Rezum

Description of Event or Problem

It was reported to Boston Scientific via an article published in the World Journal of Urology that a retrospective study evaluated the initial clinical experience and postoperative outcomes of the Rezum Water Vapor Thermal Therapy System for the treatment of benign prostatic hyperplasia (BPH) in patients with large prostates (greater than or equal to 80 cc). A total of 206 patients underwent Rezum treatment between January 2017 and February 2020. Two patients were excluded from the study because 1 patient aborted the procedure due to discomfort, and one patient had undergone two Rezum procedures within a 4 month timeframe. A total of 204 patients were analyzed in this study, including 168 patients with prostates <80 cc (small prostate cohort) and 36 patients with prostates greater than or equal to 80 cc (large prostate cohort; mean prostate volume 106.8 cc). Following the procedure, patients underwent postoperative Foley catheter placement for urinary drainage and subsequently underwent a trial of void evaluation. Patients in the large prostate cohort required a significantly longer duration of catheterization prior to Foley catheter removal compared with patients in the small prostate cohort (mean 9 days versus 5.71 days). Following the procedures, in the small prostate cohort the following complications were reported: urgency (51 patients), hematuria (66 patients), frequency (52 patients), bladder spasms (41 patients), dysuria (39 patients), retention (36 patients), postoperative urinary tract infection (17 patients), fever (7 patients), erectile dysfunction (3 patients), clot retention (3 patients), and hematospermia (4 patients). 30 patients in the small prostate cohort visited the emergency department within 90 days of the procedure (3 for fever, 2 for clot retention, 1 for chest pain, 1 for dysuria, 2 for urine leakage, 1 for malaise, 1 for a sore throat, and 1 for testicular pain). Additionally, 8 patients in the small prostate cohort were readmitted to the hospital within 90 days (4 for urinary tract infection, 1 for COPD exacerbation, 1 for COVID-19 infection, 1 for hematuria, and 1 for urinary retention). In the large prostate cohort, reported postoperative complications included urgency (18 patients), hematuria (18 patients), frequency (13 patients), bladder spasms (11 patients), dysuria (9 patients), urinary retention (7 patients), postoperative urinary tract infection (7 patients), fever (3 patients), erectile dysfunction (2 patients), and clot retention (1 patient). 8 patients in the large prostate cohort visited emergency department within 90 days (4 for urinary retention, 2 for fever, 1 for clot retention, and 1 for chest pain). Additionally, 3 patients in the large prostate cohort were readmitted to the hospital within 90 days (2 for urosepsis and 1 for urinary tract infection). All three patients who were readmitted to the hospital were given IV antibiotics, were discharged within 4 days of admission, and fully recovered. One of the two patients who experienced urosepsis had a concomitant history of bladder stones, and his urosepsis-related readmission occurred 7 days after he underwent cystoscopy with unsuccessful removal of a bladder stone. Alpha-blocker utilization decreased significantly following treatment in both cohorts; however, many patients continued to require medical therapy post-procedure.This complaint is for the 204 patients whose data was reported in aggregate.

Additional Manufacturer Narrative

Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other product specific information. If additional details become available, a supplemental report will be submitted.Garden, E. B., Shukla, D., Ravivarapu, K. T., Kaplan, S. A., Reddy, A. K., Small, A. C., & Palese, M. A. (2021). Rezum therapy for patients with large prostates (greater than or equal to 80 g): Initial clinical experience and postoperative outcomes. World Journal of Urology, 39(8), 3041-3048. https://doi.org/10.1007/s00345-020-03548-7.