Stesura Seveso Archivio Italiano di Urologia e Andrologia 2023; 95(4):12138 1 ORIGINAL PAPER INTRODUCTION Persistent urinary incontinence (UI) after radical prostatec- tomy (RP), commonly referred to as post-prostatectomy incontinence (PPI), is an adverse event that leads to sig- nificant distress. Ficarra et al. (1) found that for a "no pad" definition of UI, rates ranged from 4% to 31%, with a mean of 16%. The PPI is influenced by muliple elements, anatomic com- ponents and biological factors (2). The anatomic compo- nents that influence on urinary continence, after RP, are the urethral sphincter complex, the supporting structures of the membranous urethra (3), the fibrosis after surgery (4), the neural components (5-8), the zone of urothelium coaptation. The biological factors contributing to PPI are the age (9), the functional bladder changes (10), the body mass index (11), pre-existing low urinary tract symptoms (12), TURP before RP (13), the prostate size (14) and the membranous urethral length (15). The urethral sphincter complex consists of two functional- ly independent components, an internal or lissosphincter of smooth muscle and an outer or external rhabdosphinc- ter of skeletal muscle, that are thought to be responsible for passive and active continence, respectively (16). The inter- nal sphincter maintains continence during normal activity when there is little stress on the bladder outlet. Its smooth muscle maintains tone for long periods with minimal exer- tion. The external urethral sphincter is a muscle that is very strong but becomes fatigued very quickly. The urothelium is surrounded by elastic tissue and fibers Introduction: The post-prostatectomy inconti- nence is influenced by multiple elements, anatomic components and biological factors. The bladder neck preservation, more accurate during robot assisted radical prostatectomy, works on two anatomic components responsible for post-prostatectomy continence. The bladder neck preserva- tion spares the internal sphincter, which is responsible for pas- sive continence, and results in earlier return to continence and lower rates of post-prostatectomy incontinence. Moreover, this surgical technique spares the zone of urothelium coaptation and provides primary resistance to the urine to maintain post- prostatectomy continence. The potential risk of bladder neck positive surgical margins (PSM) may prevent the usage of the bladder neck preservation. Aim: The purpose of this study is to evaluate the surgical and pathological outcome in prostate cancer patients underwent robot assisted radical prostatectomy with bladder neck preser- vation. Materials and methods: Prospectively, we have collected demo- graphic, clinical, surgical and pathological data of prostate can- cer patients underwent robot assisted radical prostatectomy with bladder neck preservation, from January 2014 to December 2016, in Urological Clinic of the University of Padua. Moreover, it was valued the presence of alterations or continuous solutions of specimen external capsule, attributable to the surgical tech- nique of bladder neck preservation, by microscopic and macro- scopic pathological analysis. Results: According to D'Amico risk classification, 40 patients (45.4%) had a low risk neoplasia, 35 patients (39.8%) had an intermediate risk neoplasia, 13 patients (14.8%) had an high risk neoplasia. The median prostatic volume, valued on speci- men, was 30.84 cc (21.5-44.75 cc). The median prostatic weight, valued on specimen, was 51 gr (36-67 gr). The pathological stage of disease was pT2a in 11 cases (12.5%), pT2b in 37 cases (42.1%), pT3a in 28 cases (31.8%), pT3b in 12 cases (13.6%). The pathological stage of lymph node involvement was pNx in 17 cases (19.3%), pN0 in 66 cases (75%), pN1 in 5 cases (5.7%). The prostate cancers diagnosed had a Gleason score at speci- men of 6 in 10 cases (10.4%), 7 (3+4) in 30 cases (34.1%), 7 (4+3) in 20 cases (22.7%), 8 in 19 cases (21.6%) and 9 in 9 cases (10.2%). The prostatic base was involved by neoplasia in 14 patients (15.9%); of these, 5 patients (35.7%) had bladder neck PSM. The patients with bladder neck PSM had: a patholog- ical stage of disease as pT3a in 2 cases (40%) and pT3b in 3 cases (60%); a pathological stage of lymph node involvement as pN0 in 2 cases (40%) and pN1 in 3 cases (60%); a Gleason score at specimen of 8 in 3 cases (60%) and 9 in 2 cases (40%); The bladder neck preservation in robot assisted radical prostatectomy: Surgical and pathological outcome Michele Zazzara 1, Marina P. Gardiman 2, Fabrizio Dal Moro 1 1 Urology Clinic, Department of Surgical Oncological and Gastroenterological Sciences, University of Padua, Padua, Italy; 2 Surgical Pathology and Cytopathology Unit, Department of Medicine, University of Padua, Padua, Italy. DOI: 10.4081/aiua.2023.12138 Summary multiple PSM. Nobody had alterations or continuous solutions of specimen external capsule, attributable to surgical technique of bladder neck preservation. Conclusions: The bladder neck preservation, during robot assist- ed radical prostatectomy, is a safe oncological procedure result- ing in a good functional outcome, about post-prostatectomy con- tinence, working on two anatomic components responsible for post-prostatectomy continence. The bladder neck PSM are linked to neoplasia with adverse pathological features, rather than the bladder neck preservation. KEY WORDS: RARP; Bladder Neck Sparing Surgery; Prostate cancer. Submitted 27 November 2023; Accepted 30 November 2023 Archivio Italiano di Urologia e Andrologia 2023; 95(4):12138 M. Zazzara, M.P. Gardiman, F. Dal Moro 2 of smooth and striated muscle. At the junction of the infe- rior bladder and the proximal urethra, the urothelium becomes a key component of sphincter function. The elas- tic components of the proximal urethral wall are responsi- ble for coaptation of the urothelium (zone of coaptation). This proper adhesion of the urethral wall provides primary resistance to the urine to maintain continence (17). Little is known about the optimal length of the zone of coapta- tion. It is hypothesized that it should be at least 5-10 mm to ensure continence (18). The bladder neck preservation (BNP), more accurate during robot assisted radical prostatectomy (RARP), works on these two anatomic components responsible for post-prostatec- tomy continence influencing PPI. The potential risk of bladder neck PSM may prevent the usage of the BNP. The current study investigates the surgical and patholog- ical outcome of BNP in prostate cancer patients treated with RARP. MATERIALS AND METHODS Between January 2014 and December 2016, 88 patients with prostate cancer underwent daVinci® RARP with BNP at the Urology Department of the University of Padua. We prospectively collected demographic data including age, body mass index, comorbidities, previous surgery, erectile function as per the International Index of Erectile Function 5 (IIEF-5) questionnaire (19), and lower urinary tract symptoms as per the International Prostate Symptom Score (IPSS) questionnaire (20), as well as clinical data including prostate-specific antigen status, clinic stage according to tumor, node, and metastasis staging (21), bioptic Gleason Score (22) and D’Amico risk classification (23) for each patient. Surgical data including total opera- tive duration, blood loss, whether a transfusion was per- formed, time to drain removal, time to cystography and time to catheter removal were also recorded. The BNP was considered reached when the diameter of the BN was adequate to the diameter of the urethra, not requiring BN neck reconstruction before anastomosis. All surgical procedures were performed by the same expert surgeon. The prostate specimen was formalin fixed in the standard manner; the paraffin-embedded specimen was examined histologically in the form of 4-mm, whole mount, haema- toxylin and eosin stained sections. Therefore, the speci- men was examined in its entirety in every case. A positive surgical margin was defined as the presence of tumour at the inked margin (24). Therefore, for each patient we evaluated the following pathological parameters: site and side of the tumour, definitive Gleason Score, pathological extension of the primary tumour and the lymph node involvement. Moreover, it was valued the presence of alterations or continuous solutions of specimen external capsule, attributable to the surgical technique of bladder neck preservation, by microscopic and macroscopic pathological analysis. A single expert uro-pathologist reviewed all RP specimens. This study did not receive any funding. All patients pro- vided written informed consent for the procedures described herein. Descriptive data are presented as the mean ± standard deviation or median (interquartile range). RESULTS Table 1 summarizes patient demographic and clinical data. The mean patient age was 64.77 ± 6.75 years and the mean body-mass index was 26.73 ± 3.04 kg/m2. The median IPSS score was 9 (4,5-14) and the median IIEF-5 score was 17 (11-23). The median prostate-specific anti- gen value was 6.09 ng/ml (4.92-8.01 ng/ml). The median prostatic volume was 40 cc (38.75-50 cc). Clinical stag- ing was cT1c in 51 patients (58%), cT2a in 26 patients (29.5%), cT2b in 8 patients (9.1%), cT2c in 2 patients (2.3%) and cT3a in 1 patient (1.1%). The bioptic Gleason score was 6 in 48 patients (54.6%), 7 [3 + 4] in 27 patients (30.7%), 7 [4 + 3] in 3 patients (3.4%), 8 in 9 patients (10.2%), 9 in 1 patient (1.1%). As per the D'Amico risk classification, 40 patients (45.4%) had low- risk prostate cancer, 35 patients (39.8%) had intermedi- ate-risk prostate cancer, and 13 patients (14.8%) had high-risk prostate cancer. Table 2 summarizes pathological data. The median prosta- tic volume, valued on specimen, was 30.84 cc (21.5-44.75 cc). The median prostatic weight, valued on specimen, was 51 gr (36-67 gr). Pathological stage was pT2a in 11 cases (12.5%), pT2b in 37 cases (42.1%), pT3a in 28 cases (31.8%), pT3b in 12 cases (13,6%). The pathological stage of lymph node involvement was pNx in 17 cases (19.3%), pN0 in 66 cases (75%), pN1 in 5 cases (5.7%). The prostate cancers diagnosed had a Gleason score at speci- men of 6 in 10 cases (10.4%), 7 (3+4) in 30 cases (34.1%), 7 (4+3) in 20 cases (22.7%), 8 in 19 cases (21.6%) and 9 in 9 cases (10.2%). The prostatic base was involved by neoplasia in 14 patients (15.9%); of these, 5 patients (35.7%) had bladder neck PSM. The patients with bladder neck PSM had: a pathological stage of disease as pT3a in 2 cases (40%) and pT3b in 3 cases (60%); a pathological Table 1. Patient demographic and clinical data. Parameter Value Age (years) (64.77 ± 6.75) BMI (kg/m2) (26.73 ± 3.04) IPSS score (9; 4.5-14) IIEF-5 score (17; 11-23) Prostatic volume (cc) (40; 38.75-50) PSA (ng/ml) (6.09; 4.92-8.01) Bioptical Gleason score - 6 48 (54.6%) - 7 (3+4) 27 (30.7%) - 7 (4+3) 3 (3.4%) - 8 9 (10.2%) - 9 1 (1.1%) cT - cT1c 51 (58%) - cT2a 26 (29.5%) - cT2b 8 (9.1%) - cT2c 2 (2.3%) - cT3a 1 (1.1%) D'Amico risk classification - Low risk 40 (45.4%) - Intermediate risk 35 (39.8%) - High risk 13 (14.8%) Archivio Italiano di Urologia e Andrologia 2023; 95(4):12138 3 Bladder neck preservation in robot assisted radical prostatectomy stage of lymph node involvement as pN0 in 2 cases (40%) and pN1 in 3 cases (60%); a Gleason score at specimen of 8 in 3 cases (60%) and 9 in 2 cases (40%); multiple PSM. Nobody had alterations or continuous solutions of speci- men external capsule, attributable to surgical technique of bladder neck preservation. The median time to cystogra- phy was 6 days (4.5-14). In one case, there was anasto- mosis urinary leakage at cystography (1.13%). DISCUSSION The bladder neck preservation spares the internal sphinc- ter, which is responsible for passive continence, and results in earlier return to continence and lower rates of post-prostatectomy incontinence (25-27). Moreover, this surgical technique spares the zone of urothelium coapta- tion and provides primary resistance to the urine to main- tain post-prostatectomy continence (17). Thus, the BNP is a surgical factor contributing to PPI, act- ing on two anatomic components influencing PPI. The other anatomic components are the targets of several sur- gical procedure, as supporting structures of the membra- nous urethra are the targets of anterior fixation or poste- rior reconstruction, as the neural components are the tar- gets of nerve-sparing surgery. Therefore, the continence recovery after RP is multifactor- ial and its achievement is due to several surgical approach- es and not exclusively to a single surgical procedure. For this reason, in our study, it was not investigated the conti- nence outcome. The current study investigates the surgical and pathological outcome of BNP during RARP. In fact, the potential risk of bladder neck PSM may prevent the usage of the BNP. Nowadays, this topic is controversial; some authors sup- port that BNP may raise the bladder neck PSM (8, 29), contrarily, a meta-analysis (30) and other studies (31-36), support that the BNP would not compromise the onco- logical control of disease and that the mini-invasive approach, in particular RARP, and the best imaging diag- nostic tools may allow a more safe procedure. To address this controversy, we have evaluated in our study the presence of alterations or continuous solutions of specimen external capsule, attributable to the surgical technique of BNP, by microscopic and macroscopic pathological analysis. In our series, no specimen exhibit- ed alterations or continuous solutions of specimen exter- nal capsule, referring to the surgical technique of BNP. However, in 5 of the 14 cases (35.7%) with basal tumor, there were bladder neck PSM. Evaluating the pathological features of these cases, it was shown an extraprostatic extension of disease (pT3a-3b), a low grade of disease dif- ferentiation (G.S. 8-9), a lymph node involvement in more part of them, multiple PSM and not exclusive of BN; therefore, all patients with bladder neck PSM showed unfavorable pathological features. According to Golabeck (34), the potential risk of bladder neck PSM would be linked to neoplasia with extraprosta- tic extension and a low grade of disease differentiation. Our study shows that BNP during RARP doesn't cause alterations or continuous solutions of specimen external capsule, attributable to the surgical technique of bladder neck preservation, by microscopic and macroscopic pathological analysis, and that the bladder neck PSM are linked to neoplasia with adverse pathological features, rather than the BNP. Moreover, all case with bladder neck PSM showed multiple PSM, and, therefore, the PSM would be present regardless of BNP. There are several limitations to this study. Although the data on our patients are collected prospectively, there isn't a control group, the patients are not randomized, and the number of patients is weak. Moreover, the BN approach was decided intraoperatively. Thus, it is possible that patients were selected according to individual features and technical considerations encountered intraoperatively. Cases of large prostate, prominent middle lobe or more dif- ficult dissection would likely be spared the BNP approach. CONCLUSIONS The BNP during RARP is a safe oncological procedure resulting in a good functional outcome, about post-prosta- Table 2. Patient pathological data. Parameter Value Prostatic volume (cc) (30.84; 21, 5-44, 75) Prostatic weight (gr) 51; 36-67) pT - pT2a 11 (12.5%) - pT2b 37 (42.1%) - pT3a 28 (31.8%) - pT3b 12 (13.6%) pN - pNx 17 (19.3%) - pN0 66 (75%) - pN1 5 (5.7%) Gleason score - 6 10 (10.4%) - 7 (3+4) 30 (34.1%) - 7 (4+3) 20 (22.7%) - 8 19 (21.6%) - 9 9 (10.2%) Tumor site - Base 14 (15.9%) - Other sites 74 (84.1%) Basal PSM - Present 5 (35.7%) - Absent 9 (64.3%) pT in patients with basal PSM - pT3a 2 (40%) - pT3b 3 (60%) pN in patients with basal PSM - pN0 2 (40%) - pN1 3 (60%) Gleason score in patients with basal PSM - 8 3 (60%) - 9 2 (40%) Multiple PSM in patients with basal PSM - Present 88 (100%) - Absent 0 (0%) Continuous solutions of specimen external capsule due to surgery - Present 0 (0%) - Absent 88 (100%) Archivio Italiano di Urologia e Andrologia 2023; 95(4):12138 M. Zazzara, M.P. Gardiman, F. Dal Moro 4 tectomy continence, working on two anatomic compo- nents responsible for post-prostatectomy continence. 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Laparoscopic radical prosta- tectomy with bladder neck preservation: positive surgical margin and urinary continence status. Wideochir Inne Tech Maloinwazyjne. 2014; 9:362-70. 34. Gomez CA, Soloway MS, Civantos F, Hachiya T. Bladder neck preservation and its impact on positive surgical margins during rad- ical prostatectomy. Urology. 1993; 42:689-93. 35. Bianco FJ, Grignon DJ, Sakr WA, et al. Radical prostatectomy with bladder neck preservation: impact of a positive margin. Eur Urol. 2003; 43:461-6. 36. Gawlas W, Golabek T, Hessel T, et al. Bladder neck preservation and the risk of positive surgical margins after laparoscopic radical prostatectomy. Eur Urol, Suppl. 2014; 13:e1275. Correspondence Michele Zazzara, MD michele.zazzara@gmail.com Fabrizio Dal Moro, MD Urology Clinic, Department of Surgical Oncological and Gastroenterological Sciences, University of Padua, Padua, Italy Marina P. Gardiman, MD Surgical Pathology and Cytopathology Unit, Department of Medicine, University of Padua, Padua, Italy Conflict of interest: The authors declare no potential conflict of interest.