Posterior Reconstruction of the Rhabdosphincter Allows a Rapid Recovery of Continence after Transperitoneal Videolaparoscopic Radical Prostatectomy

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1 european urology 51 (2007) available at journal homepage: Laparoscopy Posterior Reconstruction of the Rhabdosphincter Allows a Rapid Recovery of Continence after Transperitoneal Videolaparoscopic Radical Prostatectomy Bernardo Rocco a, Andrea Gregori b, Silvio Stener b, Luigi Santoro c, Andrea Bozzola b, Stefano Galli b, Roberto Knez b, Francesco Scieri b, Alessandra Scaburri d, Franco Gaboardi b, * a Division of Urology, European Institute of Oncology, Milan, Italy b Department of Urologic Surgery, Luigi Sacco University Medical Center, Milan, Italy c Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy d Environmental and Cancer Registry Unit, Istituto Nazionale dei Tumori, Milan, Italy Article info Article history: Accepted October 5, 2006 Published online ahead of print on October 23, 2006 Keywords: Continence Laparoscopy Prostate cancer Abstract Objectives: Urinary incontinence is one of the major drawbacks of radical retropubic prostatectomy (RRP). One of the possible reasons for this urinary incontinence is a postoperative deficiency of the rhabdosphincter (RS). It has been recently demonstrated that reconstruction of the posterior aspects of the RS allows a rapid recovery of continence after RRP. This study evaluated the application of this technique in videolaparoscopic radical prostatectomy (VLRP), assessing the percentage of continent patients at 3, 30, and 90 d after catheter removal. Methods: A two-arm prospective comparative trial was carried out with 31 patients recruited for each arm. Group A underwent standard VLRP and group B underwent VLRP with RS reconstruction (VLRP-R). Continence was defined as no pads or one diaper/24 h and was assessed 3, 30, and 90 d after the procedure. Results: At catheter removal, 74.2% versus 25% ( p = ) of patients were continent with the VLRP-R technique versus VLRP, respectively. A statistically significant difference was present at 30 d (83.8% vs. 32.3%; p = ) At 90 d the difference, although still present, was not statistically significant (92.3% vs. 76.9%; p = 0.25). Conclusions: In this preliminary report, the posterior reconstruction of the RS appears to be an easy and feasible technique even in a laparoscopic setting. Time to continence recovery was significantly shortened. # 2006 European Association of Urology. Published by Elsevier B.V. All rights reserved. * Corresponding author. U.O. Urologia, Ospedale Sacco, Via Grassi, 74, Milan, Italy. Tel ; Fax: address: fgaboar@tin.it (F. Gaboardi) /$ see back matter # 2006 European Association of Urology. Published by Elsevier B.V. All rights reserved. doi: /j.eururo

2 european urology 51 (2007) Introduction Urinary incontinence (UI) is one of the major drawbacks of radical prostatectomy (RP) and in the majority of patients is due to sphincter malfunction or bladder dysfunction or both [1,2]. Large contemporary series report incontinence rates that range widely, from 8% to 47% [3,4]. However, persistent post-rp UI (after 1 yr) affects <5% of patients [5]. Although temporary, UI affects the physical, psychological, and social well-being of patients and, thus, has a considerable impact on quality of life. Several technical modifications of open and laparoscopic RP (e.g., meticulous and atraumatic apical dissection, preservation of the bladder neck, or preservation of the puboprostatic ligaments, nerve-sparing and seminal vesicle-sparing techniques when possible) have been advocated to improve early and late urinary continence [6,7]. A simple modification of Walsh s RP technique [8] was recently introduced by Rocco et al. [9] with the aim of reducing time to continence by restoring the anatomic and functional length of the rhabdosphincter (RS) and providing a firm support for its Figs. 1 2 Placement of the first suture for the posterior reconstruction of the rhabdosphincter. It can be seen clearly that the suture does not involve the posterior portion of the urethra. C = catheter; LA = levator ani; NVB = neurovascular bundle; PF = prostatic fascia; RS = rhabdosphincter; U = urethra.

3 998 european urology 51 (2007) posterior aspect by fixing the whole structure in its natural position. We evaluated the Rocco modification in patients who underwent laparoscopic transperitoneal necksparing RP and compared it with a standard laparoscopic transperitoneal neck-sparing RP. 2. Patients and methods 2.1. Brief description of the original modification by Rocco et al. Rocco et al. [9] report that the musculofascial plate, comprised of the striated sphincter, Denonvilliers fascia, and the dorsal aspect of the prostate, acts as a suspensory system for the prostatomembranous urethra and that its division during RP results in the loss of the posterior cranial insertion of the sphincter, the caudal displacement of the sphincteric complex, and a prolapse of the perineum. Therefore, they propose to reconstruct this musculofascial plate by joining the posterior median raphe with the connected dorsal wall of the RS to the residuum of the Denonvilliers fascia and to suspend it to the posterior wall of the bladder, 1 2 cm cranially and dorsally to the new bladder neck [9] Application of the Rocco technique to transperitoneal neck-sparing VLRP The standard technique we use is performed by a transperitoneal approach with a V- shaped arrangement of the trocars (12-mm umbilical port, 12-mm paramedian right port, and three 5-mm ports, one paramedian left and two pararectal). The puboprostatic ligaments are divided and the bladder neck is incised with a neck-sparing technique. After division of the urethra, the posterior insertion of the striated sphincter is incised proximally. The standard technique ends with vesicourethral anastomosis with six or seven interrupted sutures. In the variant by Rocco et al. [9], before anastomosis the posterior portion of the RS is identified (Figs. 1 and 2) and anchored with two interrupted sutures to the remaining portion of the Denonvilliers fascia (Fig. 3). The sutures are then tightened immediately after they have both been placed (Fig. 4). To easily tighten the sutures, a gentle pressure is applied on the perineum from the outside. They are then passed 1 2 cm cranially and posteriorly to the bladder neck (Fig. 5) and then tightened. Once the reconstruction is done, anastomosis is then completed, as described in the standard technique Patients After institutional approval, from January 2005 to October 2005, 62 patients (Table 1) underwent neck-sparing VLRP performed by a single experienced surgeon (F.G.). Patients were alternatively assigned to one of two groups: group A underwent standard neck-sparing VLRP, and group B underwent the modified neck-sparing VLRP with posterior suspension of the striated sphincter, as described by Rocco et al. [9]. Fig. 3 The suture is then passed through the remaining part of the Denonvilliers fascia. B = bladder; DF = Denonvilliers fascia LA = levator ani; PF = prostatic fascia. End points of the study were the comparison of percentage of continent patients in the two groups at 3, 30, and 90 d after surgery. At 90 d, follow-up was available only for 26 patients (13/group). According to the Rocco definition [9], early continence was defined as zero pads. Some patients used one diaper/24 h for safety, for fear of incontinence or because of the leakage of a few drops of urine on exertion. These patients were also considered continent. Moderate incontinence was defined as two pads/24 h and severe incontinence as more than two pads/24 h. Due to the small number of cases, the statistical analysis was carried out grouping patients with moderate and severe incontinence together. There was no direct contact (i.e., telephone interview) between the staff and the patients. The questions concerning continence were asked by an external interviewer, in a double-blind fashion.

4 european urology 51 (2007) Fig. 4 The musculofascial plate is reconstructed by joining the posterior median raphe with the connected dorsal wall of the RS to the residuum of Denonvilliers fascia. As can be seen, the urethra is not involved in this suture. Panoramic view. B = bladder; C = catheter; DF = Denonvilliers fascia; LA = levator ani; NVB = neurovascular bundles; PF = prostatic fascia; RS = rhabdosphincter; SP = Santorini plexus; U = urethra Statistical methods Categorical variables are summarised in frequency tables, the continuous ones by mean standard deviation, median, and range. Because this was a nonrandomised comparative study, differences among patient characteristics undergoing standard neck-sparing VLRP (group A) and patients undergoing the modified one (group B) were compared by means of univariate tests. For categorical variables the comparison was performed by the Pearson x 2 test. For continuous variables either the t test (in case of normal distribution) or the Mann-Whitney-Wilcoxon Fig. 5 The suture is then inserted 1 2 cm cranially and posteriorly to the bladder neck (white circle) and is then tightened, completing the reconstruction. BN = bladder neck (white circle); C = catheter; DF = Denonvilliers fascia; LA = levator ani; PF = prostatic fascia. method (in case of violation of the normality assumption) was used. Comparison of continence rate within each time point between groups was performed by the Pearson x 2 test, taking into account the continuity correction. Because the two groups were not different in terms of baseline characteristics, as provided by the univariate tests, no multivariate analysis was considered. 3. Results Patients were similar in terms of age and preoperative and postoperative predictive factors. The data are summarised in Table 1. The most significant disparities concerned positive lymph nodes (3.2% in group A vs. 12.9% in group B) and high Gleason scores (Gleason score 8 10: group A 12.9% vs. group B

5 1000 european urology 51 (2007) Table 1 Patient characteristics No. of patients Group A Group B p Follow-up, mo Mean SD y Median (range) 5 (1 10) 5 (1 10) Age, yr Mean SD y Median (range) 66 (49 74) 64 (44 75) PSA, ng/ml Mean * SD z Median (range) 8.4 ( ) 8.3 ( ) Stage pt2 21 (67.7%) 19 (61.3%) 0.34 pt3a 7 (22.6%) 6 (19.4%) pt3b 2 (6.5%) 6 (19.4%) pt4 1 (3.2%) 0 (0%) N+ 1 (3.2%) 4 (12.9%) 0.14 Gleason score (48.3%) 16 (51.6%) (38.7%) 14 (45.1%) (12.9%) 1 (3.2%) Results (mean) Operative time Mean SD y Median (range) 230 ( ) 230 ( ) Blood loss Mean SD // Median (range) 300 ( ) 250 (50 800) Nerve-sparing Yes (monolateral) 5 (16.1%) 6 (19.3%) 0.84 Bilateral 16 (51.6%) 17 (54.8%) No 10 (32.3%) 8 (25.8%) Mean prostate volume, cc Mean * SD z Median (range) 40 (25 96) 43 (24 55) Positive margins 7 (22.5%) 7 (22.5%) 1.00 Positive margins in pt2 3/21 (14.2%) 1/19 (5.3%) 0.34 Discharge, d Mean SD // Median (range) 5 (3 10) 5 (3 22) Indwelling catheter, d Mean SD // Median (range) 10 (4 18) 8 (6 15) * Geometric mean. y The t test for independent group. z The t test for independent group on logarithm basis transformation. Pearson x 2. // Nonparametric Mann-Whitney-Wilcoxon test. 3.2%). In terms of overall positive margins, in both groups seven patients (22.5%) presented positive margins. However, for pt2 patients, men in group A had 14.2% positive margins, whereas those in group B had 5.3%. With respect to operative times, the median was 230 min for both groups. Table 2 reports the continence rate at 3, 30, and 90 d from catheter removal. At 90 d, only 26 of 31 patients per group were evaluable after surgery. Continence recovery was more rapid in the group of patients who underwent the modified technique. Even at 3 d after catheter removal, 74.2% of the patients who underwent surgery with modified technique were continent versus 25.8% of the subjects who underwent standard surgery. At 30 d, these percentages were 83.8% and 32.3% and at 3 mo, 92.3% versus 76.9%, respectively. At statistical analysis, the difference between group A and group B was statistically significant at discharge and at 30 d after the procedure. At 90 d, group A had a larger number of continent patients, but the difference from group B was not statistically significant. 4. Discussion The VLRP performed in specialised centres is now considered a safe, established procedure [10 12]. With the laparoscopic technique the rate of continent patients at 1 yr varies from 50% to 91.7% according to a recent review by Rassweiler [13] and from 83% to 100% according to a review by Trabulsi and Guilloneau [14]. These authors underline the correlation between postoperative continence and the progress along the learning curve of the surgeon. In particular, Rassweiler argues that the surgeon s experience has a significant impact on the time to continence recovery. Stolzenburg et al. have published a study on preservation of puboprostatic ligaments for a quicker recovery of continence [12]. According to these authors, at 2 wk after surgery, 24% of the subjects with puboprostatic ligament preservation were continent (0 1 diaper/d) versus 12% of other subjects. At 3 mo the rates were 76% and 48%, respectively. This study was the first to focus on rapid recovery of continence with the laparoscopic technique, and it considered anterior anchorage of the urethral-sphincter complex to be the key element for continence. As Rassweiler and Guilloneau emphasise in the editorial comment [12], however, the study presents some controversial aspects. It is based on two consecutive series of patients, it is not randomised and, furthermore, the preservation of puboprostatic ligaments can increase the risk of impairing radicality. The technique of Rocco we performed laparoscopically is based on the anatomic-functional assumption that it is especially the reconstruction of the

6 european urology 51 (2007) Table 2 Continence rates after catheter removal 3d 30d 90d Group A (N = 31) Group B (N = 31) Group A (N = 31) Group B (N = 31) Group A (N = 26) Group B (N = 26) n (%) n (%) n (%) n (%) n (%) n (%) Continence 8 (25.8) 23 (74.2) 10 (32.3) 26 (83.8) 20 (76.9) 24 (92.3) Incontinence 23 (74.2) 8 (25.8) 21 (67.7) 5 (16.2) 6 (23.1) 2 (7.7) Moderate Severe Pearson x 2* p * Yates s continuity correction. posterior insertion of the RS that ensures continence. In particular, Rocco and colleagues report that Denonvilliers fascia, the dorsal aspect of the prostate, and the posterior median raphe with the connected dorsal wall of the RS form a unique musculofascial plate that constitutes an important support structure within the pelvis and appears to serve as a fixation point for the muscle fibres of the rhabdosphincter [...]. The musculofascial plate is a dynamic suspensory system for the prostatomembranous urethra [9,15]. In light of this, the recreation of this musculofascial plate with the simple placement of two sutures between the posterior portion of the striated sphincter, the remaining portion of Denonvilliers fascia, and the bladder, 1 2 cm dorsally to the bladder neck, appears able to significantly speed up the recovery of continence. Rocco and coworkers reported that 72% of patients were continent with the modified technique at 3 d from catheter removal versus 14% of those with the standard technique. At 30 and 90 d the difference remains significant. It must be noted that Rocco s technique is carried out without preservation of the puboprostatic ligaments and without conservation of the bladder neck, therefore with the utmost effort to achieve radicality. The above-mentioned study, however, is not randomised and the population of patients undergoing the unmodified technique had a more advanced pathologic/disease stage that in a multivariate analysis appears to be associated with a less rapid recovery of continence. Our prospective randomised study, although limited in the number of cases, confirms a very significant difference, both statistically and clinically, similar to that obtained by Rocco et al. with the open surgery technique. We learned about this technique from a preliminary report [16] and since 2002 we have tried to introduce it in our surgical practice in well-selected patients with favourable anatomic characteristics, in whom the dissection of the apex and isolation of the urethra were particularly apt to application of the open surgery technique in a laparoscopic setting. In 2004, we therefore carried out a small pilot study on 17 consecutive nonselected cases (15 assessable, 4 with the Da Vinci robot) [17] with the Rocco technique, obtaining early continence at catheter removal in 40% of the cases. Although satisfactory, this percentage was not exceptionally different from the results obtained in our global population [18]. We attributed the reasons for this result to the fact that in the Rocco technique the sutures were placed in all the described structures and then tied in a single step. Although in the patients selected from the global population this had not created any particular difficulty, in the nonselected population of the pilot study, in some cases we encountered major difficulties in tightening the sutures correctly without tearing the tissues. We therefore subsequently tried to join the structures in two different steps. First we joined the RS with Denonvilliers fascia (Fig. 3) and then the RS-Denonvilliers fascia complex with the bladder. This allowed us to carry out all the manoeuvres under vision and controlling tension, so that the procedure became much easier and more reproducible. All the patients included in this study underwent two-step suturing. The end point of this study, early continence, was significantly improved at catheter removal in the patients who underwent the modified technique, both from a statistical and clinical viewpoint, with results basically identical to those of the open surgery technique. The difference remained statistically significant at 1 mo, whereas at 3 mo, with only 26 patients assessable for each group, the difference was still present but was no longer statistically significant.

7 1002 [1] Kielb SJ, Clemens JQ. Comprehensive urodynamics evaluation of 146 men with incontinence after radical prostatectomy. Urology 2005;66:392. [2] Groutz A, Blaivas JG, Chaikin DC, Weiss JP, Verhaaren M. The pathophysiology of post-radical prostatectomy incontinence: a clinical and video urodynamic study. J Urol 2000;163: [3] Catalona WJ, Carvalhal GF, Mager DE, Smith DS. Potency, continence and complication rates in 1, 870 consecutive radical retropubic prostatectomies. J Urol 1999;162:433. [4] Fowler Jr FJ, Barry MJ, Lu-Yao G, Roman A, Wasson J, Wennberg JE. Patient-reported complications and follow-up treatment after radical prostatectomy. The National Medicare Experience: (updated June 1993). Urology 1993;42:622. [5] Peyromaure M, Ravery V, Boccon-Gibod L. The management of stress urinary incontinence after radical prostatectomy. BJU Int 2002;90:155. [6] Ravery V. How to preserve continence after radical prostatectomy. Eur Urol Suppl 2005;4(4):8 11. [7] Janetschek G, Montorsi F. Open versus laparoscopic radical prostatectomy. Eur Urol Suppl 2006;5: [8] Walsh PC. Radical retropubic prostatectomy. In: Walsh PC, Retik AB, Stamey TA, Vaughan Jr ED, editors. Campbell s Urology. Philadelphia: Saunders; p [9] Rocco F, Carmignani L, Acquati P, et al. Restoration of posterior aspect of rhabdshpincter shortens continence time after radical retropubic prostatectomy. J Urol 2006; 175: [10] Rassweiler J, Sentker L, Seemann O, Hatzinger M, Rumpelt HJ. Laparoscopic radical prostatectomy with the Heileuropean urology 51 (2007) With respect to complications, Rocco et al. [9] describe bladder-neck strictures and acute urinary retention in <5% of patients in both groups. Probably due to the much smaller number of cases, to date neither of these complications occurred in the patients we treated. With regards to operative times, there was no significant difference between standard technique and the modified technique. Furthermore, the reconstruction of the musculofascial plate seems to be helpful for the urethrovesical anastomosis, which can be carried out in tension-free conditions. We carry out the Rocco reconstruction pushing the perineal plane from the exterior. Once the posterior plate is reconstructed it is possible to continue with the anastomosis and it is not necessary to keep pushing the perineal plane any longer. Our study has some limitations. First, the patient assignment to the two groups was very elementary and consisted in alternating patients according to their order of arrival to the hospital. Second, the methodology for continence assessment is imperfect. No information on continence baseline evaluation nor information on the impact of postoperative incontinence on quality of life of the patients were provided. Furthermore, questionnaire administration by would have been more desirable than third-party interviews [19]. However, certain methodologic flaws seem common to the existing laparoscopic literature [20]. In addition, in this study, we tried to reproduce an open surgical technique, and therefore we used the same continence indicator as used in the original study [9]. Third, the number of cases is very small. If, on the one hand, this does not appear to be a significant limitation for evaluation of the main end point, which is the recovery of early continence, considering the marked difference that was seen in the two groups, on the other hand it may conceal the possible appearance of side-effects such as acute urinary retention or urethral stenosis, though these were very rare even in the larger number of cases presented by Rocco et al. with the open surgery technique. Fourth, the follow-up period was short. However, because the aim of the study was the evaluation of early continence, this limitation, too, does not appear to have particular bearing on the end point. Nevertheless, we have not been able to verify whether this technique also allows improvement in long-term continence. 5. Conclusions Posterior reconstruction of the RS is a simple and effective technique. It allows for a much more rapid recovery of continence after laparoscopic RP compared to the standard technique. To be performed correctly, the structures involved in the reconstruction must be sutured together in two separate steps, so as to not tear the tissues or, on the other hand, to not leave surgical knots loose. A longer follow-up and a greater number of cases could help clarify any risks of complications, none of which have been found to date, and perhaps to obtain a higher percentage of continent patients in the long term. Conflicts of interest Authors declare no consultancies, stock ownership or other equity interests, patents received and/or pending, or any commercial relationship which might be in any way considered related to a submitted article. References

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