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 Dr. Rochester, who presented the data at the 2024 annual meeting of the European Association of Urology.
CLEAR RCT Called First MIST Controlled Trial
Dr. 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 Rezum (Boston Scientific), known as water vapor thermal therapy (WVTT).
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, Dr. 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 Dr. Rochester.