AUA 2026 preview: Practice-changing trials in benign urology

At the 2026 Annual Meeting of the American Urological Association in Washington, DC, the P2 plenary abstracts in benign urology are set to spotlight emerging technologies and late-breaking clinical data across stone disease, benign prostatic hyperplasia (BPH), and overactive bladder care. Presentations will feature pivotal trial updates tied to several recently cleared or approved devices, including the FDA-cleared Break Wave lithotripsy system for anesthesia-free stone treatment and the Urocross Expander System for lower urinary tract symptoms (LUTS) secondary to BPH.

Additional studies will examine the durability and safety of novel minimally invasive BPH therapies, comparative sexual function outcomes following HoLEP vs Rezum, and quality-of-life findings with the investigational Intibia tibial nerve stimulation system for urgency urinary incontinence.

For additional AUA 2026 coverage, see our preview of the P2 abstracts in urologic oncology.

Notable data presentations in benign urology

Abstract: Break Wave Lithotripsy: FDA-Cleared, Anesthesia-Free Point-of-Care Technology Redefining Stone Management (S.O.U.N.D. Pivotal Trial)

Presenter: Ben H. Chew, MD, MSc, FRCSC

Summary: Ben Chew, MD, MSc, FRCSC, will kick off the benign urology P2s with a discussion of the S.O.U.N.D. pivotal trial (NCT05701098), assessing the safety and efficacy of the Break Wave lithotripsy device for upper tract urinary stones. Results from this study led to FDA clearance of the Break Wave device in January 2026.¹

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Abstract: Urine Volume and Urine Osmolality and Risk of Recurrent Stone Events: Results from the Prevention of Urinary Stones with Hydration (PUSH) trial

Presenter: Jonathan D. Harper, MD

Summary: Jonathan D. Harper, MD, will then share findings from the Prevention of Urinary Stones with Hydration (PUSH) randomized clinical trial (NCT03244189), evaluating a multicomponent behavioral intervention to increase fluid intake among patients with history of urinary stone disease. The results, published in The Lancet in March 2026, showed that the intervention did not reduce symptomatic recurrence of urinary stones, indicating that achieving and maintaining a high fluid intake is challenging for patients with stone disease.²

Related: Behavioral hydration program falls short in reducing kidney stone recurrence

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Abstract: 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

Presenter: Kevin T. McVary, MD

Summary: In the plenary session on Saturday afternoon, Kevin T. McVary, MD, will report on 30-month results from the Expander-2 pivotal trial (NCT05400980) of the Urocross Expander system. Findings from the study supported FDA clearance of the device in March 2026 for the management of LUTS secondary to BPH.³ In the trial, investigators reported a mean improvement in International Prostate Symptom Score of 48.1% at 12 months following implantation, corresponding to 6 months after device retrieval.

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Abstract: Efficacy And Safety Of Zenflow Prostatic Spring For Treatment Of Lower Urinary Tract Symptoms Secondary To Benign Prostatic Hyperplasia ; Results From A Pivotal IDE Clinical Trial

Presenter: Dean Elterman, MD, MSc, FRCSC

Summary: Dean Elterman, MD, MSc, FRCSC, will then share results on the safety and efficacy of the Zenflow Prostatic Spring for BPH. The Zenflow Spring Implant and Delivery System received FDA approval in December 2025 based on results from the BREEZE pivotal study, which demonstrated a 60% responder rate at 1 year, compared with 33% with sham.⁴

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Abstract: A Prospective Randomized Study of Sexual and Ejaculatory Outcomes Following Water Vapor Therapy Versus Holmium Laser Enucleation for Large-Volume Benign Prostatic Hyperplasia

Presenter: Hany Ahmed

Summary: Hany Ahmed will present on data comparing sexual function and ejaculation outcomes among patients who underwent holmium laser enucleation of the prostate (HoLEP) vs water vapor therapy with Rezum for BPH. The goal of the study is to determine which therapy provide better preservation of sexual function while maintaining clinical efficacy.⁵

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Abstract: Randomized, Controlled, Double-Blind Trial In Patients With Urgency Urinary Incontinence: Quality of Life Outcomes With the Intibia System

Presenter: Catherine A. Matthews, MD

Summary: The P2 abstracts will wrap up with a presentation from Catherine A. Matthews, MD, on quality-of-life outcomes from the Intibia pivotal trial (NCT05250908). The study is assessing the safety and efficacy of Intibia, an investigational implantable tibial nerve stimulator, in patients with urgency urinary incontinence.⁶

REFERENCES
1. SONOMOTION ANNOUNCES FDA CLEARANCE FOR ITS BREAK WAVE™ LITHOTRIPSY DEVICE FOR TREATMENT OF KIDNEY STONES. News release. SonoMotion, Inc. January 21, 2026. Accessed May 13, 2026. https://www.prnewswire.com/news-releases/sonomotion-announces-fda-clearance-for-its-break-wave-lithotripsy-device-for-treatment-of-kidney-stones-302666229.html

2. Desai AC, Maalouf NM, Harper JD, et al. Prevention of urinary stones with hydration: a randomised clinical trial of an adherence intervention. Lancet. 2026. 407;10534(P1171-1181). doi:10.1016/S0140-6736(25)02637-6

3. Prodeon Medical receives FDA 510(k) clearance for the Urocross® Expander System, a novel non-permanent retrievable implant for treating urinary symptoms associated with benign prostatic hyperplasia. News release. Prodeon Medical. March 16, 2026. Accessed May 13, 2026. https://www.globenewswire.com/news-release/2026/03/16/3256258/0/en/Prodeon-Medical-Receives-FDA-510-k-Clearance-for-the-Urocross-Expander-System-a-Novel-Non-Permanent-Retrievable-Implant-for-Treating-Urinary-Symptoms-Associated-with-Benign-Prostat.html

4. FDA approves the Zenflow Spring Implant and Delivery System for first-line interventional therapy of patients with benign prostatic hyperplasia (BPH). News release. Zenflow, Inc. December 11, 2025. Accessed December 11, 2025. https://www.globenewswire.com/news-release/2025/12/11/3204336/0/en/FDA-Approves-the-Zenflow-Spring-Implant-and-Delivery-System-for-First-Line-Interventional-Therapy-of-Patients-with-Benign-Prostatic-Hyperplasia-BPH.html

5. Holmium Laser Enucleation Of the Prostate Versus Water Vapor Therapy Of The Prostate on Sexual Function and Ejaculation. ClinicalTrials.gov. Last updated May 5, 2026. Accessed May 13, 2026. https://clinicaltrials.gov/study/NCT07566689

6. INTIBIA Pivotal Study. ClinicalTrials.gov. March 2, 2026. Accessed May 13, 2026. https://clinicaltrials.gov/study/NCT05250908