A novel prostatic urethral stent shows promise in the treatment of benign prostatic hyperplasia

A nitinol-based stent that is currently under investigation in the United States may soon redefine minimally invasive treatment of benign prostatic hyperplasia (BPH), according to first-time results from a phase 3 randomized, sham-controlled clinical trial. Steven Kaplan, MD, a professor of urology at the Icahn School of Medicine at Mount Sinai, in New York City, presented 12-month outcomes from the ProVIDE study at the 2025 Annual Meeting of the American Urological Association (AUA 2025) in Las Vegas, Nevada.

The ProVee device, which is currently undergoing premarket approval review in the United States, was designed to alleviate lower urinary tract symptoms by opening the urethra through the application of radial force to the prostatic lobes, without any incisions. Unlike other devices used in the treatment of BPH, the stent, engineered from low-density nitinol, has no crossing points. The device can be used for enlarged prostates with volumes between 30 and 80 cc. 

The ProVIDE prospective, randomized, double-blind clinical trial was designed to evaluate the safety, effectiveness, and performance of the ProVee system by comparing it with a sham intervention consisting of a simulated delivery without stent deployment. Participants aged 45 years or older with moderate-to-severe symptomatic BPH were randomized 2:1 to be treated with ProVee or the sham intervention after a medication washout period. Questionnaires assessing International Prostate Symptom Scores (IPSS) and other parameters were administered at every follow-up visit, from one month to 2 to 5 years after the procedure. All participants were unblinded at the 3-month follow-up visit, allowing those in the sham group to elect treatment with ProVee after unblinding. The trial enrolled 221 participants; 150 of those were included in the intent-to-treat analysis at 12 months. 

The safety endpoints consisted of the rate of device- or procedure-related serious adverse events within 12 months after the procedure and the rate of extended postoperative urinary catheterization (more than 7 days post-procedure) for participants treated with the ProVee device. Both primary safety endpoints were met, with no events reported over 12 months. Adverse events in the treatment arm were typically mild (eg, dysuria, hematuria), transient, and commonly associated with urologic procedures. 

ProVee also met the efficacy endpoints, showing “super-superiority” (>125%) in symptom improvement compared with the sham intervention at 3 months (p=0.001) and a greater than 30% improvement in IPSS over baseline (ITT, 150 participants) at 12 months (p=0.002). Patients treated with the ProVee stent experienced improvements in symptoms and quality of life, as well as significant improvements in flow rate compared to those assigned to the sham intervention. 

Additionally, cystoscopy performed at 12 months across the cohort revealed that there was no device encrustation in more than 99% (132) of participants. “The challenges with stents in the past – pain and encrustation - were not seen here,” Kaplan remarked. “That’s an important advancement in the technology.” The analysis showed no changes in pain scores pre- and post-procedure, and no increases in pain scores were reported throughout the 12-month follow-up period. 

“We met every endpoint, which is unusual for BPH studies,” Kaplan concluded. “Clinical effectiveness and safety were durable over 12 months with improved symptoms, flow rate, quality of life, and preserved erectile and ejaculatory function.” Kaplan noted that the “practice-changing” findings from the ProVIDE study, presented for the first time at AUA 2025, are likely to have an impact on the way that urologists approach minimally invasive therapies for BPH. “The procedure was well tolerated and can be performed under local anesthesia in an outpatient or office setting as [it] evolves into a flexible technology,” the presenter added.