Hypothesis / aims of study
Urinary incontinence (UI) due to sphincter incompetence (SI) significantly impairs quality of life (QoL) in children with myelomeningocele (MMC). Conventional treatments often provide unsatisfactory outcomes in this population. Although the artificial urinary sphincter (AUS) is considered an effective option, data in pediatric patients, particularly in public health settings, remain scarce. This study aimed to evaluate continence, quality of life, and complications in children and adolescents with MMC and UI due to SI following AMS-800™ AUS implantation.
Study design, materials and methods
This prospective cohort study included 10 male patients aged 8–18 years with MMC and neurogenic lower urinary tract dysfunction associated with SI, presenting with stress or continuous UI. All patients underwent AMS-800™ AUS implantation between October 2019 and March 2025. Baseline evaluation included clinical, imaging, and urodynamic assessments. Continence was assessed by diaper use, and QoL was evaluated using the Pediatric Incontinence Questionnaire (PIN-Q), from both patient and caregiver perspectives. Patients were followed postoperatively and reassessed using the same parameters. Outcomes included continence, QoL, need for additional treatments, surgical complications (early and late), and device-related events. Statistical analysis was performed using Student’s t-test and repeated measures ANOVA, with significance set at p < 0.05.
Results
All patients underwent successful AUS implantation. Mean age at surgery was 12.3 ± 3.1 years, with a mean follow-up of 14.9 months (range 8–60). A significant reduction in diaper use was observed, particularly within the first three months after surgery (p < 0.001), indicating marked improvement in continence. QoL improved significantly after implantation, both from the patients’ perspective (p = 0.0248) and caregivers’ perception (p = 0.0009). No device-related infections or cuff erosion were observed. However, complications included a 30% rate of pump extrusion and 20% device malfunction. A total of five reoperations were required, including two due to mechanical failure and three for complete AUS reimplantation.
Interpretation of results
AUS implantation resulted in significant improvements in continence and QoL in children and adolescents with MMC and SI. The absence of severe complications such as infection or cuff erosion supports the safety of the procedure in this setting. However, the relatively high rate of mechanical complications and reoperations highlights the need for careful patient selection, long-term follow-up, and consideration of device durability in pediatric populations.