Hypothesis / aims of study
The artificial urinary sphincter (AUS) has been the gold standard treatment for moderate-to-severe stress urinary incontinence following radical prostatectomy for over four decades. Despite its proven efficacy on continence, device-related complications remain substantial, with revision-free survival rates as low as 40% at 10 years. This study aims to characterize postoperative complications following AUS implantation in France and to identify patient- and procedure-related risk factors for device revision or explantation at a national scale.
Study design, materials and methods
We conducted a nationwide retrospective cohort study using the French medico-administrative hospital database (PMSI), which records all inpatient stays across public and private sectors. All men who underwent a first AUS implantation for post-prostatectomy incontinence between January 2017 and December 2019 were included, with follow-up until December 2023 (up to 7 years). Postoperative complications were identified through ICD-10 diagnostic codes and CCAM procedure codes. Univariate logistic regression was applied to comorbidities (odds ratios, ORs), and univariate Poisson regression to procedural exposures (incidence rate ratios, IRRs). Only exposures occurring in at least 10 cases per group were analyzed, in compliance with French data privacy regulations.
Results
A total of 1,790 men were included. The most frequent complications were persistent or recurrent urinary incontinence (ICD-10 codes N39.3, N39.4, R32; 2,423 admissions, 68.7% of all events), mechanical device dysfunction (T83.1; 210 admissions), and infectious complications (N39.0, A41, R65; 333 admissions). Explantation occurred in 268 patients (15%), predominantly between 13 and 36 months post-implantation. The strongest comorbidity-based risk factors were urethral fistula (OR 6.12), pelvic trauma (OR 12.11), urethral stricture (OR 3.64), beta-lactam resistance (OR 2.29), protein-energy malnutrition (OR 1.96), tobacco use (OR 1.74), prior radiotherapy (OR 1.70), chronic anticoagulation (OR 1.70), obesity (OR 1.52), and diabetes (OR 1.46). Among procedural factors, indwelling urethral catheterization (IRR 3.25), repeated cystoscopy (IRR 3.24), and blood transfusion (IRR 2.47) were strongly associated with explantation.
Interpretation of results
Urethral fragility represents the most critical risk factor for early cuff erosion. Cardiometabolic comorbidities impair tissue healing and promote infectious complications. Prior pelvic radiotherapy doubles the risk of erosion, while tobacco use, anticoagulation, and bacterial resistance act as additional aggravating factors. Procedurally, urethral catheterization and endoscopic instrumentation appear to directly contribute to cuff erosion, consistent with current best-practice guidelines. Blood transfusion likely reflects perioperative instability rather than acting as a direct causal factor.
Concluding message
This nationwide PMSI-based study provides the most comprehensive assessment to date of AUS complications and explantation risks in France. It identifies clinically actionable risk profiles — including urethral fragility, cardiometabolic disease, malnutrition, prior radiotherapy, and infection-related factors — that significantly increase the likelihood of device removal. These findings underscore the critical importance of careful patient selection, preoperative optimization of modifiable comorbidities, and strict postoperative management, particularly regarding urethral instrumentation, to improve long-term device durability and patient outcomes following AUS implantation.