Reversible Implants Up the Game in the Minimally Invasive Treatment of Benign Prostatic Hyperplasia

Men looking for relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) are increasingly turning away from the traditional menu of procedures and looking to innovative technologies that can preserve sexual function, avoid the operating room, and ensure a quick recovery. Temporary, reversible prostatic devices may address those needs, according to urologists specializing in the minimally invasive treatment of BPH. 

The Urocross Expander System, a temporary nitinol-based implant designed for intentional retrieval at 6 months, is one such innovative technology approved for the treatment of BPH in the United States. The device is implanted with the use of a standard cystoscope and is retrieved after it mechanically dilates and reshapes the obstructed prostatic urethra. “[The procedure] is straightforward and well tolerated,” Kevin McVary, MD, professor of urology at Stritch School of Medicine, Loyola University Medical Center, said during a plenary session at the 2026 Annual Meeting of the American Urological Association (AUA 2026). “Implantation and retrieval are made for your office.” 

The prospective, randomized sham-controlled Expander-2 trial showed that the Urocross Expander System improved International Prostate Symptom Scores (IPSS) and peak urinary flow rates in treated participants, who were able to maintain those improvements 2 years after the removal of the device. Expander-2 enrolled 240 men (160 Urocross and 80 sham) aged 45 years or older with moderate-to-severe symptomatic BPH and prostate volumes ranging from 30 to 80 cc. Participants had an average IPSS of 25, severe LUTS, and reduced urinary flow rates. 

Urocross achieved a mean IPSS improvement of 49%. Once the device was retrieved at 6 months following the prostate remodeling, the researchers noticed an IPSS improvement boost. IPSS scores were maintained or further improved at 2 years after device removal. Three-quarters of the Urocross recipients achieved treatment response, defined as an improvement of at least 30% in IPSS, by 1 year. Quality of life reflected the improvements in IPSS, following the same pattern of boost after retrieval. The analysis also showed an immediate improvement in peak urinary flow rate, which was sustained 2 years after the device was removed. 

“An incremental improvement in LUTS is a newer observation, unique as far as I am aware, which I think validates in part our concept of remodeling the prostate by having this indwelling [implant] for a limited period of time, followed by a planned retrieval and sustained improvement over the following 2 years,” McVary noted. The lack of a permanent foreign body in the urethra, which minimizes treatment toxicity, may appeal to many men with BPH, the speaker added. Urocross recipients reported only mild discomfort during implantation and retrieval and experienced no serious adverse events. The procedure did not affect erectile or ejaculatory functions, which, in fact, improved slightly after treatment. 

While the Urocross Expander System was designed to be removed 6 months after implantation, innovative options for the treatment of BPH now include a prostatic spring that may be reversed anytime, at patients’ request. 

“The Zenflow clinical evidence now spans more than 300 patients over multiple years,” Dean Elterman, MD, associate professor of urology at the University of Toronto, remarked during a presentation at AUA 2026. “Clinical trials have been conducted by top urologists, demonstrating a well-tolerated procedure with a fast recovery, a low rate of side effects, and durable results.” 

Elterman reviewed 12-month outcomes from BREEZE, a phase 3 pivotal trial enrolling more than 200 patients, which was designed to evaluate the safety and efficacy of the Zenflow Spring System in relieving LUTS associated with BPH. 

“The Zenflow spring system is a gentle, stable, and reversible device,” Elterman said. “It has been informed by the evaluation of over 300 prostatic urethras to optimize implant design, sizing, and stability. From the design perspective, it is gentle, with no piercing, cutting, heating, or tissue removal. It is placed with a flexible cystoscope designed for patient comfort during the procedure. It has a unique design virtually eliminating concerns for encrustation and migration and it is fully reversible, allowing for a safe retrieval, and does not preclude any future treatment options. From the sizing perspective, it is the only BPH solution with multiple sizing options [enabling providers] to find the best fit based on prostatic urethral length.” 

BREEZE enrolled men aged 45 years and older with baseline IPSS of 13 or higher and prostate volumes ranging from 25 to 80 cc. Baseline peak urinary flow rate (Qmax) values were between 5 and 15 mL/sec. The study showed that Zenflow implantation was amenable to a variety of clinical settings, with 44% of the procedures performed in the office. Only one-quarter of the participants underwent general anesthesia, while the rest of the cohort used nitrous oxide, oral sedation, intravenous sedation, or prostate block. 
“Intention-to-treat analysis did not reach statistical significance,” Elterman noted. “However, in the intended use group, after exclusion of the patients with median lobes or intravesical prostatic protrusion - those who should not have been in the study – we do see statistically significant achievement of the primary endpoints, both the responder rate [of at least 30% improvement in IPSS] at 3 months as well as the improvement from baseline at 12 months.”

Three months after Zenflow implantation, 59.6% of the treated patients achieved at least a 30% improvement in IPSS compared to only 33% in the sham group. At 12 months, the mean percent IPSS reduction from baseline was 37.2%, which exceeded the 30% target. In terms of symptoms relief, Zenflow achieved a rapid and sustained improvement, showing a marked improvement of 8.8 points in urinary symptoms at 12 months compared to baseline – double the improvement typically seen with medical therapy at this point in the therapeutic process. Qmax rates also improved through 12 months in treated participants. 

The Zenflow spring system also scored high in safety points, with no serious adverse events reported through 12 months after implantation. A vast majority of patients required no catheterization following the procedure, and no participants required surgical reintervention up to 1 year after treatment. Moreover, sexual function was preserved in all cases and actually improved by 12 months. 

“What we have been able to demonstrate in the BREEZE study is that we have a clinically proven procedure that is comfortable for patients,” Elterman added. “We see a preservation of sexual function, both erectile and ejaculatory, in all patients. And, of course, it is totally reversible if required.” 
The speaker noted that 96% of the patients treated with Zenflow did not require pharmacotherapy for BPH up to 1 year after the procedure. Nearly 98% of the recipients retained their prostatic springs at 12 months, with only two removals by choice and one for migration.