Stesura Seveso Archivio Italiano di Urologia e Andrologia 2024; 96(1):12214 1 ORIGINAL PAPER physiological mechanisms: urethral hypermobility and intrinsic sphincter deficiency (ISD) (2). While in the former case there is a more consensual treatment strategy, the lat- ter has a less unanimous management approach. Artificial urinary sphincter (AUS) is a treatment option for women with severe SUI after failure of previous urinary inconti- nence surgeries and/or as a primary procedure in severe ISD (3, 4). However, since it is a challenging technique with high risk morbidity and due to the paucity of long- term follow-up, its current role in the surgical treatment of SUI is still lacking evidence. According to the European Association of Urology guidelines, AUS should be implant- ed only as a last resort procedure and only in expert cen- ters. The panel recommends synthetic sling, colposus- pension and autologous sling as first options in these patients. When proposing AUS, it is important to inform the patients of the high risk of complications, mechanical failure, or need for explantation (level of evidence 3, grade of recommendations: weak) (3). We report 18-year experience of AUS laparoscopic implantation in Clinique du Pré, assessing the long-term efficacy and risk factors for surgical revision and definitive explantation of AUS laparoscopic implantation in female patients. MATERIALS AND METHODS A retrospective and descriptive review of all female patients submitted to AUS implantation between April 2005 and March 2023 was conducted. Eighty-one females with SUI as a result of ISD were treated with laparoscopic implantation of the AMS 800 Urinary Control System (Boston Scientific, Marborough, MA, USA). All patients were diagnosed with ISD based on clinical history, physical examination and urodynamics, namely maximum urethral closure pressures (MUCP) and Valsalva leak point (VLPP). Manual dexterity was determined as no evidence of cogni- tive impairment, extremity weakening or tremor. Inclusion criteria included: motived women with type III incontinence, with proper dexterity and with no cervical urethral hypermobility; negative Marshall/Bonney or Ulmsten test (urine leakage on straining or coughing not corrected by urethral support); MUCP under 20 cmH2O and a VLPP under 60 cmH2O; and normal detrusor func- Introduction and objectives: Artificial urinary sphincter (AUS) is a treatment option for women with stress urinary incontinence (SUI) after failure of previous surgery or as a primary procedure in severe intrinsic sphincter deficiency (ISD). The aim of the study was to assess the long-term efficacy and risk factors for surgical revision and definitive explantation of AUS laparoscopic implantation in female patients. Methods: A retrospective review of all women submitted to AUS implantation between April 2005 and March 2023 was conduct- ed. The AUS was implanted via transperitoneal laparoscopic approach, by two experienced surgeons. The primary endpoint was postoperative continence. Continence was defined as no leakage and no pad usage or leakage and/or pad usage with no impact on social life and failure as leakage and/or pad usage impacting social life. As secondary outcomes, clinical predictive factors for AUS revision and definitive explantation were evalu- ated. Results: In the last 18 years, females with a mean age of 68 ± 12 years-old were submitted to laparoscopic implantation of AUS. Early overall complication rate was 16%, but only one case was Clavien-Dindo ≥ 3. After a median follow-up of 67 months, 22.2% of the patients needed a device revision, the majority due to mechanical device dysfunction. AUS definitive explantation was performed in 16%, mainly due to urethral/vaginal erosion (9.9%) and infection (6.2%). Patients with age ≥ 70 years and follow-up ≥ 10 years significantly predisposed for device revi- sion. At the time of the last follow-up, 72% of the patients were keeping the urinary continency. Conclusions: Laparoscopic AUS implantation in females is an effective treatment for SUI due to ISD. Meanwhile, adequate patient selection, multidisciplinary evaluation and careful expec- tation management are essential to achieving good results, con- cerning their significant complication rate. KEy wORDS: Artificial urinary sphincter; Female urinary inconti- nence; Intrinsic sphincter deficiency; Laparoscopy. Submitted 20 December 2023; Accepted 23 December 2023 INTRODUCTION Stress urinary incontinence (SUI) in women is a prevalent and bothersome condition with significant impact on quality of life (1). It is mainly attributed to two patho- Eighteen years of experience in laparoscopic implantation of artificial urinary sphincter in women with intrinsic sphincter deficiency Débora Araújo 1, Pierre-Emmanuel Bryckaert 2, Miguel Miranda 3, Vasco Rodrigues 4, Nicolas de Saint Aubert 2, Johann Menard 2, Eric Mandron 2 1 Urology Department, Centro Hospitalar Vila Nova de Gaia/Espinho EPE, Vila Nova de Gaia, Portugal; 2 Urology Department, Clinique du Pré, Technopôle Université, Le Mans, France; 3 Urology Department, Centro Hospitalar Universitário Lisboa Norte EPE, Lisboa, Portugal; 4 Urology Department, Centro Hospitalar Universitário de São João EPE, Porto, Portugal. DOI: 10.4081/aiua.2024.12214 Summary Archivio Italiano di Urologia e Andrologia 2024; 96(1):12214 D. Araújo, P.-E. Bryckaert, M. Miranda, et al. 2 tion and bladder compliance. Previous anti-incontinence procedures or the presence of genital prolapse were not a contraindication for AUS implantation. Patients with urge incontinence alone or previously submitted to pelvic radiotherapy were excluded. The AUS was implanted via transperitoneal laparoscopic approach, by two experi- enced surgeons, according to a previous described tech- nique (5, 6). In cases of 132 concomitant genitourinary prolapse, laparoscopic anterior and posterior mesh sacro- colpopexy was carried out before inserting the AUS com- ponents, according to a previous described technique (7, 8). Informed consent was obtained from all patients. Patients were assessed at 6 weeks (sphincter activation), on periodical follow-up visits at 3-, 6- and 12-months post-operative and yearly subsequently. Data collected included demographic and baseline characteristics; surgi- cal procedure details; post operative results and complica- tions; revision for partial or total component replacement, deactivation and definitive explantation rates, as well as their causes; and current continence. The primary end- point was postoperative continence. Continence was defined as no leakage and no pad usage or leakage and/or pad usage with no impact on social life and failure as leak- age and/or pad usage impacting social life. The results were evaluated short term (1 year after implantation) and long term (at last follow-up), based on clinical interviews. As secondary outcomes, clinical predictive factors of AUS revision and definitive explantation were assessed. Statistical analyses were performed using IBM SPSS Statistics software version 25. Categorical variables are presented as frequencies and percentages, and continu- ous variables as means and standard deviations, or medi- ans and interquartile ranges for variables with skewed distributions. Pearson's chi-squared or Fisher's Exact test were used to test for associations in categorical variables. Simple and multiple logistic regression were performed to determine clinical predictive factors of need of revision and definitive explantation AUS surgery. A p-value ≤ 0.05 was considered statistically significant. RESULTS In the last 18 years, 81 females with a mean age of 68 ± 12 years-old were submitted to laparoscopic implantation of AUS. All patients reported continual use of pads (> 3 pads/day). The median body index mass (BMI) was 29 kg/m2 (IQR 25-35). The patients' medical history includ- ed hypertension (49.4%), anxiety/depression (17.3%), diabetes (17.3%), smoking (14.8%) and asthma or others pulmonary diseases (16.0%). In 4 patients (5.1%), ISD resulted from an underlying neurological condition (three myelomeningocele and one spinal cord injury). Most of the patients had previous pregnancies (64.5%) and the mean number of deliveries per patient was 2 ± 1. A total of 12 patients underwent to a primary AUS implantation without previous urogynecological surgeries as a result of severe ISD. Regarding previous surgeries, 38.3% under- went a hysterectomy, 84% incontinence surgery (mainly midurethral slings) and 27.1% prolapse surgery (mainly laparoscopic sacropromontofixation). A history of other abdominal or pelvic surgeries was present in 49.4% of patients, for example appendicectomy or cholecystecto- my. On urodynamics, median MUCP was 16 cmH2O (IQR 12-20). Patients’ characteristics are summarized in Table 1. Mean operative time was 115 ± 40 minutes (range to 50-190 min). No case of laparotomy conversion was reported. In 6 cases, simultaneous laparoscopic ante- rior and posterior sacrocolpopexy was carried out. Intraoperative blood loss was negligible with no need of blood transfusion. The most frequently chosen cuff length was 7 cm (48.6%) and all patients had balloon pressure of 61-70 cmH2O in the reservoir. The average length of hospital stay was 2 days (with a range of 1 to 8 days). There were no intraoperative complications, except for one small vaginal perforation (less than 1 cm). It was immediately repaired in two layers with resorbable sutures and without any comorbidity involved. Early overall complication rate was 16% (n = 13). Most were Clavien-Dindo as acute pelvic pain, urinary tract infec- tions and acute urinary retention. Just one case of Clavien-Dindo ≥ 3 was observed: a sepsis due to sphinc- ter infection with necessity of AUS removal; the follow-up of this patient was lost. Considering the functional out- comes in the first 12 months, 77 patients were continent (96.3%) and 3 (3.8%) had unchanged incontinence. After a median follow-up of 67 months (IQR 14-110), 48 of the patients were continent (72%). The follow-up was lost in 14 cases. Eighteen patients needed a device revision (22.2%). All revision surgeries were performed laparo- Table 1. Patient characteristics. Variables Value No, patients included (n) 81 Age (years) [Mean ± SD] 68 ± 12 Body mass index (Kg/m2 ) [Median (IQR)] 29 (25-35) Diabetes, n (%) 14 (17.3) Hypertension, n (%) 40 (49.4) Smoking, n (%) 12 (14.8) Anxiety or depression, n (%) 14 (17.3) Asthma or others pulmonary diseases, n (%) 13 (16.0) Previous birth number, [Mean ± SD] 2 ± 1 History of pelvic urogynecological surgery, n (%) Hysterectomy 31 (38.3) Vaginal 7 (9.3) Suprapubic 19 (25.3) Laparoscopy 1 (1.3) Missing data 4 (4.9) Anti-incontinence surgery 69 (85.2) TOT procedure 48 (59.3) TVT procedure 7 (8.6) Burch procedure 9 (11.1) Marshall-Marchetti procedure 3 (3.7) Artificial urinary sphincter (vaginal approach) 2 (2.5) Surgical prolapse repair 14 (17.3) Laparoscopic sacrocolpopexy 8 (9.9) Abdominal sacrocolpopexy 2 (2.5) Vaginal prolapse repair 3 (3.7) Missing data 1 (1.2) Others previous laparoscopic surgeries, n (%) 40 (49.4) Maximum urethral closure pressure (cmH2O) [Median (IQR)] 16 (12-20) TOT: transobturador tape; TVT: Transvaginal tape. Archivio Italiano di Urologia e Andrologia 2024; 96(1):12214 3 Laparoscopic implantation of artificial urinary sphincter scopically. Most of them were needed to mechanical device dysfunction (n = 12, 14.8%) such as perforation of the cuff/balloon/tubing or depressurization of the system. Failure in achieving continence, need for pump reposi- tion and periurethral atrophy with cuff dislodgement (loss of weight in obese patients) were additional reasons for device revisions (n = 6, 7.4%). The mean time between implantation and device 197 exchange due to mechanical problems was 76 ± 49 months. Patients with age ≥ 70 years and follow-up ≥ 10 years significantly pre- disposed for device revision (OR = 0.27, 95% CI [0.08, 0.93], p = 0.04 and OR = 5.5, 95% CI [1.67, 18.1], p = 0.01, respectively). Nine patients (11.1%) required AUS deactivation. The main reasons were decreased manual dexterity or cognitive ability due to diseases such as rheumatism, dementia and bedridden patients. These pathologies resulting in poor bladder emptying with high postvoiding residues, frequent urinary tract infections and incontinence were the main reasons to AUS deactiva- tion. Two of these patients had permanent catheterization and the others used adsorbent pads. AUS definitive explantation was performed in thirteen patients (16%), mainly due to urethral/vaginal erosion (n = 8, 9.9%) and infection (n = 5, 6.2%). The median time between implantation and definite explantation was 38 months (IQR 2-75). Diabetes, history of previous prolapse sur- gery or history of other previous abdominal or pelvic sur- geries are significantly associated with definitive explan- tation rate on univariate analyses but not in multivariate analyses. DISCUSSION AUS implantation in females is an effective long-term treatment for SUI due to ISD with a good postoperative success rate. With a median follow-up of 6-years, 72% of the patients were continent. The excellent functional out- comes of AUS in female patients with SIU due to ISD have been reported for decades (9). The definition of ISD is controversial, however, most authors advocate the use of a combination of clinical and urodynamic criteria. The com- bined presence of a negative urodynamic evaluation and negative Marshall-Bonney and Ulmsten tests is the most favoured scenario to AUS implantation in women with non-neurogenic SUI (10). Peyronnet et al performed a sys- tematic review and showed the complete continence rates and improved incontinence ranged from 61.1% to 100% and 81% to 100%, respectively, regardless of the surgical approach (11). Reus et al demonstrated that the outcome “zero to one pad” varied between 58% and 100% in the female AUS implantation (12). Comparing to other SIU surgeries, as transobturador tape outcomes, the cure rate was lower in females with ISD combined with fixed ure- thra (67%) (13). Women with low urethral closure pres- sure, isolated or combined with a lack of urethral mobili- ty, have an increased risk of refractory SUI after midurethral slings, as high as 75% (14). The main theori- cal advantage of AUS over other surgical options for female SUI due to ISD is that it is the only anti-inconti- nence procedure that can mimic the physiological func- tion of the sphincter with the ability to restore both nor- mal storage and voiding function by increasing the outlet resistance at rest when the cuff is closed but maintaining low resistance during the voiding phase with the cuff being opened (11) Despite its efficacy there is a non-neg- ligible associated morbidity. The revision rate (22.2%), including mechanical failure (14.8%) and explantation rate (16%), is comparable to those in the current litera- ture. A recent systematic review reported revision rates ranging between 6 to 45%, with mechanical failure between 2% to 41%. The explantation rate due to infec- tion and/or erosion varied between 2% to 31% (12). Peyronnet et al also reported explantation rates up to 45% (11). During the last decades, the retropubic open approach was the most popular, but the rise of minimally invasive surgical approaches reduced the inherent mor- bidity (9). The main advantage of laparoscopic and robot- ic-assisted approach is the easier access to the pelvis and better dissection of the bladder neck with better visualiza- tion, especially in obese patients (15). Mandron and col- Table 2. Simple and Multiple logistic regression analyses of clinical parameters in predicting device revision (n = 18) and AUS definitive explantation (n = 13). Device Revision AUS definitive explantation Variables Simple logistic Multiple logistic Simple logistic Multiple logistic regression regression regression regression P value 95% CI OR P value P value 95% CI OR P value Age ≥ 70 years 0.03 0.08- 0.93 0.27 0.04 0.46 Obesity 0.23 0.08 Diabetes 0.50 0.04 0.36 Hypertension 0.31 0.73 Smoking 0.06 0.40 Asthma or others pulmonary diseases 0.72 1.00 Obstetric history 0.98 0.76 History of previous hysterectomy 0.95 0.55 History of previous anti-incontinence surgeries 1.00 1.00 History of previous prolapse surgeries 0.37 0.04 0.13 History of other abdominal or pelvic surgeries 0.06 0.08 0.03 0.06 MUCP ≤ 16 0.71 1.00 AUS surgery time > 10 years 0.01 1.67- 18.1 5.5 0.01 0.28 Surgery time ≥ 120 minutes 0.81 0.13 0.337 AUS: artificial urinary sphincter; MUCP: maximum urethral closure pressure. Archivio Italiano di Urologia e Andrologia 2024; 96(1):12214 D. Araújo, P.-E. Bryckaert, M. Miranda, et al. 4 leagues were the first teams to publish their preliminary experience in laparoscopic AUS implantation in the late 2000s. Some of these patients were included in this cohort. They reported good results, as 82.6% of the patients were continent at a mean follow-up of 26.1 months (6). In the last years, several series with a robotic- assisted approach were published, including “anterior” robotic technique and more recently a “posterior” tech- nique (16-18). Considering the laparoscopic or robotic approaches, the continence rate reported as zero pads ranged from 63% to 83% in female patients, similar to what demonstrated in open technique (42 to 86%) (12). To our knowledge, there was only one study comparing robotic to open approach and reported a significantly decrease in intra- and postoperative complications rate with similar continence results (17). Robotic approach allows lower technical complexity, enhanced dexterity, better mobility of the instruments and physiological tremor filtering relatively to the laparoscopic route (9, 19). Given the limited information available in literature, it is still early to compare the performance and safety of the different surgical techniques and further prospective stud- ies are required. We believe that the differences in compli- cation and explantation rates between centers can be explained by distinct levels of experience. There was low level of evidence-based data, with significant clinical and methodological heterogeneity across studies. Most of the studies had a limited number of patients, had mainly short-term follow-up and were single-center retrospective in nature. The VENUS study is a prospective cohort study in recruitment with the purpose to evaluate the outcomes of female AUS surgery involving 25 European centers, including robotic assisted, laparoscopic and open patients. When compared to other works, our results are similar with the ones from larger series which may reflect that sur- gical experience and high volume could favour successful outcomes. As the AUS implantation is more demanding than sling procedures, specialized centers with a proper training are required to perform this surgery (10). Therefore, we believe that AUS implantation must be restrict to a limited number of hospitals/centers world- wide. It was advocated that the specialized centers are trained in making the correct diagnosis, had experience to perform other surgical interventions for SUI (not limiting the patients’ choice) and, more importantly, had experi- ence in managing the complications of AUS implantation (10). The optimal time to AUS implantation was unknown and AUS was rarely used as a first surgical intervention. Some authors support performing the procedure after fail- ure of at least one and a maximum of two previous inter- ventions. The number of previous anti-incontinence pro- cedures decreases the success rate of AUS and increases the risk of erosion (10, 12, 16). In our study the number of previous surgeries did not correlate with the success rate. However, we demonstrate that advanced age and long-term AUS (more than 10 years) significantly predis- posed for device change. The median time until mechani- cal failure was 76 months, which corresponds to approxi- mately 6 years of device survival. Device failure was man- aged by either exchange of the damaged component or by total replacement, without the need of definitive explanta- tion. Chung et al advised that all patients need to be informed that the risk for potential revision surgery increases with time; in his cohort the median time of AUS revision surgery was 88 months and he demonstrated that women with more than 35 years had more revision or removal surgery for cuff erosion and infection (20). Other study reported that a presence of higher BMI (more than 30 kg/m2) and multiple surgeries were associated with higher revision rates (21). In the literature, the major risk factors for explantation are pelvic irradiation, age > 70 years, neurological pathology and history of pelvic surgery, including the Burch procedure and sacral colpopexy (16, 22, 23). In our cohort, history of diabetes, previous pro- lapse surgery or other previous abdomino-pelvic surgeries may predispose for definitive explantation, although these association were not statistically significant. Our study had several limitations. First, the single-center, retrospective design of the study and the fact that the procedures were performed by two surgeons with extensive experience in the implantation of AUS, limit the generalization of the results to centers with a low volume of procedures. Second, the absence of a validated incontinence question- naire, since our surgeries started 18 years ago, to evaluate patient satisfaction. Thirdly, larger studies, prospective and randomized, are required to properly evaluate the value of laparoscopic female AUS implantation compared with the open or robotic approaches and other therapeutic options (eg, pubovaginal sling). Regarding the risk factors of sur- gical revision and definitive AUS explantation, more stud- ies are needed. CONCLUSIONS Laparoscopic AUS implantation in females is an effective treatment for SUI due to ISD. Meanwhile, adequate patient selection, multidisciplinary evaluation and careful expectation management are essential to achieving good results, concerning their significant complication rate. The patients should be informed about the high risk of complications, need to surgical revision, mechanical fail- ure or need for explantation. 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Correspondence Débora Araújo, MD deboracerqueiraaraujo@gmail.com Urology Department, Centro Hospitalar Vila Nova de Gaia/Espinho EPE Conceição Fernandes st., 4434-502, Vila Nova de Gaia, Portugal Pierre-Emmanuel Bryckaert, MD bryckaert@wanadoo.fr Nicolas de Saint Aubert, MD nicolas.desaintaubert@gmail.com Johann Menard, MD johann.menard@orange.fr Eric Mandron, MD dr.mandron@wanadoo.fr Urology Department, Clinique du Pré, Technopôle Université René Laennec 13 Avenue, 72000 Le Mans, France Miguel Miranda, MD msmmmiranda@gmail.com Urology Department, Centro Hospitalar Universitário Lisboa Norte EPE Professor Egas Moniz Avenue, 1649-028 Lisbon, Portugal Vasco Rodrigues, MD ocsav.1992@gmail.com Urology Department, Centro Hospitalar Universitário de São João EPE Professor Hernâni Monteiro Avenue, 4200-319 Porto, Portugal Conflict of interest: The authors declare no potential conflict of interest.