Archivio Italiano di Urologia e Andrologia 2017; 89, 3186 ORIGINAL PAPER The impact of bladder neck sparing on urinary continence during laparoscopic radical prostatectomy; Results from a high volume centre Ali Serdar Gozen 1, Yigit Akin 2, Mutlu Ates 3, Marcel Fiedler 1, Jens Rassweiler 1 1 Department of Urology, SLK-Klinikum Heilbronn, University of Heidelberg, Heilbronn, Germany; 2 Department of Urology, Izmir Katip Celebi University School of Medicine, Izmir, Turkey; 3 Department of Urology, Antalya Teaching and Research Hospital, Antalya, Turkey. Objective: To evaluate the effects of bladder neck reconstruction techniques on early con- tinence after laparoscopic radical prostatectomy (LRP). Materials and methods: This non-randomized retrospective study analyzed prospectively collected data concerning LRP. In total, 3107 patients underwent LRP between March 1999 and December 2016. Exclusion criteria were preoperative uri- nary incontinence, previous history of external beam radiother- apy, co-morbities which may affect urinary continence such as diabetes mellitus and/or neurogenic disorders, irregular follow- up, and follow-up shorter than 24 months. All patients were divided into one of three groups, posterior reconstruction being performed in Group 1 (n = 112), anterior reconstruction in Group 2 (n = 762), and bladder neck sparing (BNS) in Group 3 (n = 987). Demographic and pre-, peri-, and postoperative data were collected. Multivariate analyses were performed to deter- mine factors affecting early continence after LRP. Results: 1861 patients were enrolled in the study. The mean follow-up period was 48.12 ± 29.8 months, and subjects’ mean age was 63.6 ± 6.2 years. There was no significant difference among the groups in terms of demographic or preoperative data. Postoperative data, including oncological outcomes, were similar among the groups. The level of early continence was higher in Group 3 than in the other groups (p < 0.001). Multivariate analyses identified BNS and age as parameters significantly affecting early continence levels after LRP (p < 0.001 and p < 0.001, respectively). Bladder neck recon- struction provided less earlier continence than BNS. KEY WORDS: Bladder neck; Laparoscopy; Surgery; Prostate cancer; Radical prostatectomy; Urinary continence. Submitted 10 May 2017; Accepted 2 June 2017 Summary No conflict of interest declared. successfully used as contemporary surgical options in organ-confined PCa with similar oncological and fuction- al results (4). However, the RALP procedure, including the robotic device,is still expensive. LRP thus still assumes a more important place among surgical treat- ment options for PCa. Although LRP can provide the well-known advantages of laparoscopy, urinary inconti- nence is one of the main functional problems that can concern patients after surgery. In addition, incontinence has an adverse impact on quality of life and causes indi- rect workforce losses (5). Early continence is therefore important for rapid recovery after LRP. The level of con- tinence ranges between 60% and 94% at short-term fol- low-ups (6, 7). This variation may be also due to differ- ent definitions of continence levels and different follow- up strategies. Various surgical modifications, such as bladder neck sparing (BNS), have been introduced for early continence (8, 9). However, in addition to surgical mod- ifications for providing early continence, surgeons are also consistently developing new techniques for achiev- ing continence in the light of improvements in endouro- logical technology (10). Nonetheless, the exact factors affecting urinary continence after LRP have not yet been clearly defined. Additionally, to the best of our best knowledge, no comparison of techniques performed on the bladder neck, such as posterior reconstructions, ante- rior reconstructions and BNS, in LRP have to date been reported in the literature. The purpose of thıs study was to investigate BNS and bladder neck reconstruction tech- niques in term of providing early continence after LRP. MATERIALS AND METHODS This study represents a non-randomized retrospective view of prospectively collected data. All patients fully under- stood the treatment and aim of the study and provided written informed consent. All data were recorded prospec- tively on a Microsoft Office Excel spreadsheet. This series is part of an ongoing LRP project in our department. Patient selection We identified 3107 patients undergoing LRP due to organ- confined PCa between March 1999 and December 2016. DOI: 10.4081/aiua.2017.3.186 INTRODUCTION Prostate cancer (PCa) is the most common solid organ cancer among men worldwide (1). Although there are different ways to treat PCa, radical prostatectomy (RP) is still the gold standard treatment modality for organ-con- fined PCa (2, 3). Nearly two-thirds of PCa cases are con- fined to the prostate and can be treated by RP (3). Recently, minimally invasive surgical techniques, such as laparoscopic radical prostatectomy (LRP) and robotic-assist- ed laparoscopic radical prostatectomy (RALP), have been Gozen _Stesura Seveso 28/09/17 10:15 Pagina 186 187Archivio Italiano di Urologia e Andrologia 2017; 89, 3 BNS and early continence in LRP Exclusion criteria were preoperative urinary incontinence, previous history of external beam radiotherapy, comor- bidities which may affect urinary continence, such as dia- betes mellitus and/or neurogenic disorders, irregular fol- low-up, and a follow-up duration of less than 24 months. Finally, 1861 patients were enrolled into the study. All LRP patients were divided into three groups depending on BNS or bladder neck reconstruction techniques in order to evaluating the impact of these on early continence after surgery. Group 1 (n = 112) consisted of patients undergoing posterior reconstruction (dorsal reconstruc- tion), Group 2 (n = 762) of patients undergoing anterior reconstruction (ventral reconstruction), and Group 3 (n = 987) of patients undergoing BNS. Subgroups based on early and late continence status were also established. Factors affecting early continence were investigated. Data collection Patient data including age, body mass index (BMI), pre- operative prostate specific antigen (PSA), previous opera- tions, co-morbidities, clinical stage, operation time, surgi- cal methods used for bladder neck reconstruction, nerve sparing surgery, estimated blood loss (EBL), prostate vol- ume, length of hospital stay, duration of urethral catheter, histopathological and oncological outcomes and urinary continence rates were recorded. Potency was defined as erection sufficient for intercourse, with or without med- ication. Patients were administered International Index of Erectile Functions (IIEF) questionnaires, before and after surgery. Patients with IIEF-5 scores ≤ 11 were regarded as having erectile dysfunction (ED). Surgical techniques The Heilbronn ascending LRP technique has been described previously in the literature (11, 12). Pelvic lymph node dissections were performed in an extended fashion for patients with PSA > 10 ng/mL and/or a Gleason score > 6. Urethro-vesical anastomoses were performed with continuous sutures as described by van Velthoven, including reconstruction of the bladder neck (13). Posterior reconstruction technique This technique was used in cases with a large prostate, with a large median lobe, with a possible bladder neck invasion and in case of a previous transurethral resection of prostate (Group 1). The bladder neck should be recon- structed in these cases, after the necessary wide resection. Posterior reconstruction began from the distal and close to the trigonal part of bladder neck to the superior part of the bladder neck using a running suture (3/0 Vicryl-V-loc). The bladder neck should resemble a ‘reverse tennis rac- quet’ after the reconstruction (Figure 1), as reported by Sarle et al. (14) A DJ stenting was necessary in 3 cases. Anastomosis was performed after the bladder neck recon- struction using the Van Velthoven technique (10, 11). Anterior reconstruction technique This procedure was performed in the case of bladder neck was larger than urethral lumen (Group 2). Our aim was to reconstruct the bladder neck based on its unique anatomical structures (15). We closed the bladder neck in the form of figure-of-eight stitches, on the ventral side (12 o clock) (Figure 2.). The larger bladder neck has been adjusted in this way to the urethra. Bladder neck sparing technique Group 3 consisted of patients undergoing a full bladder neck preservation. Briefly, the base of the prostate was hold to the ventral side by the application of traction to the urethral catheter balloon. The fatty space between the bladder and the anterior leaf of Denonvilliers’ fascia was observed. Blunt dissections were then performed using a right-angle dissector around the bladder neck. The anterior wall of the bladder neck was incised there- after horizontally, and careful stepwise dissections were performed around the catheter, thus exposing the mus- cle fibers of bladder neck (Figure 3.) Follow-up and continence status Cystography was performed in all cases, on the 7th day of surgery. If no leak was determined, the urethral catheter was removed. All complications were classified according to the modified Clavien classification (16). Indications for Figure 1. Posterior bladder neck reconstruction resembling a “reverse tennis racquet”. The arrow shows the tip of the racquet. Figure 2. Anterior bladder neck reconstruction with “figure-of-eight” stitches on the ventral side of the bladder neck. Gozen _Stesura Seveso 28/09/17 10:15 Pagina 187 Archivio Italiano di Urologia e Andrologia 2017; 89, 3 A. Serdar Gozen, Y. Akin, M. Ates, M. Fiedler, J. Rassweiler 188 adjuvant hormone therapy and radiotherapy were deter- mined using the Walz score (17). Self-administered mod- ified International Continence Society questionnaires were used to evaluate early continence status. This was also evaluated by physical examination, including the Valsalva or cough stress tests. All patients were advised to perform Kegel's exercises after removal of the urinary catheter. No patients received any surgical treatment for stress urinary incontinence during 24-month follow-up after LRP. Safety pads were applied before the tests. Patients without urine leakage during coughing or sneez- ing, as well as those who stayed totally dry, were considered urinary continent. Patients who were consistently dry but used a safety pad occasional- ly during normal daily activity (ie, work, exercise, and walking) were considered continent. Patients who used more than one protective pad per day and/or who experienced urine leak during cough- ing, sneezing or nocturnally were considered incontinent. Time to continence was classified into two time intervals; early (within 3 months after LRP), and late continence (4-24 months after LRP). Continence status was evaluated at the 1st and 3rd month after LRP by physical examinations including the tests summarized above. Continence status was then assessed at quarterly intervals within the first year and semi-annually thereafter. The BNS and reconstruction tech- niques, nerve sparing surgical techniques, clinical stage, BMI, age, prostate volume, duration of ure- thral catheter use, and oncological results were evaluated using multivariate analyses in order to determine the factors affecting continence. All postoperative complications were evaluated based on modified Clavien-Dindo classifications (18). Statistical analysis Associations in the subgroups were examined using the Chi square, One Way Anova and Kruskal Wallis tests. Multivariate logistic regression analyses were performed to evaluate factors affecting early continence. All statisti- cal tests were performed on Statistical Package for Social Sciences, version 16.0 (SPSS, Chicago, IL) software. Statistical significance was set at p < 0.05. RESULTS The mean follow-up period was 48.12 ± 29.8 months, and mean age was 63.6 ± 6.2 years. Mean values for demo- graphic data are shown in Table 1. No significant differ- ence was determined among the groups in terms of demo- graphic data. Parameters including mean PSA, clinical stage, and prostate volume were also comparable between the groups. These are summarized in Table 2. Operative and postoperative data are presented in Table 3. No significant difference was determined between the groups in terms of operative time (p < 0.001). Levels of nerve sparing surgical techniques, EBL, hospital stay, and duration of catheterization were similar among the groups (Table 4). Table 1. Details of demographic and operative data. Table 2. Perioperative results of groups. Parameter Data Mean age 63.9 ± 6.2 Mean BMI 26.8 ± 1.2 Mean PSA 10 ± 3.7 Mean prostate volume 36.2 ± 16.5 BMI: Body mass index; PSA: Prostate specific antigen. Figure 3. The bladder neck sparing surgical technique. Anatomical dissections were able to be performed to separate the bladder neck and prostate. The yellow arrows shows the neurovascular bundle. Parameter Group 1 Group 2 Group 3 P (n = 112) (n = 762) (n = 987) value Mean age (years) One way anova 64.5 ± 5.9 64 ± 5.9 63.7 ± 6.4 0.26 BMI (kg/m2) < 25 (n,%) 35 (30.7%) 242 (31.7%) 335 (33.6%) 0.76 Chi square 25-30 (n,%) 43 (37.7%) 283 (37%) 377 (37.8%) > 30 (n,%) 36 (31.5%) 238 (31.1%) 284 (28.5%) Mean PSA (ng/ml) One way anova 10 ± 7 9.8 ± 6.4 10.1 ± 12.4 0.86 Clinical stage (n, %) Chi square T1 22 (19.2%) 150 (19.6%) 231 (23.1%) 0.42 T2 57 (50%) 367 (48%) 452 (45.3%) T3 35 (30.7%) 246 (24.6%) 313 (31.4%) Prostate volume (cc) (n, %) Chi square ≤ 50 93 (81.5%) 637 (83.4%) 844 (84.7%) 0.59 > 50 21 (18.4%) 126 (16.5%) 152 (15.2%) Mean prostat volume One way anova) 38.6 ± 18.8 35.6 ± 18 36.4 ± 14.9 0.15 BMI: Body mass index; PSA: Prostate specific antigen. Gozen _Stesura Seveso 28/09/17 10:15 Pagina 188 189Archivio Italiano di Urologia e Andrologia 2017; 89, 3 BNS and early continence in LRP No significant difference were also determined in terms of pathological findings, including patho- logical stage, Gleason score, positive surgical margins, and biochemical recurrence. Complication rates were similar in the groups (Table 5). Forty-two (36.8%) patients in Group 1.374 (49%) patients in Group 2 and 601 (60.3%) patients in Group 3 were continent 3 months after LRP. Continence levels were similar between Group 1 (poste- rior reconstruction) and Group 2 (anterior reconstruc- tions). The level of early continence was higher in Group 3 than in the bladder reconstruction groups (p < 0.001). At multivariate analyses, BNS and age were determined as parameters that significantly affected early continence levels after LRP (p < 0.001 and p < 0.001, respectively) (Table 6). DISCUSSION Urinary continence is an essential parameter for early recovery after LRP (19). Surgical modifications have therefore been introduced in order to provide early con- tinence after prostatectomy in patients with PCa. BNS and bladder neck reconstruction techniques can provide early continence after radical prostatectomy (20). All these surgical techniques can be performed during LRP, which includes the well-known benefits of laparoscopy (12). No published data, including comparisons of all sur- gical techniques with large numbers of patients, after LRP have to date been available. Additionally, the exact factors involved in the provision of early continence had not been identified. To the best of our knowledge, this is the first series with large patient numbers to investigate early con- tinence was investigated after LRP in terms of BNS and bladder neck reconstruction techniques. On the basis of our results, bladder neck reconstruction techniques (Group 1 and Group 2) provided similar continence lev- els. High levels of early urinary continence were achieved with BNS in younger patients after LRP. Clinical stage, nerve sparing surgical technique, biochemical recurrence, and pathological stage did not significant affect early continence levels at multivariate analysis. Stolzenburg et al. reported early continence using BNS after LRP (21). Chlosta et al. achieved similar results in their series of 194 LRP patients (22). Our series involved 987 (53%) BNS patients, 601 (60.3%) of whom were continent in the 3rd month of LRP. The BNS technique contributes a sphincter mechanism which includes striated and smooth muscle fibres (23). Additionally, the striated muscle fibers in the urethra are horseshoe-shaped and these also assist with continence. However, urological stud- Table 3. Details of operative and postoperative data. Parameter Data Mean operation time 212.3 ± 43.4 Mean EBL 828.4 ± 440.6 Mean hospital stay 10.2 ± 4.5 Mean duration of catheter 9.4 ± 4.9 Continence n = 1753, 94.1% Biochemical recurrence n = 337, 18.1% EBL: Estimated blood loss. Table 6. Factors effecting early continence status in multivariate logistic regression analyses. Table 5. Oncological and functional results of groups. Table 4. Peri and postoperative results of groups. Parameter P value BNS surgical technique < 0.001* Anterior reconstruction 0.3 Posterior reconstruction 0.4 Clinical stage 0.47 Age (year) < 0.001* BMI 0.15 Prostate volume 0.28 Preoperative PSA 0.95 Operation time 0.2 Nerve sparing surgical technique 0.06 Duration of urethral catheter 0.3 Surgical margin 0.74 Biochemical recurrence 0.55 BMI: Body mass index; BNS: Bladder neck sparing; PSA: Prostate specific antigen *Statistical significant p value Parameter Group 1 Group 2 Group 3 P (n = 112) (n = 763) (n = 996) value Mean operation time (min.) 212 ± 45 217.3 ± 45.8 208.5 ± 41 < 0.001* Nerve sparing surgery (n,%) 54 (47.3%) 375 (49.1%) 432 (43.3%) 0.052 Mean EBL (ml) 775.4 ± 352.6 824.7 ± 468.4 837.2 ± 427.5 0.34 Mean Hospital stay (day) 9.7 ± 2.8 10.3 ± 3.3 10.3 ± 5.4 0.41 Mean duration of catheter (day) 9.1 ± 4.1 9.4 ± 4.8 9.4 ± 5 0.86 Abbreviations: EBL: Estimated blood loss *Statistical signifiant p value. Parameter Group 1 Group 2 Group 3 P (n = 114) (n = 763) (n = 996) value pT pT0-2 64 (56.1%) 474 (62.1%) 594 (59.6%) 0.35 pT3-4 50 (43.8%) 289 (37.8) 402 (40.3%) Mean prostate volume (cc) 44.8 ± 20.4 44.4 ± 18.3 43.6 ± 17 0.59 Mean pathological < 7 40 (35%) 340 (44.5%) 425 (42.6%) 0.23 Gleason acore (n, %) 7 60 (52.6%) 348 (45.6%) 486 (48.7%) > 7 14 (12.2%) 75 (9.8%) 85 (8.5%) Pozitive surgical margin 34 (29.8%) 178 (23.3%) 237 (23.7%) 0.31 Early continence (n, %) 42 (36.8%) 374 (49%) 601 (60.3%) < 0.001* Biochemical recurrence 21 (18.4%) 160 (20.9%) 196 (19.6%) 0.75 *Statistical significant p value. Gozen _Stesura Seveso 28/09/17 10:15 Pagina 189 Archivio Italiano di Urologia e Andrologia 2017; 89, 3 A. Serdar Gozen, Y. Akin, M. Ates, M. Fiedler, J. Rassweiler 190 ies have shown that these cannot sustain contraction over 60 sec. (24, 25) Smooth muscle fibers of course assist continence. The BNS technique permits the smooth muscle fibers to remain place. We tried to per- form as many BNS procedures in LRP cases as possible. During LRP, these fibers can be preserved more than with open surgical techniques through the well-known advantages of laparoscopy. Rosenblatt et al. reported that bladder neck reconstruction surgical techniques may be required by 10-15% of LRP patients (26). Rocco et al. described a surgical technique for bladder neck recon- struction and reported early continence as one advantage of this (27). In another study, they reported no signifi- cant complications associated with the posterior mus- culofascial plate reconstruction technique, and described reconstruction of the posterior musculofascial plate as encouraging in terms of earlier continence recovery (27). Nevertheless, this subject is still controversial (28). Posterior reconstruction was performed in 114 (4.4%) of our cases. The early continence level was 54% in LRP patients, lower than that achieved with BNS (60.3%). We performed posterior bladder neck reconstruction in 71 (6.1%) cases. Daouacher and Walden recently described anterior and posterior reconstructions during LRP as safe and effective, without affecting voiding or surgical margins (29). In our recent series, anterior reconstruction was performed in 763 (40.9%) cases. Both posterior and anterior reconstructions may provide early continence. However, the level of early continence was statistically significantly higher in Group 3 (BNS) than in the other groups. Poon et al. compared the out- comes of BNS with those of bladder neck repairing tech- niques as anterior and posterior reconstructions in a series of patients undergoing open radical prostatectomy (30). No significant difference was determined in early and late continence levels during follow-up. Our series differs from that of Poon et al. (30). The normal anatomy of the bladder neck was preserved by using laparoscopy in all patients in Group 3. Optic magnification of anatomical structures and the use of precision instru- ments may have contribute to the good results as well as the advanced laparoscopic techniques employed. Katz et al. reported that a wide resection of the bladder neck can decrease positive margins on bladder neck (31). But, this may also have an adverse effect on conti- nence after LRP. However, the positive surgical margin levels were similar among the groups in the present study. Additionally, a positive surgical margin did not emerge as a significant factor in early continence at mul- tivariate analyses. Multivariate analysis identified mean age as a factor affecting early continence. Kadono et al. reported age as a predictive factor for incontinence following minimally invasive surgical treatment of PCa (32). Kumar et al. investigated 3241 patients and concluded similar results (33). Our data are comparable with those previous stud- ies, and early continence was adversely affected by advanced age. This raises the question of early detection of PCa. Robot-assisted laparoscopic prostatectomy (RALP) can provide more anatomical details for surgeons during surgery (25). BNS can thus be performed more accurately during RALP. Tunc et al. reported their early continence results after RALP by presenting a novel tech- nique for BNS. Our results are parallel to those of their study. We think that superior magnification can improve surgeons techniques and learning curves (25). Early con- tinence can thus be established after LRP/RALP, and this will in turn assist early recovery after surgery. The main limitation of this study is that numbers of patients in the groups were not similar, because our sur- gical technique did not usually require bladder neck reconstructions (34). The aim of the present series is to compare BNS and bladder neck repairing techniques in LRP among large numbers of patients. 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Correspondence Ali Serdar Gozen, MD, Associate Professor of Urology ali.goezen@slk-kliniken.de Marcel Fiedler, MD marcel.fiedler@slk-kliniken.de Jens Rassweiler, MD, Professor of Urology jens.rassweiler@slk-kliniken.de Department of Urology, SLK-Klinikum Heilbronn, University of Heidelberg, Am Gesundbrunnen 20-26, D-74078 Heilbronn, Germany Yigit Akin, MD, Associate Professor of Urology yigitakin@yahoo.com Department of Urology, Izmir Katip Celebi University School of Medicine, 35060, Izmir, Turkey Mutlu Ates, MD, Associate Professor of Urology drmutluates@gmail.com Department of Urology, Antalya Teaching and Research Hospital, 07059, Antalya, Turkey Gozen _Stesura Seveso 28/09/17 10:15 Pagina 191