Water vapor ablation yields positive results at 2 years

September 8, 2017
Aine Cryts

Aine Cryts is a freelancer based in Boston. She is a frequent contributor to Managed Healthcare Executive on topics such as diabetes, oncology, hospital admissions and readmissions, senior patients, and health policy.

Treatment of lower urinary tract symptoms/BPH with convective water vapor ablation (Rezum System) appears to provide significant improvement on two key outcome measures versus medical therapy at up to 2 years, according to a study presented at the AUA annual meeting in Boston.

Boston-Treatment of lower urinary tract symptoms/BPH with convective water vapor ablation (Rezum System) appears to provide significant improvement on two key outcome measures versus medical therapy at up to 2 years, according to a study presented at the AUA annual meeting in Boston.

The study compared water vapor ablation therapy with medical therapy based on a historical cohort from the Medical Therapy of Prostatic Symptoms (MTOPS) trial. Findings were presented by first author Nikhil K. Gupta, MD, who was with Southern Illinois University School of Medicine in Springfield at the time of the study.

Dr. GuptaMinimally invasive surgical therapies have aimed to “thread the needle” between surgical and pharmacologic options, said Dr. Gupta, who is currently assistant professor of urology at Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ.

“The daily grind of taking pills is an underappreciated barrier to treatment, especially for the average BPH patient who is older and likely has comorbidities requiring treatment. Symptom relief without increasing medication burden or affecting sexual function can significantly improve quality of life for our patients and can have a real impact on BPH treatment patterns moving forward,” Dr. Gupta told Urology Times.

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Rezum uses convection energy in the form of water vapor, which distributes itself evenly within the treated tissue while remaining within collagen barriers and causing a uniform cell necrosis. According to previously published data, the treatment delivers durable symptom relief with minimal sexual side effects.

When looking at the effect of medical therapies for BPH, the MTOPS study is considered the gold standard, he said. In three treatment arms of the trial, patients received an alpha-blocker, a 5-alpha-reductase inhibitor, or a combination of both. As there is no reliable contemporary cohort, Dr. Gupta pointed out that the high-quality MTOPS trial provides a “reliable, historical medical therapy cohort” for comparing outcomes of BPH treatments.

In the current study, results of the Rezum II trial (J Urol 2017; 197:1507–16) were compared with the three treatment arms of the MTOPS trial. For uniformity, Dr. Gupta and colleagues limited their focus to patients with prostate volume of at least 30 mL and International Prostate Symptom Score (IPSS) of at least 13.

Standard clinical outcomes measures were used in this study, and comparisons were performed at 3 months, 6 months, 1 year, and 2 years. In addition, propensity score weighting was used to eliminate differences in IPSS, quality of life, and prostate volume between the groups at baseline.

Next: Better IPSS improvement at 2 years

 

Better IPSS improvement at 2 years

In looking at the outcomes, patients treated with the Rezum System showed greater improvement in IPSS and BPH impact index than those receiving the alpha-blocker at 2 years. In addition, Rezum appeared to result in a greater maximum flow rate (Qmax) than alpha-blockers, but this didn’t reach statistical significance and there was no clear pattern that emerged when comparing post-void residual volume.

Read: OTC alpha-blocker use feasible

When comparing Rezum and the 5-alpha-reductase inhibitor cohort, Rezum showed significantly greater improvements in IPSS and BPH impact index than the 5-alpha-reductase inhibitor over 2 years, Dr. Gupta said. When comparing Rezum with combination medical therapy, IPSS and BPH impact index were similar at 2 years. Rezum improved Qmax as versus combination therapy at 1 year, with medical therapy catching up at 24 months. Combination therapy improved post-void residual volume to a greater extent than Rezum, he added.

“Though flow rate and short-term symptom improvement are encouraging, 3-, 5-, and 10-year data will dictate whether the procedure will remain a part of the urologist’s armamentarium,” Dr. Gupta said.

One of Dr. Gupta’s co-authors is an investigator and meeting participant/lecturer for NxThera, Inc. Several study co-authors have a financial and/or other relationship with one or more pharmaceutical companies.

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