Important Patient Safety Information
The RezumTM System is a treatment for men; intended to reduce prostate tissue and relieve urinary symptoms caused by an enlarged prostate, otherwise known as BPH (Benign Prostatic Hyperplasia). With all medical procedures, there are risks associated with the procedure and the use of the device. The risks include but are not limited to painful or frequent urination, blood in the urine or semen, inability to urinate or completely empty the bladder, post-op discomfort, urinary tract infection (UTI), decrease in ejaculatory volume, and an urgent need to urinate. During the healing phase following the procedure, urinary symptoms may continue or worsen, which may require the use of a catheter for several days. Be sure to talk with your doctor so that you thoroughly understand all the risks and benefits associated with the use of the device.
References:
- McVary KT, Gittelman MC, Goldberg KA, et al. Final 5-year outcomes of the multicenter randomized sham-controlled trial of Rezūm water vapor thermal therapy for treatment of moderate-to-severe lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol. 2021 Sep;206(3):715-24.
- Tallman CT, Zantek PF, Hernandez N, et al. Effectiveness of convective water vapor energy therapy versus prostatic urethral lift for symptomatic benign prostatic hyperplasia: a systematic review and indirect comparison. World J Urol. 2021 Sep;39(9):3207-1
- McVary KT, El-Arabi A, Roehrborn C. Preservation of Sexual Function 5 Years After Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia. Sex Med. 2021 Oct 30;9(6):100454.
CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at http://www.ifu-bsci.com/. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France. This material is for informational purposes only and not meant for medical diagnosis. This information does not constitute medical or legal advice, and Boston Scientific makes no representation regarding the medical benefits included in this information. Boston Scientific strongly recommends that you consult with your physician on all matters pertaining to your health.
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