Abstract

Abstract Introduction Sodium-glucose co-transporter 2 inhibitors (SGLT2i) prevent the reabsorption of glucose and facilitate its excretion in urine. These medications are a newer treatment for Type 2 Diabetes Mellitus patients and have also been associated with positive cardiorenal effects. Patients taking these medications are at a hypothetical increased risk of urinary tract infections given the mechanism of action. Objective We questioned whether patients taking SGLT2i would be at an increased risk of genitourinary device infection or failure. As these medications are newer and without widespread use, we sought to utilize the power of a multinational database to generate a sufficient sample size to generate our answer. Methods TriNetX is a collaborative research enterprise which collects real-time data from almost 89 million patients located in 58 healthcare organizations across the globe and analyzes patient data from 20 years back to present (2002-2022). We queried TriNetX for all adult male patients undergoing Artificial Urinary Sphincter (AUS) or Inflatable Penile Prosthesis (IPP). For each implant, we separated patients into two cohorts defined by those taking an SGLT2i within 1 year before and/or after surgery and those not taking this class of medications. Cohorts and outcomes were defined using Current Procedural Terminology (CPT) and International Classification of Diseases (ICD-10) codes. We used the impact of Age, Race, Ethnicity, Body Mass Index, diabetes (DM) smoking history, history of radiation, and history of prostatectomy to generate propensity score matching (PSM). Our primary outcome was need for re-intervention (revision, removal, or replacement surgery) at any point after implantation based on CPT codes. Secondary outcomes included infection rate and overall device complication rate, including infections based on ICD-10 codes. Analytics were performed via TriNetX on demographic data which calculated Risk Ratios and were run on June 14th, 2022 Results In total, there were 8864 patients who underwent IPP and 4272 who underwent AUS (Table 1). After PSM, there were 292 patients in each IPP cohort and 74 patients in each AUS cohort. After matching for IPP and AUS, patients were similar ages (60.6 vs 60.6 years and 67.9 vs 67.8 years) with similar comorbidity profiles. The average Hemoglobin A1c level was 8.0 vs 7.4% (p<0.01) for IPP and 7.9% vs 7.3% (p=0.13) for AUS. Patients with an IPP on an SGLT2i were at a lower risk of overall complication (RR 0.60, p=0.02). There was no difference for AUS and risk of complication. There was no difference for either implant on risk of infection or need for second procedures for both AUS and IPP. Conclusions Patients taking SGLT2is may be safely offered urologic implants. To our knowledge, this is the first study to evaluate this class of medications in this patient population. There may be a difference in overall risk of complication for patients on SGLT2is getting an IPP, however there are similar rates of infection and re-intervention. These newer medications remain incompletely studied but the data supports their use in patients interested in implants. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific, Coloplast.

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