Post-Market International Study Comparing Safety of iTind Temporary Nitinol Device and UroLift System for Symptomatic Benign Prostatic Hyperplasia

What this Trial Is About

Researchers are evaluating the safety of two minimally invasive devices, iTind and UroLift, for treating lower urinary tract symptoms caused by benign prostatic hyperplasia BPH in men aged 50 and older. The study compares the temporary iTind device, which reshapes the prostatic urethra over 5 to 7 days, with the permanent UroLift implants that widen the urethral passage by retracting enlarged prostate lobes. This international, randomized study aims to assess the safety and effectiveness of these treatments for BPH symptoms. Participants will be randomly assigned to receive either the iTind temporary nitinol implant or the UroLift permanent implant procedure. The iTind device remains in place for 5 to 7 days before removal, while UroLift implants are placed permanently during the procedure. Both treatments are minimally invasive and designed to relieve urinary symptoms by improving urine flow through the prostate. During the study, participants will attend scheduled visits to monitor safety and symptom changes using questionnaires like the International Prostate Symptom Score IPSS and quality of life assessments at multiple time points up to 60 months. Researchers will also track any intraoperative or post-operative complications within the first 3 months and monitor rates of additional interventions needed. The study involves detailed evaluations including prostate imaging and urinary flow measurements to assess treatment outcomes and participant well-being over time.

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