A head-to-head trial of minimally invasive procedures to manage benign prostatic hyperplasia found that urethral implants appear to provide more durable control of symptoms than thermal therapy.
The ongoing CLEAR RCT study includes 68 men in the United States and the United Kingdom who have undergone one of two minimally invasive surgical techniques (MISTs). It found a procedure in which prostate tissue is lifted away from the urethra to improve urinary flow provided faster relief of symptoms, lower rates of catheterization, and higher patient satisfaction at 1 month than did an alternative approach that relies on thermal energy for tissue ablation, according to Mark Rochester, MD, a consultant urologist at the Norfolk and Norwich University Hospitals in England.
"These results give clinicians and patients some data with which to choose between devices," said Rochester, who presented the data at the 2024 annual meeting of the European Association of Urology.
CLEAR RCT Called First MIST Controlled Trial
Rochester called CLEAR RCT "the first head-to-head randomized controlled trial to compare two contemporary MISTs": UroLift (Teleflex), known generically as a prostatic urethral lift (PUL), and Rezūm (Boston Scientific), known as water vapor thermal therapy (WVTT).
In the PUL technique, a delivery device is introduced into the urethra and advanced to the site of hyperplasia where implants are placed to lift and hold the tissue away on each side of the urethra. The implants are designed for long-term relief of the obstruction that inhibits urinary flow.
In the WVTT technique, thermal energy in the form of water vapor is introduced into the enlarged prostate tissue where it disperses through the interstices to produce denaturization of the tissue and cell death. Over time, the ablated tissue, which is eventually reabsorbed in the healing process, relieves pressure on the urethra to improve passage of urine.
Both procedures can be performed on an outpatient basis without general anesthesia. Each typically permits discontinuation of medications commonly prescribed for lower urinary tract symptoms, and both are associated with a low risk of erectile dysfunction. Most routine activities can be resumed within a few days.
Baseline characteristics of the 35 patients randomized to PUL and 33 patients randomized to WVTT were similar in regard to body mass index, prostate volume, baseline International Prostate Symptom Score (IPSS), post-void volume test, and maximum urinary flow.
Although this is a preliminary 3-month analysis of a study not yet completed, the primary endpoint was catheter independence on postop day 3 through 7. No patients randomized to PUL failed the primary endpoint versus nine (26%) of the patients randomized to WVTT.
Of the nine, six failed because they were not catheter-independent by day 3; three more failed after they had initially achieved catheter independence but then required the device in order to void within 7 days, Rochester reported. Four of these patients had further recurrences within 3 months of the procedure.
The response measured by symptoms and objective studies of such variables as peak flow (Qmax) also favored PUL over WVTT in the early postperative period, according to the analysis. By 14 days, for example, IPSS scores were superior at 14 days and 1 month, although they no longer differed statistically at the 3-month mark. Qmax was significantly greater in the PUL group at 14 days but not at 1 or 3 months, according to Rochester.
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%), 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, 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," 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, 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 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.
Rochester reported financial relationships with Intuitive Surgical and Teleflex, which manufactures UroLift and was the sponsor of the CLEAR RCT trial. Elterman reported financial relationships with BioRobotics and Olympus,
Ted Bosworth is a medical journalist based in New York City.