| Real-world clinical study evaluating the performance of the Optilume® BPH catheter system in men with symptomatic benign prostatic hyperplasia (SUMMIT) |
Benign prostatic hypertrophy (BPH) is a benign enlargement of the prostate, common in older men and sometimes in younger men as young as 31 years old. Symptoms include urinary problems such as delayed urination, frequent urination, dysuria, increased risk of urinary tract infections, and urinary retention.
Transurethral resection of the prostate (TURP) is the standard treatment for BPH. Although it improves symptoms in most men, side effects may occur, and urinary problems may return if the prostate continues to enlarge. Some young men may therefore require this procedure several times due to their propensity for this type of age-related problem.
The device used in this research is the OptilumeTM BPH catheter system, approved by Health Canada. Composed of a predilatation catheter and a dilatation catheter coated with paclitaxel, this system aims to dilate the prostatic urethra. The dilation catheter features an inflatable balloon with two lobes coated with paclitaxel, which, when inflated, releases the medication to prevent scar tissue formation and maintain patency of the urethral canal.
The primary objective of this study is to evaluate the effectiveness and safety of the OptilumeTM BPH catheter system, already approved in Canada, by collecting additional data.
Stade de la Maladie: Précoce
Organe: Prostate
