FDA approves ProVee System for benign prostatic hyperplasia

On December 9, 2025, the FDA approved the ProVee System, a prostatic urethral stent for the treatment of patients with benign prostatic hyperplasia (BPH), ProVerum Limited announced in a news release.¹

"FDA approval of the ProVee System marks a major step forward for ProVerum and for men living with BPH," said Paul Bateman, CEO of ProVerum, in the news release.¹ "With the ProVee System, urologists have a safe, effective, and straightforward procedure that can deliver meaningful symptom relief and improvement in quality of life."

The approval was supported by findings from the phase 3, randomized ProVIDE study (NCT05186740), in which patients who received the ProVee System demonstrated durable relief of lower urinary tract symptoms (LUTS) and improved urinary flow through 12 months.²

In total, the prospective, double-blinded study included 221 patients with LUTS secondary to BPH. Patients were eligible for the study if they were 45 years of age or older with moderate-to-severe symptomatic BPH, an International Prostate Symptom Score (IPSS) of at least 13, and an IPSS V/S of at least 1 at baseline assessment. Patients also needed to have prostate volumes of at least 30 cc but no larger than 80 cc, with prostatic urethral L2 lengths of at least 3.75 cm by transrectal ultrasound.

Patients were randomly assigned 2:1 to receive the ProVee System or to the sham arm. Study participants were unblinded after 3 months, at which point patients in the sham arm could opt for treatment with ProVee.

Overall, patients who received treatment with the ProVee System demonstrated a statistically significant improvement in IPSS at 3 months compared with sham. Specifically, at 3 months, the mean improvement in IPSS was 9.5 in the ProVee arm vs 5.6 in the sham arm, representing a greater than 125% mean improvement favoring the treatment arm (P = .001). Further, at 12 months, patients in the ProVee arm demonstrated a ≥30% improvement in IPSS compared with baseline.

No procedural or device-related serious adverse events (AEs) were reported through 12 months. Sexual function was preserved throughout the study follow-up period, with investigators reporting no incidence of de novo sustained retrograde ejaculation or erectile dysfunction. Additionally, no patients required a catheter at discharge, and no patients had extended (greater than 7 days from treatment) post-operative urinary catheterization.

Safety events through 12 months in the intent-to-treat population included dysuria (n = 15), hematuria (n = 11), micturition urgency (n = 6), urge incontinence (n = 5), and pollakiuria (n = 4).

"The data from the ProVIDE clinical study are very impressive and make a strong case for the ProVee System to become a first-line interventional therapy to treat BPH," noted global lead investigator Steven A. Kaplan, MD, professor of urology at the Icahn School of Medicine at Mount Sinai, in the news release.¹

REFERENCES

1. FDA approves the ProVee System - the first of a new generation of prostatic urethral stents for treatment of BPH. News release. ProVerum Limited. December 9, 2025. Accessed December 9, 2025. https://www.prnewswire.com/news-releases/fda-approves-the-provee-system--the-first-of-a-new-generation-of-prostatic-urethral-stents-for-treatment-of-bph-302637233.html

2. Kaplan SA, Parekattil SJ, Wu NZ, et al. 12-month outcomes from a randomized, sham controlled study evaluating a novel prostatic urethral stent for the treatment of BPH. J Urol. doi:10.1097/01.JU.0001111604.90306.91.08