*post-hoc analysis: Analysis that is done years after receiving the treatment
**novo device: An alternative means of classifying low- to moderate-risk devices.
References
- 1.Westwood J, Geraghty R, Jones P, et al. Rezum: a new transurethral Water Vapour Therapy for benign prostatic hyperplasia. Ther Adv Urol. 2018;10(11):327–333
- 2.Gravas S, Cornu JN, Gacci M, et al. EAU guidelines on management of non-neurogenic male LUTS. March 2023. Available at: https://uroweb.org/guidelines/management-of-non-neurogenic-male-luts. [Accessed September 2023].
- 3.Rezum. Directions for Use.
- 4.Mynderse LA, Hanson D, Robb RA, et al. Rezūm System water vapor treatment for lower urinary tract symptoms/benign prostatic hyperplasia: validation of convective thermal energy transfer and characterization with magnetic resonance imaging and 3-dimensional renderings. Urology. 2015 Jul;86(1):122-7.
- 5.Dixon C, Cedano ER, Pacik D, Vit V, Varga G, Wagrell L, Tornblom M, Mynderse L, Larson T. Efficacy and Safety of Rezūm System Water Vapor Treatment for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. Urology. 2015 Nov;86(5):1042-7. doi: 10.1016/j.urology.2015.05.046. Epub 2015 Jul 26. PMID: 26216644.
- 6.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 May;195(5):1529‐38.
- 7.Gupta N, Rogers T, Holland B, et al. Three-year treatment outcomes of water vapor thermal therapy (Rezūm System) compared to doxazosin, finasteride and combination drug therapy for men with benign prostatic hyperplasia: cohort data from the Medical Therapy of Prostatic Symptoms (MTOPS) Trial. J Urol. 2018 Aug;200(2):405-13.
- 8.McVary KT, Rogers T, Roehrborn CG. Rezūm water vapor thermal therapy for lower urinary tract symptoms associated with benign prostatic hyperplasia: 4-year results from randomized controlled study. Urology. 2019;126:171–179.
- 9.NICE. Rezum for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia. [Medical technologies guidance 49]. 24 June 2020. Available at: https://www.nice.org.uk/guidance/mtg49. [Accessed September 2023].
- 10.Rijo E, Hindley R, Tabatabaei S, et al. Minimally invasive surgery for benign prostatic obstruction: new insights and future technical standards. Curr Opin Urol. 2021;31(5):461–467.
- 11.McVary, Al-Arabi A, Roehrborn C, et al. Preservation of sexual function 5 years after water vapor thermal therapy for benign prostatic hyperplasia. Sex Med. 2021;9(6):100454.
The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men with a prostate volume 30cm3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe. Potential risks associated with Rezūm Water Vapor Therapy include but are not limited to dysuria, hematuria, hematospermia, decrease in ejaculatory volume, suspected urinary tract infection (UTI), urinary frequency, and retention or urgency.
The GreenLight™ laser system is intended for incision/excision, vaporization, ablation, hemostasis, and coagulation of soft tissue, including photoselective vaporization of the prostate for benign prostatic hyperplasia (BPH). The laser system is contraindicated for patients who: are contraindicated for surgery, contraindicated where appropriate anesthesia is contraindicated by patient history, have calcified tissue, require hemostasis in >2mm vessels, have uncontrolled bleeding disorders, have prostate cancer, have acute urinary tract infection (UTI), or severe urethral stricture.Possible risks and complications include, but are not limited to, irritative symptoms (dysuria, urgency, frequency), retrograde ejaculation, urinary incontinence, erectile dysfunction, hematuria - gross, UTI, bladder neck contracture/outlet obstruct, urinary retention, perforation - prostate, urethral stricture..
The Lumenis Pulse 120H System is intended to relieve symptoms and obstructions and reduce prostate tissue associated with BPH It is contraindicated for patients who are unable to receive endoscopic treatments or are intolerant to prolonged anesthesia, as well as for resection or excision of large vascularized organs. Holmium lasers are intended solely for use by physicians trained in the use of the Ho:YAG (2.1 μm) wavelength. Incorrect treatment settings can cause serious tissue damage. The laser should be used only on tissues that are fully observable. Possible risks and complications include, but are not limited to, irritative symptoms (dysuria, urgency, frequency), retrograde ejaculation, urinary incontinence, erectile dysfunction, hematuria - gross, UTI, bladder neck contracture/outlet obstruct, urinary retention, perforation - prostate, urethral stricture. You should talk with your doctor about benefits and risks before moving forward with any treatment option.
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