Giacomo Novara

Systematic Review and Meta-analysis of Studies Reporting Urinary Continence Recovery After Robot-assisted Radical Prostatectomy

CONTEXT Robot-assisted radical prostatectomy (RARP) was proposed to improve functional outcomes in comparison with retropubic radical prostatectomy (RRP) or laparoscopic radical prostatectomy (LRP). In the initial RARP series, 12-mo urinary continence recovery rates ranged from 84% to 97%. However, the few available studies comparing RARP with RRP or LRP published before 2008 did not permit any definitive conclusions about the superiority of any one of these techniques in terms of urinary continence recovery. OBJECTIVE The aims of this systematic review were (1) to evaluate the prevalence and risk factors for urinary incontinence after RARP, (2) to identify surgical techniques able to improve urinary continence recovery after RARP, and (3) to perform a cumulative analysis of all available studies comparing RARP versus RRP or LRP in terms of the urinary continence recovery rate. EVIDENCE ACQUISITION A literature search was performed in August 2011 using the Medline, Embase, and Web of Science databases. The Medline search included only a free-text protocol using the term radical prostatectomy across the title and abstract fields of the records. The following limits were used: humans; gender (male); and publication date from January 1, 2008. Searches of the Embase and Web of Science databases used the same free-text protocol, keywords, and search period. Only comparative studies or clinical series including >100 cases reporting urinary continence outcomes were included in this review. Cumulative analysis was conducted using the Review Manager v.4.2 software designed for composing Cochrane Reviews (Cochrane Collaboration, Oxford, UK). EVIDENCE SYNTHESIS We analyzed 51 articles reporting urinary continence rates after RARP: 17 case series, 17 studies comparing different techniques in the context of RARP, 9 studies comparing RARP with RRP, and 8 studies comparing RARP with LRP. The 12-mo urinary incontinence rates ranged from 4% to 31%, with a mean value of 16% using a no pad definition. Considering a no pad or safety pad definition, the incidence ranged from 8% to 11%, with a mean value of 9%. Age, body mass index, comorbidity index, lower urinary tract symptoms, and prostate volume were the most relevant preoperative predictors of urinary incontinence after RARP. Only a few comparative studies evaluated the impact of different surgical techniques on urinary continence recovery after RARP. Posterior musculofascial reconstruction with or without anterior reconstruction was associated with a small advantage in urinary continence recovery 1 mo after RARP. Only complete reconstruction was associated with a significant advantage in urinary continence 3 mo after RARP (odds ratio [OR]: 0.76; p=0.04). Cumulative analyses showed a better 12-mo urinary continence recovery after RARP in comparison with RRP (OR: 1.53; p=0.03) or LRP (OR: 2.39; p=0.006). CONCLUSIONS The prevalence of urinary incontinence after RARP is influenced by preoperative patient characteristics, surgeon experience, surgical technique, and methods used to collect and report data. Posterior musculofascial reconstruction seems to offer a slight advantage in terms of 1-mo urinary continence recovery. Update of a previous systematic review of literature shows, for the first time, a statistically significant advantage in favor of RARP in comparison with both RRP and LRP in terms of 12-mo urinary continence recovery.

Preoperative Aspects and Dimensions Used for an Anatomical (PADUA) Classification of Renal Tumours in Patients who are Candidates for Nephron-Sparing Surgery

BACKGROUND Besides clinical tumour size, other anatomical aspects of the renal tumour are routinely considered when evaluating the feasibility of elective nephron-sparing surgery (NSS). OBJECTIVE To propose an original, standardised classification of renal tumours suitable for NSS based on their anatomical features and size and to evaluate the ability of this classification to predict the risk of overall complications resulting from the surgery. DESIGN, SETTING, AND PARTICIPANTS We enrolled prospectively 164 consecutive patients who underwent NSS for renal tumours at a tertiary academic referral centre from January 2007 to December 2008. INTERVENTION Open partial nephrectomy without vessel clamping. MEASUREMENTS All tumours were classified by integrating size with the following anatomical features: anterior or posterior face, longitudinal, and rim tumour location; tumour relationships with renal sinus or urinary collecting system; and percentage of tumour deepening into the kidney. We generated an algorithm evaluating each anatomical parameter and tumour size (the preoperative aspects and dimensions used for an anatomical [PADUA] score) to predict the risk of complications. RESULTS AND LIMITATIONS Overall rates of complication were significantly correlated to all the evaluated anatomical aspects, excluding clinical size and anterior or posterior location of the tumour. By multivariate analysis, PADUA scores were independent predictors of the occurrence of any grade complications (hazard ratio [HR] for score 8-9 vs 6-7: 14.535; HR for score ≥10 vs 6-7: 30.641). Potential limitations were the limited number of patients with T1b tumours included in the study and the lack of laparoscopically treated patients. Further external validation of the PADUA score is needed. CONCLUSIONS The PADUA score is a simple anatomical system that can be used to predict the risk of surgical and medical perioperative complications in patients undergoing open NSS. The use of an appropriate score can help clinicians stratify patients suitable for NSS into subgroups with different complication risks and can help researchers evaluate the real comparability among patients undergoing NSS with different surgical approaches.

Systematic Review and Meta-analysis of Studies Reporting Potency Rates After Robot-assisted Radical Prostatectomy

BACKGROUND Although the initial robot-assisted radical prostatectomy (RARP) series showed 12-mo potency rates ranging from 70% to 80%, the few available comparative studies did not permit any definitive conclusion about the superiority of this technique when compared with retropubic radical prostatectomy (RRP) and laparoscopic radical prostatectomy (LRP). OBJECTIVES The aims of this systematic review were (1) to evaluate the current prevalence and the potential risk factors of erectile dysfunction after RARP, (2) to identify surgical techniques able to improve the rate of potency recovery after RARP, and (3) to perform a cumulative analysis of all available studies comparing RARP versus RRP or LRP. EVIDENCE ACQUISITION A literature search was performed in August 2011 using the Medline, Embase, and Web of Science databases. Only comparative studies or clinical series including >100 cases reporting potency recovery outcomes were included in this review. Cumulative analysis was conducted using Review Manager v.4.2 software designed for composing Cochrane Reviews (Cochrane Collaboration, Oxford, UK). EVIDENCE SYNTHESIS We analyzed 15 case series, 6 studies comparing different techniques in the context of RARP, 6 studies comparing RARP with RRP, and 4 studies comparing RARP with LRP. The 12- and 24-mo potency rates ranged from 54% to 90% and from 63% to 94%, respectively. Age, baseline potency status, comorbidities index, and extension of the nerve-sparing procedure represent the most relevant preoperative and intraoperative predictors of potency recovery after RARP. Available data seem to support the use of cautery-free dissection or the use of pinpointed low-energy cauterization. Cumulative analyses showed better 12-mo potency rates after RARP in comparison with RRP (odds ratio [OR]: 2.84; 95% confidence interval [CI]: 1.46-5.43; p=0.002). Only a nonstatistically significant trend in favor of RARP was reported after comparison with LRP (OR: 1.89; p=0.21). CONCLUSIONS The incidence of potency recovery after RARP is influenced by numerous factors. Data coming from the present systematic review support the use of a cautery-free technique. This update of previous systematic reviews of the literature showed, for the first time, a significant advantage in favor of RARP in comparison with RRP in terms of 12-mo potency rates.

Updated Systematic Review and Meta-Analysis of the Comparative Data on Colposuspensions, Pubovaginal Slings, and Midurethral Tapes in the Surgical Treatment of Female Stress Urinary Incontinence

CONTEXT Burch colposuspension, pubovaginal sling, and midurethral retropubic tape (RT) and transobturator tape (TOT) have been the most popular surgical treatments for female stress urinary incontinence (SUI). Several randomized controlled trials (RCTs) have been published comparing the different techniques, with conflicting results. OBJECTIVE Our aim was to evaluate the efficacy, complication, and reoperation rates of midurethral tapes compared with other surgical treatments for female SUI. EVIDENCE ACQUISITION A systematic review of the literature was performed using the Medline, Embase, Scopus, Web of Science databases, and Cochrane Database of Systematic Reviews. EVIDENCE SYNTHESIS Thirty-nine RCTs were identified. Patients receiving midurethral tapes had significantly higher overall (odds ratio [OR]: 0.61; confidence interval [CI]: 0.46-0.82; p=0.00009) and objective (OR: 0.38; CI: 0.25-0.57; p<0.0001) cure rates than those receiving Burch colposuspension, although they had a higher risk of bladder perforations (OR: 4.94; CI: 2.09-11.68; p=0.00003). Patients undergoing midurethral tapes and pubovaginal slings had similar cure rates, although the latter were slightly more likely to experience storage lower urinary tract symptoms (LUTS) (OR: 0.31; CI: 0.10-0.94; p=0.04) and had a higher reoperation rate (OR: 0.31; CI: 0.12-0.82; p=0.02). Patients treated with RT had slightly higher objective cure rates (OR: 0.8;CI: 0.65-0.99; p=0.04) than those treated with TOT; however, subjective cure rates were similar, and patients treated with TOT had a much lower risk of bladder and vaginal perforations (OR: 2.5; CI: 1.75-3.57; p<0.00001), hematoma (OR: 2.62; CI: 1.35-5.08; p=0.005), and storage LUTS (OR: 1.35; CI: 1.05-1.72; p=0.02). Meta-analysis demonstrated similar outcomes for TVT-O (University of Liège, Liège, Wallonia, Belgium) and Monarc (AMS, Minnetonka, MN, USA). CONCLUSIONS Patients treated with RT experienced slightly higher continence rates than those treated with Burch colposuspension, but they faced a much higher risk of intraoperative complications. RT and pubovaginal slings were similarly effective, although patients with pubovaginal slings were more likely to experience storage LUTS. The use of RT was followed by objective cure rates slightly higher than TOT, but subjective cure rates were similar. TOT had a lower risk of bladder and vaginal perforations and storage LUTS than RT. The strength of these findings is limited by the heterogeneity of the outcome measures and the short length of follow-up.

Systematic Review and Meta-analysis of Studies Reporting Oncologic Outcome After Robot-assisted Radical Prostatectomy

CONTEXT Despite the large diffusion of robot-assisted radical prostatectomy (RARP), literature and data on the oncologic outcome of RARP are limited. OBJECTIVE Evaluate lymph node yield, positive surgical margins (PSMs), use of adjuvant therapy, and biochemical recurrence (BCR)-free survival following RARP and perform a cumulative analysis of all studies comparing the oncologic outcomes of RARP and retropubic radical prostatectomy (RRP) or laparoscopic radical prostatectomy (LRP). EVIDENCE ACQUISITION A systematic review of the literature was performed in August 2011, searching Medline, Embase, and Web of Science databases. A free-text protocol using the term radical prostatectomy was applied. The following limits were used: humans; gender (male); and publications dating from January 1, 2008. A cumulative analysis was conducted using Review Manager software v.4.2 (Cochrane Collaboration, Oxford, UK) and Stata 11.0 SE software (StataCorp, College Station, TX, USA). EVIDENCE SYNTHESIS We retrieved 79 papers evaluating oncologic outcomes following RARP. The mean PSM rate was 15% in all comers and 9% in pathologically localized cancers, with some tumor characteristics being the most relevant predictors of PSMs. Several surgeon-related characteristics or procedure-related issues may play a major role in PSM rates. With regard to BCR, the very few papers with a follow-up duration >5 yr demonstrated 7-yr BCR-free survival estimates of approximately 80%. Finally, all the cumulative analyses comparing RARP with RRP and comparing RARP with LRP demonstrated similar overall PSM rates (RARP vs RRP: odds ratio [OR]: 1.21; p=0.19; RARP vs LRP: OR: 1.12; p=0.47), pT2 PSM rates (RARP vs RRP: OR: 1.25; p=0.31; RARP vs LRP: OR: 0.99; p=0.97), and BCR-free survival estimates (RARP vs RRP: hazard ratio [HR]: 0.9; p=0.526; RARP vs LRP: HR: 0.5; p=0.141), regardless of the surgical approach. CONCLUSIONS PSM rates are similar following RARP, RRP, and LRP. The few data available on BCR from high-volume centers are promising, but definitive comparisons with RRP or LRP are not currently possible. Finally, significant data on cancer-specific mortality are not currently available.

Systematic review and meta-analysis of perioperative outcomes and complications after robot-assisted radical prostatectomy.

CONTEXT Perioperative complications are a major surgical outcome for radical prostatectomy (RP). OBJECTIVE Evaluate complication rates following robot-assisted RP (RARP), risk factors for complications after RARP, and surgical techniques to improve complication rates after RARP. We also performed a cumulative analysis of all studies comparing RARP with retropubic RP (RRP) or laparoscopic RP (LRP) in terms of perioperative complications. EVIDENCE ACQUISITION A systematic review of the literature was performed in August 2011, searching Medline, Embase, and Web of Science databases. A free-text protocol using the term radical prostatectomy was applied. The following limits were used: humans; gender (male); and publications dating from January 1, 2008. A cumulative analysis was conducted using Review Manager software v.4.2 (Cochrane Collaboration, Oxford, UK). EVIDENCE SYNTHESIS We retrieved 110 papers evaluating oncologic outcomes following RARP. Overall mean operative time is 152 min; mean blood loss is 166 ml; mean transfusion rate is 2%; mean catheterization time is 6.3 d; and mean in-hospital stay is 1.9 d. The mean complication rate was 9%, with most of the complications being of low grade. Lymphocele/lymphorrea (3.1%), urine leak (1.8%), and reoperation (1.6%) are the most prevalent surgical complications. Blood loss (weighted mean difference: 582.77; p<0.00001) and transfusion rate (odds ratio [OR]: 7.55; p<0.00001) were lower in RARP than in RRP, whereas only transfusion rate (OR: 2.56; p=0.005) was lower in RARP than in LRP. All the other analyzed parameters were similar, regardless of the surgical approach. CONCLUSIONS RARP can be performed routinely with a relatively small risk of complications. Surgical experience, clinical patient characteristics, and cancer characteristics may affect the risk of complications. Cumulative analyses demonstrated that blood loss and transfusion rates were significantly lower with RARP than with RRP, and transfusion rates were lower with RARP than with LRP, although all other features were similar regardless of the surgical approach.

A systematic review and meta-analysis of randomized controlled trials with antimuscarinic drugs for overactive bladder

CONTEXT Anticholinergic drugs are commonly used in patients with overactive bladder (OAB) who do not achieve symptom relief and quality of life improvement with conservative management. Several drugs, with different doses, formulations, and routes of administration are currently available, making the choice quite difficult. OBJECTIVE To evaluate efficacy and safety of different doses, formulations, and route of administration of the available anticholinergic drugs. EVIDENCE ACQUISITION A systematic review of the literature was performed in August 2007 using Medline, Embase, and Web of Science. Efficacy (micturitions per 24h, volume voided per micturition, urgency urinary incontinence episodes per 24h, incontinence episodes per 24h) and safety (mainly, adverse events and withdrawal rates) end points were evaluated in the randomized control trials (RCTs) assessing the role of anticholinergic drugs in non-neurogenic OAB. Meta-analysis of RCTs was conducted using the Review Manager software 4.2 (Cochrane Collaboration). EVIDENCE SYNTHESIS Our systematic search identified 50 RCTs and three pooled analyses. Tolterodine immediate release (IR) had a more favorable profile of adverse events than oxybutynin IR. Regarding different dosages of IR formulations, dose escalation might yield some limited improvements in the efficacy but at the cost of significant increase in the rate of adverse events. In the comparisons between IR and extended-release (ER) formulations, the latter showed some advantages, both in terms of efficacy and safety. With regard to the route of administration, use if a transdermal route of administration does not provide significant advantage over an oral one. CONCLUSION Many of the available RCTs have good methodological quality. ER formulations should be preferred to the IR ones. With regard to IR formulations, dose escalation might yield some improvements in the efficacy with significant increase in the AE. More clinical studies are needed to indicate which of the drugs should be used as first-, second-, or third-line treatment.

A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update

CONTEXT A number of transurethral ablative techniques based on the use of innovative medical devices have been introduced in the recent past for the surgical treatment of benign prostatic obstruction (BPO). OBJECTIVE To conduct a systematic review of the literature and a meta-analysis of available randomized controlled trials (RCTs), and to evaluate the efficacy and safety of transurethral ablative procedures for BPO. EVIDENCE ACQUISITION A systematic literature search was performed for all RCTs comparing any transurethral surgical technique for BPO to another between 1992 and 2013. Efficacy was evaluated after a minimum follow-up of 1 yr based on International Prostate Symptom Score, maximum flow rate, and postvoid residual volume. Efficacy at midterm follow-up, prostate volume, perioperative data, and short-term and long-term complications were also assessed. Data were analyzed using RevMan software. EVIDENCE SYNTHESIS A total of 69 RCTs (8517 enrolled patients) were included. No significant difference was found in terms of short-term efficacy between bipolar transurethral resection of the prostate (B-TURP) and monopolar transurethral resection of the prostate (M-TURP). However, B-TURP was associated with a lower rate of perioperative complications. Better short-term efficacy outcomes, fewer immediate complications, and a shorter hospital stay were found after holmium laser enucleation of the prostate (HoLEP) compared with M-TURP. Compared with M-TURP, GreenLight photoselective vaporization of the prostate (PVP) was associated with a shorter hospital stay and fewer complications but no different short-term efficacy outcomes. CONCLUSIONS This meta-analysis shows that HoLEP is associated with more favorable outcomes than M-TURP in published RCTs. B-TURP and PVP have resulted in better perioperative outcomes without significant differences regarding efficacy parameters after short-term follow-up compared with M-TURP. Further studies are needed to provide long-term comparative data and head-to head comparisons of emerging techniques. PATIENT SUMMARY Bipolar transurethral resection of the prostate, photovaporization of the prostate, and holmium laser enucleation of the prostate have shown efficacy outcomes comparable with conventional techniques yet reduce the complication rate. The respective role of these new options in the surgical armamentarium needs to be refined to propose tailored surgical treatment for benign prostatic obstruction relief.

Prognostic Factors in Upper Urinary Tract Urothelial Carcinomas: A Comprehensive Review of the Current Literature

CONTEXT The heterogeneity of upper tract urothelial carcinoma (UTUC) biology and prognosis, as well as the presence of different treatment options, makes the clinical decision-making process extremely challenging. OBJECTIVE Provide an overview of the currently available prognostic factors for UTUC, focusing on clinical and pathologic characteristics, as well as on molecular markers. EVIDENCE ACQUISITION A systematic literature search was conducted using the PubMed, Scopus, and Embase databases to identify original articles, review articles, and editorials regarding prognostic factors in patients with UTUC. Keywords included urothelial carcinoma, renal pelvis, ureter, upper urinary tract urothelial carcinoma, upper urinary tract transitional cell carcinoma, prognosis, prognostic factors, markers, and survival. Articles published between 2000 and 2011 were reviewed and selected with the consensus of all the authors. EVIDENCE SYNTHESIS Prognostic factors can be divided into four different categories: preoperative/clinical factors, intraoperative/surgical factors, postoperative/pathologic factors, and molecular markers. Because of the rarity of the disease, only a small amount of level 1 evidence information from prospective randomized trials is available. Conversely, several single-institutional and multi-institutional studies have been published providing level 3 evidence information on various prognostic factors. Tumor stage and grade represent the best-established predictors of prognosis in patients with UTUC, but controversies still exist regarding the prognostic impact of tumor location and tumor necrosis. Several promising biomarkers have also been evaluated, but further studies evaluating their prognostic role are still needed. Finally, few prognostic models have been developed to provide clinicians with accurate estimates of the outcome of interest. CONCLUSIONS In the past few years, several prognostic factors have been identified to help clinicians dealing with patients with UTUC in the decision-making process. However, well-designed multi-institutional studies are still needed to provide stronger evidence and to promote the use of these prognostic factors in clinical practice.

Best Practices in Robot-assisted Radical Prostatectomy: Recommendations of the Pasadena Consensus Panel

CONTEXT Radical retropubic prostatectomy (RRP) has long been the most common surgical technique used to treat clinically localized prostate cancer (PCa). More recently, robot-assisted radical prostatectomy (RARP) has been gaining increasing acceptance among patients and urologists, and it has become the dominant technique in the United States despite a paucity of prospective studies or randomized trials supporting its superiority over RRP. OBJECTIVE A 2-d consensus conference of 17 world leaders in prostate cancer and radical prostatectomy was organized in Pasadena, California, and at the City of Hope Cancer Center, Duarte, California, under the auspices of the European Association of Urology Robotic Urology Section to systematically review the currently available data on RARP, to critically assess current surgical techniques, and to generate best practice recommendations to guide clinicians and related medical personnel. No commercial support was obtained for the conference. EVIDENCE ACQUISITION A systematic review of the literature was performed in agreement with the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement. EVIDENCE SYNTHESIS The results of the systematic literature review were reviewed, discussed, and refined over the 2-d conference. Key recommendations were generated using a Delphi consensus approach. RARP is associated with less blood loss and transfusion rates compared with RRP, and there appear to be minimal differences between the two approaches in terms of overall postoperative complications. Positive surgical margin rates are at least equivalent with RARP, but firm conclusions about biochemical recurrence and other oncologic end points are difficult to draw because the follow-up in existing studies is relatively short and the overall experience with RARP in locally advanced PCa is still limited. RARP may offer advantages in postoperative recovery of urinary continence and erectile function, although there are methodological limitations in most studies to date and a need for well-controlled comparative outcomes studies of radical prostatectomy surgery following best practice guidelines. Surgeon experience and institutional volume of procedures strongly predict better outcomes in all relevant domains. CONCLUSIONS Available evidence suggests that RARP is a valuable therapeutic option for clinically localized PCa. Further research is needed to clarify the actual role of RARP in patients with locally advanced disease.