12-Month Outcomes from a Randomized, Sham Controlled Trial Evaluating a Novel Prostatic Urethral Stent for the Treatment of Benign Prostatic Hyperplasia

PURPOSE: The ProVee System for benign prostatic hyperplasia is a new generation permanent prostatic urethral stent for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. ProVIDE is a prospective, randomized, double-blind, sham-controlled study evaluating the safety and effectiveness of ProVee against a sham procedure.

MATERIALS AND METHODS: Men at least aged 45 years were eligible for the study if they had International Prostate Symptom Score ≥ 13, peak urinary flow rate < 12 mL/s, prostate volume 30 to 80 cc, and prostatic urethral length ≥3.75 cm. Primary effectiveness endpoints were a mean improvement in International Prostate Symptom Score at 3 months and 12 months. Symptomatic improvement, uroflowmetry, quality of life, and sexual function were assessed at follow-up.

RESULTS: A total of 221 participants were randomized 2:1 (150 ProVee, 71 sham) at 15 centers in the United States and 2 centers outside the United States. Treatments were performed in an ambulatory surgery center or office setting and required no catheterization postprocedure. Intention-to-treat analyses showed a > 25% mean improvement in International Prostate Symptom Score over sham at 3 months (9.5 vs 5.6, P = .001) and a > 30% mean improvement from baseline to 12 months in the ProVee arm (37.8%, P = .002). There were no device-related or procedure-related serious adverse events through 12 months, and no incidence of de novo sustained retrograde ejaculation or erectile dysfunction.

CONCLUSIONS: Treatment with ProVee was reliably performed and resulted in a statistically superior improvement in International Prostate Symptom Score at 3 months compared with a sham procedure with sustained response at 12 months.

CLINICAL TRIAL REGISTRATION NUMBER: NCT05186740.