Publications by authors named "Luca Di Gianfrancesco"

23 Publications

  • Page 1 of 1

Synchronous Partial Nephrectomy and Renal Artery Aneurysm Repair in Bilateral Renal Cancers: Case Report and Literature Review.

Urol Int 2021 Feb 18:1-5. Epub 2021 Feb 18.

Unit of Urology, A. Gemelli Hospital, IRCCS - Catholic University of the Sacred Heart, Rome, Italy.

The treatment of renal cancer has changed in the last decades with an increase in application of conservative surgery such as partial nephrectomy (PN) in order to achieve an optimal oncological outcome with the maximum preservation of renal function. The indication for PN is mandatory in case of bilateral tumors or in case of impaired renal function. Renal artery (RA) aneurysm (RAA) is a rare occurrence, and its treatment could be radiological or surgical according to the anatomy of the aneurysm and the clinical characteristics of the patients. Here, we report a case of simultaneous ipsilateral occurrence of renal cancer and RAA in a patient with bilateral renal masses, treated with 1 surgical procedure with good functional and oncological outcomes. This rare occurrence must be known by surgeons treating renal cancers, and it is possible to perform the 2 procedures in 1 surgical step.
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http://dx.doi.org/10.1159/000511755DOI Listing
February 2021

Rate of clinically significant prostate cancer on repeat saturation biopsy after a diagnosis of atypical small acinar proliferation.

Urologia 2021 Feb 12:391560321993595. Epub 2021 Feb 12.

Department of Urology, Catholic University of the Sacred Heart - Fondazione Policlinico Universitario "A. Gemelli" - IRCSS, Rome, Italy.

Background: Atypical small acinar proliferation (ASAP) occurs in approximately 5% of prostate biopsies. Approximately 30%-40% of these patients may develop prostate cancer (PCa) within a 5-year period, often not clinically significant. Current guidelines recommend a repeat biopsy within 3-6 months after the initial diagnosis, but it seem not to be the best strategy.

Methods: -evaluating the natural history of ASAP, stratifying the risk of csPCa after ASAP, identifying predictive factors of PCa after atypical diagnosis. -retrospective single-institutional study on patients undergoing prostate biopsy for suspicious PCa (2005-2016). We evaluated the incidence of overall PCa, intermediate-high risk of PCa and csPCa in case of ASAP, according to D'Amico classification and Epstein modified criteria.

Results: Out of 4.567 patients undergoing prostate biopsy, ASAP was detected in 2.6% of cases. All patients with ASAP underwent repeat saturation biopsy within 6 months and PCa was diagnosed in 34.5%. According to D'Amico classification, 26%, 5.9%, and 2.5% had low, intermediate, and high-risk disease, respectively. According modified Epstein criteria, the incidence of csPCa was 12.6%. LRT showed that the overall probability to develop PCa doubled when PSA density (PSAD) moved from values lower than 0.13 ng/ml/cc to class 0.13-0.30 ng/ml/cc, and it tripled when PSAD was higher than 0.30 ng/ml/cc.

Conclusions: The rate of csPCa in patients with an initial diagnosis of ASAP who had repeat biopsy was 12.6%. The overall PCa rate was 34.5%. Among patient undergoing RP, an upgrading from ncsPCa to csPCa was reported in 35% of cases. PSAD is the only predictive factor directly associated to the risk of developing PCa on repeat biopsy. These findings suggest that immediate repeat biopsy remains the correct strategy in absence of novel predictor factors and non-invasive diagnostic evaluations.
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http://dx.doi.org/10.1177/0391560321993595DOI Listing
February 2021

How Can the COVID-19 Pandemic Lead to Positive Changes in Urology Residency?

Front Surg 2020 24;7:563006. Epub 2020 Nov 24.

Department of Urology, IEO European Institute of Oncology IRCCS, Milan, Italy.

The COVID-19 outbreak, in a few weeks, overloaded Italian hospitals, and the majority of medical procedures were postponed. During the pandemic, with hospital reorganization, clinical and learning activities performed by residents suffered a forced remodulation. The objective of this study is to investigate how urology training in Italy has been affected during the COVID-19 era. In this multi-academic study, we compared residents' training during the highest outbreak level with their previous activity. Overall 387 (67.1%) of the 577 Italian Urology residents participated in a 72-h anonymous online survey with 36 items sent via email. The main outcomes were clinical/surgical activities, social distancing, distance learning, and telemedicine. Clinical and learning activity was significantly reduced for the overall group, and after categorizing residents as those working only in COVID hospitals, both "junior" and "senior" residents, and those working in any of three geographical areas created (Italian regions were clustered in three major zones according to the prevalence of COVID-19). A significant decrease in outpatient activity, invasive diagnostic procedures, and endoscopic and major surgeries was reported. Through multivariate analysis, the specific year of residency has been found to be an independent predictor for all response modification. Being in zone 3 and zone 2 and having "senior" resident status were independent predictors associated with a lower reduction of the clinical and learning activity. Working in a COVID hospital and having "senior" resident status were independent predictors associated with higher reduction of the outpatient activity. Working in zone 3 and having "senior" resident status were independent predictors of lower and higher outpatient surgical activity, respectively. Working in a COVID hospital was an independent predictor associated with robotic surgical activity. The majority of residents reported that distance teaching and multidisciplinary virtual meetings are still not used, and 44.8% reported that their relationships with colleagues decreased. The COVID-19 pandemic presents an unprecedented challenge, including changes in the training and education of urology residents. The COVID era can offer an opportunity to balance and implement innovative solutions that can bridge the educational gap and can be part of future urology training.
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http://dx.doi.org/10.3389/fsurg.2020.563006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7732553PMC
November 2020

Second-Line Conservative Device-Assisted Intravesical Treatment in Selected Patients With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer.

Clin Genitourin Cancer 2020 Nov 13. Epub 2020 Nov 13.

Department of Urology, Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Università Cattolica del Sacro Cuore di Roma, Rome, Italy.

Introduction: In cases of recurrent high-risk non-muscle-invasive bladder cancer, radical cystectomy (RC) is recommended. We compared oncologic and treatment-related outcomes of second-line conservative device-assisted therapy to RC.

Patients And Methods: In a retrospective cohort study, we analyzed 209 consecutive patients with recurrent bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer; 107 subjects refused RC and were offered electromotive drug administration (n = 44) or chemohyperthermia (n = 63) (group A), and 102 patients underwent RC (group B). In group A, patients who did not benefit from device-assisted treatment underwent RC. The endpoints were high-grade disease-free survival, progression-free survival, cancer-specific survival, overall survival, and treatment-related complications. Follow-up was based on international guideline recommendations. Analyses were performed with log-rank and Fisher exact tests.

Results: The median follow-up was 59 months (SD ± 5.3). When comparing group A to B, overall survival rates were 91.6% and 90.2%, respectively (P > .05); cancer-specific survival was 94.4% and 96.1%, respectively (P > .05); high-grade disease-free survival was 43% and 74.5%, respectively (P < .05); and progression-free survival was 59.8% and 75.5%, respectively (P < .05). Patients with carcinoma-in-situ had worse oncologic outcomes compared to patients with papillary disease. In the multivariate analysis, multifocality, disease recurrence, and progression risk group were independently associated with device treatment failure. The 90-day RC-related overall complications rates were 63.9% in group A and 66.6% in group B (P = .63); grade 3 to 5 complications were 9.8% in group A and 9.8% in group B(P = .99). Complications within group A were comparable (P > .05).

Conclusion: Device-assisted treatment may a represent a valid second-line conservative tool in selected patients with recurrent high-risk non-muscle-invasive bladder cancer.
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http://dx.doi.org/10.1016/j.clgc.2020.11.002DOI Listing
November 2020

Implementation of frailty preoperative assessment to predict outcome in patients undergoing urological surgery: a systematic review and meta-analysis.

BJU Int 2020 Dec 1. Epub 2020 Dec 1.

Dipartimento di Scienze Mediche e Chirurgiche, Clinica Urologica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italia.

Background: A common limit of the widely used risk scores for preoperative assessment is the lack of information about aspects linked to frailty that may affect outcome, especially in the setting of elderly patients undergoing urological surgery. Frailty has recently been introduced as an additional characteristic to be assessed for better identifying patients at risk of negative outcomes.

Objective: To examine the evidence for recent advances in preoperative assessment in patients undergoing urological surgery focussing on the detrimental effect of frailty on outcome, including major (mPCs) and total postoperative complications (tPCs), discharge to a facility, and mortality. The secondary aim was to establish which cut-off scores of the modified Frailty Index (mFI, 11 items) and/or simplified FI (sFI, five items) predicted PCs.

Methods: We searched PubMed, the Excerpta Medica database (EMBASE), Cochrane Library and clinicaltrial.gov from inception to 31 May 2020. Studies reporting relationships between the investigated outcomes and patients' frailty were included. We estimated odds ratios (ORs) through a random effect model by using Revman 5.4.

Results: Frailty, assessed by different tools, was associated with a significantly higher rate of 30-day (OR 1.73, 95% confidence interval [CI] 1.58-1.89) and 90-day (OR 2.09, 95% CI 1.14-3.82) mPCs and 30-day tPCs (OR 2.10, 95% CI 1.76-2.52). A mFI of ≥2 was associated with a higher rate of 30-day mPCs (OR 1.79, 95% CI 1.69-1.89) and greater 30-day mortality (OR 3.46, 95% CI 2.10-5.49). A pre-planned post hoc analysis also revealed that a sFI of ≥3 was predictive of mPCs (OR 3.30, 95% CI 2.12-5.12).

Conclusions: Frailty assessment may help to predict PCs and mortality in patients undergoing major urological surgery. Either a mFi of ≥2 or sFI of ≥3 should be considered potential 'red flags' for preoperative risk assessment and decision-making. There is not enough evidence to confirm the necessity to perform frailty assessment in minor urological surgery.
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http://dx.doi.org/10.1111/bju.15314DOI Listing
December 2020

Immediate ileal ureter replacement for ureteral avulsion during ureterescopy.

IJU Case Rep 2020 Nov 18;3(6):241-243. Epub 2020 Aug 18.

Urology Clinic A. Gemelli Hospital Catholic University of the Sacred Heart Rome Italy.

Introduction: Complete ureteral avulsion represents a rare and fearsome complication of ureteroscopy, reported in less than 1% of cases. In literature there are few reports and different options are presented for its treatment. We present a case of a ureteral avulsion managed with ileal ureter replacement.

Case Presentation: A 67-year-old man with a left proximal ureter stone was treated at our department with ureteroscopy. During retrieval of the instrument a complete ureteral avulsion was discovered, with a so-called "scabbard lesion". We decided to proceed with immediate laparotomy and we performed a ileal ureter replacement.

Conclusion: Ureteral avulsion is a rare complication but must be known as a possible complication in high volume center. There is no standard definition regarding its treatment, and in our experience immediate treatment with ileal ureter replacement proved to be safe and effective without any changes in renal function.
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http://dx.doi.org/10.1002/iju5.12202DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7609185PMC
November 2020

Artificial urinary sphincter significantly better than fixed sling for moderate post-prostatectomy stress urinary incontinence: a propensity score-matched study.

BJU Int 2021 02 26;127(2):229-237. Epub 2020 Aug 26.

"Fondazione Policlinico Universitario Agostino Gemelli IRCCS", Università Cattolica del Sacro Cuore, Rome, Italy.

Objective: To compare the efficacy of artificial urinary sphincter (AUS) vs retrourethral transobturator sling (RTS) in men with moderate post-prostatectomy urinary incontinence (PPI) using propensity score-matching analysis to enhance the validity of the comparison (Canadian Task Force classification II-2).

Patients And Methods: Consecutive men with moderate (3-5 pads/day) stress-prevalent PPI were included if implanted with a RTS (TiLOOP Male; pfm medical, Köln, Germany) or AUS (AMS800 ; Boston Scientific, Boston, MA, USA) since July 2011 to December 2017 and with ≥12 months of follow-up. Preoperative assessment included 24-h pad usage, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), urethrocystoscopy, and urodynamics if indicated. Propensity score-matching analysis was based on age, body mass index, Charlson Comorbidity Index, pad usage, previous radiotherapy, and urethrotomy. The primary outcome was at least 'much improved' response at 12-months according to the Patient Global Impression of Improvement questionnaire, without additional PPI surgery or prosthesis explantation.

Results: Of 109 included patients, 70 patients were matched and the study groups were well balanced for the baseline matched variables. The median baseline 24-h pad usage was four in both groups (P = 0.10), and median follow-up was 51.2 months for AUS and 47.2 months (P = 0.5) for RTS patients. In the AUS and RTS cohorts, respectively, 33 (94.3%) and 24 (68.6%) patients achieved the primary outcome (P < 0.001), the 0-1 pad/day rates was 94.3% vs 68.6% (P = 0.012) at 12 months, and 91.4% vs 68.6% (P = 0.034) at last follow-up. At the last follow-up, the median 24-h leakage volumes, median ICIQ-SF scores and satisfaction rates were 0 vs 15 mL (P = 0.017), 4 vs 10 (P = 0.001), and 94.3% vs 68.6% (P = 0.012) in the AUS and RTS cohorts, respectively. There were no significant differences in overall rates of complications and re-interventions, although Clavien-Dindo Grade III complications (n = 3) occurred only in the AUS group. At sensitivity analysis, the study was reasonably robust to hidden bias.

Conclusion: We found that AUS implantation significantly outperformed RTS in patients with moderate PPI for both subjective and objective outcomes.
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http://dx.doi.org/10.1111/bju.15197DOI Listing
February 2021

Chemoablation with Intensive Intravesical Mitomycin C Treatment: A New Approach for Non-muscle-invasive Bladder Cancer.

Eur Urol Oncol 2019 09 6;2(5):576-583. Epub 2018 Oct 6.

Department of Urology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore di Roma, Rome, Italy.

Background: Mitomycin C (MMC) is widely used, but the optimal dose and schedule have not been established.

Objective: To evaluate the ablative power and patient safety of a short-term intensive schedule of intravesical MMC in patients with recurrent non-muscle-invasive bladder cancer (NMIBC).

Design, Setting, And Participants: This was a prospective, single-center, nonrandomized study that compared 47 patients (group 1) with a history of low- to intermediate-risk NMIBC with long free-recurrence intervals, recurrence of ≤1cm in maximum diameter, and negative cytology to 47 consecutive patients with the same baseline characteristics (group 2).

Intervention: Intravesical MMC three times per week for 2 wk for group 1. Transurethral resection of bladder tumor (TUR-BT) and early instillation and a weekly schedule of intravesical MMC for group 2. All cancer-free patients underwent monthly MMC maintenance. Follow-up included bladder mapping, voiding and washing urinary cytology, TUR of suspected area, TUR of previous tumor location, and ultrasound or computed tomography/magnetic resonance imaging.

Outcome Measurement And Statistical Analysis: We used χ and Student's t test for comparison of categorical and continuous variables, respectively. Kaplan-Meier curves were plotted to estimate cancer-free survival. The significance level was set to p<0.05.

Results And Limitations: The complete response rate at 39 mo was 61.7% in group 1 and 70.2% in group 2 (p=0.38). Kaplan-Mayer analysis revealed no difference in cancer-free survival rates overall (log-rank <3.84), according to tumor size in each group (log-rank <3.84), or between the groups (log-rank <7.82). No cases of systemic toxicity were observed. Local toxicities did not differ between the groups (p=0.32) and resolved on treatment of symptoms, and no patient discontinued their treatment. Limitations include the small number of patients, selection bias because of the single tertiary center, and short follow-up.

Conclusions: The proposed MMC schedule had good ablative power that can be explained by better concordance between the scheduled timing and the tumor cell duplication rate. The short-term intensive schedule could be considered as a therapeutic strategy to replace TUR-BT in selected NMIBC patients.

Patient Summary: We report our experience of a tailored intravesical therapy schedule for bladder cancer. This schedule could be considered a therapeutic strategy to replace surgery for selected patients.
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http://dx.doi.org/10.1016/j.euo.2018.08.032DOI Listing
September 2019

Psychological aptitude for surgery: The importance of non-technical skills.

Urologia 2019 May 14;86(2):45-51. Epub 2019 Apr 14.

Urology Clinic, Catholic University of the Sacred Heart, Agostino Gemelli University Polyclinic, Rome, Italy.

Introduction: Psychological aptitude for surgery includes all the non-technical abilities that are necessary for the surgeons. However, differently from the other careers, these skills are not considered in the selection process and their role is definitively underestimated in the field of surgery. We perform a literature review of non-technical skills for surgery to identify their role and to understand how to train and evaluate these abilities among the surgeons.

Results: Different methods have been presented for the evaluation and training of non-technical skills for surgeons; based on the model of aviation and anesthesia a wide range of simulated scenarios have been proposed to practice these aptitudes and abilities. Different behavioral markers systems have been developed for correct identification and definition of these skills, these can be used in the real surgical room and even learned and trained in the simulated operating theatre.

Conclusion: This article shows the importance of non-practical abilities in the surgical performance and in defining the aptitude for surgery. Learning these skills and introducing them in surgical education can be useful to improve the surgical performance.
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http://dx.doi.org/10.1177/0391560319840523DOI Listing
May 2019

Can Neutrophil-to-Lymphocyte ratio predict the response to BCG in high-risk non muscle invasive bladder cancer?

Int Braz J Urol 2019 Mar-Apr;45(2):315-324

Department of Urology, Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS - Università Cattolica del Sacro Cuore di Roma.

Objectives: To evaluate the neutrophil-to-lymphocyte ratio (NLR) as a prognostic factor for response of high risk non muscle invasive bladder cancer (HRNMIBC) treated with BCG therapy.

Materials And Methods: Between March 2010 and February 2014 in a tertiary center 100 consecutive patients with newly diagnosed HRNMIBC were retrospectively analyzed. Patients were divided according to NLR value: 46 patients with NLR value less than 3 (NLR < 3 group), and 54 patients with NLR value more than 3 (NLR ≥ 3 group). At the end of follow-up 52 patients were high grade disease free (BCG-responder group) and 48 patients underwent radical cystectomy for high grade recurrence or progression to muscle invasive disease (BCG non-responder group). The average follow-up was 60 months.

Intervention: analysis and correlation of preoperative NLR value with response to BCG in terms of recurrence and progression.

Results: The optimal cut-off for NLR was ≥ 3 according to the receiver operating characteristics analysis (AUC 0.760, 95% CI, 0.669-0.850). Mean NLR value was 3.65 ± 1.16 in BCG non-responder group and 2.61 ± 0.77 in BCG responder group (p = 0.01). NLR correlated with recurrence (r = 0.55, p = 0.01) and progression risk scores (r = 0.49, p = 0.01). In multivariate analysis, NLR (p = 0.02) and EORTC recurrence risk groups (p = 0.01) were associated to the primary endpoint. The log-rank test showed statistically significant difference between NLR < 3 and NLR ≥ 3 curves (p < 0.05).

Conclusions: NLR value preoperatively evaluated could be a useful tool to predict BCG response of HRNMIBC. These results could lead to the development of prospective studies to assess the real prognostic value of NLR in HRNMIBC.
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http://dx.doi.org/10.1590/S1677-5538.IBJU.2018.0249DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6541147PMC
July 2019

ElectroMotive drug administration (EMDA) of Mitomycin C as first-line salvage therapy in high risk "BCG failure" non muscle invasive bladder cancer: 3 years follow-up outcomes.

BMC Cancer 2018 Dec 6;18(1):1224. Epub 2018 Dec 6.

Department of Urology, Fondazione Policlinico Universitario "A. Gemelli" IRCSS, Largo Agostino Gemelli, 8, 00168, Rome, Italy.

Background: In case of high grade non-muscle invasive bladder cancer (HG-NMIBC), intravesical BCG represents the first-line treatment; despite the "gold" standard therapy, up to 50% of patients relapse, needing radical cystectomy. Hence, alternative therapeutic strategies have been developed. The aim of the study was to evaluate a first-line salvage treatment with EMDA®-MMC in patients with HGNMIBC unresponsive to BCG.

Methods: We carried out a prospective, single-center, single-arm Phase II study in order to evaluate the efficacy (in terms of recurrence and progression) and the safety of the EMDA®-MMC treatment in 26 (21 male, 5 female) consecutive patients with "BCG refractory" HGNMIBC on a 3 years follow-up. EMDA®-MMC treatment consisted of 40 mg of MMC diluted in 100 ml of sterile water retained in the bladder for 30 min with 20 mA pulsed electric current. EMDA®-MMC regimen consisted of an induction course of 6 weekly instillations followed by a maintenance course of 6 monthly instillations. Follow-up was performed with systematic mapping biopsies of the bladder (with sampling in the prostatic urethra for men), voiding and washing urinary cytology, radiological study of the upper urinary tract. We performed Survival Kaplan-Meier curves and Log-rank test in order to analyze high grade disease-free survival.

Results: At the end of follow-up, 16 patients (61.5%) preserved their native bladder; 10 patients (38.4%) underwent radical cystectomy, in 6 patients (23.1%) for recurrent HGNMIBC and in 4 patients (15.4%) for progression to muscle-invasive disease. At the end of follow-up, stratifying patients based on TNM classification (TaG3, T1G3, Cis, TaT1G3 + Cis), disease-free rates were 75, 71.4, 50 and 25%, respectively; survival curves showed statistically significant differences (p value < 0.05). Regarding toxicity, we reported severe adverse systemic event of hypersensitivity to the MMC in 3 patients (11.5%), and local side effects in 6 patients (26.1%).

Conclusions: In the field of alternative strategies to radical cystectomy, the EMDA®-MMC could be considered safe and effective in high-risk NMIBC unresponsive to BCG, as a "bladder sparing" therapy in selected patients. Multicenter studies with a larger number of patients and a longer follow-up might confirm our preliminary results.

Trial Registration: EudraCT2017-002585-43. 17 June 2017 (retrospectively registered).
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http://dx.doi.org/10.1186/s12885-018-5134-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6282335PMC
December 2018

Patient pad count is a poor measure of urinary incontinence compared with 48-h pad test: results of a large-scale multicentre study.

BJU Int 2019 05 19;123(5A):E69-E78. Epub 2018 Oct 19.

"Agostino Gemelli" Academic Hospital Foundation-IRCCS, Catholic University School of Medicine, Rome, Italy.

Objective: To determine in a large population of community-dwelling incontinent patients the accuracy and determinants of pad count as a measure of urinary incontinence (UI), using data from a multicentre 48-h pad test study.

Materials And Methods: Incontinent patients, who were provided with absorbent products for the period January 2012 to March 2016, volunteered to perform a 48-h home-based pad test and to fill in a diary with information on pad usage. Correlations between UI measures (48-h pad count and pad weight gain, mean pad weight gain per pad) were calculated. Logistic regression analyses were conducted to investigate patient-related and pad usage-related factors influencing pad count.

Results: A total of 14 493 patients (median age 81 years) were included, with a total of 98 362 continence products used overall during the study period. The 48-h pad count showed a weak correlation with 48-h pad weight gain (R = 0.12; 0.19 for men and 0.11 for women) and mean pad weight gain per pad (R = -0.03). The weakest correlation was observed among patients using >6 pads/48 h (R = 0.02). A statistically significant negative association between pad absorption capacity and pad count was observed. Patients using products with a shaped and rectangular design had 34% and 40% higher propensity to use more pads than those using briefs (P < 0.001), respectively.

Conclusions: The results of this very large observational study confirmed that pad count is a poor measure of UI severity. Pad count only measured 12% of the variability of UI volume and was affected by several patient-related and pad usage-related factors. Consequently, pad count should not be used instead of the pad test as an objective measure of UI when an accurate evaluation is required for research or clinical purposes.
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http://dx.doi.org/10.1111/bju.14566DOI Listing
May 2019

The challenges of Bacillus of Calmette-Guerin (BCG) therapy for high risk non muscle invasive bladder cancer treatment in older patients.

J Geriatr Oncol 2018 09 16;9(5):507-512. Epub 2018 Apr 16.

Department of Urology, "Agostino Gemelli" Academic Hospital Foundation, IRCCS, Catholic University School of Medicine, Rome, Italy.

Objectives: To evaluate the efficacy and safety of a tailored endovesical immunotherapy protocol with biweekly BCG for elderly Patients with high risk non muscle invasive bladder cancer (HG-NMIBC).

Materials And Methods: We retrospectively evaluated data from 200 patients older than 80 years newly diagnosed with HG-NMIBC: 100 (group 1) with multiple comorbidities (WHO PS 2-3, ASA score ≥3, Charlson Comorbidity index ≥3, GFR<60 mL/min) were treated with BCG induction course administered biweekly; 100 (group 2) with statistically significant better conditions were treated with standard weekly BCG therapy. After the induction treatment disease-free patients underwent to at least one year of BCG maintenance therapy. Endpoints were: initial response to BCG, cancer-free survival and rate of progression at 2 years, rate of complications.

Results: No statistically significant differences were found in terms of initial response to BCG (69% in Group 1 vs 71% in Group 2, P = 0.75), cancer free survival (57% vs 55% respectively, P = 0.77) and rate of progression (20% vs 14% respectively, P = 0.26) at 2 years. The difference in the rate of overall complications was statistically significant (15% in Group 1 vs 27% in Group 2, P = 0.03), in the rate of severe complications was not statistically significant (5% in Group 1 vs 7% in Group 2, P = 0.61).

Conclusion: A tailored regimen of BCG administration is possible and safe in frail elderly patients, limiting side effects and risk of undertreatment but maintaining oncological outcomes. Preliminary results in a small patients group are promising but larger randomized studies are needed to confirm our data.
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http://dx.doi.org/10.1016/j.jgo.2018.03.020DOI Listing
September 2018

Mitomycin C: new strategies to improve efficacy of a well-known therapy.

Urologia 2016 Oct 1;83(Suppl 2):24-28. Epub 2016 Oct 1.

Department of Urology, Agostino Gemelli Hospital, Catholic University Medical School, Rome - Italy.

Mitomycin C (MMC) as an intravesical chemotherapeutic agent is a well-known option for treatment of nonmuscle invasive bladder cancer (NMIBC) recurrence; it is probably the most commonly used agent given its low rate of side effects and its efficacy.Both the American Urologic Association (AUA) and European Association of Urology (EAU) consider MMC as a standard treatment for immediate single-dose postoperative treatment and for adjuvant therapy in low and intermediate-risk NMIBC.Despite the popularity of this agent in the treatment of NMIBCs, many questions regarding the optimal approach to MMC therapy remain unanswered and the schedule widely used is empirical.Nevertheless, even when the current optimal approaches to MMC administration are used, a large proportion of NMIBCs recur.This apparent treatment resistance might be overcome by an optimization of standard MMC therapy or with a combination of MMC with other agents that have different mechanisms of action.Strategies to enhance passive delivery of MMC have been well studied and multiple measures are recommended for implementation of use in routine clinical practice.A modified scheme of instillation seems to be an easy and inexpensive alternative to increase efficacy of intravesical MMC and to also use this agent with an ablative intent.Enhancing tumor response with a sequential therapy is another option that has been investigated, mostly for chemo-immunotherapy wherein the different mechanisms of action of Bacillus of Calmette and Guerìn (BCG) and MMC are combined to achieve a higher response.
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http://dx.doi.org/10.5301/uro.5000193DOI Listing
October 2016

Postoperative Quality of Life in Patients with Ileal Neobladder at Short-, Intermediate- and Long-Term Follow-Up.

Urol Int 2016 12;97(1):54-60. Epub 2016 Apr 12.

Urology Clinic, Catholic University of the Sacred Heart, Rome, Italy.

Background: To evaluate the difference at different steps of follow-up of the postoperative quality of life (QoL) in patients who had undergone radical cystectomy and ileal orthotopic neobladder derivation.

Patients And Methods: A multicentric, cross-qualitative study was performed in 5 Italian centers of reference for the treatment of bladder cancer. One hundred seventy one patients who underwent radical cystectomy and creation of ileal orthotopic neobladder according to 'Vescica Ileale Padovana' between 2006 and 2011 have been analyzed. The validated and dedicated questionnaires EORTC QLQ-C30, IOB-PRO and EORTC QLQ-BLM30 were used.

Results: All data gathered were then processed, specifically means ± SD were included for comparison during 4 periods of follow-up (quartile): the first ranging from 1 to 18 months; the second ranging from 19 to 36 months; the third from 37 to 72 months and the fourth >72 months. Cancer-specific and health-related factors were analyzed separately, and the change was determined during follow-up.

Conclusions: The global QoL, highlighted by validated cancer-specific and health-related questionnaires, is certainly on a satisfactory level. Thus, the education of the patient, the exploration of the pros and cons of an orthotopic neobladder and the active participation in treatment decision seem to be the keys to better improve the post-operative QoL during the follow-up period.
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http://dx.doi.org/10.1159/000443185DOI Listing
April 2017

The occult urothelial cancer.

Urologia 2016 May 14;83(2):55-60. Epub 2016 Mar 14.

Department of Urology, Catholic University of the Sacred Heart, Rome - Italy.

Transitional cell carcinoma (TCC) is the tumor that most frequently affects the urinary tract. The most common location is in the bladder; the diagnosis, as the follow-up, is based on urine cytology, endoscopic, and radiological examinations. Urinary cytology is an important non invasive tool used in the diagnosis and follow-up of patients with TCC. A positive urine cytology result is highly predictive of the presence of TCC, even in the presence of normal cystoscopy, because malignant cells may appear in the urine long time before any cystoscopically visible lesion becomes apparent. The presence of a positive urinary cytology, in the absence of clinical or endoscopic evidence of a TCC, can identify an occult urothelial cancer, located in any site of the urinary tract (upper urinary tract, bladder, prostatic urethra). Most of the urothelial tumors of the renal pelvis and ureters are diagnosed by radiological examinations, but we can observe a high rate of false negatives. In order to improve the diagnostic role of urinary cytology and other conventional examinations, numerous molecular markers have been identified; however, the real clinical application remains unclear. Photodynamic diagnosis and narrow band imaging (NBI) cystoscopy increase the diagnostic accuracy of endoscopic examinations in the presence of lesions not easily detectable. The aim of this review is to analyze the current diagnostic standards in the presence of occult urothelial cancer.
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http://dx.doi.org/10.5301/uro.5000131DOI Listing
May 2016

NBI: results review.

Urologia 2015 Oct 9;82 Suppl 2:S9-11. Epub 2015 Oct 9.

Fondazione Policlinico Universitario A. Gemelli, Catholic University of the Sacred Heart, Rome - Italy.

The narrow band imaging (NBI) is a new technology introduced to complement the traditional endoscopy in order to enhance the detection of nonmuscle-invasive bladder cancer and, consequently, to improve the management of the disease. In this review, we considered the most important studies about the use of NBI in the diagnosis and treatment of bladder cancer. Current results demonstrate a greater sensitivity in the diagnosis of bladder cancer and especially a better negative predictive value of cystoscopy enhanced by NBI technology than white light standard cystoscopy. Similarly, improving the performance of endoscopic resection, this new technology would have a positive therapeutic impact in order to decrease residual tumors and relapses. The validation of the results and diffusion of NBI in clinical practice may provide new perspectives in the management of nonmuscle-invasive bladder cancer.
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http://dx.doi.org/10.5301/uro.5000155DOI Listing
October 2015

Endourethral migration of a Hem-o-Lok Clip after robot-assisted laparoscopic radical prostatectomy.

Urologia 2015 Oct-Dec;82(4):242-4. Epub 2014 Dec 16.

Department of Urology, "Agostino Gemelli" Hospital - Catholic University Medical School, Rome - Italy.

Hem-o-Lok clips (Weck Surgical Instruments, Teleflex Medical, Durham, North Carolina, USA) are widely used in robot-assisted laparoscopic radical prostatectomy because of their easy application and secure clamping. To date, there have been some reports of their migration into the urinary tract, causing urethral erosion, bladder neck contractures orcalculus formation. We report a case of endourethral migration of a hem-o-lok after robot-assisted laparoscopic prostatectomy. The hem-o-lok was almost completely endoluminal and attached to one end at the vesico-urethral anastomosis. The hem-o-lok was easily removed cystoscopically by using an endoscopic forceps.
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http://dx.doi.org/10.5301/uro.5000106DOI Listing
April 2017

[Innovative treatments of non muscle invasive bladder cancer].

Urologia 2013 Apr-Jun;80(2):120-6. Epub 2013 Jul 5.

Università Cattolica del Sacro Cuore, Facoltà di Medicina e Chirurgia "A. Gemelli", Roma - Italy.

Bladder cancer represents the second most common neoplasm of the urinary tract and the fourth in general among all the neoplastic pathologies for the male gender; in females, it is the eighth most frequent among all cancers. At the initial diagnosis, 70% of bladder tumors are non-muscle invasive. Treatment of this stage is multimodal, both surgical and pharmacological; the aim is not only to remove the tumor completely but also to prevent tumor recurrence and to inhibit its progression. The treatment for non-muscle invasive bladder cancer is a current topic in the scientific community and it is represented by the endoscopic resection of the tumor, which is generally followed by the adjuvant intravesical treatment with chemotherapy or immunotherapy agents, according to the different risk groups. Benefits and limits of intravesical therapies have been known for long; the aim of this study is to present new drugs or new treatment patterns which could emerge as a valid therapeutic alternative to conventional treatments, given the fact that, regardless of the type of treatment, 2/3 of the patients with a diagnosis of non-muscle invasive bladder cancer have a disease recurrence, and the 10-20% of these show a progression to a muscle-invasive tumor. Furthermore, the failure of intravesical therapy implies another therapeutic option, such as radical cystectomy for non-muscle invasive bladder cancer. According to this fact, new strategies include the activation of host immune system and the optimization of cytotoxic effects of chemotherapeutic drugs. Although most of these studies are still in a pre-clinical phase, the experimental outcomes and the initial results in humans are encouraging.
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http://dx.doi.org/10.5301/RU.2013.11302DOI Listing
May 2014

[Second-line intravesical therapy. What is the present role of device-assisted therapy?].

Urologia 2013 22;80 Suppl 21:37-41. Epub 2013 Mar 22.

Clinica Urologica, Università Cattolica del Sacro Cuore, Roma - Italy.

Non-muscle-invasive bladder cancer is a common urinary malignancy whose management is a challenge: strong evidence supports the use of passive intravesical chemotherapy in the management of this tumor. Despite current guidelines, the treatment is suboptimal as illustrated by the high risk of recurrence and progression. Bacillus Calmette-Guérin (BCG) is the gold standard for the treatment of high-grade non-muscle-invasive bladder cancer, but in case of disease persistence, after 2 consecutive induction courses of BCG, patients must undergo radical cystectomy. We discuss options for second-line adjuvant therapy for non-muscle-invasive bladder cancer in standard treatment non-responder patients. We investigated the use and application of device-assisted therapy for the intravesical treatment of bladder cancer, such as thermochemotherapy (TCT) and electromotive drug administration (EMDA). Many studies demonstrate their synergistic therapeutic effect, greater than the single treatment with chemotherapy, inducing an increased absorption of the chemotherapeutic agent (Mitomycin C) to the urothelium. TCT and EMDA are safe and effective in terms of outcomes. For the future it will be important to encourage the use of the existing technology within the appropriate clinical indications.
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http://dx.doi.org/10.5301/RU.2013.10863DOI Listing
August 2013

Improving flexible ureterorenoscope durability up to 100 procedures.

J Endourol 2012 Oct 11;26(10):1329-34. Epub 2012 Jul 11.

Department of Urology, Cristo Re Hospital, Via delle calasanziane 25, Rome, Italy.

Background And Purpose: Controversy exists in the literature regarding flexible ureterorenoscopy (F-URS) durability, with a variable expected number of uses from a new F-URS. In this study, a tertiary center experience with the use of two consecutive F-URS is reported and suggestions as to how to improve durability further are made.

Materials And Methods: All F-URS performed in the same tertiary care center between July 2009 and February 2011, with two new instruments Flex-X, were reviewed retrospectively. All renal pathology were included. Ureteral cases were excluded. A 9.5F semirigid ureteroscope was always used at the start for a ureteral optical predilation and to explore the upper urinary tract for possible lithotripsy/laser ablation/biopsy. The F-URS was introduced sequentially to explore the remaining calices. Data pertaining to the procedure were collected. The method of sterilization was complete immersion with Cidex®.

Results: The instruments were substituted after 113 and 102 procedures, respectively. The first F-URS was used for a total operative time of 79 hours and 10 minutes while the second one was used for 71 hours and 25 minutes (mean 75 hours and 15 min). Procedure duration was 15 to 175 minutes (mean 58 min). The flexible instruments were used for a mean of 42 minutes per procedure (range 13-153 min). The indications for F-URS were therapeutic in 75.4% and diagnostic in 22.8% of the cases. For lower pole calculi, the stone was relocated in 65.2% and managed with the nonflexed flexible instrument 90% of the time. The most common causes of damage of F-URS were: Deflection mechanism impairment, inner sheath damage, and fiberoptic bundle breaks.

Conclusions: Increased durability of F-URS was from a variety of factors, a key element of which was the method of sterilization, while routine use of the semirigid instrument initially further contributed significantly to increase the number of F-URS procedures, saving overall costs.
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http://dx.doi.org/10.1089/end.2012.0178DOI Listing
October 2012

[Therapy for non-muscle invasive bladder cancer: HP-NAP].

Urologia 2012 Apr-Jun;79(2):142-8

Clinica Urologica, Università Cattolica del Sacro Cuore, Roma, Italy.

Purpose: Patients with non-muscle invasive bladder cancer recurrence after 2 induction courses of BCG are eligible for radical cystectomy. So, in the last years research to discover new drugs for the management of non-muscle invasive bladder cancer recurrence after failure of first and second line therapy is ongoing. In accordance to the results obtained with BCG, whose mechanism depends on the induction of the T helper 1 (TH1) immune response, we investigated the activity of a Toll-like receptor (TLR) 2 ligand, named Helicobacter Pylori Neutrophil Activating Protein (HP-NAP), that we recently demonstrated being able of enhancing the differentiation of Th1 cells, both in vitro and in vivo, because of its ability to create an IL-12 enriched milieu.

Materials And Methods: We show here, in a mouse model of bladder neoplasm implants, that local administration of HP-NAP decreases tumor growth by inducing tumor necrosis.

Results: The result is joined up with a massive cluster of both CD4+ and CD8+ IFN-γ+ cells, within neoplasm and regional lymph nodes. It is of note that HP-NAP-treated tumors show also a reduced vascularization due to the anti-angiogenic activity of IFN-γ induced by HP-NAP.

Conclusions: The present study suggests that the activity of HP-NAP against urothelial tumor burden warrants subsequent in vivo studies.
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http://dx.doi.org/10.5301/RU.2012.9189DOI Listing
October 2012

First collaborative experience with thulium laser ablation of localized upper urinary tract urothelial tumors using retrograde intra-renal surgery.

Arch Ital Urol Androl 2011 Sep;83(3):147-53

Department of Urology, Cristo Re Hospital, Rome, Italy.

Purpose: Thulium laser ablation (TLA) outcomes with blinded performance evaluation after retrograde intra-renal surgical (RIRS) treatment of upper urinary tract transitional cell carcinomas (UUT-TCC).

Materials And Methods: A UUT-TCC patient cohort undergoing RIRS-TLA by an international endoscopic surgical collaboration in a European center (April 2005-July 2009), underwent outcomes evaluation. All 4 surgeons were blinded and independently scored both TLA and Holmium:YAG laser ablation performance aspects annually using a Likert scoring system (0-10).

Results: All patients (n = 59, median age 66 years, 9 with solitary kidney) had complete UUT inspection. Presenting lesion(s) were intra-renal (n = 30, 51%), ureteral (n = 13, 22%), and combined (n = 16, 27%). Single-stage TLA sufficed in 81.4% (tumors < 1.5 cm). Significant recurrence free survival differences occurred according to primary tumor size >/< 1.5 cm and multi-focality, but location made no difference. Median Likert scores were i) fiber-tip stability --5.5/8.75, p = 0.016; ii) reduced bleeding--5/8.5, p = 0.004; iii)fiber-tip precision--5.5/8.5, p = 0.003; iv) mucosal perforation reduction--3.5/7.5, p = 0.001; v) ablation efficiency tumors < 1.5 cm--6/9, p = 0.017; tumors > 1.5 cm--6.75/6.75, p = 1, and vi) overall efficiency--6/7.5, p = 0.09, for Holmium:YAG and TLA, respectively.

Conclusions: The Thulium laser delivered non-inferior recurrence free survival to RIRS-UUT-TCC Holmium:YAG laser ablation, but better median parameter performance scores in fiber-tip stability, precision, reduced bleeding and mucosal perforation reduction in expert ratings. Despite improved photothermal coagulation, and endo-visualization for tumors < 1.5 cm, both ablation and overall efficiency remained challenging for larger tumors with both existing laser technologies.
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September 2011