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.
