Real-world data and treatment patterns of patients with lower urinary tract symptoms due to benign prostatic hyperplasia in Germany: an observational study using health insurance claims data.

PURPOSE: Benign prostatic hyperplasia (BPH) is associated with lower urinary tract symptoms (LUTS), representing one of the most common urological conditions. However, insights into the actual healthcare of this patient cohort in Germany are scarce. We aimed to retrospectively analyse management patterns of patients with LUTS in Germany using health insurance claims databases. METHODS: A retrospective, longitudinal cohort analysis was conducted obtaining claims data from the German InGef health insurance database containing approximately five million member-records from over 60 nationwide statutory health insurances. First, a cross-sectional prevalence analysis was performed on all individuals with a diagnosis on LUTS (ICD-10 GM N40) in 2018. Second, a longitudinal analysis of individuals with either a newly started BPH medication or initial BPH surgery who were indexed in 2014 and followed-up for 4 years. RESULTS: In 2018, 132,386 (6.7%) prevalent BPH patients were identified from 1,979,916 continuously insured males. A potential overcoding bias could not be assessed which may influence the outpatient sector estimation. 10,361 (0.7%) patients were identified with incident BPH medication and 1768 (0.1%) patients with incident BPH surgery out of 1,575,604 males (2013-2018). Alpha-blockers were the drug of choice (95.6%) in the first year. Half of patients received specific BPH medications four years after index, while almost 98% of initial BPH surgeries were performed within the inpatient setting. TURP was the most frequent surgical intervention (76%). CONCLUSIONS: A widespread diffusion of alternative individualized minimally invasive approaches in the outpatient sector might address pharmacotherapy discontinuation and patient-access barriers to other treatments.

The Mechanism of Action of cTIND for Minimally Invasive Ischemic Incision of the Prostate: In Vivo Study.

OBJECTIVES: To understand the histologic changes of prostate tissue induced by temporary implantable nitinol device (cTIND) in a canine model. METHODS: The cTIND is a small, symmetric device comprised of nitinol wire loops welded together on an axis, which exert radial force on the tissue to induce a targeted ischemic effect. The cTIND was implanted in three live canine models, which were monitored for 14 days post-index procedure. Device placement was monitored via serial fluoroscopy and biologic effects of cTIND were studied via histopathology. RESULTS: The cTIND was successfully placed in the canine models and remained securely in position until the animal was sacrificed on postoperative day 14. The cTIND treated tissue demonstrated an abrupt transition from normal, viable prostatic glandular tissue to an area of shrunken necrosis and fibrosis between the two. CONCLUSION: In the canine models, the cTIND created focal areas of ischemic necrosis resulting in incisions in the peri-urethral prostate with minimal inflammation.