48 months post implant.

Results

The audit process began in October 2017 and culminated in June 2020 with a curated series of 2936 patients. All-cause and prostate cancer-specific death prevalence were 11% and 2.9%, respectively. The median (range) follow-up time was 10 (3–21) years and the median (range) time to death from any cause was 9 (3–21) years. At 15 years post implant the overall and prostate cancer-specific survival probability were 81% and 95%, respectively. The 15-year cumulative incidence rates of death not due and due to prostate cancer were 14% and 5%, respectively. A greater risk of death due to prostate cancer was conferred by increasing age at therapy (hazard ratio [HR] 1.1, P < 0.001), advanced clinical stages relative to T1a-T2a (HR 1.9, P = 0.048 for T2b; HR 2.7, P = 0.023 for T2c-T3b) and a 48-month PSA level >1.0 ng/mL (HR 6.8, P < 0.001).

Conclusion

This study constitutes the largest retrospective analyses of long-term mortality outcomes from prospectively collected prostate brachytherapy data and confirms the excellent treatment efficacy of LDR prostate brachytherapy for localized prostate cancer. T2 clinical stage subdivisions and 48-month PSA level >1.0 ng/mL appear to be strong indicators of prostate cancer-related survival.

Validation and Public Health Modelling of Risk Prediction Models for Kidney Cancer using UK Biobank

September 19, 2021/by

Objectives

To evaluate the usefulness of radiological re-staging after two and four cycles of neoadjuvant chemotherapy (NAC), the impact of re-staging on further patient management, and the correlation between clinical and final pathological tumour stage at radical cystectomy (RC).

Patients and Methods

We conducted a longitudinal, single-centre, cohort study of prospectively collected consecutive patients who underwent NAC and RC for urothelial muscle-invasive bladder cancer between July 2001 and December 2017. Patients underwent repeated computed tomography scans for re-staging after two cycles of NAC and after completion of NAC before RC.

Results

Of 180 patients, 110 had ≥four cycles of NAC and had complete imaging available. In the entire cohort, further patient management was only changed in 2/180 patients (1.1%) after two cycles of NAC based on radiological findings. Patients who were stable after two cycles but then downstaged after at least four cycles of NAC had a similarly lowered risk of death (hazard ratio [HR] 0.53). Only one patient downstaged after two cycles was subsequently upstaged after four cycles. Clinical downstaging was observed in 51 patients (46%), 55 patients (50%) had no change in clinical stage and four patients (3.6%) were clinically upstaged. Patients clinically downstaged after four cycles of NAC had a lower risk of death (HR 0.49, 95% confidence interval 0.25–0.94; P = 0.033) compared to those with no change or upstaged after completion of NAC.

Conclusions

Re-staging of muscle-invasive bladder cancer after two cycles of NAC offers little additional information, rarely changes patient management, and may therefore be omitted, whereas re-staging after completion of NAC by CT is a strong predictor of overall survival.