Rezūm — Water-Vapor Thermal Therapy
Rezūm treats BPH-related obstruction by delivering water vapor into prostate tissue in controlled nine-second doses. Condensation transfers heat and causes tissue ablation; this is a thermal treatment, not guaranteed preservation of adjacent mucosa, sphincter or ejaculatory structures.[1]
For selection and procedure details, see Rezūm — Water Vapor Therapy.
Components and Labeled Use
The system has a reusable generator and a single-use delivery-device kit with a retractable needle, tubing, syringe, spike adaptor and sterile-water vial. The checked US directions specify a compatible 4 mm, 30-degree, 30 cm cystoscopic lens; a generic 0-degree scope is not interchangeable. The number and position of injections depend on the anatomy and instructions.[1]
The manufacturer-posted US directions indicate treatment in men aged 50 or older with 30–80 cm³ prostates, including central-zone and/or median-lobe hyperplasia. The presence of a median lobe is also not a blanket contraindication to every other minimally invasive BPH device. Trial and guideline selection remain separate from device labeling.[1]
Safety
The checked instructions contraindicate treatment with an artificial urinary sphincter, penile prosthesis or active UTI. Prior pelvic radiation is an evidence gap in this label. Exclude other causes of obstruction, including urethral stricture, before attributing symptoms to BPH.[1]
Hot vapor during priming can burn tissue. Do not move the delivery device with the needle deployed or withdraw it before confirming complete needle retraction; follow the instructed manual-retraction procedure if required. Early irritative symptoms, bleeding and retention may require catheterization and reassessment.[1]
Clinical Evidence
The pivotal trial randomized 197 men to treatment or sham. Treated participants had sustained symptom improvement at five years, with an approximately 48% IPSS reduction and 4.4% surgical retreatment. Sham crossover was offered after three months, so the five-year results are not a five-year randomized sham comparison. Reported sexual-function preservation is reassuring, but does not guarantee no erectile or ejaculatory symptoms.[2][3]
Persistent obstruction, infection, retention or suspected urethral/bladder-neck injury require evaluation rather than automatic repeat ablation. See TURP and HoLEP for subsequent outlet-procedure planning.
References
1. Boston Scientific. Rezūm Delivery Device Kit for BPH: Directions for Use. 50998296-01, October 2019; manufacturer-posted US document accessed September 12, 2026. Directions for use.
2. McVary KT, Gange SN, Gittelman MC, et al. "Minimally invasive prostate convective water vapor energy ablation: a multicenter, randomized, controlled study for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia." J Urol. 2016;195(5):1529–38. doi:10.1016/j.juro.2015.10.181
3. McVary KT, Gittelman MC, Goldberg KA, et al. "Final 5-year outcomes of the multicenter randomized sham-controlled trial of a water vapor thermal therapy for treatment of moderate to severe lower urinary tract symptoms secondary to benign prostatic hyperplasia." J Urol. 2021;206(3):715–24. doi:10.1097/JU.0000000000001778