Aquablation Shows "Promising" Outcomes in BPH Patients With Large Prostates

By Lorraine L. Janeczko

June 11, 2019

NEW YORK (Reuters Health) - Aquablation appears to effectively and safely treat benign prostatic hyperplasia (BPH) in prostates of up to 150 cc, an industry-funded study suggests.

The technology combines ultrasound imagery with precise robot-controlled, surgeon-guided waterjet ablation to remove prostate tissue.

"I am very surprised to see a robotically executed prostate surgery performed with such speed, accuracy, and efficacy, in which the surgeon defines the tissue to be removed and the robot does the rest," said lead author Dr. Naeem Bhojani of the University of Montreal in Quebec, Canada.

"This differs from mainstream surgical robots over the last two decades where the robot's movement is defined by the manual skill and movement of the surgeon," he told Reuters Health by email.

"While men suffering from BPH because of a very large prostate (>80cc) have very few options compared to men with smaller (<80cc) prostates," Dr. Bhojani added, "the results demonstrate that Aquablation has the potential to become the standard of care for BPH for all sized glands."

Dr. Bhojani and his colleagues prospectively assessed Aquablation using the AQUABEAM System (PROCEPT BioRobotics, Redwood City, CA) in 101 men with BPH symptoms and prostate volumes of 80-150 cc, performed by 24 surgeons at 16 sites in the U.S. and Canada.

The mean operative time was 37 minutes, the mean Aquablation resection time 8 minutes, and the mean hospital stay after the procedure 1.6 days, they report in Urology, online May 3.

At 12 months, the mean International Prostate Symptom Score (IPSS) improved from 23.2 at baseline to 6.2 (P<0.0001), and mean IPSS quality of life improved from 4.6 to 1.3 (P<0.0001).

Qmax (12-month improvement of 12.5 cc/sec) and postvoid residual (drop of 171 cc in those with postvoid residual >100 at baseline) also significantly improved, and antegrade ejaculation remained in 81% of sexually active men.

No patient needed a repeat procedure and 2% had de novo incontinence. Ten patients needed a postoperative transfusion and five required fulguration.

Prostate-specific antigen (PSA) dropped from 7.1 ng/mL at baseline to 4.4 ng/mL.

"A significant advantage of this procedure is the maintenance of ejaculatory function, which is not possible with other BPH treatment modalities, especially for large prostate glands," Dr. Bhojani noted.

He and his colleagues concluded that "while the outcomes are promising, longer follow-up will be necessary to confirm these results."

Dr. Alexis E. Te, a urologist at Weill Cornell Medicine and NewYork-Presbyterian in New York City who has studied Aquablation, told Reuters Health by email, "This fast and quick operation with good results and safety is precise and relatively easy to learn, and has a sexual-side effect profile that is superior to the standard prostatectomy."

"Alternative options are more difficult, require significant experience, are skill-dependent, and can have more complications such as sexual side effects (retrograde ejaculation), incontinence, bleeding requiring transfusions, and complications from longer operating and anesthesia times," he added.

But Dr. Te, who was not involved in the study, cautioned, "patients can still have bleeding, and the procedure should not be performed on those who are on blood thinner or who have a bleeding disorder."

Dr. Bradley Gill, a urologist at Cleveland Clinic in Ohio, said, "While this technology may provide a means of allowing surgeons to efficiently treat larger glands, it appears not to be an outpatient procedure."

"Nearly all patients required catheter traction, for an average of 18 hours, with almost half requiring narcotic pain medication," he told Reuters Health by email.

Dr. Gill, who also was not involved in the study, noted that the average hospital stay was longer than one day and that most patients were discharged with a catheter that remained in place for four days on average.

"The tradeoff for operative time in light of these outcomes warrants comparison to other current methods of BPH treatment, some of which can facilitate same-day discharge and only one day of catheterization," he said.

"Aquablation rates of transfusion and cystoscopy for fulguration of bleeding areas are a bit higher than those of other approaches," Dr. Gill added. "However, this is a new technology and the learning curve may account for a portion of these outcomes."

PROCEPT BioRobotics Corporation funded the study. Dr. Bhojani was paid by the company for a training session at the American Urological Association's 2018 annual meeting, and two of his co-authors are consultants for the company.

SOURCE: https://bit.ly/2EZgxzz

Urology 2019.

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