Impact of Robotic Artificial Urinary Sphincter Implantation in Female Patients on Quality of Life and Patient-reported Outcomes

Although the artificial urinary sphincter (AUS) was originally designed for both men and women, its use has become the gold standard for men stress urinary incontinence (SUI) over the past 50 yr, while its application in women remains marginal. In recent years, the advent of robot-assisted AUS implantation has favored a new surge in its use in many countries across the world. The European Association of Urology guidelines do not recommend the AUS as a first-line treatment for female patients due to insufficient high-quality data and a quite high rate of complications. This study represents the largest cohort of robotic female AUS implantation in the literature and is the first to report the patients’ reported outcomes (PROMs) after female AUS implantation using validated questionnaires. We found significant improvement in all PROMs at 3 mo, except for the Urinary Symptoms Profile voiding dysfunction subscore. Further studies with longer follow-up are needed to confirm that these results are maintained over time. Moreover, the continence status, as subjectively reported by the patients, are significantly associated with the PROMs, which suggest that the existing literature on female AUS, which lacks such PROMS, is still of interest. Artificial urinary sphincter (AUS) is commonly used in France in female patients with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). However, it has never been assessed using patient-reported outcomes. This study aimed to evaluate the functional outcomes of robotic AUS implantation using validated questionnaires. The data from female patients who underwent robotic AUS implantation at a single academic center between 2014 and 2023 were collected prospectively. Preoperatively, all patients filled out a Urinary Symptoms Profile (USP) questionnaire, and the International Consultation Incontinence Questionnaire Short Form (ICIQ-SF). These were repeated at 3 mo postoperatively and annually along with a Patient Global Impression of Improvement (PGII) score. Quality of life was assessed using question 5 of the ICIQ-SF. Over the study period, 101 robotic female AUS implantation cases were performed by three surgeons. The median patient age was 66 yr (interquartile range: 53–73), and 86.9% had a history of previous SUI surgery. In our cohort, 12 patients had neurogenic SUI (11.8%). In terms of complications, there were 16 intraoperative (15.8%) and 26 postoperative (25.7%) complications, all of Clavien grade 1 or 2 except seven of Clavien grade 3B (major complication rate: 6.8%). All patient-reported outcomes improved significantly at 3 mo. The USP SUI subscore decreased from 7.3 preoperatively to 0.8 at 3 mo (/9; p < 0.0001), the USP overactive bladder subscore decreased from 12.6 to 5.1 (/21; p < 0.0001), and the ICIQ-SF decreased from 16.5 to 3.1 (/21; p < 0.0001). Quality of life improved, with the ICIQ-QoL decreasing from 8.8 preoperatively to 0.9 at 3 mo (/10; p < 0.0001). The 3-mo PGII score was 1/7 (very much improved) in 79 patients (78.8%). Robot-assisted AUS implantation in female patients has low morbidity and improves the patient-reported outcomes and quality of life of female patients with SUI due to ISD. This study represents the largest cohort of robotic female artificial urinary sphincter (AUS) implantation in the literature and is the first to report the patient-reported outcomes (PROMs) after female AUS implantation using validated questionnaires. We found significant improvement in all PROMs at 3 mo, except for voiding dysfunction symptoms. This study brings new robust data to help the widespread use of female AUS across the world, even if further studies with longer follow-up are needed to confirm that these results are maintained over time. We then compared the continence status reported by the patients with PROMs, finding a significant association. This highlights that the existing literature on female AUS, which lacks such PROMs, remains of interest.