QOL Advantage at 1 Month Lost at 3 Months
From baseline, more patients in the PUL than WVTT group had a meaningful improvement in quality of life (QoL) at 14 days (39.5% vs 5.6%) and 1 month (47.8% vs 19.2%), Dr. Rochester said. Again, however, the between-group differences had lost significance by 3 months.
Patients who were satisfied or very satisfied at 1 month (48% vs 25%) also favored PUL, and about the same proportion (55%) were satisfied at 3 months, Dr. Rochester said.
Adverse events attributed to these procedures were slightly higher in the PUL group (21%) than the WVTT group (17%), but none was serious. At longest follow-up to date, which is 1 year in some patients, one man in each group required an invasive retreatment.
Patients or clinicians might prefer one technique over the other in an individual case, but the goal of CLEAR RCT was to provide objective evidence when educating patients about treatment options.
“Patients typically want to know which one is preferred, and we needed data to back up this conversation,” Dr. Rochester said.
Measuring the Right Endpoint?
While longer follow-up might reveal differences in the durability of symptom relief, outcomes other than the primary endpoint of CLEAR RCT should be considered when selecting between these modalities, according to Dean Elterman, MD, MSc, an associate professor in urology at the University of Toronto in Canada. He suggested that catheter-free rates on days 3-7 is “a unique primary endpoint.”
“Patients choose different therapies for different personal reasons. For some, having a catheter for less time is an important short-term goal, while for others the long-term benefit may carry more weight,” said Dr. Elterman, who led a study in 2021 that pooled data from two sham-controlled trials to consider differences between PUL and WVTT at 3 years. In that study, WVTT was associated with fewer surgical retreatments (4.4% vs 10.7%) and better symptom relief at long-term follow-up.
Given the differences in the mechanisms of PUL and WVTT, he said it is probably inappropriate to consider just one endpoint, such as early catheter independence, in considering the differences between the two MISTs.
“This study does show PUL patients have less interference with participation in daily activities within the first month, but the clinical improvement and quality of life are the same in each group at 3 months,” he noted.
“If short-term benefits are weighed as more important to a patient, then this study may be informative,” he said. But he thinks many patients will be at least as interested in long-term follow-up to see if early benefits are durable.
Dr. Rochester reported financial relationships with Intuitive Surgical and Teleflex, which manufactures UroLift and was the sponsor of the CLEAR RCT trial. Dr. Elterman reported financial relationships with BioRobotics and Olympus.
A version of this article appeared on Medscape.com.