UroLift vs. Rezūm: CLEAR Study Results

Among the results, the study showed better early patient satisfaction and sexual function with the UroLift System (PUL) compared to RezūmWater Vapor Therapy (WVTT).

CLEAR is the first head-to-head randomized controlled trial (RCT) comparing early patient outcomes following treatment with UroLift™ PUL and Rezūm™ WVTT, two minimally invasive treatments for the symptoms of benign prostatic hyperplasia (BPH). The study provides critical insights into patient experience, safety, and efficacy, helping physicians and patients make informed treatment decisions.

“Comparative clinical trials play a crucial role in guiding treatment decisions for benign prostatic hyperplasia by providing clear, evidence-based insights into safety, efficacy, and patient experience,” said Dr. Matt Ashley, Associate Medical Director at Teleflex. “Understanding how these therapies perform not only in clinical settings but also in real-world patient recovery is essential. At Teleflex, we are committed to advancing research that supports the UroLift procedure as a trusted, patient-preferred option for BPH symptom treatment.”

Key Study Findings:

• i. The primary endpoint of the study was catheter-independence between days three and seven post-procedure, measuring how quickly patients could recover without needing catheter support.
• ii. Additional endpoints assessed critical factors such as patient satisfaction, sexual function, and the impact of the procedure on daily activities, including discomfort from pain or bleeding during urination.
• iii Among the 37 patients treated with Rezūm, 10 failed to achieve catheter-independence within the target timeframe, whereas only one out of 42 UroLift System patients failed to meet this benchmark.
• iv. A greater proportion of patients who underwent treatment with Rezūm reported interference in daily activities due to pain while urinating and blood in urine, with these effects persisting at 14 days and one month post-procedure compared to those who received UroLift  System.
• v. Sexual function outcomes favored the UroLift System, with significantly better scores in erectile and orgasmic function domains on the International Index of Erectile Function (IIEF) at one month, along with improved overall sexual satisfaction and ejaculatory function at three months.
• vi. When assessing overall patient satisfaction, UroLift System patients consistently rated their experience more favorably. Composite satisfaction scores, which measure happiness with the procedure, satisfaction with voiding symptoms, and likelihood to recommend the treatment, were significantly higher for UroLift System patients at both 14 days and one-month post-procedure.

Mr. Mark Rochester, Consultant Urologist and Service Director for operating theatres at Norfolk and Norwich University Hospital and lead investigator on the CLEAR trial,* emphasized the significance of the findings: These results provide important insights into the real-world recovery experience of BPH patients undergoing minimally invasive treatments. The differences in patient experience between UroLift System and Rezūm, particularly in terms of early recovery, sexual function, and overall satisfaction, are key considerations for both clinicians and patients selecting a treatment path.”