Investigational ProVee System impresses in phase 3 trial in BPH

The investigational ProVee Urethral Expander System for benign prostatic hyperplasia (BPH) met all of its safety and effectiveness end points in a phase 3 study, according to data presented at the 2025 American Urological Association Annual Meeting in Las Vegas, Nevada.¹

Steven A. Kaplan, MD

Steven A. Kaplan, MD, presented data from ProVIDE (NCT05186740), a phase 3 prospective, multicenter, randomized, double-blind, sham-controlled study evaluating the safety, performance, and effectiveness of ProVee. Patients were randomly assigned in 2:1 fashion to ProVee or sham (simulated delivery with no stent deployed). Men were included in 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. Men had 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. Study participants were unblinded after 3 months, at which point men in the sham arm could opt for treatment with ProVee.

The study included primary safety end points as well as primary effectiveness end points. Safety end points included serious adverse events (AEs) through 12 months, and need for urinary catheterization beyond 7 days post procedure. Efficacy end points included reduction in BPH symptoms compared with sham at 3 months (defined as mean 3-month improvement from baseline demonstrating “a minimum statistical margin of over 25% compared with mean improvement from baseline for sham alone,” according to the investigators), and symptoms improvement at 12 months (defined as mean percent change in ProVee arm of at least a 30% improvement over baseline score).

In terms of baseline characteristics for the intent-to-treat population, mean prostate volume in the ProVee group (n = 150) was 47.1 ± 14.0 mL, 49.5 ± 12.9 mL in the sham group (n = 71), and 47.8 ± 13.7 mL in the entire cohort (n = 221). Mean prostatic urethral length was 4.9 ± 0.6 cm in both treatment groups. Mean IPSS score was 24.6 ± 5.0, 23.4 ± 5.4, and 24.2 ± 5.1 in the ProVee, sham, and entire cohort, respectively. Mean IPSS V/S score was 1.5 ± 0.5 in both groups. Mean maximum flow rate (Qmax) was 8.8 ± 2.0 mL/sec, 8.8 ± 2.2 mL/sec, and 8.8 ± 2.1 mL/sec in the ProVee, sham, and entire cohort, respectively. Mean post-void residual was 57.3 ± 59.4 mL, 59.3 ± 55.4 mL, and 57.9 ± 58.0 in the ProVee, sham, and entire cohort, respectively. Mean prostate-specific antigen (PSA) level 2.3 ± 1.8 ng/mL, 2.6 ± 2.1 ng/mL, and 2.4 ± 1.9 ng/mL in the ProVee, sham, and entire cohort, respectively.

No device- or procedure-related serious AEs were observed through 12 months across the entire study population, Kaplan reported. Similarly, the rate of extended post-operative urinary catheterization beyond 7 days from treatment was 0.0% in the entire study population, as was the rate of post-operative urinary catheterization at discharge.

Patients in the ProVee arm had a mean IPSS improvement of –9.5 vs –5.6 in the sham arm (P = .001). In addition, “The primary effectiveness end point of symptom improvement at 12 months, that treatment end point was met as well,” Kaplan said. Further, he commented, “Unlike perhaps some of the more recent BPH devices that were actually approved, every end point was met.” Kaplan is director of the Men's Wellness Program at Mount Sinai Health System and professor at Icahn School of Medicine at Mount Sinai in New York, New York.

Kaplan also reported a sustained 10- to 11-point improvement in IPSS. There was also a 2-point improvement in quality of life. Looking at Qmax improvement over time, Kaplan reported a 5.4 mL/sec improvement.

“That’s very, very significant; if we look at historical devices and compare it to some of the MIST [minimally invasive surgical therapy] devices. This is a very significant improvement in flow rate,” Kaplan said.

The investigators also assessed pain and reported no change in pain score pre- and post-procedure. In addition, mean International Index of Erectile Function score (SD) was 17.0 (6.5), 17.5 (6.9), 17.7 (6.8), and 17.3 (6.5) at baseline, 3 months, 6 months, and 12 months, respectively. Mean Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD) score (SD) for questions 1-3 was 8.9 (3.8), 10.1 (4.2), 9.8 (4.3), and 9.7 (4.0) at baseline, 3 months, 6 months, and 12 months, respectively. Mean HSHQ-EjD bother score (SD) was 2.1 (1.6), 1.4 (1.6), 1.6 (1.7), and 1.6 (1.5) at baseline, 3 months, 6 months, and 12 months, respectively. The investigators also reported no incidence of de novo sustained retrograde ejaculation or erectile dysfunction.

Looking at safety events through 12 months in the intent-to-treat population, the investigators reported instances of dysuria (n = 15), hematuria (n = 11), micturition urgency (n = 6), urge incontinence (n = 5), and pollakiuria (n = 4).

Kaplan also addressed the subject of encrustation. All patients prospectively underwent cystoscopy at 12 months. No encrustation was reported in 99.2% of subjects. In no patient was there encrustation that resulted in removal of the device.

“We met every end point, which is unusual, frankly, in a BPH study. It met the effectiveness end points, it showed a superiority of 125%, there was a 30% improvement over baseline, no device- or procedure-related serious adverse events, and no subject required catheterization following their index procedure. The clinical effectiveness was durable at 12 months. In every parameter we looked at, the AEs were very mild and transient. It was well tolerated and performed under local anesthesia in a local setting.”

REFERENCE

1. Kaplan S, 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. 2025;213(5S):e4. doi:10.1097/01.JU.0001111604.90306.91.08