FDA approves ProVee prostatic urethral stent for BPH: A potential first-line interventional therapy

[madman]

* Sexual function was preserved throughout the study follow-up period, with investigators reporting no incidence of de novo sustained retrograde ejaculation or erectile dysfunction.

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Key Takeaways

• The ProVee System received FDA approval for treating BPH, offering a safe and effective procedure for symptom relief and quality of life improvement.
• The ProVIDE study showed significant improvement in IPSS scores at 3 and 12 months for patients using the ProVee System compared to the sham arm.
• No serious adverse events or extended post-operative urinary catheterization were reported, and sexual function was preserved throughout the study.
• The ProVee System is considered a potential first-line interventional therapy for BPH, supported by impressive clinical study data.

FDA approves ProVee System for benign prostatic hyperplasia | Urology Times

The approval is supported by results from the randomized ProVIDE study.

www.urologytimes.com

The approval is supported by results from the randomized ProVIDE study.

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

 

[madman]

* Mechanistically, Kaplan emphasizes that ProVee’s key differentiator is not simply that it is an expanding urethral device, but that it belongs to a new class of flexible, catheter-like technologies. Its delivery through a flexible cystoscope under local anesthesia fundamentally changes how and when BPH can be treated. Unlike other minimally invasive therapies that require rigid instrumentation, operating room resources, or more invasive tissue ablation, ProVee can be placed quickly—often at the initial office visit—much like placing a urinary catheter.


* Kaplan characterizes this ease of delivery and short procedural time as a “game changer,” arguing that ProVee is the first technology positioned to compete directly with BPH medications rather than surgery.

Steven A. Kaplan, MD, discusses ProVee System and the future of BPH care | Urology Times

Mechanistically, Kaplan emphasizes that ProVee’s key differentiator is not simply that it is an expanding urethral device, but that it belongs to a new class of flexible, catheter-like technologies.

www.urologytimes.com

Mechanistically, Kaplan emphasizes that ProVee’s key differentiator is not simply that it is an expanding urethral device, but that it belongs to a new class of flexible, catheter-like technologies.


In this video, Steven A. Kaplan, MD, director of the Men's Wellness Program at Mount Sinai Health System and a professor at Icahn School of Medicine at Mount Sinai, discusses how the ProVee prostatic urethral stent represents a meaningful shift in the management of benign prostatic hyperplasia (BPH), particularly when viewed against both surgical interventions and medical therapy.

Mechanistically, Kaplan emphasizes that ProVee’s key differentiator is not simply that it is an expanding urethral device, but that it belongs to a new class of flexible, catheter-like technologies. Its delivery through a flexible cystoscope under local anesthesia fundamentally changes how and when BPH can be treated. Unlike other minimally invasive therapies that require rigid instrumentation, operating room resources, or more invasive tissue ablation, ProVee can be placed quickly—often at the initial office visit—much like placing a urinary catheter.

Kaplan characterizes this ease of delivery and short procedural time as a “game changer,” arguing that ProVee is the first technology positioned to compete directly with BPH medications rather than surgery. Historically, new therapies have been benchmarked against transurethral resection of the prostate (TURP), which he describes as a “historic standard” rather than a true gold standard. ProVee, by contrast, offers the possibility of avoiding medications altogether, thereby sparing patients from drug-related side effects while offering rapid symptom relief. He suggests that shifting even a portion of medication-managed patients to an office-based stent therapy could have a dramatic impact on BPH care.

Regarding patient selection, Kaplan explains that the ProVIDE trial criteria—prostate volumes of 30 cc to 80 cc and appropriate urethral length—reflect the overwhelming majority of men presenting with lower urinary tract symptoms due to BPH. In real-world practice, extensive pre-procedure workups are often unnecessary. Basic evaluation, such as transrectal ultrasound or clinical examination, is usually sufficient. The largely “one-size-fits-all” design further simplifies decision-making. Although larger prostates may eventually be studied, current criteria appropriately target the patient population most likely to benefit today.

 

[madman]

Proverum Medical | ProVee System

The ProVee stent from Proverum Medical uses 3-D geometry which mirrors and engages with the anatomy of the prostate. The system alleviates Lower Urinary Tract Symptoms (LUTS) by opening the prostatic urethra, applying radial force to the prostatic lobes.

www.proverummedical.com

 

[madman]

Proverum ProVee

The ProVee device is a ‘stent-like’ nitinol expander designed to gently reshape and open the obstructed urethra without heating, piercing, cutting, or removing part of the prostate. The delivery system for the expander is thinner than most treatment options, and the uncomplicated procedure is intended to be performed in an outpatient or doctor’s office setting with local anesthetic [37]

Thread 'Office‑based prostatic stents: minimally invasive treatment of BPH'

Sep 9, 2023

Abstract

Purpose

To conduct a scoping review of the existing literature and recent developments on prostatic stents for the treatment of benign prostatic hyperplasia (BPH).

Methods

A comprehensive search was performed on Embase, MEDLINE, and Web of Science to identify English literature on prostatic stents for the treatment of BPH. Additional studies and upcoming devices were identified through grey literature search and expert consultation. Study characteristics and stent information were extracted and tabulated narratively.

Results

Of the 1171...

• madman
• bph/luts; stents; prostate; treatment
• Replies: 3
• Forum: Prostate Related Issues

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