PUL yields superior early patient experience to WVTT for BPH

Initial data from the CLEAR trial (NCT04338776) showed a superior patient recovery experience through 3 months with prostatic urethral lift (PUL) with the UroLift System compared with water vapor thermal therapy (WVTT) with Rezum in the treatment of patients with benign prostatic hyperplasia (BPH).

Completion of the CLEAR study is expected in December 2025.

The preliminary data from the study were presented by Claus G. Roehrborn, MD, at the 2024 American Urological Association Annual Meeting in San Antonio, Texas.1 According to the authors, the CLEAR trial represents the first head-to-head randomized controlled trial compared the patient experience between PUL and WVTT.

Overall, the interim analysis included data from 35 patients who received PUL and 33 patients who received WVTT.

No patients who received PUL failed the primary end point, which was the proportion of subjects who were catheter-free at 3 days post-operation through day 7. In the WVTT arm, 27% (9/33) patients failed the end point due to extended catheterization. Of the 9 patients in the WVTT arm who failed the primary end point, 6 failed at day 3. Further, 44% (4/9) of patients who failed the primary end point had recurrent catheterization within 1 year.

Data also showed that patients in the PUL cohort yielded improvements in International Prostate Symptom Score (IPSS) and Quality of Life questionnaires more rapidly vs WVTT (P < .01), but the measures were similar between the 2 arms by 3 months. Additionally, patients who received PUL experienced a greater reduction in inference regarding outdoor entertainment and community activities at 1 month vs WVTT.

The proportion of patients who were overall satisfied and would recommend the procedure was higher among patients who received PUL compared with patients who received WVTT at both 14 days and 1 month following the procedure. Within 1 year, 1 patient in each treatment arm received surgical retreatment.

The authors wrote, "By better understanding the perioperative experience, these results may help providers and patients in deciding which treatment to choose."

In total, the prospective, multinational CLEAR trial is seeking to enroll 120 male patients who will be randomly assigned 1:1 to receive PUL with UroLift or to WVTT with Rezum.² The investigators are recruiting patients across clinical trial sites in the United States and the United Kingdom.

Patients included in the trial will complete questionnaires and assessments at day 3, day 7, day 14, 1 month, 3 months, and 12 months following the initial procedure. The primary outcome measure is the number of patients who are catheter independent at 3 days and remain catheter independent through 1 week. Other outcome measures include symptom/QoL improvement, patient experience (postoperative activity interference and satisfaction), and surgical retreatment rates.

To be included in the study, patients must be aged 50 or older, have a diagnosis of symptomatic BPH, and have a prostate volume between 30 cm³ and 80 cm³.

Patients will be excluded from the trial if they have a current urinary tract infection, current catheter dependent urinary retention or a PVR of 500 mL or greater, urinary incontinence presumed to be due to incomplete sphincter, gross hematuria, a urinary sphincter implant, a penile prosthesis, or urethra conditions that may prevent insertion of a delivery system into the bladder. Further, participants in the trial must have not had a prior surgical procedure for BPH or be enrolled in any other clinical trial that has not yet completed the primary end point.

Completion of the CLEAR study is expected in December 2025.

References

1. Roehrborn CG, Rochester M, Berber N. The early patient experience following treatment with PUL and WVTT, two contemporary MISTs for BPH: preliminary results from the CLEAR Study. Presented at: 2024 American Urological Association Annual Meeting. May 3-6, 2024, San Antonio, Texas. Abstract MP46-02

2. Comparing UroLift Experience Against Rezūm (CLEAR). ClinicalTrials.gov. Last updated May 3, 2024. Accessed May 9, 2024. https://clinicaltrials.gov/study/NCT04338776