-
BMC Urology Jan 2024To summarize current evidence to report a comparative systematic review and meta-analysis of prostatic artery embolization (PAE) with transurethral resection of the... (Meta-Analysis)
Meta-Analysis
Comparing prostatic artery embolization to surgical and minimally invasive procedures for the treatment of benign prostatic hyperplasia: a systematic review and meta-analysis.
BACKGROUND
To summarize current evidence to report a comparative systematic review and meta-analysis of prostatic artery embolization (PAE) with transurethral resection of the prostate (TURP) and open simple prostatectomy (OSP) for the treatment of benign prostatic hyperplasia (BPH).
METHODS
A systematic literature search was performed to identify studies published from inception until August 2021. The search terms used were (prostate embolization OR prostatic embolization) AND (prostatic hyperplasia OR prostatic obstruction) as well as the abbreviations of PAE and BPH. Risk of bias was assessed using the Cochrane Risk of Bias tool for randomized controlled trials (RCTs) and the Risk of Bias in Non-randomized Studies-of Interventions (ROBINS-I) tool for observational studies. Random-effects meta-analysis was performed using Revman 5.4.
RESULTS
Seven studies were included with 810 patients: five RCTs and one observational study compared PAE with TURP, and one observational study compared PAE with OSP. The included studies had considerable risk of bias concerns. TURP and OSP were associated with more statistically significant improvements in urodynamic measures and BPH symptoms compared to PAE. However, PAE seems to significantly improve erectile dysfunction compared to OSP and improve other outcome measures compared to TURP, although not significantly. PAE appeared to reduce adverse events and report more minor complications compared with TURP and OSP, but it is unclear whether PAE is more effective in the long-term.
CONCLUSION
PAE is an emerging treatment option for patients with symptomatic BPH who cannot undergo surgery or have undergone failed medical therapy. Overall, PAE groups reported fewer adverse events. Future ongoing and longer-term studies are needed to provide better insight into the benefit of PAE compared to other treatment options.
Topics: Male; Humans; Prostate; Prostatic Hyperplasia; Treatment Outcome; Transurethral Resection of Prostate; Embolization, Therapeutic; Arteries; Minimally Invasive Surgical Procedures; Lower Urinary Tract Symptoms; Observational Studies as Topic
PubMed: 38281906
DOI: 10.1186/s12894-023-01397-1 -
Prostate Cancer and Prostatic Diseases Sep 2023To compare the initial perioperative outcomes of single-port transvesical simple prostatectomy (SP RASP) patients to those of open simple prostatectomy (OSP).
OBJECTIVE
To compare the initial perioperative outcomes of single-port transvesical simple prostatectomy (SP RASP) patients to those of open simple prostatectomy (OSP).
PATIENTS AND METHODS
Perioperative data from 42 consecutive patients with BPH who underwent SP RASP were prospectively reviewed. Similarly, data from forty-three consecutive patients who underwent the standard OSP, were retrospectively collected. Through direct suprapubic bladder access, prostatic enucleation was performed using the prostatic capsule as a landmark. Then a complete vesicourethral mucosal advancement flap was accomplished. OSP was performed according to the standard approach. Demographics, Intra- and perioperative data were analyzed and assessed with a descriptive analysis.
RESULTS AND LIMITATIONS
Baseline characteristics were comparable between the two groups, except for the preoperative median post-void residual volume, which was higher in the OSP group (p = 0.004). The SP RASP group had less intraoperative estimated blood loss (p < 0.001), no need for continuous bladder irrigation (p < 0.001), and less in-hospital opioid use (p < 0.001). Patients in the SP RASP group were discharged on postoperative day zero, compared to a median of 2 days for OSP (p < 0.001). The median Foley catheter duration was 7 days for SP RASP, compared to a median of 10 days for OSP (p < 0.001). SP RASP group had fewer postoperative complications, however, this did not reach statistical significance.
CONCLUSION
SP RASP is an alternative approach in treating surgical BPH. It may offer patients less morbidity in comparison to OSP.
Topics: Male; Humans; Prostatic Hyperplasia; Retrospective Studies; Prostatic Neoplasms; Treatment Outcome; Length of Stay; Prostatectomy; Robotic Surgical Procedures; Blood Loss, Surgical
PubMed: 35851618
DOI: 10.1038/s41391-022-00566-x -
World Journal of Urology Mar 2024To compare oncological, functional, and surgical outcomes of a large cohort of patients who underwent open retropubic radical prostatectomy (ORP) or robot-assisted...
PURPOSE
To compare oncological, functional, and surgical outcomes of a large cohort of patients who underwent open retropubic radical prostatectomy (ORP) or robot-assisted radical prostatectomy (RARP).
MATERIALS AND METHODS
Data from 18,805 RPs performed with either the open or the robot-assisted approaches at a single tertiary referral center between 2008 and 2022 were analyzed. The impact of surgical approach on biochemical recurrence-free survival, salvage radiotherapy-free survival, and metastasis-free survival was analyzed by log-rank test and Kaplan-Meier analysis in a propensity score (PS)-based matched cohort. Intraoperative and postoperative surgical outcomes were assessed. One-week, 3-month, and 12-month continence rates and 12-month erectile function (EF) were analyzed.
RESULTS
No statistically significant differences in oncological outcomes were found between ORP and RARP. A slight statistically significant difference in favor of RARP was noted in urinary continence at 3 months (RARP vs. ORP: 81% vs. 77%, p = 0.007) and 12 months (91% vs. 89.3%, p = 0.008), respectively. The rate of EF was statistically significantly higher (60%) after RARP than after ORP (45%, p < 0.001).
CONCLUSION
Both RARP and ORP yielded similar oncological outcomes. RARP offered a slight advantage in terms of continence recovery, but its clinical significance may be less meaningful. RARP resulted in significantly improved postoperative EF, suggesting a potential influence of both surgical experience and minimally invasive approach.
Topics: Male; Humans; Robotics; Propensity Score; Treatment Outcome; Robotic Surgical Procedures; Prostatectomy
PubMed: 38478106
DOI: 10.1007/s00345-024-04824-6 -
European Urology Oncology Jun 2024High-risk prostate cancer (PCa) patients frequently experience recurrence and progression after radical prostatectomy (RP). Neoadjuvant androgen deprivation therapy... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
High-risk prostate cancer (PCa) patients frequently experience recurrence and progression after radical prostatectomy (RP). Neoadjuvant androgen deprivation therapy (ADT) has not demonstrated a clear oncological benefit and is not currently recommended.
OBJECTIVE
The SUGAR trial is the first phase 2, randomised, controlled, multicentre, noncommercial, open-label study investigating single-agent perioperative darolutamide compared with the standard of care (ie, upfront RP, without neoadjuvant ADT).
DESIGN, SETTING, AND PARTICIPANTS
SUGAR aims to randomise 240 men affected by nonmetastatic PCa, with the major eligibility criteria being International Society of Urological Pathology grade group ≥4, seminal vesicle invasion at magnetic resonance imaging and/or clinically node-positive disease. Patients in the experimental arm will undergo neoadjuvant darolutamide monotherapy, RP, and adjuvant darolutamide, completing 9 mo of treatment.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
The primary endpoint is noncurable recurrence-free survival, an innovative and clinically meaningful measure; the secondary endpoints encompass safety; recurrence-free, metastasis-free, and overall survival; pathological response; and quality of life. A predictive biomarker analysis will also be performed.
RESULTS AND LIMITATIONS
Initial data suggest that intensified neoadjuvant treatment with androgen receptor signalling inhibitors (ARSIs) is associated with a sustained pathological response and may improve outcomes, via tumour downstaging and micrometastasis eradication. ARSI monotherapy could further enhance tolerability.
CONCLUSIONS
SUGAR will provide efficacy and safety information on perioperative darolutamide monotherapy compared with upfront RP, in a contemporary high-risk PCa population undergoing surgery.
PATIENT SUMMARY
The on-going SUGAR clinical trial evaluates 9 mo of darolutamide treatment in addition to radical prostatectomy, in men affected by prostate cancer with specific high-risk characteristics. It investigates whether this hormonal treatment can lower the rates of noncurable recurrences, maintaining a favourable tolerability profile.
Topics: Humans; Male; Prostatic Neoplasms; Prostatectomy; Pyrazoles; Sulfonamides; Aged; Middle Aged; Neoadjuvant Therapy
PubMed: 37806843
DOI: 10.1016/j.euo.2023.09.020 -
The Journal of Urology Jul 2024Limited high-quality studies have compared robot-assisted laparoscopic prostatectomy (RALP) vs open retropubic radical prostatectomy. We sought to compare their... (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
Perioperative, Oncological, and Functional Outcomes Between Robot-Assisted Laparoscopic Prostatectomy and Open Radical Retropubic Prostatectomy: A Randomized Clinical Trial.
PURPOSE
Limited high-quality studies have compared robot-assisted laparoscopic prostatectomy (RALP) vs open retropubic radical prostatectomy. We sought to compare their postoperative outcomes in a randomized setting.
MATERIALS AND METHODS
In a single center, 354 men with newly diagnosed prostate cancer were assessed for eligibility; 342 were randomized (1:1). The primary outcome was 90-day complication rates. Functional outcomes and quality of life were assessed over 18 months, and oncological outcomes, biochemical recurrence-free survival, and additional treatment over 36 months.
RESULTS
From 2014 to 18, 327 patients underwent surgery (retropubic radical prostatectomy = 156, RALP = 171). Complications occurred in 27 (17.3%) vs 19 (11.1%; = .107). Patients undergoing RALP experienced lower median bleeding (250.0 vs 719.5 mL; < .001) and shorter hospitalization time. Urinary EPIC (Expanded Prostate Cancer Index Composite) median scores were better for RALP over 18 months, with higher continence rate at 3 months (80.5% vs 64.7%; = .002), 6 months (90.1% vs 81.6%; = .036) and 18 months (95.4% vs 78.8%; < .001). Sexual EPIC and Sexual Health Inventory for Men median scores were higher with RALP up to 12 months, while the potency rate was superior at 3 months (23.9% vs 5.3%; = .001) and 6 months (30.6% vs 6.9%; < .001). Quality of life over the 18 months and oncological outcomes over 36 months were not significantly different between arms.
CONCLUSIONS
Complications at 90 days were similar. RALP showed superior sexual outcomes at 1 year, improved urinary outcomes at 18 months, and comparable oncological outcomes at 36 months.
TRIAL REGISTRATION
Prospective Analysis of Robot-Assisted Surgery; NCT02292914. https://clinicaltrials.gov/ct2/show/NCT02292914?cond=NCT02292914&draw=2&rank=1.
Topics: Humans; Male; Prostatectomy; Robotic Surgical Procedures; Prostatic Neoplasms; Laparoscopy; Middle Aged; Quality of Life; Aged; Postoperative Complications; Treatment Outcome
PubMed: 38723593
DOI: 10.1097/JU.0000000000003967 -
European Urology Focus Apr 2024The implementation of quality assurance programs (QAPs) within urological practice has gained prominence; yet, their impact on outcomes after radical prostatectomy (RP)... (Review)
Review
BACKGROUND AND OBJECTIVE
The implementation of quality assurance programs (QAPs) within urological practice has gained prominence; yet, their impact on outcomes after radical prostatectomy (RP) remains uncertain. This paper aims to systematically review the current literature regarding the implementation of QAPs and their impact on outcomes after robot-assisted RP, laparoscopic RP, and open prostatectomy, collectively referred to as RP.
METHODS
A systematic Embase, Medline (OvidSP), and Scopus search was conducted, according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) process, on January 12, 2024. Studies were identified and included if these covered implementation of QAPs and their impact on outcomes after RP. QAPs were defined as any intervention seeking quality improvement through critically reviewing, analyzing, and discussing outcomes. Included studies were assessed critically using the Risk of Bias in Nonrandomized Studies of Interventions (ROBINS-I) tool, with results summarized narratively.
KEY FINDINGS AND LIMITATIONS
Ten included studies revealed two methodological strategies: periodic performance feedback and surgical video assessments. Despite conceptual variability, QAPs improved outcomes consistently (ie, surgical margins, urine continence, erectile function, and hospital readmissions). Of the two strategies, video assessments better identified suboptimal surgical practice and technical errors. Although the extent of quality improvements did not appear to correlate with the frequency of QAPs, there was an apparent correlation with whether or not outcomes were evaluated collectively.
CONCLUSIONS AND CLINICAL IMPLICATIONS
Current findings suggest that QAPs have a positive impact on outcomes after RP. Caution in interpretation due to limited data is advised. More extensive research is required to explore how conceptual differences impact the extent of quality improvements.
PATIENT SUMMARY
In this paper, we review the available scientific literature regarding the implementation of quality assurance programs and their impact on outcomes after radical prostatectomy. The included studies offered substantial support for the implementation of quality assurance programs as an incentive to improve the quality of care continuously.
PubMed: 38631992
DOI: 10.1016/j.euf.2024.03.004 -
Journal of Endourology Oct 2023The aim of this study was to explore the safety and efficacy of radical prostatectomy with a novel Shurui single-port (SR-SP) robotic surgical system. A total of 11...
The aim of this study was to explore the safety and efficacy of radical prostatectomy with a novel Shurui single-port (SR-SP) robotic surgical system. A total of 11 patients with prostate cancer were enrolled in this study. Extraperitoneal radical prostatectomy was performed using the SR-SP robotic surgical system for all patients. Clinicopathologic data, perioperative data, and short-term surgical outcomes were prospectively collected and analyzed. Of the 11 patients, the median age was 65 years (range 52-73), and the median body mass index was 22.6 kg/m (range 20.2-26.7). The median operative time was 229 minutes (range 194-317), and the median console time was 167 minutes (range 141-265). The median blood loss was 40 mL (range 10-120), and none of the patients required intraoperative transfusion. There was no conversion to open surgery during the operation, and no assistant ports were added. The surgeons reported a good task load rating with a National Aeronautics and Space Administration Task Load Index (NASA-TLX) score of 25.1 ± 3.3 points. The median postoperative hospital stay time was 7 days (range 4-15). There were no severe intraoperative or postoperative complications (Clavien grade ≥3). Postoperative positive surgical margin occurred in 4 (36.4%) patients. No biochemical recurrence occurred within 1 month of surgery. The continence rate was 72.7% (8/11) 1 month after surgery. The new SR-SP robotic surgical system is safe, effective, flexible, and stable for application in radical prostatectomy.
PubMed: 37597208
DOI: 10.1089/end.2023.0185 -
Urology Apr 2024To evaluate the effects of Prostate artery embolization (PAE) and open simple prostatectomy (OP) on lower urinary tract symptoms and urodynamic parameters in subjects...
OBJECTIVE
To evaluate the effects of Prostate artery embolization (PAE) and open simple prostatectomy (OP) on lower urinary tract symptoms and urodynamic parameters in subjects with prostate size >80cc³.
METHODS
PoPAE study (OP or PAE) was a randomized, open-label controlled trial performed between January 2020 and May 2022. Subjects with large prostates (>80cc³), urodynamic parameters meeting obstruction criteria (Bladder Outlet Obstruction Index-BOOI>40), and good detrusor function (Bladder contractility index>100) were included. The primary and co-primary endpoints were the variation in peak flow rate on uroflowmetry (Qmax) and BOOI. The secondary endpoints were the IPSS and ultrasonographic changes.
RESULTS
Twenty three and 25 subjects underwent PAE and OP were evaluated, respectively. At baseline, the 2 groups have shown similar clinical, radiological, laboratory, and urodynamic parameters. After 6 months, Qmax improved 8,3 ± 4.17 mL/sec in PAE and 15.1 ± 8.04 mL/sec in OP (mean difference 6.78 in favor of PE; P = .012 [CI -9.00 to -3.00]). After treatment, 88% of those men underwent OP were classified as unobstructed or equivocal (BOOi<40). On the other hand, 70% of subjects underwent PAE remained obstructed (BOOI>40) and none of them shifted to unobstructed status (BOOI<20). It was observed a similar reduction in IPSS and PVR in both groups.
CONCLUSION
PAE was inferior to conventional surgery for releasing BOO and improving peak urinary flow in large prostates. Nevertheless, PAE was able to improve symptoms and PVR, and might be an alternative method in selected patients.
PubMed: 38697363
DOI: 10.1016/j.urology.2024.04.024 -
Prostate Cancer and Prostatic Diseases Mar 2024Robot-Assisted Simple Prostatectomy (RASP) has emerged as a promising alternative in the treatment of benign prostatic obstruction (BPO). However, there is currently a...
BACKGROUND
Robot-Assisted Simple Prostatectomy (RASP) has emerged as a promising alternative in the treatment of benign prostatic obstruction (BPO). However, there is currently a lack of comparative studies evaluating different robotic platforms for performing RASP. Therefore, we aimed to compare perioperative and functional outcomes of RASP performed using the HUGO™ RAS System versus the DaVinci® Xi System.
METHODS
Forty consecutive cases of RASP performed between May 2021 and March 2023 with the HUGO™ RAS and the DaVinci® Xi at OLV Hospital (Aalst, Belgium) were included in this retrospective study. All surgeries were performed by three experienced surgeons using the same approach. Baseline characteristics, peri-operative and functional outcomes were collected and compared between the two groups.
RESULTS
The population was equally divided between the two groups with 20 patients in each group. There were no significant differences in preoperative patient characteristics between the two groups, except for the presence of bladder stones prior to the surgery (p = 0.03). No significant differences in total operative time and console time between the two groups were reported (p = 0.3). No cases required conversion to open surgery or additional port placement. During one case performed with the HUGO™ RAS, a malfunctioning monopolar curved shear had to be replaced. However, there was no statistically significant differences in terms of technical robotic problems between the groups (p = 0.3). There was no significant difference between the two groups in perioperative and functional outcomes (all p ≥ 0.2).
CONCLUSIONS
We did not observe any statistically significant difference in perioperative and functional outcomes in case of RASP performed with the HUGO™ RAS System and with the DaVinci® Xi System. These findings provide compelling support for considering the HUGO™ RAS as a promising tool for robot-assisted procedures, thereby expanding the utilization of robotics for benign conditions.
Topics: Male; Humans; Robotics; Robotic Surgical Procedures; Prostatic Hyperplasia; Retrospective Studies; Treatment Outcome; Prostatectomy; Prostatic Neoplasms
PubMed: 37770613
DOI: 10.1038/s41391-023-00726-7 -
BMJ Open Oct 2023Patients undergoing prostate radiotherapy with an enlarged prostate can have short-term and long-term urinary complications. Currently, transurethral resection of the...
mparing Urolift and tandard ransurethral resection of prostate head of adiotherapy in men with urinary symptoms secondary to prostate enlargement in Southwest London and North Cumbria (CO-STAR): a study protocol for a randomised feasibility study.
INTRODUCTION
Patients undergoing prostate radiotherapy with an enlarged prostate can have short-term and long-term urinary complications. Currently, transurethral resection of the prostate (TURP) is the mainstay surgical intervention for men with urinary symptoms due to an enlarged prostate prior to radiotherapy. UroLift (NeoTract, Pleasanton, CA, USA) is a recent minimally invasive alternative, widely used in benign disease but is untested in men with prostate cancer.
METHODS AND ANALYSIS
A multicentre, two-arm study designed in collaboration with a Patient Reference Group to assess the feasibility of randomising men with prostate cancer and coexisting urinary symptoms due to prostate enlargement to TURP or UroLift ahead of radiotherapy. 45 patients will be enrolled and randomised (1:1) using a computer-generated programme to TURP or UroLift. Recruitment and retention will be assessed over a 12 month period. Information on clinical outcomes, adverse events and costs will be collected. Clinical outcomes and patient reported outcome measures will be measured at baseline, 6 weeks postintervention and 3 months following radiotherapy. A further 12 in-depth interviews will be conducted with a subset of patients to assess acceptability using the Theoretical Framework of Acceptability. Descriptive analysis on all outcomes will be performed using Stata (StataCorp V.2021).
ETHICS AND DISSEMINATION
The trial has been approved by the Research Ethics Committee (REC) NHS Health Research Authority (HRA) and Health and Care Research Wales (HCRW). The results will be published in peer-reviewed journals, presented at national meetings and disseminated to patients via social media, charity and hospital websites.
TRIAL REGISTRATION NUMBER
NCT05840549.
Topics: Humans; Male; Feasibility Studies; London; Prostate; Prostatic Hyperplasia; Prostatic Neoplasms; Transurethral Resection of Prostate; Randomized Controlled Trials as Topic
PubMed: 37802612
DOI: 10.1136/bmjopen-2023-076621