What Historical Barriers Have Limited the Use of the Female Artificial Urinary Sphincter? Do Current Trends Justify a Shift in Practice?

The AMS artificial urinary sphincter (AUS) was introduced over 50 years ago, with the current model, the AMS 800 (by Boston Scientific), becoming the most widely used version (Figure 1). While it is considered the gold standard for treating male stress urinary incontinence (SUI), its use in female patients remains limited. This is largely due to the high complication rates historically associated with female AUS implantation via the open surgical approach, which results in significant technical challenges. Bladder neck dissection was mostly done blindly by palpation and digital feeling with 1 or 2 fingers in the vagina, making the technique difficult to reproduce and challenging to teach.

Figure 1. Female artificial urinary sphincter (AMS800, Boston Scientific). A, Pressure-regulating balloon in the abdominal cavity. B, Cuff around the bladder neck. C, Pump in the labia majora.

At the same time, during the 1990s, Delancey’s theory brought a paradigm shift in the understanding of female SUI. This anatomical insight laid the foundation for midurethral sling procedures, such as the tension-free vaginal tape and transobturator tape, which aim to replicate the biomechanical support of compromised native tissues. Over time, these techniques became the gold standard for treating female SUI.¹ However, their efficacy has been called into question in certain contexts, particularly in the absence of urethral hypermobility.² Moreover, although generally effective, concerns over complications have led to an unprecedented controversy in recent years.

In the current context, given the less predictable outcomes of second synthetic sling insertion, the increasing prevalence of intrinsic sphincter deficiency with age, and the complexity of cases following midurethral sling complications, the AUS may play a key role in the treatment of female SUI.³

Furthermore, with the recent introduction of robot-assisted implantation techniques, the number of AUS procedures has increased significantly. This approach provides enhanced 3D visualization and improved instrument control, enabling more precise and reproducible bladder neck dissection, which in turn helps reduce complication and explantation rates.⁴

Finally, AUS has the unique asset over all other female surgical SUI treatments to increase the outlet resistance during storage while maintaining low outlet resistance during the voiding phase as the cuff is opened by squeezing the pump. It is therefore, at least in theory, able to restore the most physiologic storage and voiding function, making it a particularly valuable option, especially for patients with severe incontinence or bladder hypocontractility, with prevalence increasing in the aging and increasingly comorbid population.

Who Are the Right Candidates? How Should the AUS Be Implanted in Women?

In some countries, the AUS is now commonly used to treat nonneurogenic patients with SUI underpinned predominantly by intrinsic sphincter deficiency (ISD), typically defined by a positive cough stress test with poor urethral mobility.⁵ Several arguments reinforce the suspicion of ISD: the severity of SUI and a history of failed previous anti-incontinence surgeries. Virtually all female patients with recurrent or persistent SUI after midurethral slings (or Burch or pubovaginal slings) can be good candidates for an AUS. AUS implantation has also been reported as a safe and effective treatment option for neurogenic SUI in female patients.⁶

While AUS implantation has historically been performed through an open approach, there has been a shift in the past decade, with the vast majority of female AUSs being implanted robotically. Two robotic techniques have the described: the “anterior” and “posterior” approaches. For the anterior approach, the patient is positioned at a 23° Trendelenburg position with a side docking to maintain access to the vagina. A 14F urethral catheter is inserted. Five ports are placed in a straight line at the level of the umbilicus, following the standard setup for robotic pelvic surgery. The peritoneum is incised, and the bladder is dropped down from the anterior abdominal wall to open the Retzius space. After exposing the endopelvic fascia bilaterally, any previously placed anti-incontinence materials (such as midurethral slings, Burch sutures, or pubovaginal slings) are removed. The bladder neck is then carefully dissected under constant vision with the assistant exposing the anterior vaginal fornices with a finger in the vagina. A measuring tape is then placed around the bladder neck to determine the appropriate cuff size (typically 7-8 cm). The cuff is then positioned around the bladder neck, the pressure-regulating balloon is inserted either through the assistant port or via a 3-cm suprapubic incision, and the cuff tubing is tunneled through the same incision. Finally, the pump is placed in the labia majora through the same incision after careful dissection to correctly place the pump.⁷

Figure 2. The UroMems UroActive electromechanical sphincter. Reprinted with permission from UroMems.

What Do the Outcomes Tell Us? Where Are the Limitations?

A major challenge in evaluating the functional outcomes of female AUS implantation is the lack of high-quality evidence. Nonetheless, promising results have been reported in large retrospective cohort studies, with complete continence at last follow-up ranging from 63.6% to 85.6%.⁸ However, interpretation of these results is limited by heterogeneity in functional end points, largely due to the absence of a standardized definition for postoperative continence. Recent studies have also demonstrated improvements in patient-reported outcomes, quality of life, and even a positive impact on sexual function.^9,10 Pending confirmation through the 2 prospective trials that have been completed and whose results should be published in 2026 (VENUS [clinicaltrials.gov identifier: NCT04114266] and SUACT [clinicaltrials.gov identifier: NCT02490917]), female AUS appears as the most effective surgical option for female SUI due to ISD.

These encouraging functional results must be weighed against the risk of postoperative complications. Reported revision rates range from 5% to 32.7%, depending largely on the length of follow-up. As expected, erosion rates are generally lower than revision rates: for the open abdominal approach, erosion rates range from 5.6% to 14.3%, while for the laparoscopic approach, they range from 0% to 9.9%. While revision procedures often yield satisfactory outcomes, erosion cases are significantly more complex, typically necessitating device removal and resulting in recurrence of severe urinary incontinence, although it does not preclude further AUS reimplantation. Erosion is not the only adverse event associated with the device; other issues such as mechanical failure, nonmechanical failure, infection, difficulties in manipulating the pump, and de novo overactive bladder symptoms have also been described. However, device survival appears to be longer in female vs male AUS patients.

What Does the Future Hold for Female AUS?

The broader adoption of this device in female patients presents new challenges, including pump handling difficulties, erosion management, and the development of de novo overactive bladder, which are issues that remain incompletely resolved. Research in this area is highly active, with promising new directions such as the development of electromechanical sphincters aimed at improving ease of use, and novel surgical techniques, like the use of a peritoneal flap, to reduce the risk of vaginal erosion. The first pilot study of electromechanical AUS implantation in female patients was completed in 2025 with the UroActive device (UroMems), with no erosion or explantation reported after 1 year for the 6 patients (clinicaltrials.gov identifier: NCT05828979; Figure 2).

Although Food and Drug Administration approval for female AUS implantation is still pending due to a lack of robust prospective data, its use is well established and justified based on existing literature. Ongoing prospective studies and randomized trials—such as the VENUS trial and the SUACT trial—are expected to further clarify and strengthen the role of the female AUS, potentially reshaping the landscape of treatments for female SUI.

Conflict of Interest Disclosures: Dr Peyronnet reported being a consultant for Boston Scientific, Intuitive, Medtronic, Pierre Fabre, IBSA, Coloplast, Schwa Medico, Hollister, Ipsen, and AbbVie. No other disclosures were reported.