Comparing the Safety of the Temporary iTind Device and Permanent UroLift System for Treating Enlarged Prostate Symptoms in Men Aged 50 and Older

What this Trial Is About

This research aims to compare the safety and effectiveness of two minimally invasive treatments for relieving lower urinary tract symptoms caused by benign prostatic hyperplasia BPH in men aged 50 and older. The study evaluates the temporary iTind device against the permanent UroLift system to determine which approach better manages symptoms related to an enlarged prostate. The iTind device is a self-expanding implant placed temporarily for 5 to 7 days to reshape the prostatic urethra by applying localized pressure. In contrast, the UroLift system involves permanently placed implants that retract the enlarged prostate lobes to widen the urethra. Participants are randomly assigned to receive either the iTind or the UroLift treatment, allowing direct comparison of both devices. Participants will undergo assessments including symptom scoring using the International Prostate Symptom Score IPSS at baseline and multiple follow-up points up to 36 months. Researchers will monitor adverse events, quality of life, and rates of additional interventions. The study will track changes in urinary symptoms and safety outcomes through regular visits over several years, ensuring thorough evaluation of both devices impact.

Post-Market Study to Assess iTind Safety in Comparison to UroLift