European urology focus最新文献

Background: The KangDuo Surgical Robot (KD-SR) is a newly developed surgical robot.

Objective: To compare the safety and efficacy of robot-assisted radical prostatectomy (RARP) using the KD-SR with those of the da Vinci Si Surgical System (DV-SS-Si).

Design, setting, and participants: A prospective double-center noninferiority randomized controlled trial was conducted among 18-75-yr-old patients with suspected T1-2N0M0 prostate cancer (PCa) scheduled for RARP.

Intervention: RARP with the KD-SR (KD-RARP) versus RARP with the DV-SS-Si (DV-RARP).

Outcome measurements and statistical analysis: The primary outcome was surgical success, defined as follows: surgery can be performed according to the established protocol, without switching to other surgical modalities, and without secondary surgery due to surgical complications after surgery. The secondary outcome was short-term functional and oncological outcomes. The noninferiority threshold was set at 10%.

Results and limitations: Eighty patients were enrolled, while the full analysis set finally included 79 patients (40 with KD-RARP and 39 with DV-RARP). The success rate was 100% in both groups. We could not find differences in urinary continence rate at 1, 2, 3, and 4 wk after catheter removal between the groups (p > 0.05). The rate of Clavien-Dindo grade II adverse events was 20% in the KD-RARP group and 17.9% in the DV-RARP group (p = 0.82), and no grade ≥III adverse events occurred. The median operation time was significantly longer in the KD-RARP group than in the DV-RARP group (177.5 vs 145 min, p = 0.012). The main limitations were the short follow-up period and that survival was not considered as the primary outcome.

Conclusions: The KD-SR is a viable option for RARP, with acceptable short-term outcomes compared with the DV-SS-Si for T1-2 PCa.

Patient summary: This is the first prospective randomized controlled trial to compare the KangDuo Surgical Robot (KD-SR) versus the da Vinci Si Surgical System (DV-SS-Si) for robot-assisted radical prostatectomy, which determines that the KD-SR is noninferior to the DV-SS-Si regarding safety and efficacy for T1-T2 prostate cancer.

Background and objective: While international guidelines advocate for a multifaceted approach to treating erectile dysfunction (ED) involving physical activities, psychological support, and education, structured programs are infrequent. To address this gap, an app-based therapy was developed, offering a systematic approach. This randomized, single-blind controlled trial aimed to assess the effectiveness of an app-based therapeutic in improving ED.

Methods: A total of 241 patients (49.74, standard deviation 12.73 yr) with ED (International Index of Erectile Function [IIEF]-5 <22) were randomized to the 12-wk app-based therapy (treatment group [TG], n = 122) or a waiting list for the app with continuation of their current management protocol (control group [CG], n = 119). Patients on long-term medication for ED were included, but subsequent exclusion occurred for those starting new medication. Coprimary endpoints were improvements from baseline to 12 wk in erectile function (IIEF-5), disease-related quality of life (QOL-Med-15), and patient activation (Patient Activation Measure [PAM-13]).

Key findings and limitations: Erectile function (IIEF-5) improved by 4.5 points in the TG versus 0.2 points in the CG (p < 0.0001, 95% confidence interval [CI] 3.4-5.0) group. Quality of life (QOL-Med) improved by 20.5 points in the TG versus -0.0 points in the CG (p < 0.0001, 95% CI 19.2-26.0) group. Patient activation (PAM-13) improved by 11.2 points in the TG versus 0.6 points in the CG (p < 0.0001, 95% CI 9.1-13.6) group. Phosphodiesterase type 5 inhibitor intake had no influence on all observed treatment effects.

Conclusions and clinical implications: App-based therapy of patients with ED provided a significant, clinically meaningful improvement. Quality of life and patient activation were also enhanced significantly. This program has the potential to change clinical practice in the treatment of ED.

Patient summary: A therapy app improved sexual function and overall well-being for men experiencing erectile dysfunction, leading to better quality of life.

Background and objective: We assessed the safety of atezolizumab in unselected patients (including understudied populations typically excluded from clinical trials) with pretreated urinary tract carcinoma (UTC). The prespecified final analysis updates previously reported safety and efficacy data.

Methods: The single-arm prospective SAUL study (NCT02928406) enrolled 1004 patients with locally advanced/metastatic urothelial/non-urothelial UTC that had progressed during/after one to three prior treatment lines for advanced UTC (or <12 mo after [neo]adjuvant therapy). Broad eligibility criteria allowed enrollment of patients with complex comorbidities approximating the real-world setting. Patients received atezolizumab 1200 mg every 3 wk until disease progression or unacceptable toxicity. The primary endpoint was safety. Secondary endpoints included duration of response and overall survival (OS).

Key findings and limitations: The treated cohort included 10% of patients with poor performance status, 5% with creatinine clearance <30 ml/min, and 4% with autoimmune disease. At median follow-up of 55 mo, median atezolizumab duration was 2.8 mo (range 0-62); 68 patients (7%) continued atezolizumab for >4 yr. Treatment-related grade ≥3 adverse events occurred in 16% of patients (death in 1%); 8% discontinued atezolizumab for adverse events. Median OS was 8.6 mo (95% confidence interval 7.8-9.7) and 136 patients (14%) had OS longer than 4 yr. Limitations include the small sample size for some subgroups of special interest.

Conclusions and clinical implications: Long-term safety and efficacy data continue to show a benefit of atezolizumab in unselected patients with UTC. Remarkably, 14% of patients lived for >4 yr after starting atezolizumab. These results can inform multidisciplinary team discussions and treatment decision-making for patients with UTC with complex comorbidities.

Patient summary: The SAUL study looked at how well tolerated a drug called atezolizumab was in patients with urinary tract cancer who had already received up to three previous treatments for their cancer, including people who are usually not included in clinical trials because of other medical conditions. The length of survival after starting treatment was also assessed. Overall, the results show that atezolizumab was well tolerated. People for whom other therapies had failed lived for about 8.6 months on average after starting treatment, and 14% of the patients were still alive after 4 years.

Background and objective: It is considered standard for authors of scientific papers to provide access to their raw data. The purpose of this study was to investigate data availability statements (DAS) and the actual availability of data in urology.

Methods: The DAS policies of the top ten urology journals were retrieved. Then 190 selected papers were classified according to their DAS status. Finally, we contacted the corresponding authors of papers that stated that data were available on request to enquire about this possibility.

Key findings and limitations: All journals either required or highly recommended a DAS. Among the selected articles, 52% (99/190) included a DAS stating data availability, most often on reasonable request to the corresponding author. A formal DAS was lacking in 29.5% (56/190) of the articles, with an additional 18.3% (35/190) citing various reasons for data unavailability. On contact, 23.4% (15/64) of corresponding authors indicated a willingness to share their data. Overall, data were unavailable in 73.7% (140/190) of cases. There was no difference between papers dealing with malignant and benign diseases.

Conclusions and clinical implications: There is a gap between the intention to share data and actual practice in major urological journals. As data sharing plays a critical role in safeguarding the reliability of published results and in the potential for reanalysis and merging of datasets, there is a clear need for improvement. Easier access to data repositories and stronger enforcement of existing journal policies are essential.

Patient summary: To ensure the reliability of data and allow further analyses, major urology journals require authors to make their data available to other researchers when possible. However, in practice we found that data were only accessible for about a quarter of published scientific papers.

Background and objective: Several minimally invasive treatments have been developed to treat benign prostatic obstruction (BPO) via a transurethral approach, with a non-negligible risk of complications such as urethral stricture and external sphincter damage. Our aim was to present the Gozzi surgical technique for suprapubic transvesical adenoma resection of the prostate (STAR-P) for BPO and to assess its safety, feasibility, and outcomes.

Methods: We conducted a retrospective analysis of 44 consecutive patients who underwent STAR-P for BPO. All the procedures were performed in a single private hospital by one surgeon from 2020 to 2022. An innovative resectoscope designed by the surgeon was subsequently produced by Tontarra Medizintechnik (Wurmlingen, Germany) with a 42.06 Fr external sheath that allows the use of loops of three different sizes. The instrument is inserted into the bladder via suprapubic access, which ensures greater freedom of movement without compromising the external sphincter. Clinical data were retrospectively collected. Preoperative and intraoperative variables, postoperative complications, and functional outcomes of the STAR-P procedure were assessed. A descriptive statistical analysis was performed.

Key findings and limitations: No intraoperative complications were observed. Two patients (4.5%) experienced urinary urgency symptoms after catheter removal that resolved within 90 d. Median times were 105 min for surgery overall and 65 min for resection. All patients showed an improvement in voiding quality.

Conclusions and clinical implications: STAR-P is a safe, feasible, and cost-effective procedure that spares the bulbomembranous and penile urethra and the external urethral sphincter, and should be discussed with patients as a possible option for treatment of BPO.

Patient summary: We describe a new, safe, and feasible technique for surgical treatment of urinary obstruction caused by a large prostate. Keyhole surgery is performed through the lower abdomen, which means that the urethra below the prostate is not damaged. Only a small scar of 2-3 cm in the lower abdomen is evident at the end of the healing process.

Background and objective: Our aim was to report the first clinical trial of TENSI+, a new device for transcutaneous posterior tibial nerve stimulation (TNS) for treatment of overactive bladder (OAB).

Methods: A prospective, multicentre clinical trial was conducted in adults with OAB in seven French centres. The main exclusion criteria were prior percutaneous or transcutaneous TNS or invasive OAB treatment, current antimuscarinic use, 24-h polyuria, known bladder disease, postvoid residual volume >150 ml, and pelvic organ prolapse stage >2. Patients self-administered daily TTNS sessions of 20 min with TENSI+ at home after education by a specialized nurse. A bladder diary, Urinary Symptom Profile and OAB-q questionnaires, and Patient Global Impression of Improvement (PGI-I) scores were evaluated at baseline and 3 and 6 mo. The primary endpoint was efficacy, based on PGI-I and variations in bladder diary parameters. Success was defined as a PGI-I score ≤3 and any improvement ≥30% in bladder diary parameters.

Key findings and limitations: The study included 78 patients (13 males). Nine patients had neurological disease, 21 had previously tried antimuscarinics, and 41 had wet OAB at baseline. At 3 mo, 65/78 patients had a full analysis set. Treatment was successful in 44/65 patients (67%), with 25/65 (38%) reporting both an objective improvement and high satisfaction. All OAB-related endpoints were significantly improved, except bladder capacity and total voided volume per 24 h. At 6 mo, only five of 44 patients had interrupted their treatment. No factor predictive of success was identified. Two adverse events (pain at stimulation site and/or pelvic pain) were reported and spontaneously resolved without treatment interruption.

Conclusions and clinical implications: TENSI+ is a safe and effective TTNS treatment option for OAB management.

Patient summary: TENSI+ is a new device for nerve stimulation in patients with overactive bladder. Patients use the device at home every day. In our short-term trial, TENSI+ use improved symptoms in 67% of patients. Further evaluation over a longer period of time is needed.

Background and objective: The aim of this study was to evaluate the stone-free status (SFS) rate and complications after flexible ureteroscopy (fURS) for treatment of renal stones using a flexible and navigable suction (FANS) ureteral access sheath.

Methods: Data for adults undergoing fURS in 25 centers worldwide were prospectively collected (August 2023 to January 2024). Exclusion criteria were abnormal renal anatomy and ureteral stones. All patients had computed tomography scans before and within 30 d after fURS with a FANS ureteral access sheath. SFS was defined as follows: grade A, zero fragments; grade B, a single fragment ≤2 mm; grade C, a single fragment 2.1-4 mm; and grade D, single/multiple fragments >4 mm. Data for continuous variables are presented as the median and interquartile range (IQR). Multivariable logistic regression was performed to evaluate predictors of grade A SFS.

Key findings and limitations: The study enrolled 394 patients (59.1% male) with a median age of 49 yr (IQR 36-61). The median stone volume was 1260 mm³ (IQR 706-1800). Thulium fiber laser (TFL) was used in 45.9% of cases and holmium laser in the rest. The median lasing time was 18 min (IQR 11-28) and the median operative time was 49 min (IQR 37-70). One patient required a blood transfusion and 3.3% of patients had low-grade fever. No patient developed sepsis. Low-grade ureteral injury occurred in eight patients (2%). The grade A SFS rate was 57.4% and the grade A + B SFS rate was 97.2%, while 2.8% of patients had grade C or D SFS. Eleven patients underwent repeat fURS. Multivariable analysis revealed that a stone volume of 1501-3000 mm³ (odds ratio 0.50) and of >3000 mm³ (odds ratio 0.29) were significantly associated with lower probability of grade A SFS, while TFL use was associated with higher SFS probability (odds ratio 1.83). Limitations include the lack of a comparative group.

Conclusions and clinical implications: fURS using a FANS ureteral access sheath resulted in a high SFS rate with negligible serious adverse event and reintervention rates.

Patient summary: We looked at 30-day results for patients undergoing telescopic laser treatment for kidney stones using a special type of vacuum-assisted sheath to remove stone fragments. We found a high stone-free rate with minimal complications.

Context: Penile shaft sparing (PSS) surgery for localised penile cancer (PeCa) aims to balance oncological and functional outcomes.

Objective: To summarise the published evidence on different PSS approaches.

Evidence acquisition: We performed a systematic review adhering to Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. The systematic search was performed on PubMed, EMBASE, and Scopus databases up to February 14, 2023. The inclusion criteria encompassed retrospective or prospective studies including patients ≥18 yr of age with localised PeCa treated with different PSS approaches, classified as laser ablation, circumcision, wide local excision, glansectomy with or without split skin graft, glans resurfacing, and mixed technique excision. The risk of bias was assessed using the Newcastle-Ottawa scale. A quantitative synthesis was not performed due to anticipated data heterogeneity and a lack of comparative studies.

Evidence synthesis: Out of 4343 articles identified, 47 met our inclusion criteria, including 10 847 patients. The year of publication ranged between 1983 and 2021. Nine studies were prospective case series, while the remaining studies were retrospective. No comparative studies were identified. Most of the cases included in these studies were Ta and T1. The oncological outcomes were good for all the approaches, with cancer-specific mortality ranging between 0% and 18%. Sexual and cosmetic outcomes, despite being under-reported, were good for all the approaches, with almost all patients being satisfied with their quality of life after surgery. The Newcastle and Ottawa scale revealed a high or severely high risk of bias in all the included studies.

Conclusions: PSS approaches were safe and had good functional outcomes, considering however the overall low quality of the studies on this issue.

Patient summary: The perioperative, function, and oncological outcomes of penile shaft sparing approaches are good. However, high-quality studies are needed to determine whether these approaches benefit patients with localised penile cancer.