Stress urinary incontinence (SUI) in female population is a prevalent and bothersome symptom with significant impact on quality of life. It is mainly attributed to two pathophysiological mechanisms: urethral hypermobility and intrinsic sphincter deficiency (ISD). While in the former case, there is a more consensual treatment strategy, the latter has a less unanimous management approach. Artificial urinary sphincter (AUS) is a treatment option for SUI with ISD, however, due to being 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. We aim to describe the long-term efficacy and safety of AUS implantation in female patients through a minimally invasive approach and to identify clinical predictive factors of complications, need of sphincter revision and definitive explantation.

A retrospective review of all the female patients submitted to AUS implantation between April 2005 and March 2023 was conducted. All patients were diagnosed with SUI based on the clinical history, examination, and urodynamics, namely the urethral pressure profile. The AUS (AMS 800™, American Medical System, Minnesota, USA) was implanted via transperitoneal laparoscopic approach, by two experienced surgeons. Patients were assessed at 6 weeks (sphincter activation) and on periodical follow-up visits at 6- and 12-months post-operative and yearly subsequently. Data collected included demographics and baseline characteristics; surgical procedure details; post-operative results and complications; revision (partial or total component replacement), deactivation, and definitive explantation rates, as well as its cause; and current continence and satisfaction status. Postoperative functional outcomes were defined as success (no leaking, no pad use), improvement (>50% decrease in number of leakage episodes, >50% decrease in number of pads used or use of light protection) or failure (<50% improvement, persistent or increased leaking). As secondary outcome, clinical predictive factors of complications, need of sphincter revision and failure of AMS were evaluated.

Over a 18 years period, 81 females with a mean age of 68±12 years-old were submitted to laparoscopic implantation of AUS. Most of the patients had previous pregnancies (89.5%), the majority being eutocic deliveries (72.7%). Concerning previous surgeries, 38.3% underwent hysterectomy, 84% incontinence surgery (mainly midurethral slings) and 27.1% prolapse surgery (mainly laparoscopic sacropromontofixation). Fifty percent had a history of other previous abdominal or pelvic surgeries. Median maximum urethral closure pressure was 16cmH2O. Mean operative time was 115±40 minutes. The most frequently chosen cuff length was 7cm (48.6%) and balloon pressure was 61-80cmH2O. No case of laparotomy conversion was reported. Intraoperative blood loss was negligible and median hospital stay was 2 days (IQR 2-3). Post-operative outcomes showed that 71.3% (n=57) had no incontinence, 25% (n=20) had an improvement and 3.7% (n=3) had incontinence persistence. Early overall complication rate was 16% (n=13). Most were mild complications, with only one being Clavien-Dindo≥3 (sepsis due to sphincter infection). Concerning late complications, a total rate of 60% was found, most of them due to mechanical problems of the device (14.8%), followed by erosion (9.8%) and infection (6.2%).
At a median follow-up of 67 months (IQR 14-110), 13 patients (16%) had sphincter failure due to urethral/vaginal erosion (n=8) and infection (n=5) and required explantation. The median time between implantation and definite explantation was 38 months (IQR 2-75). Eighteen patients needed replacement of the device (22.2%), most frequently because of mechanical device dysfunction (n=12). The mean time between implantation and device exchange due to mechanical problems was 76±49 months. Nine patients (11.1%) had to undergo AMS deactivation after a median of 72 months (IQR 48-96), mainly because of decreased manual dexterity or cognitive ability. Currently, 72% patients are continent and satisfied with the surgical outcomes. The follow-up was lost in 14 cases. 
Diabetes, history of previous prolapse surgery and previous abdominal surgeries other than incontinence or prolapsus surgery were significantly associated with definitive explantation rate in univariate analyses but not in multivariate analyses. Patients with age ≥70 years and follow-up ≥10 years had a clinically significant predisposition for device exchange (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).

AUS implantation in females is an effective treatment for SUI due to ISD with a postoperative success rate (continence or symptom improvement) of 96.3% and median 6 years follow-up continence rate and overall satisfaction of 72.0%. Despite its efficacy, there is a non-negligible associated morbidity. The explantation rate (16%); revision rate (22.2%) and deactivation rate (11.1%) are in line with the current literature. When compared to other works, our results are more similar to the ones from larger series which may reflect that surgical experience and high volume could favor successful outcomes. The median time until mechanical failure was 76 months, which corresponds to approximately 6 years of survival of the device. Device failure was managed by either exchange of the damaged component or by total replacement, without the need of definitive explantation. Indeed, the only reported causes of definitive failure of the AUS were urethral/vaginal erosion and infection. Diabetes may predispose for urinary tract infections and, therefore, increase the risk of device infection, possibly explaining the higher risk of explantation rate. Furthermore, both diabetes and history of previous surgeries, may be associated with a higher risk of erosion either due to fibrosis or incomplete wound healing. However, both these associations were not verified in multivariate analysis. The minimally invasive approach aims to enhance recovery from surgery, reduce hospital stay and improve cosmetic results when compared to open approach. Currently, robot-assisted AUS implantation has also been described as alternative to laparoscopy. However, further data is still needed comparing both approaches, not only in terms of peri-operative and long-term functional outcomes, but also concerning costs, availability and learning curves.

Laparoscopic AUS implantation in females is an effective treatment for SUI caused by ISD. Its functional outcomes showed a high rate of success, while the long-term complications and device global survival were acceptable, given the previous failed treatments and poor quality of life due to SUI. Despite being challenging, laparoscopy is a feasible and non-inferior technique when compared to other approaches.

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Continence 7S1 (2023) 100774
DOI: 10.1016/j.cont.2023.100774