Top 10 Urology Times articles in benign prostatic hyperplasia

The innovation in benign prostatic hyperplasia (BPH) in 2025 has been exciting, with several new treatment options entering the market. Urology Times’® top stories in this arena reflect the growing number of therapies, the questions emerging on patient selection, and the innovation yet to come. Take a look through the key highlights below.

Expert discusses the promise of emerging MISTs for BPH

In an interview with Urology Times, James C. Ulchaker, MD, shared his insights on the current range of BPH therapies, with a particular focus on the investigational Butterfly Prostatic Retraction Device—a novel addition to the expanding lineup of minimally invasive surgical therapies (MISTs).

Investigational ProVee System impresses in phase 3 trial in BPH

Data presented at the 2025 American Urological Association Annual Meeting in Las Vegas, Nevada, showed that the ProVee Urethral Expander System met all safety and effectiveness end points in a pivotal phase 3 study for BPH.¹ The stent was later approved for BPH based on results from this trial in December 2025.²

FDA approves label expansion for Rezūm Water Vapor Therapy for BPH

In June 2025, the FDA granted 510(k) clearance to a label expansion for the Rezūm System, raising the maximum prostate volume that can be treated with the device from 80 cm³ to 150 cm³ for patients with BPH.³ The approval was supported by several studies highlighting the efficacy of the therapy in patients with larger prostates.

WATER III: Aquablation achieves comparable outcomes to laser enucleation for BPH

Three-month data from the WATER III trial (NCT04801381) were presented in March 2025 at the 40th Annual European Association of Urology (EAU) Congress in Madrid, Spain.⁴ Overall, data showed that patients with BPH who underwent treatment with Aquablation achieved similar short-term symptom improvement to those who underwent transurethral laser enucleation of large prostates (LEP; 80 to 180 mL) while demonstrating lower rates of ejaculatory dysfunction and stress incontinence.

SoBPD: How many ways can you treat BPH or BPD?

In an editorial, Urology Times’ co-editor in chief Gopal H. Badlani, MD, recapped key themes from the 2025 SoBPD Annual Meeting. Overall, discussions underscored HoLEP’s expanding role across gland sizes and salvage settings, growing interest in newer MISTs and adjunctive approaches, and ongoing debate around preoperative evaluation, guideline development, and prostate artery embolization. Overall, the meeting reinforced that management of BPH is increasingly complex, technology-driven, and individualized, with no single solution fitting all patients.

Intraprostatic drug elution therapy shows promise for BPH-related LUTS

Six-month data from a phase 1 first-in-human study (NCT06136819) demonstrated the feasibility of paclitaxel eluting bioabsorbable implants for patients with LUTS secondary to BPH.⁵ The data, which were presented at the American Urological Association (AUA) 2025 Annual Meeting in Las Vegas, Nevada, showed favorable safety and encouraging efficacy in the first 5 patients implanted with the therapy.

Enrollment goal met in trial of Urocross Expander Implant for BPH-related LUTS

In January 2025, Prodeon Medical announced that the target enrollment goal was met in their pivotal Expander-2 trial (NCT05400980), evaluating the the Urocross Expander System and Retrieval Sheath in patients with LUTS secondary to BPH.⁶ According to the company, the Urocross Expander System is an investigational minimally invasive, non-permanent implantable nitinol tissue expander for BPH-related LUTS.

Pivotal trial launches of FloStent System for BPH

In April 2025, Rivermark Medical announced that they had enrolled the first patient in their pivotal RAPID III trial (NCT06849258), evaluating the safety and effectiveness of the FloStent System in patients with LUTS secondary to BPH.⁷ The prospective, multicenter, double-blind trial is aiming to enroll 215 adult patients across 19 clinical trial sites in the US and Australia.

UroLift may offer improved early recovery period vs Rezūm for BPH

Results from the CLEAR trial (NCT04338776) suggest that patients with BPH who undergo prostatic urethral lift (PUL) with the UroLift System may face better recovery outcomes in terms of patient satisfaction, interference with daily activities, and sexual function compared with patients who undergo Rezūm Water Vapor Thermal Therapy (WVTT).⁸ The data were presented at the 40th Annual EAU Congress in Madrid, Spain.

We got a little MIST-y at this year’s AUA Annual Meeting

In this commentary, Garrett Pohlman, MD, highlights how the BPH treatment landscape has rapidly expanded, with minimally invasive surgical techniques taking center stage at the 2025 AUA Annual Meeting and the Society of Benign Prostatic Disease meeting. He emphasizes that the growing array of MIST options enables more personalized care, and he stressed that urologists must remain flexible and current with evolving data and technologies.

REFERENCES

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

2. FDA approves the ProVee System - the first of a new generation of prostatic urethral stents for treatment of BPH. News release. ProVerum Limited. December 9, 2025. Accessed December 19, 2025. https://www.prnewswire.com/news-releases/fda-approves-the-provee-system--the-first-of-a-new-generation-of-prostatic-urethral-stents-for-treatment-of-bph-302637233.html

3. Section 510(k) premarket notification for Rezūm System. FDA. March 25, 2019. Accessed December 19, 2025. https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190093.pdf

4. Ritter M, Stein J, Barber N, et al. WATER III: Aquablation vs. Transurethral laser enucleation of large prostates (80-180ml) in benign prostatic hyperplasia. Presented at 40th Annual European Association of Urology Congress. Madrid, Spain. March 21-24, 2025. Abstract GC4

5. Vermeulen LP, Ordones FV, Gilling PJ, et al. A first in human safety and feasibility study of intraprostatic drug eluting bioabsorbable implants for treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol. 2025;213(5S):e987. doi:10.1097/01.JU.0001110064.72214.9d.10

6. Prodeon Medical announces enrollment completion for Expander-2 pivotal trial. News release. Prodeon Medical. January 13, 2025. Accessed December 19, 2025. https://www.globenewswire.com/news-release/2025/01/13/3008413/0/en/Prodeon-Medical-Announces-Enrollment-Completion-for-Expander-2-Pivotal-Trial.html

7. Rivermark Medical announces first patient enrolled in RAPID III clinical study evaluating the FloStent System. News release. Rivermark. April 23, 2025. Accessed December 19, 2025. https://www.prnewswire.com/news-releases/rivermark-medical-announces-first-patient-enrolled-in-rapid-iii-clinical-study-evaluating-the-flostent-system-302436035.html

8. Rochester M, Barber N, Mazzarella B, et al. Results from the CLEAR RCT suggest the road to recovery is not equivalent between UroLift PUL and Rezum WVT. Presented at: 40th Annual European Association of Urology Congress. Madrid, Spain. March 21-24, 2025. Poster P436