(139) THE ARTIFICIAL URINARY SPHINCTER IMPROVES DEPRESSION, ANXIETY AND OVERALL EMOTIONAL HEALTH IN MEN WITH STRESS URINARY INCONTINENCE; ANALYSIS OF THE ARTIFICIAL URINARY SPHINCTER CLINICAL OUTCOMES TRIAL (AUSCO)

Abstract Introduction The artificial urinary sphincter (AUS) has been available for over 50 years with excellent outcomes for the treatment of male stress urinary incontinence (SUI). However, few reports focus on the effects an AUS may have on mental health in men with SUI. Objective We examined the effects on depression, anxiety and overall emotional health in patients treated for SUI with the AUS. Methods The Artificial Urinary Sphincter Clinical Outcomes Trial (AUSCO) is a single-arm, prospective, multi-center study designed to evaluate objective and subjective outcomes of men with SUI treated with the AMS 800 AUS. This was approved by each institutional committee on ethics in human investigation (NCT04088331). A total of 115 subjects were implanted at 17 sites. Subjects served as their own controls and follow-up assessments at 3-, 6-, and 12-months post device activation were compared to baseline values. The Incontinence QoL (IQoL), Incontinence Impact Questionnaire (IIQ-7), and EQ-5D-5L were administered at these intervals. Results Of the 115 implanted subjects, 100 completed QoL assessments at 12 months as of May 2024. Depression rating (Item 5, IQoL) significantly improved from baseline to 12 months, with 85% (85/100) of patients reporting feeling at least “a little” depressed at baseline decreasing to 39% (39/100) at 12 months (p < 0.0001). Emotional health rating (Item 6, IIQ-7) also improved, with 16% (16/100) patients reporting being “greatly” affected by incontinence at baseline decreasing to 3% (3/100) at 12 months (p < 0.0001). The anxiety/depression domain on the EQ-5D-5L (Item 5) was also significantly improved, with 50% (50/100) of patients reporting being at least “slightly” anxious or depressed at baseline decreasing to 30% (30/100) at 12 months (p = <0.0001) (Table). Conclusions The AUS has been commonly referred to as the “gold standard” for treatment of men with stress urinary incontinence for over half a century. While multiple reports focus on improvement in volume of leakage, fewer concentrate on quality of life with emphasis on its effects on depression and related mental health scores. This data clearly demonstrates that treatment of SUI in patients with the AUS improves depression symptoms and anxiety for these patients. Disclosure Yes, this is sponsored by industry/sponsor: Boston Scientific. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific.