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Robotic-assisted Laparoscopic Implantation of Artificial Urinary Sphincter in Women With Intrinsic Sphincter Deficiency Incontinence: Initial Results
Laparoscopy and Robotics Robotic-assisted Laparoscopic Implantation of Artificial Urinary Sphincter in Women With Intrinsic Sphincter Deficiency Incontinence: Initial Results Georges Fournier, Pierre Callerot, Maxime Thoulouzan, Antoine Valeri, and Marie-Aimee Perrouin-Verbe OBJECTIVE
PATIENTS AND METHODS
RESULTS
CONCLUSION
To investigate the feasibility, safety, and functional results of robotic-assisted artificial urinary sphincter (R-AUS) laparoscopic implantation in women with stress urinary incontinence due to intrinsic sphincter deficiency. Six women underwent an R-AUS implantation between 2012 and 2013. The mean age was 65 9.6 years. Five patients had previous surgery for incontinence. The mean duration of follow-up was 14.3 months. A transperitoneal approach with a lateral positioning of the robotic arms was performed. The cuff implantation, positioning of the reservoir, and the pump were carried out similarly to the laparoscopic technique. Operative time, intraoperative occurrence of injuries of the bladder or vagina, postoperative complications, and continence (pad per day) were assessed. The R-AUS implantation was feasible in all cases without intraoperative injury and 1 grade 1 postoperative complication. Mean operative time, postoperative bladder catheterization, and hospitalization time were 210 32 minutes, 7 days, and 6 days, respectively. At the end of the follow-up, 83% of cases were fully continent. R-AUS implantation in incontinent women with intrinsic sphincter deficiency was feasible and safe with good functional results. More data are needed before concluding to the superiority of this new technique compared with open or laparoscopic approaches. UROLOGY 84: 1094e1098, 2014. 2014 Elsevier Inc.
A
rtificial urinary sphincter (AUS) implantation is a treatment option for women with genuine stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). In most cases, it is a last resort procedure indicated after failure of other operations (suburethral or bladder neck slings, Burch’s colpopexy). Feasibility, long-term efficacy, and safety of the procedure have been demonstrated, and 61%-91% of women are fully continent after procedure.1-7 The laparoscopic approach for AUS implantation in 4 women was reported for the first time in 2005.8 Available data for this approach are currently limited to 59 cases from 4 centers, with comparable results to open series.8,9-11 Whatever the surgical approach, open (abdominal or transvaginal) or laparoscopic, the circumferential dissection of the bladder Financial Disclosure: The authors declare that they have no relevant financial interests. From the Department of Urology, Brest University Hospital, Brest, France Address correspondence to: Georges Fournier, M.D., Department of Urology, Brest University Hospital, Hopital de la cavale blanche, Boulevard Tanguy Prigent, 29200 Brest, France. E-mail: [email protected] Submitted: February 18, 2014, accepted (with revisions): July 3, 2014
1094
ª 2014 Elsevier Inc. All Rights Reserved
neck is a challenging step of the procedure. Indeed, 66%100% of candidates to the AUS have been previously operated on for incontinence and/or prolapse, with subsequent adhesions in the retzius space and/or around the bladder neck. These adhesions can lead to intraoperative bladder neck or vaginal injuries with the subsequent risk of cessation of the procedure or early erosion.5,6,9-12 Besides adhesions, the blind and deep dissection between bladder neck and vagina is also a risk factor for injuries of these surrounding anatomic structures. To secure the dissection in this area, some surgeons control the integrity of the vaginal wall with fingers introduced into the vagina during passage of instruments. Therefore, this maneuver leaves the surgeon working in suboptimal conditions, with only one hand in the surgical area. To overcome these limitations, the robotic assistance could, in theory, lead to better intraoperative working conditions and subsequently decrease the risk of bladder, urethra, or vagina injuries. The articulated extremity of the instruments, combined with the enhanced 3-dimensional vision, and the 3 operating arms available could improve http://dx.doi.org/10.1016/j.urology.2014.07.013 0090-4295/14
the safety of AUS implantation. To assess the feasibility and the potential benefit of the robotic approach, we operated on 6 women with SUI due to ISD. We report the technical features of the procedure, feasibility, and perioperative and functional results. To our knowledge, there is no publication on this approach.
PATIENTS AND METHODS Between 2012 and 2013, 6 women underwent a robotic-assisted AUS (R-AUS) laparoscopic implantation (AMS-800; American Medical Systems, Minnetonka, MN). Inclusion criteria were females with SUI and ISD. Clinically, all had absence of urethral hypermobility with negative Marshall-Bonney and submidurethral tape tests during pelvic examination. Mixed incontinence was not an exclusion criterion.
Figure 1. Lateral positioning of the robot da Vinci. (Color version available online.)
Preoperative Workup Patient interview recorded the number of pads per day, past surgery for incontinence, prolapse or other pelvic surgery, body mass index, and manual dexterity. Pelvic examination was carried out with the patient in lithotomy position to check for prolapse, bladder neck or urethral mobility, and urinary leakage while coughing. Marshall-Bonney and submidurethral tape tests were performed in all cases and considered negative in case of persistent urine leakage during cough while performing bladder neck or paraurethral elevation. Cystoscopy and urodynamic testing were conducted for all patients. Absence of detrusor overactivity and normal compliance were checked. Detailed information on the R-AUS laparoscopic implantation was given, and the oral consent was obtained in all cases.
Surgical Technique Al patients had preoperative sterile urine and antibiotic prophylaxis with cephalosporin. The procedure was performed by a single surgeon. The robot da Vinci HD Si (Intuitive surgical, Sunnyvale, CA) was positioned close and lateral to the right leg, allowing the bedside assistant to have an access to the vagina during the procedure (Fig. 1). The legs were flexed at 45 with a trendelenburg positioning of the patient. A 16F Foley catheter was inserted, and a transperitoneal approach was performed using a 5 ports configuration. The ports included a 12-mm trocar at the umbilical site for the video camera, three 8-mm trocars (2 on the right and 1 on the left) for the operating robotic arms, and a 12-mm trocar in the left iliac fossa. Occasionally, a supplementary supraumbilical 5-mm port was inserted for the assistant on the left side between the video camera and the left robotic arm. A 0 lens was used. After filling the bladder with 120 mL of water, a transversal peritoneal incision was carried out following the convexity of the bladder. The prevesical dissection of the retzius space was made close to the pubic bone arch to avoid bladder wall injury. In the first 2 patients, the dissection of the bladder neck was carried out without opening of the bladder. The bladder neck was identified by the balloon of the Foley catheter. An incision of the endopelvic fascia was performed 2 cm lateral to the bladder neck on each side. In the 4 latter patients, we performed an anterior vertical cystotomy at the bladder dome, away from the future location of the cuff. The Foley catheter was removed. The dissection was performed with a simultaneous intra- and extravesical vision while creating the pathway between the bladder neck and the vagina. The orientable extremities of the UROLOGY 84 (5), 2014
Figure 2. Posterior dissection of the bladder neck completed with the prograsp forceps in place and opened bladder. (Color version available online.)
scissors and grasping forceps allowed the surgeon to dissect parallel to the vaginal wall from lateral to medial on each side of the bladder neck. During this step, a Hegar bougie was introduced into the vagina by the assistant and pushed laterally toward the anterior cul-de-sac on each side. In this way, the vaginal wall was retracted from the posterior wall of the bladder neck. The prograsp articulated forceps was progressively introduced from the right to the left side to complete the pathway behind the bladder neck (Fig. 2). After closure of the cystotomy with an absorbable running suture, a 12F bladder catheter was inserted, and the watertightness was checked. After measurement of the circumference of the bladder neck, the cuff was introduced using the 12 mm left iliac fossa port and fastened in its correct position. The 61-70 cm H20 pressure-regulating balloon was introduced through an additional 3 cm-long suprapubic left-sided incision. After filling the pressureregulating balloon of the AUS, the connecting tubes from the reservoir and the cuff were extracted through the suprapubic incision, and the peritoneum was closed by a running suture. After desufflation, the control pump was introduced into the left labia major through a subcutaneous pathway between the suprapubic incision and the labia. The connections of the tubes 1095
Table 1. Patient characteristics Age (y)
Pad/d
Urethral Closure Pressure
1 2
75 66
3 4
17 30
3 4
74 58
4 6
30 30
Case Number
5 6 Mean SD
50 8 67 2 65 9.6 4.5 2.1
15 11 22.1 8.8
Previous Surgery: (Urinary Incontinence/Other Pelvic Surgery)
BMI
Burch/hysterectomy and sacrocolpopexy 30 Transvaginal tape (TVT), urethral erosion, 23 transobturator tape (TOT), and urethral erosion/hysterectomy þ sacrocolpopexy TVT/hysterectomy 23 24.7 TVT (2), urethral erosion (2), artificial urinary sphincter, bladder neck erosion, and retzius space abscess No 37.6 TOT/annexectomy and pelvic prolapse þ hysterectomy 33.9 2.3 2.2/1 0.9 28.9 6
BMI, body mass index; SD, standard deviation.
Table 2. Perioperative and functional results Case Number
Operative Time (min)
Bladder Neck Dissection Time (min)
Cuff Size (cm)
Catheterization Time (d)
Hospitalization Time (d)
Follow-up (mo)
Continence (Pad/d)
1 2 3 4 5 6 Mean SD
240 240 180 240 180 180 210 32
60 60 Not available 90 70 50 66 15
7.5 7 7.5 9 8 9 8 0.8
2 9 7 7 7 7 72
4 5 8 6 6 9 62
21 21 20 15 6 3 14.3 9
0 0 1 0 0 0 —
Abbreviation as in Table 1.
were carried out in the subcutaneous area at the level of the suprapubic incision. The sphincter was deactivated, and a Foley catheter was left for 2-7 days, whether a cystotomy was performed.
Outcome Measures and Patient Follow-up Assessment of intraoperative criteria included total operative time, the time needed for circumferential dissection of the bladder neck, and complications. Postoperative complications were classified according to the Clavien-Dindo classification.13 Postoperative catheterization time and duration of hospital stay were calculated. Functional results were assessed at each visit, respectively, at 6 weeks (sphincter activation) and 3, 6, 12, and 24 months of follow up. The number of pad per day was the end point used for the evaluation of continence. Other criteria included handling of the pump by the patient and postvoid residual urine on bladder ultrasonography.
RESULTS Patients A total of 6 patients were implanted with an R-AUS. Five patients had at least 1 previous surgery for incontinence (mean, 2.3) and 4 patients had a previous gynecologic surgery (mean, 1). All patients had negative Marshall-Bonney or submidurethral tests. One patient had a neurologic incontinence with ISD and acontractile bladder. One patient had a mixed incontinence treated by anticholinergics. In the patient who had a cystocele with uterine prolapse, a sacrocolpopexy was performed at the same time as the AUS implantation (Table 1). 1096
Perioperative Results No intraoperative bladder, urethral, or vaginal injuries occurred. One hematoma of the labia major resolved spontaneously, classified as a grade 1 severity in the Clavien-Dindo classification. Five patients voided after catheter removal without residual urine. One patient was performing clean intermittent self-catheterization before the procedure (acontractile detrusor) and, as expected, remained so after the AUS implantation (Table 2). Functional Results The sphincter activation was performed at the 6-week follow-up visit in all cases. Five patients were fully continent (83.3%). In 1 patient, continence was improved from 4 to 1 pad/day. She had mixed incontinence preoperatively and urge incontinence remained after the procedure. In all cases, a satisfying handling of the pump was reported, and no mechanical complications occurred (Table 2).
COMMENT This is the first study to report initial results of R-AUS. Regarding the inclusion criteria for implantation of the AUS, all patients had moderate-to-severe SUI due to ISD with a negative Marshall-Bonney and submidurethral tape tests. The age, body mass index, urethral closure pressure, and the frequency of previous surgery in this series are comparable with those previously reported from other centers who perform AUS implantation for intractable incontinence.5-10,12 UROLOGY 84 (5), 2014
In this limited case series, we found the procedure feasible and safe, without injuries of the bladder, urethra, or vaginal wall. This has to be compared with the 3.4%27% rate of intraoperative injuries reported in open or purely laparoscopic series, with the subsequent risk of abandonment of the procedure or explantation due to erosion.9-12 In the series by Costa, 2 procedures were abandoned and explantations occurred in 5.9% of patients, respectively. There was an association between intraoperative injuries and risk of explantation (16.3% vs 2.6%).12 Regarding the laparoscopic series, Mandron et al9 reported only 1 vaginal perforation (4%), but 2 others patients were reoperated for explantation of the AUS during the first month of follow-up. In the extraperitoneal laparoscopic series, bladder or vaginal injuries occurred in 25% of cases, leading to the abandonment of the procedure in 1 case and conversion to open surgery to repair the injury in 3 cases. However, no subsequent explantation of the devices was necessary.10 In the same way, Trolliet et al11 reported 1 case of short-term postoperative explantation due to a vaginal injury. However, the total operating time of 210 minutes is longer than that previously reported by pure laparoscopic approach (92-180 minutes)8-11 Compared with our previous experience of AUS implantation by open or laparoscopic approach (data not shown), we found the robotic approach to be helpful for the circumferential dissection of the bladder neck. In the same way, Storm et al14 reported that bladder neck dissection for sling placement in 2 children was improved with robotic assistance. We found that the 3-dimensional visualization was superior to the 2-dimensional vision of conventional laparoscopy, and the orientable extremity of the instruments were more suitable for the dissection of the bladder neck. In this setting, the prograsp or cadiere forceps were especially useful to progress through the pathway behind the bladder neck from one side to the other because of the length of the extremity of the angulated instruments. Moreover, the 3 operating arms of the robot extended the possibility of exposition, with typically 2 arms working for the creation of the passage between bladder neck and vagina and the third one used as an autostatic retractor of the bladder wall. Robotic assistance avoided the need to use one of the operative surgeon’s hand introduced into the vagina, allowing him to perform surgery with both hands. However, it was not possible to dispense with the vaginal control, and this was achieved by using a Hegar dilator held by the bedside assistant. To improve the access to the vagina, the lateral positioning of the robot was helpful. The notoriously difficult step of performing circumferential dissection around bladder neck, in the presence of adhesions and scar tissue, without injury to the bladder or vagina, although improved with the robotic assistance, should not be underestimated. In this series, the mean operative time of this step alone was 66 minutes. Beside the advantages provided by the robotic assistance per se, we believe that the opening of the bladder UROLOGY 84 (5), 2014
increased the safety by avoiding the risk of bladder injury. The progression of the scissors or grasping forceps behind the bladder neck can be followed with a direct vision while passing from one side to another. Moreover, in theory, it can lead to a precise positioning of the cuff around the bladder neck, avoiding the dissection of the proximal urethra. The 4 patients in whom planned cystotomy was undertaken did not experienced additional complications, even considering the necessity of an indwelling catheter to ensure bladder drainage while healing. Although not universally performed in the reported literature, cystotomy has been found useful in complicated cases and in those in whom an intraoperative bladder perforation was detected during the procedure.5 Patients were catheterized for a mean of 7 days. This result is similar to the Ngninkeu series but shorter than the 10 days reported by Roupret with a pure laparoscopic approach. The catheterization time was only 2 days in the Mandron9 series, but they reported a 20% rate of transient retention after catheter removal. Aside from the planned restarting of intermittent clean self-catheterization in the patient with neurogenic incontinence and a poor detrusor contractility, there were no postoperative problems with urinary retention. We cannot exclude that the longer size of the cuff used in our experience (mean, 8 cm) compared to the Mandron series (mean, 6.4 cm) could play a role in this difference. Finally, there was only 1 postoperative low-grade complication in our experience, which highlights the low morbidity of the procedure. With 14.3 months of follow-up, 83% of women were fully continent, which is similar to the reported 61%-91% success reported in the literature.1-3,5,6 We believe that this is an acceptable success rate in this population where AUS implantation is considered as a last resort procedure. The observations of this study are limited because of the small number of patients treated so far and the lack of long-term follow-up data. It also describes a single-surgeon, single-center experience without randomization or control groups, and we will therefore be cautious in the conclusion that we draw. Supplementary data are needed to assess the reproducibility of this new approach. The higher cost of the procedure because of the robotic equipment must also be taken into account, and future medicoeconomic studies would be necessary to compare this technique to open or pure laparoscopic approaches.
CONCLUSION This study is the first reporting R-AUS laparoscopic implantation. The procedure was feasible, safe, and initial results are encouraging. More data are needed to clarify the role of this approach compared with open and pure laparoscopic AUS implantations. References 1. Diokno AC, Hollander JB, Alderson TP. Artificial urinary sphincter for recurrent female urinary incontinence: indications and results. The J Urol. 1987;138:778-780.
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2. Thomas K, Venn SN, Mundy AR. Outcome of the artificial urinary sphincter in female patients. The J Urol. 2002;167:1720-1722. 3. Petero VG Jr, Diokno AC. Comparison of the long-term outcomes between incontinent men and women treated with artificial urinary sphincter. The J Urol. 2006;175:605-609. 4. Chung E, Cartmill RA. 25-year experience in the outcome of artificial urinary sphincter in the treatment of female urinary incontinence. BJU Int. 2010;106:1664-1667. 5. Vayleux B, Rigaud J, Luyckx F, et al. Female urinary incontinence and artificial urinary sphincter: study of efficacy and risk factors for failure and complications. Eur Urol. 2011;59:1048-1053. 6. Costa P, Poinas G, Ben Naoum K, et al. Long-term results of artificial urinary sphincter for women with type III stress urinary incontinence. Eur Urol. 2013;63:753-758. 7. Chartier-Kastler E, Van Kerrebroeck P, Olianas R, et al. Artificial urinary sphincter (AMS 800) implantation for women with intrinsic sphincter deficiency: a technique for insiders? BJU Int. 2011;107:1618-1626. 8. Ngninkeu BN, van Heugen G, di Gregorio M, et al. Laparoscopic artificial urinary sphincter in women for type III incontinence: preliminary results. Eur Urol. 2005;47:793-797; discussion 7.
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9. Mandron E, Bryckaert PE, Papatsoris AG. Laparoscopic artificial urinary sphincter implantation for female genuine stress urinary incontinence: technique and 4-year experience in 25 patients. BJU Int. 2010;106:1194-1198; discussion 8. 10. Roupret M, Misrai V, Vaessen C, et al. Laparoscopic approach for artificial urinary sphincter implantation in women with intrinsic sphincter deficiency incontinence: a single-centre preliminary experience. Eur Urol. 2010;57:499-504. 11. Trolliet S, Mandron E, Lang H, et al. [Laparoscopic approach for artificial urinary sphincter implantation for women with severe stress urinary incontinence]. Prog Urol. 2013;23:877-883. 12. Costa P, Mottet N, Rabut B, et al. The use of an artificial urinary sphincter in women with type III incontinence and a negative Marshall test. The J Urol. 2001;165:1172-1176. 13. Clavien PA, Barkun J, de Oliveira ML, et al. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009;250:187-196. 14. Storm DW, Fulmer BR, Sumfest JM. Robotic-assisted laparoscopic approach for posterior bladder neck dissection and placement of pediatric bladder neck sling: initial experience. Urology. 2008;72: 1149-1152.
UROLOGY 84 (5), 2014
PATIENTS AND METHODS
RESULTS
CONCLUSION
To investigate the feasibility, safety, and functional results of robotic-assisted artificial urinary sphincter (R-AUS) laparoscopic implantation in women with stress urinary incontinence due to intrinsic sphincter deficiency. Six women underwent an R-AUS implantation between 2012 and 2013. The mean age was 65 9.6 years. Five patients had previous surgery for incontinence. The mean duration of follow-up was 14.3 months. A transperitoneal approach with a lateral positioning of the robotic arms was performed. The cuff implantation, positioning of the reservoir, and the pump were carried out similarly to the laparoscopic technique. Operative time, intraoperative occurrence of injuries of the bladder or vagina, postoperative complications, and continence (pad per day) were assessed. The R-AUS implantation was feasible in all cases without intraoperative injury and 1 grade 1 postoperative complication. Mean operative time, postoperative bladder catheterization, and hospitalization time were 210 32 minutes, 7 days, and 6 days, respectively. At the end of the follow-up, 83% of cases were fully continent. R-AUS implantation in incontinent women with intrinsic sphincter deficiency was feasible and safe with good functional results. More data are needed before concluding to the superiority of this new technique compared with open or laparoscopic approaches. UROLOGY 84: 1094e1098, 2014. 2014 Elsevier Inc.
A
rtificial urinary sphincter (AUS) implantation is a treatment option for women with genuine stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). In most cases, it is a last resort procedure indicated after failure of other operations (suburethral or bladder neck slings, Burch’s colpopexy). Feasibility, long-term efficacy, and safety of the procedure have been demonstrated, and 61%-91% of women are fully continent after procedure.1-7 The laparoscopic approach for AUS implantation in 4 women was reported for the first time in 2005.8 Available data for this approach are currently limited to 59 cases from 4 centers, with comparable results to open series.8,9-11 Whatever the surgical approach, open (abdominal or transvaginal) or laparoscopic, the circumferential dissection of the bladder Financial Disclosure: The authors declare that they have no relevant financial interests. From the Department of Urology, Brest University Hospital, Brest, France Address correspondence to: Georges Fournier, M.D., Department of Urology, Brest University Hospital, Hopital de la cavale blanche, Boulevard Tanguy Prigent, 29200 Brest, France. E-mail: [email protected] Submitted: February 18, 2014, accepted (with revisions): July 3, 2014
1094
ª 2014 Elsevier Inc. All Rights Reserved
neck is a challenging step of the procedure. Indeed, 66%100% of candidates to the AUS have been previously operated on for incontinence and/or prolapse, with subsequent adhesions in the retzius space and/or around the bladder neck. These adhesions can lead to intraoperative bladder neck or vaginal injuries with the subsequent risk of cessation of the procedure or early erosion.5,6,9-12 Besides adhesions, the blind and deep dissection between bladder neck and vagina is also a risk factor for injuries of these surrounding anatomic structures. To secure the dissection in this area, some surgeons control the integrity of the vaginal wall with fingers introduced into the vagina during passage of instruments. Therefore, this maneuver leaves the surgeon working in suboptimal conditions, with only one hand in the surgical area. To overcome these limitations, the robotic assistance could, in theory, lead to better intraoperative working conditions and subsequently decrease the risk of bladder, urethra, or vagina injuries. The articulated extremity of the instruments, combined with the enhanced 3-dimensional vision, and the 3 operating arms available could improve http://dx.doi.org/10.1016/j.urology.2014.07.013 0090-4295/14
the safety of AUS implantation. To assess the feasibility and the potential benefit of the robotic approach, we operated on 6 women with SUI due to ISD. We report the technical features of the procedure, feasibility, and perioperative and functional results. To our knowledge, there is no publication on this approach.
PATIENTS AND METHODS Between 2012 and 2013, 6 women underwent a robotic-assisted AUS (R-AUS) laparoscopic implantation (AMS-800; American Medical Systems, Minnetonka, MN). Inclusion criteria were females with SUI and ISD. Clinically, all had absence of urethral hypermobility with negative Marshall-Bonney and submidurethral tape tests during pelvic examination. Mixed incontinence was not an exclusion criterion.
Figure 1. Lateral positioning of the robot da Vinci. (Color version available online.)
Preoperative Workup Patient interview recorded the number of pads per day, past surgery for incontinence, prolapse or other pelvic surgery, body mass index, and manual dexterity. Pelvic examination was carried out with the patient in lithotomy position to check for prolapse, bladder neck or urethral mobility, and urinary leakage while coughing. Marshall-Bonney and submidurethral tape tests were performed in all cases and considered negative in case of persistent urine leakage during cough while performing bladder neck or paraurethral elevation. Cystoscopy and urodynamic testing were conducted for all patients. Absence of detrusor overactivity and normal compliance were checked. Detailed information on the R-AUS laparoscopic implantation was given, and the oral consent was obtained in all cases.
Surgical Technique Al patients had preoperative sterile urine and antibiotic prophylaxis with cephalosporin. The procedure was performed by a single surgeon. The robot da Vinci HD Si (Intuitive surgical, Sunnyvale, CA) was positioned close and lateral to the right leg, allowing the bedside assistant to have an access to the vagina during the procedure (Fig. 1). The legs were flexed at 45 with a trendelenburg positioning of the patient. A 16F Foley catheter was inserted, and a transperitoneal approach was performed using a 5 ports configuration. The ports included a 12-mm trocar at the umbilical site for the video camera, three 8-mm trocars (2 on the right and 1 on the left) for the operating robotic arms, and a 12-mm trocar in the left iliac fossa. Occasionally, a supplementary supraumbilical 5-mm port was inserted for the assistant on the left side between the video camera and the left robotic arm. A 0 lens was used. After filling the bladder with 120 mL of water, a transversal peritoneal incision was carried out following the convexity of the bladder. The prevesical dissection of the retzius space was made close to the pubic bone arch to avoid bladder wall injury. In the first 2 patients, the dissection of the bladder neck was carried out without opening of the bladder. The bladder neck was identified by the balloon of the Foley catheter. An incision of the endopelvic fascia was performed 2 cm lateral to the bladder neck on each side. In the 4 latter patients, we performed an anterior vertical cystotomy at the bladder dome, away from the future location of the cuff. The Foley catheter was removed. The dissection was performed with a simultaneous intra- and extravesical vision while creating the pathway between the bladder neck and the vagina. The orientable extremities of the UROLOGY 84 (5), 2014
Figure 2. Posterior dissection of the bladder neck completed with the prograsp forceps in place and opened bladder. (Color version available online.)
scissors and grasping forceps allowed the surgeon to dissect parallel to the vaginal wall from lateral to medial on each side of the bladder neck. During this step, a Hegar bougie was introduced into the vagina by the assistant and pushed laterally toward the anterior cul-de-sac on each side. In this way, the vaginal wall was retracted from the posterior wall of the bladder neck. The prograsp articulated forceps was progressively introduced from the right to the left side to complete the pathway behind the bladder neck (Fig. 2). After closure of the cystotomy with an absorbable running suture, a 12F bladder catheter was inserted, and the watertightness was checked. After measurement of the circumference of the bladder neck, the cuff was introduced using the 12 mm left iliac fossa port and fastened in its correct position. The 61-70 cm H20 pressure-regulating balloon was introduced through an additional 3 cm-long suprapubic left-sided incision. After filling the pressureregulating balloon of the AUS, the connecting tubes from the reservoir and the cuff were extracted through the suprapubic incision, and the peritoneum was closed by a running suture. After desufflation, the control pump was introduced into the left labia major through a subcutaneous pathway between the suprapubic incision and the labia. The connections of the tubes 1095
Table 1. Patient characteristics Age (y)
Pad/d
Urethral Closure Pressure
1 2
75 66
3 4
17 30
3 4
74 58
4 6
30 30
Case Number
5 6 Mean SD
50 8 67 2 65 9.6 4.5 2.1
15 11 22.1 8.8
Previous Surgery: (Urinary Incontinence/Other Pelvic Surgery)
BMI
Burch/hysterectomy and sacrocolpopexy 30 Transvaginal tape (TVT), urethral erosion, 23 transobturator tape (TOT), and urethral erosion/hysterectomy þ sacrocolpopexy TVT/hysterectomy 23 24.7 TVT (2), urethral erosion (2), artificial urinary sphincter, bladder neck erosion, and retzius space abscess No 37.6 TOT/annexectomy and pelvic prolapse þ hysterectomy 33.9 2.3 2.2/1 0.9 28.9 6
BMI, body mass index; SD, standard deviation.
Table 2. Perioperative and functional results Case Number
Operative Time (min)
Bladder Neck Dissection Time (min)
Cuff Size (cm)
Catheterization Time (d)
Hospitalization Time (d)
Follow-up (mo)
Continence (Pad/d)
1 2 3 4 5 6 Mean SD
240 240 180 240 180 180 210 32
60 60 Not available 90 70 50 66 15
7.5 7 7.5 9 8 9 8 0.8
2 9 7 7 7 7 72
4 5 8 6 6 9 62
21 21 20 15 6 3 14.3 9
0 0 1 0 0 0 —
Abbreviation as in Table 1.
were carried out in the subcutaneous area at the level of the suprapubic incision. The sphincter was deactivated, and a Foley catheter was left for 2-7 days, whether a cystotomy was performed.
Outcome Measures and Patient Follow-up Assessment of intraoperative criteria included total operative time, the time needed for circumferential dissection of the bladder neck, and complications. Postoperative complications were classified according to the Clavien-Dindo classification.13 Postoperative catheterization time and duration of hospital stay were calculated. Functional results were assessed at each visit, respectively, at 6 weeks (sphincter activation) and 3, 6, 12, and 24 months of follow up. The number of pad per day was the end point used for the evaluation of continence. Other criteria included handling of the pump by the patient and postvoid residual urine on bladder ultrasonography.
RESULTS Patients A total of 6 patients were implanted with an R-AUS. Five patients had at least 1 previous surgery for incontinence (mean, 2.3) and 4 patients had a previous gynecologic surgery (mean, 1). All patients had negative Marshall-Bonney or submidurethral tests. One patient had a neurologic incontinence with ISD and acontractile bladder. One patient had a mixed incontinence treated by anticholinergics. In the patient who had a cystocele with uterine prolapse, a sacrocolpopexy was performed at the same time as the AUS implantation (Table 1). 1096
Perioperative Results No intraoperative bladder, urethral, or vaginal injuries occurred. One hematoma of the labia major resolved spontaneously, classified as a grade 1 severity in the Clavien-Dindo classification. Five patients voided after catheter removal without residual urine. One patient was performing clean intermittent self-catheterization before the procedure (acontractile detrusor) and, as expected, remained so after the AUS implantation (Table 2). Functional Results The sphincter activation was performed at the 6-week follow-up visit in all cases. Five patients were fully continent (83.3%). In 1 patient, continence was improved from 4 to 1 pad/day. She had mixed incontinence preoperatively and urge incontinence remained after the procedure. In all cases, a satisfying handling of the pump was reported, and no mechanical complications occurred (Table 2).
COMMENT This is the first study to report initial results of R-AUS. Regarding the inclusion criteria for implantation of the AUS, all patients had moderate-to-severe SUI due to ISD with a negative Marshall-Bonney and submidurethral tape tests. The age, body mass index, urethral closure pressure, and the frequency of previous surgery in this series are comparable with those previously reported from other centers who perform AUS implantation for intractable incontinence.5-10,12 UROLOGY 84 (5), 2014
In this limited case series, we found the procedure feasible and safe, without injuries of the bladder, urethra, or vaginal wall. This has to be compared with the 3.4%27% rate of intraoperative injuries reported in open or purely laparoscopic series, with the subsequent risk of abandonment of the procedure or explantation due to erosion.9-12 In the series by Costa, 2 procedures were abandoned and explantations occurred in 5.9% of patients, respectively. There was an association between intraoperative injuries and risk of explantation (16.3% vs 2.6%).12 Regarding the laparoscopic series, Mandron et al9 reported only 1 vaginal perforation (4%), but 2 others patients were reoperated for explantation of the AUS during the first month of follow-up. In the extraperitoneal laparoscopic series, bladder or vaginal injuries occurred in 25% of cases, leading to the abandonment of the procedure in 1 case and conversion to open surgery to repair the injury in 3 cases. However, no subsequent explantation of the devices was necessary.10 In the same way, Trolliet et al11 reported 1 case of short-term postoperative explantation due to a vaginal injury. However, the total operating time of 210 minutes is longer than that previously reported by pure laparoscopic approach (92-180 minutes)8-11 Compared with our previous experience of AUS implantation by open or laparoscopic approach (data not shown), we found the robotic approach to be helpful for the circumferential dissection of the bladder neck. In the same way, Storm et al14 reported that bladder neck dissection for sling placement in 2 children was improved with robotic assistance. We found that the 3-dimensional visualization was superior to the 2-dimensional vision of conventional laparoscopy, and the orientable extremity of the instruments were more suitable for the dissection of the bladder neck. In this setting, the prograsp or cadiere forceps were especially useful to progress through the pathway behind the bladder neck from one side to the other because of the length of the extremity of the angulated instruments. Moreover, the 3 operating arms of the robot extended the possibility of exposition, with typically 2 arms working for the creation of the passage between bladder neck and vagina and the third one used as an autostatic retractor of the bladder wall. Robotic assistance avoided the need to use one of the operative surgeon’s hand introduced into the vagina, allowing him to perform surgery with both hands. However, it was not possible to dispense with the vaginal control, and this was achieved by using a Hegar dilator held by the bedside assistant. To improve the access to the vagina, the lateral positioning of the robot was helpful. The notoriously difficult step of performing circumferential dissection around bladder neck, in the presence of adhesions and scar tissue, without injury to the bladder or vagina, although improved with the robotic assistance, should not be underestimated. In this series, the mean operative time of this step alone was 66 minutes. Beside the advantages provided by the robotic assistance per se, we believe that the opening of the bladder UROLOGY 84 (5), 2014
increased the safety by avoiding the risk of bladder injury. The progression of the scissors or grasping forceps behind the bladder neck can be followed with a direct vision while passing from one side to another. Moreover, in theory, it can lead to a precise positioning of the cuff around the bladder neck, avoiding the dissection of the proximal urethra. The 4 patients in whom planned cystotomy was undertaken did not experienced additional complications, even considering the necessity of an indwelling catheter to ensure bladder drainage while healing. Although not universally performed in the reported literature, cystotomy has been found useful in complicated cases and in those in whom an intraoperative bladder perforation was detected during the procedure.5 Patients were catheterized for a mean of 7 days. This result is similar to the Ngninkeu series but shorter than the 10 days reported by Roupret with a pure laparoscopic approach. The catheterization time was only 2 days in the Mandron9 series, but they reported a 20% rate of transient retention after catheter removal. Aside from the planned restarting of intermittent clean self-catheterization in the patient with neurogenic incontinence and a poor detrusor contractility, there were no postoperative problems with urinary retention. We cannot exclude that the longer size of the cuff used in our experience (mean, 8 cm) compared to the Mandron series (mean, 6.4 cm) could play a role in this difference. Finally, there was only 1 postoperative low-grade complication in our experience, which highlights the low morbidity of the procedure. With 14.3 months of follow-up, 83% of women were fully continent, which is similar to the reported 61%-91% success reported in the literature.1-3,5,6 We believe that this is an acceptable success rate in this population where AUS implantation is considered as a last resort procedure. The observations of this study are limited because of the small number of patients treated so far and the lack of long-term follow-up data. It also describes a single-surgeon, single-center experience without randomization or control groups, and we will therefore be cautious in the conclusion that we draw. Supplementary data are needed to assess the reproducibility of this new approach. The higher cost of the procedure because of the robotic equipment must also be taken into account, and future medicoeconomic studies would be necessary to compare this technique to open or pure laparoscopic approaches.
CONCLUSION This study is the first reporting R-AUS laparoscopic implantation. The procedure was feasible, safe, and initial results are encouraging. More data are needed to clarify the role of this approach compared with open and pure laparoscopic AUS implantations. References 1. Diokno AC, Hollander JB, Alderson TP. Artificial urinary sphincter for recurrent female urinary incontinence: indications and results. The J Urol. 1987;138:778-780.
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2. Thomas K, Venn SN, Mundy AR. Outcome of the artificial urinary sphincter in female patients. The J Urol. 2002;167:1720-1722. 3. Petero VG Jr, Diokno AC. Comparison of the long-term outcomes between incontinent men and women treated with artificial urinary sphincter. The J Urol. 2006;175:605-609. 4. Chung E, Cartmill RA. 25-year experience in the outcome of artificial urinary sphincter in the treatment of female urinary incontinence. BJU Int. 2010;106:1664-1667. 5. Vayleux B, Rigaud J, Luyckx F, et al. Female urinary incontinence and artificial urinary sphincter: study of efficacy and risk factors for failure and complications. Eur Urol. 2011;59:1048-1053. 6. Costa P, Poinas G, Ben Naoum K, et al. Long-term results of artificial urinary sphincter for women with type III stress urinary incontinence. Eur Urol. 2013;63:753-758. 7. Chartier-Kastler E, Van Kerrebroeck P, Olianas R, et al. Artificial urinary sphincter (AMS 800) implantation for women with intrinsic sphincter deficiency: a technique for insiders? BJU Int. 2011;107:1618-1626. 8. Ngninkeu BN, van Heugen G, di Gregorio M, et al. Laparoscopic artificial urinary sphincter in women for type III incontinence: preliminary results. Eur Urol. 2005;47:793-797; discussion 7.
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9. Mandron E, Bryckaert PE, Papatsoris AG. Laparoscopic artificial urinary sphincter implantation for female genuine stress urinary incontinence: technique and 4-year experience in 25 patients. BJU Int. 2010;106:1194-1198; discussion 8. 10. Roupret M, Misrai V, Vaessen C, et al. Laparoscopic approach for artificial urinary sphincter implantation in women with intrinsic sphincter deficiency incontinence: a single-centre preliminary experience. Eur Urol. 2010;57:499-504. 11. Trolliet S, Mandron E, Lang H, et al. [Laparoscopic approach for artificial urinary sphincter implantation for women with severe stress urinary incontinence]. Prog Urol. 2013;23:877-883. 12. Costa P, Mottet N, Rabut B, et al. The use of an artificial urinary sphincter in women with type III incontinence and a negative Marshall test. The J Urol. 2001;165:1172-1176. 13. Clavien PA, Barkun J, de Oliveira ML, et al. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009;250:187-196. 14. Storm DW, Fulmer BR, Sumfest JM. Robotic-assisted laparoscopic approach for posterior bladder neck dissection and placement of pediatric bladder neck sling: initial experience. Urology. 2008;72: 1149-1152.
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