OBJECTIVE:To calculate additional information from urological trials which do not report statistically significant results, and assess whether language manipulation is used when such studies were reported. MATERIALS AND METHODS:Many randomised controlled trials (RCTs) do not yield statistically significant primary outcomes; such results are challenging to interpret using traditional statistical practices. An alternative approach, the likelihood ratio (LR), uses Bayesian statistical methods to compare the null (no significant effect of treatment) and alternative (significant effect of treatment) hypotheses, and provides quantitative strength of evidence for one compared to the other. A lower LR indicates stronger support for the alternate hypothesis over the null and vice versa. We performed a cross-sectional review of urological RCTs, published in the period 2018-2024, with a primary outcome that did not reach statistical significance. For each outcome, an LR was calculated. For each included article the use of language manipulation ('spin') was also analysed. RESULTS:Eighty-two articles with 98 primary outcomes were identified. For 13% of these outcomes the data provided greater support for the alternative hypothesis compared to the null, as indicated by an LR < 1. This suggests these trials, such as the EVEREST trial (LR = 0.26), should be considered for further investigation. For 36% of results the LR was >100, indicating decisive evidence in favour of the null hypothesis, and suggesting these trials, including SWOG S1011 (LR = 250), need not be repeated. Spin was identified in 41.5% of abstracts. After adjustment, only impact factor and LR <1 were associated with spin use. This study was limited by its analysis of only articles published in high impact factor journals in the past 7 years. CONCLUSIONS:Many urological RCTs with primary outcomes that were not statistically significant by traditional measures warrant further investigation. Researchers should apply the LR to future trials to aid interpretation of their results.
The datasets used during the current study are available to bona fide researchers from the corresponding author on reasonable request.
OBJECTIVE:To evaluate the feasibility and performance of the StoneSense™ module (SSM; IPG Medical, Marlborough, MA, USA), a prototype real-time target recognition unit integrated into a IPG Thulium Fiber Laser (TFL). MATERIALS AND METHODS:The SSM analyses the spectral signature of back reflected light-emitting diode (LED) light from the target, stopping laser energy emission when incoming signal is originating from tissue or when the fibre-to-target distance is larger than pre-defined threshold (typically, ≥2-4 mm). The ex vivo tests were conducted on artificial BegoStone phantoms ((Bego GmbH & Co. KG, Bremen, Germany) embedded in porcine kidney tissue using energy settings of 0.1-2 J and 5-100 Hz at two fibre-scanning speeds (1 and 3 mm/s) through a translation stage movement. Human urinary stones were subsequently tested at 2 and 5 mm/s with setting of 0.5 J × 20 Hz. The in vivo trial was conducted by lithotripsy of pre-implanted human stones in porcine urinary tract. Primary outcome measures included ablation efficiency as well as specificity and sensitivity of stone recognition. RESULTS:Soft tissue ablation was completely prevented in all the ex vivo trials while maintaining high lithotripsy efficiency. Mean stone ablation reduction was 2.75% and 3% at fibre scanning speeds of 1 and 3 mm/s, respectively. The system achieved 100% sensitivity and up to 98% specificity in inhibiting laser emission to soft tissue. In vivo, complete dusting with fragments <500 μm was achieved for all studied stone types without observable mucosal injury. Specificity ranged from 85% to 100%, while sensitivity ranged from 90% to 100%. CONCLUSIONS:Integration of back reflected-light-spectra-based laser emission control into a TFL-based lithotripsy system is feasible and effective. The SSM enables precise real-time stone recognition, minimises unnecessary lasing, and preserves dusting efficiency.
OBJECTIVE:To present large-scale safety outcomes, with a particular focus on postoperative bleeding following Aquablation for benign prostatic hyperplasia. PATIENTS AND METHODS:Patients who underwent Aquablation between 2019 and 2024 across Asia, Europe, and North America were assessed to evaluate trends in treated prostate sizes, which were visualised using density plots. A corporate prospective database was maintained, incorporating case recordings and data collected by on-site company representatives. In addition, the incidence of postoperative bleeding-defined as transfusion or surgical takeback for haemostatic fulguration-was analysed using data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database and procedure counts by the manufacturer. RESULTS:A total of 70 270 Aquablation procedures were evaluated over the period from 2019 to 2024. The mean (standard deviation) prostate volume was 87.3 (42.4) mL, with a maximum recorded size of 1189 mL. Density plot analysis of prostate volumes demonstrated consistent utilisation of Aquablation across the full range of prostate sizes throughout all years studied. The overall rate of blood transfusion or return to the operating room for haemostatic fulguration was 0.2%, indicating a favourable safety profile across a very wide range of prostate sizes. CONCLUSIONS:Aquablation has been consistently utilised across a broad spectrum of prostate sizes, with a low overall rate of transfusion or return to the operating room for bleeding control. These findings highlight the procedure's broad applicability and favourable safety profile in real-world practice from 2019 to 2024.
OBJECTIVE:To determine the likelihood of definitive treatment and risk of post-treatment recurrence for patients with Gleason Grade Group (GG) 2 cancer diagnosed using targeted biopsies relative to men with GG1 cancer diagnosed using systematic biopsies. MATERIALS AND METHODS:We performed a retrospective study using a large tertiary centre registry (the HUS Acamedic data lake) to retrieve data on prostate cancer (PCa) diagnosis, treatment, and cancer recurrence. We included patients with either GG1 PCa detected by systematic biopsies (n = 3317) or GG2 PCa detected with targeted biopsies (n = 554) between 1993 and 2019. We assessed the risk of curative treatment and recurrence after treatment. Kaplan-Meier curves were used to estimate treatment- and recurrence-free survival, and Cox proportional hazards regression was used to evaluate the risk of post-treatment recurrence. RESULTS:Patients with systematic biopsy-detected GG1 cancer had a significantly longer median time to treatment (31 months) than those with targeted biopsy-detected GG2 cancer (4 months; P < 0.0001). Risk of recurrence after curative treatment was similar in the two groups, with the upper bound of the 95% confidence interval (CI) excluding any significant difference (hazard ratio 1.04, 95% CI 0.75-1.43; P = 0.83). CONCLUSION:Men diagnosed with GG2 PCa based on MRI-targeted biopsy had a similar risk of recurrence after treatment compared to men with GG1 disease diagnosed using systematic biopsy, although they were more likely to undergo curative treatment. These findings suggest that at least a portion of the apparent increase in GG2 diagnoses in the MRI era may reflect reclassification rather than more aggressive disease. Improved risk stratification is needed to identify which men with MRI-era GG2 cancer may be suitable for active surveillance.
OBJECTIVES:To characterise 3-year pelvic pain and urinary symptom trajectories and to identify baseline factors associated with urologic chronic pelvic pain syndrome (UCPPS) improvement. PATIENTS AND METHODS:The Trans-Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Symptom Patterns Study was a multicentre, prospective cohort study of UCPPS, including interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome. Patients completed four weekly run-in assessments, baseline visit, and quarterly visits up to 3 years, providing clinical and patient-reported data. A functional clustering approach, applied separately to Pelvic Pain Severity (PPS) and Urinary Symptom Severity (USS) longitudinal change scores, was used to generate symptom trajectory clusters dichotomised as Group 0 'improvers' vs Groups 1-3 'non-improvers'. Logistic regression models explored baseline factors associated with improvement and included run-in period average and baseline scores to adjust for regression to the mean effects. RESULTS:A total of 545 patients (66% female) were followed for a median (interquartile range) of 34 (23-35) months. Four trajectory clusters were identified for each of PPS and USS, consistent with moderate improvement (Group 0), slight improvement (Group 1), no change (Group 2), and slight worsening (Group 3). In all, 18% and 19% of patients were in the moderately improved PPS and USS groups, respectively, representing 30% of patients overall. Female sex, better sleep, and less opioid use were associated with PPS improvement (Group 0); younger age and baseline cystoscopic treatment were associated with USS improvement (Group 0). CONCLUSION:In all, 30% of patients with UCPPS demonstrated improvement in pain and/or urinary symptoms over 3 years. Baseline factors associated with improvement may represent markers of a milder or localised phenotype and/or treatment effects.
Objective To develop a deep learning model for differential diagnosis of acute scrotum using single ultrasound (US) images.Patients and Methods We analysed 1172 patients with acute scrotal pain evaluated by Doppler US at four hospitals. From each case, we selected a representative axial colour Doppler US image. We trained a binary classification model to distinguish torsion from non-torsion using an EfficientNet architecture. The dataset was split 70% for training and 30% for validation. We addressed class imbalance with data augmentation and class weighting. Class Activation Mapping was used to interpret model decisions.Results The model achieved robust performance: accuracy 97%, precision 98%, sensitivity 97%, and F1 score 97%. Class activation mapping heatmaps localised decision-making to pathologically critical regions, including absent testicular blood flow and whirlpool signs. In a 20-patient prospective pilot study, the system correctly identified both surgically confirmed torsion cases, with one non-torsion case misclassified as torsion.Conclusions A deep learning model demonstrated promising diagnostic performance in differentiating acute scrotal emergencies using single US images. Its feasibility was preliminarily assessed in a small pilot study. These findings support further investigation, with larger and more balanced multicentre studies required to establish clinical utility and effective workflow integration.
OBJECTIVES:To test whether prehabilitation (PreHab), delivered digitally or as digital + on-site, improves early continence after robot-assisted radical prostatectomy (RARP) vs no PreHab, and to evaluate implementation by quantifying programme uptake after transitioning from an on-site programme to a digital pathway. PATIENTS AND METHODS:Two-centre, high-volume, non-randomised before-after consecutive cohort over 3 years (N = 350; Control = 204; PreHab = 146). PreHab combined pelvic floor muscle training, structured education, and optimisation via a smartphone pathway with or without a 1-day class. PRIMARY OUTCOME:6-week continence (0-1 pad/day). SECONDARY OUTCOMES:same-day discharge (SDD), complications (Clavien-Dindo Grade ≥III), 30-day unplanned visits and readmissions, postoperative physiotherapy, satisfaction (0-10 visual analogue scale), and continence at 6 and 12 months. Group comparisons used chi-square/Fisher's and Mann-Whitney U; multivariable logistic regression provided adjusted estimates. RESULTS:For the PreHab vs Control cohorts: 6-week continence 84.2% vs 67.6% (P = 0.003); SDD 47.3% vs 35.3% (P = 0.025); high-grade complications 2.1% vs 7.4% (P < 0.001); mean (standard deviation) satisfaction score 9.4 (0.7) vs 8.4 (1.3) (P < 0.001). Readmissions 3.4% vs 7.8% (P = 0.086) and unplanned visits 3.4% vs 6.4% (P = 0.218) were not different. Continence remained higher with PreHab at 6 months 97.7% vs 84.3% (P < 0.001) and 12 months 99.2% vs 93.6% (P = 0.004). Adjusted analyses showed lower odds of 6-week incontinence (odds ratio 0.43, 95% confidence interval 0.22-0.85; P = 0.015). Uptake rose from 26.6% (on-site era) to 48.2% and 68.7% across successive digital periods (P < 0.001). Effects did not differ by delivery mode. CONCLUSIONS:Prehabilitation, regardless of delivery mode, improves early continence vs no PreHab without compromising safety; digitisation increased programme uptake, indicating that digital PreHab is an effective and scalable option.
OBJECTIVE:To assess the effect of structured perioperative nutritional optimisation on complication rates, recovery metrics, and body composition in patients undergoing radical cystectomy (RC) with urinary diversion. PATIENTS AND METHODS:In this prospective, randomised controlled trial, 74 patients scheduled for RC were allocated to either a nutritional optimisation group (NOG, n = 37) receiving individualised pre- and postoperative dietary interventions, or a standard care group (SCG, n = 37). Protocol included immunonutrition, caloric/protein adjustment, and close clinical and laboratory monitoring. The primary endpoint was overall complication rates within 30 days. Secondary endpoints included time to gastrointestinal recovery, length of hospital stay, wound healing time, nutritional markers, and body composition measurements. RESULTS:Baseline characteristics were comparable between the groups. Although the overall complication rate was lower in the NOG (54%) than SCG (68%), the difference was not statistically significant (P = 0.236). Nutritional optimisation significantly accelerated gastrointestinal recovery; time to flatus (mean [SD] 39.6 [10.2] vs 64.8 [12.4] h, P < 0.001) and stool passage (mean [SD] 63.4 [12.1] vs 84.2 [13.8] h, P = 0.002) were shorter in the NOG. Length of stay (mean [SD] 7.78 [1.13] vs 10.59 [3.67] days, P = 0.002) and wound healing time (mean [SD] 14.22 [0.92] vs 15.5 [0.88] days, P < 0.001) were also significantly improved. The NOG maintained higher skeletal muscle mass and phase angle measurements at 30 days postoperatively (P ≤ 0.007). CONCLUSIONS:Structured perioperative nutritional optimisation significantly improved gastrointestinal recovery, reduced hospital stay, accelerated wound healing, and preserved skeletal muscle mass in patients undergoing RC.
OBJECTIVE:To present a novel technique for cystoscopic application of RADA16, a self-assembling peptide that promotes both haemostasis and healing within the irradiated bladder, and describe its efficacy for intractable haematuria from radiation cystitis. PATIENTS AND METHODS:A total of 15 patients who had failed standard treatment for haematuria from radiation cystitis were offered this novel treatment at Guy's Hospital, London and Cleveland Clinic London, UK between February and October 2024. A standard saline cystoscopy was performed under general anaesthetic and the bladder emptied. CO2 insufflation of the bladder was performed and the RADA16 deployed over the area of radiation telangiectasia. This was left for 5 min and then the gas evacuated from the bladder. Patients were followed up for a minimum of 3 months for complications and re-bleeding. RESULTS:In all, 14 of the 15 patients had significant reduction in their bleeding at 6 weeks. One patient with ongoing bleeding proceeded to salvage cystectomy. Two patients required further cystodiathermy and RADA16 application within 3 months. No other modified Clavien-Dindo ≥III complications occurred within 3 months. Patients who had a follow-up cystoscopy within 3 months of application showed significant regression of the radiation-induced telangiectasia with no evidence of bladder scarring or ureteric orifice obstruction. CONCLUSIONS:Cystoscopic application of RADA16 shows promise for treating intractable haematuria from radiation cystitis. It is the first treatment option that potentially provides both haemostasis as well as promoting bladder healing and regression of radiation-induced telangiectasia.
OBJECTIVE:The objective of this study is to address the lack of real-life study comparing the impact of the three surgical approaches for radical prostatectomy (RP), i.e., open (ORP), laparoscopic (LRP) and robot-assisted (RARP), on the occurrence of postoperative events by measuring the association between surgical approach and risk of death, transfer to an intensive care unit (ICU), or complications during hospitalisation for RP. PATIENTS AND METHODS:This study used the French National Health Data System (Système National des Données de Santé [SNDS]) to study the 38 481 patients who underwent a RP in French hospitals in 2020-2021. The primary endpoint was the occurrence of any event (death, ICU admission, or complications) during hospitalisation for RP. Secondary endpoints were the occurrence of death, ICU admission, complications, and each of the complication subtypes. Outcomes were analysed by uni- and multivariable logistic regression. RESULTS:A RARP was associated with the lowest risk of an event during hospitalisation, followed by LRP compared with ORP (adjusted odds ratio [aOR] 0.51, 95% confidence interval [CI] 0.48-0.55; and aOR 0.63, 95% CI 0.58-0.68, respectively). RARP was associated with a reduction in the risk of most complications compared with ORP. Minimally-invasive procedures were associated with an increased risk of hernia. To the best of our knowledge, this is the first French nationwide study of its sort and limitations are related to the observational nature of our study, the use of a medico-administrative database, and the length of follow-up. To confirm the main results 30-day sensitivity analyses were performed. CONCLUSIONS:There were significantly fewer short-term postoperative events for RARP. Additional studies with a longer follow-up period are required to investigate the medium- and long-term risks.
OBJECTIVES:To assess the feasibility of conducting a multicentre trial comparing NeuroSAFE with a novel technique based on confocal laser microscopy (LaserSAFE) and evaluate the diagnostic performance of LaserSAFE for real-time surgical margin assessment. PATIENTS AND METHODS:This was a non-randomised, prospective feasibility study conducted at a high-volume academic UK centre (ClinicalTrials.gov identifier: NCT06398470). Patients with localised prostate cancer (clinical T2-T3a N0 M0) scheduled for robot-assisted radical prostatectomy and deemed unsuitable for bilateral intrafascial nerve sparing (NS) based on a multidisciplinary plan were included. LaserSAFE imaging was performed in the operating room after which the NeuroSAFE technique results guided NS decisions. Pathologists, blinded to NeuroSAFE and final histology, retrospectively evaluated LaserSAFE images. Diagnostic accuracy metrics and concordance between modalities were calculated. Feasibility was assessed based on recruitment rate and the ability to activate additional sites. RESULTS:A total of 20 patients were recruited at a single site within 12 months of recruitment start. However, expansion to additional centres was not feasible due to limitations in implementing the NeuroSAFE protocol. LaserSAFE achieved a sensitivity of 0.91 (95% confidence interval [CI] 0.59-1.00) and specificity of 1.00 (95% CI 0.88-1.00) for detecting positive surgical margins ≥0.5 mm. Cohen's kappa demonstrated strong agreement with NeuroSAFE and final pathology. LaserSAFE was completed within a median of 7 min, significantly shorter than the 63 min required for NeuroSAFE. Limitations include the small sample size, single-centre setting, and lack of intraoperative decision-making based on LaserSAFE findings. CONCLUSION:While a multicentre study based on NeuroSAFE as a comparison was not achievable, LaserSAFE proved to be a rapid and accurate alternative for intraoperative margin assessment. These findings support the design of a larger trial in which NS decisions are informed by LaserSAFE, with a view to broadening access to real-time margin assessment.
