MISTs can be an alternative to medical therapy and invasive surgery; they should offer significant symptom relief with rapid recovery, low morbidity, and low rates of postoperative catheterization. CLEAR is the first head-to-head RCT comparing the patient experience between PUL and Rezūm (WVTT). This preliminary report on the CLEAR study focuses on the early patient experience through 3mo.
CLEAR is a prospective, multinational, 1:1 RCT comparing patient experience, safety and efficacy in BPH patients treated with PUL or WVTT. The primary endpoint compared the proportion of subjects who were catheter-independent at 3d post-op and through 7d. Also examined were symptom/QoL improvement, patient experience (postoperative activity interference and satisfaction) and surgical retreatment. This is a preliminary analysis of the data gathered through Sept 2023.
33 WVTT and 35 PUL subjects were included in this preliminary analysis of the CLEAR RCT. Baseline demographics (age, BMI, prostate volume, IPSS, QoL, Qmax, PVR) were similar between PUL and WVTT. No PUL subjects failed the primary endpoint; 27% (9/33) of WVTT subjects failed the endpoint due to extended catheterization. Of the 9 WVTT subjects who failed, 6 failed at 3d and 3 more failed by 7d. 44% (4/9) of those who failed the primary endpoint had recurrent catheterization by 365d. IPSS and QoL improved more rapidly for PUL (p<0.01) but was similar to WVTT by 3mo (Figure 1). At 1mo, PUL subjects experienced greater reduction of interference when examining outdoor entertainment (e.g., going to movies), and community (e.g., visiting with family) activities vs. WVTT. The proportion of PUL patients who were overall satisfied and would recommend the procedure was higher than WVTT at 14d and 1mo. Within 1yr, 1 patient from each treatment group underwent surgical retreatment.
This is a preliminary look at the CLEAR trial, the first head-to-head RCT comparing early patient outcomes after PUL and WVTT. These data suggest that PUL yields a superior patient recovery experience through 3mo with lower catheterization, more rapid symptom relief, and higher satisfaction. By better understanding the perioperative experience, these results may help providers and patients in deciding which treatment to choose.
