Expanding Indications for Aquablation Therapy?
Size-independent treatment for benign prostatic hyperplasia faces age hurtle in Florida.
Benign prostatic hyperplasia (BPH) is a very common urological condition affecting about 50% of men by age 60. The prevalence climbs to nearly 90% by age 85.
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Symptomatic patients experience voiding dysfunction that can progress without treatment to urinary tract infections, bladder stones, hematuria and kidney damage. “About half of men with an enlarged prostate will develop symptoms that require treatment, but most can be treated with medication,” says R. Carrington Mason, DO, FACS, a board-certified urologist with Cleveland Clinic Indian River Hospital.
If medicines do not relieve BPH symptoms, there are a number of surgical techniques to remove or destroy the prostate tissue around the urethra, including an alternative, minimally invasive treatment called Aquablation®. Approved by the FDA in 2017, the robotic waterjet ablation therapy has been gaining wider use in recent years as a treatment for enlarged prostates. Dr. Mason is the first urologic surgeon with Cleveland Clinic in Florida to offer this approach.
Aquablation is an image-guided resective procedure that uses a heat-free waterjet controlled by robotic technology to remove the prostate tissue obstructing urine flow through the urethra. It is the only surgical procedure for BPH that combines a cystoscope with ultrasound imaging to allow the surgeon to see the entire prostate in real time.
“With this enhanced view I’m able to quickly debulk the prostate and avoid injury to the bladder neck, ejaculatory ducts, and external sphincter,” says Dr. Mason, who has performed more than two dozen waterjet ablation procedures since July. “My patients have been very satisfied with their results.”
According to clinical studies, patients who undergo aquablation therapy have very low rates of incontinence, retrograde ejaculation, and erectile dysfunction, complications associated with other BPH surgical treatments. Notably, one double-blinded, multicenter prospective randomized controlled trial published in 2022 demonstrated a larger safety and efficacy benefit for aquablation over transurethral resection of the prostate (TURP), the most common surgical treatment for small and medium-sized prostates.
Current American Urological Association (AUA) guidelines for the surgical management of lower urinary tract symptoms (LUTS) associated with BPH recommend robotic waterjet treatment for patients within the prostate volume range of 30 to 80 mL. Dr. Mason points out, however, that these guidelines do not reflect the latest research.
The final WATER II 5-Year clinical trial results, which were published earlier this year in The Journal of Urology, found the aquablation procedure to be “safe with durable efficacy and low rates of retreatment in men with large prostates (80-150 mL).”
“I anticipate future consideration will be made in extending the recommended prostate volume range for aquablation in light of the most recent WATER II trial findings,” he explains.
Dr. Mason also notes a number of early adopters of the technology are using the approach independent of prostate size, though AUA guidelines currently recommend laser enucleation or simple prostatectomy for large (>80-150 mL) and very large (>150 mL) prostates.
“This procedure has been shown to be size-independent, and I wouldn’t hesitate to recommend it for appropriate patients with larger prostates,” adds Dr. Mason. “The largest prostate I’ve treated with waterjet ablation therapy was 260 mL, and the patient had an excellent outcome.”
In addition to individual symptoms, prostate size, excess tissue location, and tolerance of potential treatment side effects, age is another factor that may influence treatment recommendations for BPH.
Currently not all insurance providers approve aquablation for men over 80. This includes some Medicare Administrative Contractors, though efforts are underway in various states to broaden access. This is particularly relevant in Florida, the state with the second-highest percentage of 65+ residents and nearly 5 million Medicare enrollees.
“Because prostate volume increases incrementally with age, older men in their 80s are more likely to be surgical candidates and to have large-volume prostate glands,” notes Dr. Mason. “As the compelling data from the WATER II trial demonstrate, these individuals could and should benefit from access to this treatment option.”