Urocross Expander demonstrates sustained LUTS improvement through 24 months in pivotal BPH trial

A temporary nitinol-based implant designed to remodel the prostatic urethra without leaving a permanent foreign body demonstrated sustained symptom improvement through 24 months after device retrieval in men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), according to interim results from the pivotal Expander-2 randomized controlled trial (NCT05400980).

The findings were presented by Kevin T. McVary, MD, at the 2026 American Urological Association Annual Meeting in Washington, DC.

Investigators reported that the Urocross Expander System achieved durable improvements in International Prostate Symptom Score (IPSS), quality-of-life measures, and urinary flow rates after a planned 6-month implantation period followed by intentional retrieval. The study also showed low rates of catheterization and no device- or procedure-related serious adverse events.

The Urocross system received FDA clearance in March 2026 and is designed as a temporary prostatic urethral implant that remains in place for up to 6 months before removal. McVary noted that the concept differs from other minimally invasive surgical therapies (MISTs) for BPH because the device is designed to induce remodeling of the prostatic urethra during the indwelling period and then be removed.

“[The] advantage to patients is [that there is] no permanent foreign body left in the urethra, which I think has an intrinsic appeal to many men,” McVary noted during the presentation.

Expander-2 results

Expander-2 was a prospective, multicenter, blinded randomized controlled trial conducted at 23 sites in the US and Canada. The study enrolled 240 men aged 45 years or older with symptomatic BPH and a prostate volume between 30 cc to 80 cc by TRUS. Patients were randomly assigned in a 2:1 fashion to receive the Urocross implant (n = 160) or sham cystoscopy (n = 80). Men with obstructive median lobes or high bladder neck anatomy were excluded. Implant retrieval was planned at 6 months.

Baseline characteristics were generally consistent with prior BPH device studies, according to McVary, with a mean age of 66 years, a mean prostate volume of approximately 46 cc, a mean IPSS score of 24.6, and a mean Qmax of 8.7. The primary safety end point evaluated postoperative extended catheterization lasting more than 7 days due to inability to void.

At 6 months, prior to device retrieval, patients in the treatment arm experienced a mean IPSS reduction of 8.2 points, corresponding to a 32.0% improvement from baseline. Investigators reported additional symptom improvement after device removal. Mean IPSS improvement reached 11.3 points at 7 months and 12.0 points at 12 months, representing a 49.0% reduction from baseline. Approximately 74.4% of treated patients achieved at least a 30% improvement in IPSS at 12 months.

Symptom improvements appeared durable through longer-term follow-up, which the authors interpreted as evidence supporting the remodeling mechanism. At 30 months, corresponding to 24 months after retrieval, the mean IPSS reduction was 55.2% from baseline (n = 25).

“The incremental improvement in LUTS is a newer observation, unique as far as I’m aware, which I think validates in part our concept of remodeling the prostate by having this indwell for a limited period of time, and then a planned retrieval,” McVary said during the presentation.

Quality-of-life scores improved from 4.6 at baseline to 2.2 at 12 months, while maximum urinary flow rate (Qmax) increased from 8.8 mL/s to 12.1 mL/s. Post void residual was 63.8 mL at baseline, 65.2 mL at 12 months, and 64.9 mL at 30 months. Investigators also reported stable erectile (16.0 at baseline vs 19.3 at 30 months) and ejaculatory function (8.2 at baseline vs 11.3 at 30 months) throughout follow-up (with higher scores indicating improvements). Incontinence outcomes, assessed using the Michigan Incontinence Symptom Index, also improved modestly (6.0 at baseline vs 5.2 at 30 months, with lower scores indicating improvement).

The average post-procedure pain, measured via a Visual Analog Scale, was 2.5 post-implantation and 1.0 at 1 week after the procedure. Post-retrieval pain was 1.9.

According to McVary, these findings suggest that “discomfort is in a reasonable stage.” The authors also noted that these pain levels are similar to those seen with diagnostic cystoscopy.

The safety profile appeared generally consistent with other office-based BPH interventions. Extended catheterization occurred in 0.6% of patients after implantation and 2.5% after retrieval. Treatment-related adverse events occurred in 36.9% of patients after implant (0 to 30 days) and in 18.8% of patients after retrieval (0 to 30 days). Most adverse events were classified as Clavien-Dindo grade 1 or 2. No device- or procedure-related serious adverse events were reported.

REFERENCE

1. McVary KT, Rukstalis D, et al. A pivotal, randomized, sham-controlled trial of the Urocross expander system for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia: 30 month safety and durability interim results from the Expander-2 trial. J Urol. 2026;215(5S2):e6. doi:10.1097/01.JU.0001192572.07890.f8.12