Hypothesis / aims of study
Artificial urinary sphincter (AUS) implantation is a last resort treatment in selected women with severe stress urinary incontinence (SUI) who failed previous treatment options. In these female patients, urinary incontinence is mainly attributable to intrinsic sphincter deficiency. The experience of implanting the AUS in women remains limited worldwide. Indeed, many healthcare teams are still reluctant to implant AUS devices in women due to technical difficulties due to the short length of the female urethra and to the previous pelvic surgeries, which can lead to subsequent morbidity. Robot-assisted laparoscopic AUS implantation (AMS 800TM) has been reported to be technically feasible (1, 2) and enables to overcome the dissection difficulty of the bladder neck. Our aim was to report the functional outcomes of robot-assisted laparoscopic AUS implantation (AMS 800TM) in women with stress urinary incontinence due to sphincter deficiency.
Study design, materials and methods
A prospective monocentric study included all consecutive female patients with SUI due to sphincter deficiency and implanted with an AUS (AMS 800TM) using a robot-assisted laparoscopic approach since 2012. The dissection of the bladder neck was initiated using a posterior approach of the plane between the bladder and the anterior vaginal wall with a complete visual control. The device was activated 6 weeks after surgery.
Intra and early postoperative complications were reported according to Clavien’s classification. Patients were followed-up at 1 month, 6 months, 1 year and annually thereafter. Continence (defined as no need for pads), explantation and revision rates were reported.
Overall 27 women were included, with a median age of 68 years (interquartile range IQR 56.5-72.5). The patients’ baseline characteristics are shown in table 1. The AUS median cuff length used was 7.5 cm (IQR 6.8-8).
The median operating time was 130 minutes (IQR 120-187.5). One conversion to laparotomy occurred. Overall, 3 bladder, 5 vaginal and 1 ureteral injuries were reported. Among these injuries, one injury was located at the bladder neck and another one at the left ureter. The AUS was not implanted in these 2 cases.
A total of 12 early postoperative complications occurring in 10 patients was reported: 2 clavien I (labia hematoma) and 10 clavien II (6 transient urinary retention, 3 urinary tract infection, 1 intestinal occlusion).
The median hospital stay was 7 days (IQR 7-8).
The median follow-up was 19 months (IQR 11-27). Three patients underwent a revision surgery because of mechanical failure (mean time to revision 16.6 months). At last follow up, 85.2% of patients were continent and all devices were in place and activated.
Interpretation of results
Our technique of AUS implantation differs from the previous ones reported in the literature (1,2). Indeed an anterior approach of the bladder neck with a finger control of the vagina has been reported as well as an opening of the bladder to control the dissection of the bladder neck.
Our surgical technique enables direct vision of the vesico-vaginal space and a complete control of the whole bladder neck, especially in its posterior part. A bladder or vaginal injury which is not located closed to the bladder neck does not prevent the implantation of the device. The knowledge of different approaches (anterior and posterior control) for the dissection of the bladder neck may be valuable in order to adapt to the local aspects of the pelvis.
The main early postoperative complication was transient urinary retention, managed by one week of intermittent self-catheterization, and probably due to the oedema induced by the dissection. An excessive tight cuff should be avoided in order to prevent this complication. Our results are encouraging compared to those in the literature and need to be confirmed by a longer follow-up.