Stress urinary incontinence (SUI) in women is a common condition causing significant burden to the health care industry. Surgical management is the current mainstay of therapy, but surgical choice is dependent on the etiology. Urethral hypermobility, more common in younger women, is commonly treated (in the U.S.) with a midurethral sling (MUS). Unfortunately, failure of MUS can occur in 15% of cases, and long-term recurrence of SUI has been reported in up to 68.3%.^1,2 Intrinsic sphincter deficiency (ISD), usually defined by a low Valsalva leak point pressure, along with a “fixed” urethra, is oft managed with either bulking agents or pubovaginal bladder neck autologous fascial sling (PVS). Bulking agents may not be durable, and the efficacy of the PVS—particularly in moderate to severe ISD—depends on its obstructive effect, often requiring self-catheterization. Given these facts, along with the current litigious environment surrounding polypropylene mesh slings, reconstructive surgeons should be exploring alternative approaches to treat complex SUI in women.

The artificial urinary sphincter (AUS) was developed in the 1970s and, while initially developed for use in women, it became almost exclusively used for men with SUI after radical prostatectomy and remains so today.³ The AUS offers a distinct advantage over slings, as it replicates the native sphincter function by increasing the outlet resistance during filling while allowing low pressure voiding during cuff opening. Early series from the 1980s and 1990s showed efficacy, but its general applicability was hindered by the need for open surgical placement, as transvaginal cuff placement was associated with high risks of vaginal exposure and infection. Despite the technical challenges of open AUS placement in women, given the lack of a natural plane between the bladder neck and vagina, several studies showed promising outcomes. Diokno et al published a retrospective review of 32 women who had all previously failed bladder suspension, with 31/32 having a functional AUS at an average followup of 2.5 years.⁴ The continence rate was 91% with mechanical complications occurring in 21%.

Most of the contemporary published literature is from France. Costa et al implanted 376 devices in 344 women during a 20-year period. At a mean followup of 9.6+/–4.0 years, total continence occurred in 85.6%, with an overall complication rate of 26% (mechanical 13.6% and nonmechanical requiring complete removal in 12.8%).⁵ Vayleux et al reported on 215 women with a mean followup of 6 years. The continence rate at end point was 74% and on multivariate analysis risk factors for failure included age >70 years, history of Burch colposuspension and prior pelvic radiation therapy.⁶

While the AUS may be indicated after failed bulking agent or fascial sling, to date there is no literature comparing the PVS to the AUS in women with neurogenic ISD or recurrent SUI.³ This makes the exact role of the AUS in the algorithm to treat complex SUI uncertain. However, small series have shown durable outcomes in women with neurogenic ISD. Phé et al reported on the largest long-term series of neurogenic women undergoing AUS placement, with 26 patients at a median followup of 7.5 years. At 20 years, the survival rate without explantation was 74% and without revision was 51%.⁷

Patient selection is critical. Beyond its role as a salvage procedure in the failed sling patient, the AUS may play a unique role in women who have detrusor underactivity, acting as a nonobstructive means to attain continence.³ It is imperative as part of the preoperative evaluation to rule out any urethral pathology with cystourethroscopy, as well as urodynamics in any woman with neurologic condition to assess storage pressures, as AUS placement can result in upper tract deterioration in a low compliance bladder. Relative contraindications to AUS placement in women include a history of pelvic radiation therapy as this increases the risk of erosion, and cognitive dysfunction that would preclude the ability to manually operate the device. Patients should be counseled on long-term risks of complications, including device malfunction, urethral erosion infection and urethral atrophy requiring partial or complete revision or removal of the AUS.

The introduction of the da Vinci® robotic operative platform has made bladder neck AUS placement in women a feasible option for patients with complex, recurrent SUI. The optical magnification, tremor control and access to the deep pelvis can mitigate the challenges inherent with the open surgical technique. Outcome data for robotic assisted laparoscopic AUS placement have been scarce, with several series reporting single-digit cases. The largest contemporary series by Peyronnet et al reported on 128 women at a mean followup of 13 months, with a bladder neck injury rate of 9.8%, overall complication rate of 18%, and a revision rate of 5.5%.⁸ The robotic surgical technique, assisted by tenting of the anterior vaginal wall during bladder neck dissection, has been presented by Dr. Peyronnet and is reproducible with a moderate learning curve.

Despite the current encouraging data from our French colleagues, the AUS is not approved by the U.S. Food and Drug Administration for use in women and therefore is not listed as an option in the AUA guidelines for treatment of SUI.³

In summary, those who are facile in robotic pelvic surgery in women should be open to embracing this new adaptation to a familiar device once relegated only to the postprostatectomy incontinent male. Newer technology, including wireless automatic cuff deactivation that does not require manual manipulation, is on the horizon and could expand the patient population for whom the AUS may be offered.⁹ If done correctly in carefully selected patients, the AUS in women may offer significantly higher continence rates with a durability that equals, if not surpasses, the MUS.